A surveillance project to evaluate the safety and effectiveness of transcarotid artery revascularization (TCAR) in comparison with carotid endarterectomy (CEA) is being launched by the Society for Vascular Surgery Patient Safety Organization (SVS PSO).  Carotid artery stenting (CAS) and CEA are performed in patients with atherosclerotic narrowing of the carotid artery in order to reduce stroke risk.  

In the TCAR procedure, a stent is inserted into the common carotid artery through a small neck incision (transcarotid), whereas typical carotid stents are inserted with a long catheter inserted in a groin artery (transfemoral) that must pass through the aorta to reach the carotid artery which is a potential source of stroke with the trans-femoral approach.   During TCAR, stroke risk is also reduced by temporarily reversing blood flow direction in the carotid artery, so that any debris dislodged by the procedure will not travel to the brain where it could cause stroke.  Initial publications suggest that TCAR may have a lower stroke rate than standard transfemoral CAS, potentially due to avoidance of a catheter manipulation in the aorta combined with carotid artery flow reversal.

The TCAR Surveillance Project is designed to obtain more data about real-world outcomes of TCAR in comparison with CEA as performed by centers participating in the Vascular Quality Initiative (VQI). The TCAR Surveillance Project will be directed by an SVS PSO Steering Committee that will make periodic analyses of data collected in the VQI CAS and CEA Registries.  

The TCAR Surveillance Project was evaluated by the US Food and Drug Administration (FDA) and found scientifically valid and clinically relevant.  Based on this, reimbursement for TCAR procedures performed by centers participating in the VQI TCAR Surveillance Project was approved on Sept. 1, 2016, by the Centers for Medicare and Medicaid Services (CMS) under the current National Coverage Determination.

The project requires that the procedure be performed in high surgical risk patients (asymptomatic or symptomatic) using FDA-approved or FDA-cleared devices labeled for the transcarotid approach and that data about the procedure and one-year follow-up be submitted to the VQI CAS Registry in order to qualify for Medicare coverage.  

“We are very pleased about this collaboration between the SVS PSO, CMS and the FDA that has enabled this important study,” said Dr. Larry Kraiss, Chair of the PSO Governing Council.  “It is through initiatives like the TCAR Surveillance Project that we can accomplish the SVS PSO mission, by using real-world registry data to evaluate and improve the care of our patients with carotid artery disease.”

Sites interested in participating in the project can enroll in the VQI CAS Registry if they do not already participate and obtain the National Clinical Trial identifier required for billing.

“The SVS applauds the efforts of its PSO to continually explore new and innovative ways to improve patient care,” said Dr. R. Clement Darling, President-Elect of the Society for Vascular Surgery.  “We are excited to learn what this study will find, and encourage participation in the TCAR Surveillance Project.”

For further information about participating in the VQI CAS registry, please contact [email protected] or call (603) 298-5509.

A surveillance project to evaluate the safety and effectiveness of transcarotid artery revascularization (TCAR) in comparison with carotid endarterectomy (CEA) is being launched by the Society for Vascular Surgery Patient Safety Organization (SVS PSO).  Carotid artery stenting (CAS) and CEA are performed in patients with atherosclerotic narrowing of the carotid artery in order to reduce stroke risk.  

In the TCAR procedure, a stent is inserted into the common carotid artery through a small neck incision (transcarotid), whereas typical carotid stents are inserted with a long catheter inserted in a groin artery (transfemoral) that must pass through the aorta to reach the carotid artery which is a potential source of stroke with the trans-femoral approach.   During TCAR, stroke risk is also reduced by temporarily reversing blood flow direction in the carotid artery, so that any debris dislodged by the procedure will not travel to the brain where it could cause stroke.  Initial publications suggest that TCAR may have a lower stroke rate than standard transfemoral CAS, potentially due to avoidance of a catheter manipulation in the aorta combined with carotid artery flow reversal.

The TCAR Surveillance Project is designed to obtain more data about real-world outcomes of TCAR in comparison with CEA as performed by centers participating in the Vascular Quality Initiative (VQI). The TCAR Surveillance Project will be directed by an SVS PSO Steering Committee that will make periodic analyses of data collected in the VQI CAS and CEA Registries.  

The TCAR Surveillance Project was evaluated by the US Food and Drug Administration (FDA) and found scientifically valid and clinically relevant.  Based on this, reimbursement for TCAR procedures performed by centers participating in the VQI TCAR Surveillance Project was approved on Sept. 1, 2016, by the Centers for Medicare and Medicaid Services (CMS) under the current National Coverage Determination.

The project requires that the procedure be performed in high surgical risk patients (asymptomatic or symptomatic) using FDA-approved or FDA-cleared devices labeled for the transcarotid approach and that data about the procedure and one-year follow-up be submitted to the VQI CAS Registry in order to qualify for Medicare coverage.  

“We are very pleased about this collaboration between the SVS PSO, CMS and the FDA that has enabled this important study,” said Dr. Larry Kraiss, Chair of the PSO Governing Council.  “It is through initiatives like the TCAR Surveillance Project that we can accomplish the SVS PSO mission, by using real-world registry data to evaluate and improve the care of our patients with carotid artery disease.”

Sites interested in participating in the project can enroll in the VQI CAS Registry if they do not already participate and obtain the National Clinical Trial identifier required for billing.

“The SVS applauds the efforts of its PSO to continually explore new and innovative ways to improve patient care,” said Dr. R. Clement Darling, President-Elect of the Society for Vascular Surgery.  “We are excited to learn what this study will find, and encourage participation in the TCAR Surveillance Project.”

For further information about participating in the VQI CAS registry, please contact [email protected] or call (603) 298-5509.

A surveillance project to evaluate the safety and effectiveness of transcarotid artery revascularization (TCAR) in comparison with carotid endarterectomy (CEA) is being launched by the Society for Vascular Surgery Patient Safety Organization (SVS PSO).  Carotid artery stenting (CAS) and CEA are performed in patients with atherosclerotic narrowing of the carotid artery in order to reduce stroke risk.  

In the TCAR procedure, a stent is inserted into the common carotid artery through a small neck incision (transcarotid), whereas typical carotid stents are inserted with a long catheter inserted in a groin artery (transfemoral) that must pass through the aorta to reach the carotid artery which is a potential source of stroke with the trans-femoral approach.   During TCAR, stroke risk is also reduced by temporarily reversing blood flow direction in the carotid artery, so that any debris dislodged by the procedure will not travel to the brain where it could cause stroke.  Initial publications suggest that TCAR may have a lower stroke rate than standard transfemoral CAS, potentially due to avoidance of a catheter manipulation in the aorta combined with carotid artery flow reversal.

The TCAR Surveillance Project is designed to obtain more data about real-world outcomes of TCAR in comparison with CEA as performed by centers participating in the Vascular Quality Initiative (VQI). The TCAR Surveillance Project will be directed by an SVS PSO Steering Committee that will make periodic analyses of data collected in the VQI CAS and CEA Registries.  

The TCAR Surveillance Project was evaluated by the US Food and Drug Administration (FDA) and found scientifically valid and clinically relevant.  Based on this, reimbursement for TCAR procedures performed by centers participating in the VQI TCAR Surveillance Project was approved on Sept. 1, 2016, by the Centers for Medicare and Medicaid Services (CMS) under the current National Coverage Determination.

The project requires that the procedure be performed in high surgical risk patients (asymptomatic or symptomatic) using FDA-approved or FDA-cleared devices labeled for the transcarotid approach and that data about the procedure and one-year follow-up be submitted to the VQI CAS Registry in order to qualify for Medicare coverage.  

“We are very pleased about this collaboration between the SVS PSO, CMS and the FDA that has enabled this important study,” said Dr. Larry Kraiss, Chair of the PSO Governing Council.  “It is through initiatives like the TCAR Surveillance Project that we can accomplish the SVS PSO mission, by using real-world registry data to evaluate and improve the care of our patients with carotid artery disease.”

Sites interested in participating in the project can enroll in the VQI CAS Registry if they do not already participate and obtain the National Clinical Trial identifier required for billing.

“The SVS applauds the efforts of its PSO to continually explore new and innovative ways to improve patient care,” said Dr. R. Clement Darling, President-Elect of the Society for Vascular Surgery.  “We are excited to learn what this study will find, and encourage participation in the TCAR Surveillance Project.”

For further information about participating in the VQI CAS registry, please contact [email protected] or call (603) 298-5509.

Micrograph showing MM

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended that ixazomib (Ninlaro^TM) receive conditional marketing authorization.

The recommendation is for ixazomib in combination with lenalidomide and dexamethasone as a treatment for adults with multiple myeloma (MM) who have received at least 1 prior therapy.

The CHMP’s recommendation will be reviewed by the European Commission (EC).

If the EC grants the authorization, ixazomib will be the first oral proteasome inhibitor approved for use across the European Economic Area.

Ixazomib is being developed by Takeda Pharmaceutical Company Limited.

Phase 3 trial

The CHMP’s positive opinion of ixazomib is based on results from the phase 3 TOURMALINE-MM1 trial, which were presented at the 2015 ASH Annual Meeting.

The trial included 722 patients with relapsed or refractory MM. The patients were randomized to receive ixazomib, lenalidomide, and dexamethasone (IRd, n=360) or placebo, lenalidomide, and dexamethasone (Rd, n=362).

Baseline patient characteristics were similar between the treatment arms. Fifty-nine percent of patients in both arms had received 1 prior line of therapy, and 41% in both arms had 2 or 3 prior lines of therapy.

Seventy-eight percent of patients responded to IRd, and 72% responded to Rd (P=0.035). The rates of complete response were 12% and 7%, respectively (P=0.019).

At a median follow-up of about 15 months, the median progression-free survival was 20.6 months in the IRd arm and 14.7 months in the Rd arm. The hazard ratio was 0.742 (P=0.012).

At a median follow-up of about 23 months, the median overall survival had not been reached in either treatment arm.

The incidence of adverse events (AEs) was 98% in the IRd arm and 99% in the Rd arm. The incidence of grade 3 or higher AEs was 74% and 69%, respectively. The incidence of serious AEs was 47% and 49%, respectively.

Common AEs in the IRd and Rd arms, respectively, were diarrhea (45% vs 39%), constipation (35% vs 26%), nausea (29% vs 22%), vomiting (23% vs 12%), rash (36% vs 23%), back pain (24% vs 17%), upper respiratory tract infection (23% vs 19%), thrombocytopenia (31% vs 16%), peripheral neuropathy (27% vs 22%), peripheral edema (28% vs 20%), thromboembolism (8% vs 11%), and neutropenia (33% vs 31%).

About conditional authorization

Conditional marketing authorization represents an expedited path for approval. The EC grants this type of authorization before pivotal registration studies are completed.

Conditional marketing authorization is granted to products whose benefits are thought to outweigh their risks, products that address unmet needs, and products that are expected to provide a significant public health benefit.

If ixazomib receives conditional marketing authorization, Takeda will be required to provide post-approval updates on safety and efficacy analyses for TOURMALINE-MM1 and some other ongoing studies to demonstrate the treatment’s long-term effects.

Micrograph showing MM

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended that ixazomib (Ninlaro^TM) receive conditional marketing authorization.

The recommendation is for ixazomib in combination with lenalidomide and dexamethasone as a treatment for adults with multiple myeloma (MM) who have received at least 1 prior therapy.

The CHMP’s recommendation will be reviewed by the European Commission (EC).

If the EC grants the authorization, ixazomib will be the first oral proteasome inhibitor approved for use across the European Economic Area.

Ixazomib is being developed by Takeda Pharmaceutical Company Limited.

Phase 3 trial

The CHMP’s positive opinion of ixazomib is based on results from the phase 3 TOURMALINE-MM1 trial, which were presented at the 2015 ASH Annual Meeting.

The trial included 722 patients with relapsed or refractory MM. The patients were randomized to receive ixazomib, lenalidomide, and dexamethasone (IRd, n=360) or placebo, lenalidomide, and dexamethasone (Rd, n=362).

Baseline patient characteristics were similar between the treatment arms. Fifty-nine percent of patients in both arms had received 1 prior line of therapy, and 41% in both arms had 2 or 3 prior lines of therapy.

Seventy-eight percent of patients responded to IRd, and 72% responded to Rd (P=0.035). The rates of complete response were 12% and 7%, respectively (P=0.019).

At a median follow-up of about 15 months, the median progression-free survival was 20.6 months in the IRd arm and 14.7 months in the Rd arm. The hazard ratio was 0.742 (P=0.012).

At a median follow-up of about 23 months, the median overall survival had not been reached in either treatment arm.

The incidence of adverse events (AEs) was 98% in the IRd arm and 99% in the Rd arm. The incidence of grade 3 or higher AEs was 74% and 69%, respectively. The incidence of serious AEs was 47% and 49%, respectively.

Common AEs in the IRd and Rd arms, respectively, were diarrhea (45% vs 39%), constipation (35% vs 26%), nausea (29% vs 22%), vomiting (23% vs 12%), rash (36% vs 23%), back pain (24% vs 17%), upper respiratory tract infection (23% vs 19%), thrombocytopenia (31% vs 16%), peripheral neuropathy (27% vs 22%), peripheral edema (28% vs 20%), thromboembolism (8% vs 11%), and neutropenia (33% vs 31%).

About conditional authorization

Conditional marketing authorization represents an expedited path for approval. The EC grants this type of authorization before pivotal registration studies are completed.

Conditional marketing authorization is granted to products whose benefits are thought to outweigh their risks, products that address unmet needs, and products that are expected to provide a significant public health benefit.

If ixazomib receives conditional marketing authorization, Takeda will be required to provide post-approval updates on safety and efficacy analyses for TOURMALINE-MM1 and some other ongoing studies to demonstrate the treatment’s long-term effects.

Micrograph showing MM

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended that ixazomib (Ninlaro^TM) receive conditional marketing authorization.

The recommendation is for ixazomib in combination with lenalidomide and dexamethasone as a treatment for adults with multiple myeloma (MM) who have received at least 1 prior therapy.

The CHMP’s recommendation will be reviewed by the European Commission (EC).

If the EC grants the authorization, ixazomib will be the first oral proteasome inhibitor approved for use across the European Economic Area.

Ixazomib is being developed by Takeda Pharmaceutical Company Limited.

Phase 3 trial

The CHMP’s positive opinion of ixazomib is based on results from the phase 3 TOURMALINE-MM1 trial, which were presented at the 2015 ASH Annual Meeting.

The trial included 722 patients with relapsed or refractory MM. The patients were randomized to receive ixazomib, lenalidomide, and dexamethasone (IRd, n=360) or placebo, lenalidomide, and dexamethasone (Rd, n=362).

Baseline patient characteristics were similar between the treatment arms. Fifty-nine percent of patients in both arms had received 1 prior line of therapy, and 41% in both arms had 2 or 3 prior lines of therapy.

Seventy-eight percent of patients responded to IRd, and 72% responded to Rd (P=0.035). The rates of complete response were 12% and 7%, respectively (P=0.019).

At a median follow-up of about 15 months, the median progression-free survival was 20.6 months in the IRd arm and 14.7 months in the Rd arm. The hazard ratio was 0.742 (P=0.012).

At a median follow-up of about 23 months, the median overall survival had not been reached in either treatment arm.

The incidence of adverse events (AEs) was 98% in the IRd arm and 99% in the Rd arm. The incidence of grade 3 or higher AEs was 74% and 69%, respectively. The incidence of serious AEs was 47% and 49%, respectively.

Common AEs in the IRd and Rd arms, respectively, were diarrhea (45% vs 39%), constipation (35% vs 26%), nausea (29% vs 22%), vomiting (23% vs 12%), rash (36% vs 23%), back pain (24% vs 17%), upper respiratory tract infection (23% vs 19%), thrombocytopenia (31% vs 16%), peripheral neuropathy (27% vs 22%), peripheral edema (28% vs 20%), thromboembolism (8% vs 11%), and neutropenia (33% vs 31%).

About conditional authorization

Conditional marketing authorization represents an expedited path for approval. The EC grants this type of authorization before pivotal registration studies are completed.

Conditional marketing authorization is granted to products whose benefits are thought to outweigh their risks, products that address unmet needs, and products that are expected to provide a significant public health benefit.

If ixazomib receives conditional marketing authorization, Takeda will be required to provide post-approval updates on safety and efficacy analyses for TOURMALINE-MM1 and some other ongoing studies to demonstrate the treatment’s long-term effects.

LONDON – Four questions from the eight-question COPD Assessment Test (CAT) provide about the same prognostic accuracy in patients with chronic obstructive pulmonary disease (COPD) as does the full CAT, according to an analysis presented at the annual congress of the European Respiratory Society.

When the four- and eight-question versions were compared for exacerbation and other clinical outcomes over a 1-year period of follow-up, “both strategies demonstrated similar discrimination,” reported Carlos H. Martinez, MD, division of pulmonary and critical care medicine, University of Michigan Health System, Ann Arbor.

The CAT is an eight-item tool for evaluating the health status of patients with COPD as well as for predicting risk of COPD-related events, particularly exacerbations. The test is designed for self-administration by patients. For each of the questions, which address symptoms and activity limitations, patients are asked to answer on a scale ranging from one (indicating no clinical burden) to five (indicating severe burden). Based on the maximum score of 40, a score below 10 signifies a low impact from COPD, a score of 10-20 signifies a medium impact, and a score above 20 signifies a high impact.

©designer491/Thinkstock

In this study, a simplified version of the CAT that employed just four of the questions was evaluated in 880 participants in the observational SPIROMICS (Subpopulations and Intermediate Outcomes in COPD Study), which was funded by the National Heart, Lung, and Blood Institute and has prospectively enrolled COPD patients at seven participating centers. Ever-smokers from SPIROMICS were eligible for this analysis if they had a forced expiratory volume in one second (FEV₁₎/forced vital capacity (FVC) ratio of greater than or equal to 0.70 and an FVC above the lower limit of normal.

The four questions that were retained were about cough, phlegm, chest tightness, and breathlessness. The four questions that were eliminated were about activity limitation, sleep, energy, and the effect of lung symptoms on willingness to leave the house.

With the traditional test, using a cut point of greater than or equal to 10, 51.8% were classified as having a significant COPD burden. In this group, 15.3% experienced one or more exacerbations during 1 year of follow-up. With the simplified version focused on respiratory-related symptoms alone and using a cut point of greater than or equal to 7, 45.8% were classified as having a significant COPD burden, and 15.6% had one or more exacerbations during the same period of follow-up.

“The two strategies largely identified the same individuals,” according to Dr. Martinez, who reported the agreement as 88.5% (Kappa 0.77; P less than .001). He further noted that there was no difference in the area under the curve (AUC) to predict exacerbations at 1 year.

In further analysis, “subjects identified by either method also had more depression and anxiety symptoms, poorer sleep quality, and greater fatigue [than did the lower risk group],” Dr. Martinez added.

An AUC ROC (receiver operating characteristic) statistical analysis to compare the traditional and abbreviated CATs for cross-sectional associations showed close agreement. The values were nearly identical for such variables as dyspnea, impairment as measured with the 6-minute walking distance (6MWD) test, and quality of life as measured by the St. George’s Respiratory Questionnaire (SGRQ). Similarly, the AUC ROC values diverged little or not at all for longitudinal comparisons of any exacerbation or exacerbations requiring steroids or antibiotics.

The data from this study provide “a proof of concept that simpler strategies could be used for identifying these patients [at risk of exacerbations] in primary care,” Dr. Martinez maintained. Although further validation of this four-question assessment tool is needed, Dr. Martinez implied that there is value in a relatively rapid self-assessment tool that could be interpreted quickly by clinicians.

LONDON – Four questions from the eight-question COPD Assessment Test (CAT) provide about the same prognostic accuracy in patients with chronic obstructive pulmonary disease (COPD) as does the full CAT, according to an analysis presented at the annual congress of the European Respiratory Society.

When the four- and eight-question versions were compared for exacerbation and other clinical outcomes over a 1-year period of follow-up, “both strategies demonstrated similar discrimination,” reported Carlos H. Martinez, MD, division of pulmonary and critical care medicine, University of Michigan Health System, Ann Arbor.

The CAT is an eight-item tool for evaluating the health status of patients with COPD as well as for predicting risk of COPD-related events, particularly exacerbations. The test is designed for self-administration by patients. For each of the questions, which address symptoms and activity limitations, patients are asked to answer on a scale ranging from one (indicating no clinical burden) to five (indicating severe burden). Based on the maximum score of 40, a score below 10 signifies a low impact from COPD, a score of 10-20 signifies a medium impact, and a score above 20 signifies a high impact.

©designer491/Thinkstock

In this study, a simplified version of the CAT that employed just four of the questions was evaluated in 880 participants in the observational SPIROMICS (Subpopulations and Intermediate Outcomes in COPD Study), which was funded by the National Heart, Lung, and Blood Institute and has prospectively enrolled COPD patients at seven participating centers. Ever-smokers from SPIROMICS were eligible for this analysis if they had a forced expiratory volume in one second (FEV₁₎/forced vital capacity (FVC) ratio of greater than or equal to 0.70 and an FVC above the lower limit of normal.

The four questions that were retained were about cough, phlegm, chest tightness, and breathlessness. The four questions that were eliminated were about activity limitation, sleep, energy, and the effect of lung symptoms on willingness to leave the house.

With the traditional test, using a cut point of greater than or equal to 10, 51.8% were classified as having a significant COPD burden. In this group, 15.3% experienced one or more exacerbations during 1 year of follow-up. With the simplified version focused on respiratory-related symptoms alone and using a cut point of greater than or equal to 7, 45.8% were classified as having a significant COPD burden, and 15.6% had one or more exacerbations during the same period of follow-up.

“The two strategies largely identified the same individuals,” according to Dr. Martinez, who reported the agreement as 88.5% (Kappa 0.77; P less than .001). He further noted that there was no difference in the area under the curve (AUC) to predict exacerbations at 1 year.

In further analysis, “subjects identified by either method also had more depression and anxiety symptoms, poorer sleep quality, and greater fatigue [than did the lower risk group],” Dr. Martinez added.

An AUC ROC (receiver operating characteristic) statistical analysis to compare the traditional and abbreviated CATs for cross-sectional associations showed close agreement. The values were nearly identical for such variables as dyspnea, impairment as measured with the 6-minute walking distance (6MWD) test, and quality of life as measured by the St. George’s Respiratory Questionnaire (SGRQ). Similarly, the AUC ROC values diverged little or not at all for longitudinal comparisons of any exacerbation or exacerbations requiring steroids or antibiotics.

The data from this study provide “a proof of concept that simpler strategies could be used for identifying these patients [at risk of exacerbations] in primary care,” Dr. Martinez maintained. Although further validation of this four-question assessment tool is needed, Dr. Martinez implied that there is value in a relatively rapid self-assessment tool that could be interpreted quickly by clinicians.

LONDON – Four questions from the eight-question COPD Assessment Test (CAT) provide about the same prognostic accuracy in patients with chronic obstructive pulmonary disease (COPD) as does the full CAT, according to an analysis presented at the annual congress of the European Respiratory Society.

When the four- and eight-question versions were compared for exacerbation and other clinical outcomes over a 1-year period of follow-up, “both strategies demonstrated similar discrimination,” reported Carlos H. Martinez, MD, division of pulmonary and critical care medicine, University of Michigan Health System, Ann Arbor.

The CAT is an eight-item tool for evaluating the health status of patients with COPD as well as for predicting risk of COPD-related events, particularly exacerbations. The test is designed for self-administration by patients. For each of the questions, which address symptoms and activity limitations, patients are asked to answer on a scale ranging from one (indicating no clinical burden) to five (indicating severe burden). Based on the maximum score of 40, a score below 10 signifies a low impact from COPD, a score of 10-20 signifies a medium impact, and a score above 20 signifies a high impact.

©designer491/Thinkstock

In this study, a simplified version of the CAT that employed just four of the questions was evaluated in 880 participants in the observational SPIROMICS (Subpopulations and Intermediate Outcomes in COPD Study), which was funded by the National Heart, Lung, and Blood Institute and has prospectively enrolled COPD patients at seven participating centers. Ever-smokers from SPIROMICS were eligible for this analysis if they had a forced expiratory volume in one second (FEV₁₎/forced vital capacity (FVC) ratio of greater than or equal to 0.70 and an FVC above the lower limit of normal.

The four questions that were retained were about cough, phlegm, chest tightness, and breathlessness. The four questions that were eliminated were about activity limitation, sleep, energy, and the effect of lung symptoms on willingness to leave the house.

With the traditional test, using a cut point of greater than or equal to 10, 51.8% were classified as having a significant COPD burden. In this group, 15.3% experienced one or more exacerbations during 1 year of follow-up. With the simplified version focused on respiratory-related symptoms alone and using a cut point of greater than or equal to 7, 45.8% were classified as having a significant COPD burden, and 15.6% had one or more exacerbations during the same period of follow-up.

“The two strategies largely identified the same individuals,” according to Dr. Martinez, who reported the agreement as 88.5% (Kappa 0.77; P less than .001). He further noted that there was no difference in the area under the curve (AUC) to predict exacerbations at 1 year.

In further analysis, “subjects identified by either method also had more depression and anxiety symptoms, poorer sleep quality, and greater fatigue [than did the lower risk group],” Dr. Martinez added.

An AUC ROC (receiver operating characteristic) statistical analysis to compare the traditional and abbreviated CATs for cross-sectional associations showed close agreement. The values were nearly identical for such variables as dyspnea, impairment as measured with the 6-minute walking distance (6MWD) test, and quality of life as measured by the St. George’s Respiratory Questionnaire (SGRQ). Similarly, the AUC ROC values diverged little or not at all for longitudinal comparisons of any exacerbation or exacerbations requiring steroids or antibiotics.

The data from this study provide “a proof of concept that simpler strategies could be used for identifying these patients [at risk of exacerbations] in primary care,” Dr. Martinez maintained. Although further validation of this four-question assessment tool is needed, Dr. Martinez implied that there is value in a relatively rapid self-assessment tool that could be interpreted quickly by clinicians.

The majority of patients support work-hour limits for medical residents and want tighter shift caps for second-year residents and above, according to a national poll published Sept. 13 by Public Citizen.

The survey of 500 consumers by Lake Research Partners found that 86% of respondents were opposed to eliminating the Accreditation Council for Graduate Medical Education’s (ACGME) current 16-hour shift limit for first-year residents. Most respondents (80%) also favor decreasing the shift limit from 28 hours to 16 hours for second-year residents and above. More than three-quarters of respondents said hospital patients should be informed if a medical resident treating them has been working more than 16 hours without sleep.

“The public’s apprehension about resident shifts longer than 16 hours comports with the long-standing evidence on the risks of long resident work shifts for both the residents and their patients,” Michael Carome, MD, director of Public Citizen’s Health Research Group, said during a press conference. “Medical residents are not superhuman and, when sleep-deprived, put themselves, their patients, and others in harm’s way. This is not a partisan political issue, but one of public health and safety.”

But some physicians called the findings “obvious” and said they fail to address the full picture of work-hour limitations for residents. Evaluating only one aspect of a complex problem risks causing harm through unintended consequences, said Sharmila Dissanaike, MD, Peter C. Canizaro Chair of Surgery at Texas Tech University Health Sciences Center in Lubbock.

“The poll reflects that the public would prefer a well-rested physician over a sleep-deprived one – an obvious finding – since we would all prefer our physicians, nurses, police officers, firemen, and anyone who provides essential care or services to us to be well rested,” Dr. Dissanaike said in an interview. “However, interpreting this result as a mandate from the public to increase restrictions on resident duty hours, while well intentioned, is shortsighted and neglects many salient aspects of the problem, including the high risk of increased handoffs and adverse impact on GME training as a whole.”

The poll is the latest development in an ongoing debate about resident work hours and whether cutting shift time for new doctors aids or undermines patient safety. Earlier this year, a host of physician associations called on ACGME to roll back its work limits on first-year residents. The medical associations say current duty-hour restrictions are not improving care, and that the limits are negatively impacting physician training. The American College of Surgeons (ACS) for example, recommends the only restrictions on resident duty hours be a total of 80 hours per week, averaged over a 4-week period, with no other limitations.

The physician associations note a recent landmark study of 117 general surgery residency programs that found longer shifts have not markedly affected patient outcomes. The Flexibility in Duty Hour Requirements for Surgical Trainees (FIRST) Trial, published Feb. 25 in the New England Journal of Medicine, showed extended work hours for residents are not associated with a greater risk of early serious postoperative complications or death (N Engl J Med. 2016;374:713-27). Other studies have found similar results.

During a Sept. 13 press conference, Public Citizen representatives called the FIRST study and ongoing iCOMPARE trials “unethical.” The studies have forced some first-year residents to work shifts of 28 consecutive hours or more without their consent or the consent of patients, Dr. Carome said. When polled, 84% of survey respondents said if admitted to a hospital, they would want to know if their health provider was participating in such trials. Public Citizen and the American Medical Student Association have requested prompt investigation and suspension of the trials by the Office for Human Research Protections and have urged ACGME not to allow the trials to continue.

Sleep-deprived physicians are more prone to making errors, injuring themselves, and incurring chronic health ailments, said Charles A. Czeisler, PhD, MD, chief of the division of sleep and circadian disorders at Brigham & Women’s Hospital and director of the division of sleep medicine at Harvard University School of Medicine, Boston.

“One of the concerns of the extended-duration shifts that resident physicians work is the impairment of performance,” Dr. Czeisler said during the press conference. “We know when an individual is awake for more than 24 hours, their performance is impaired by an amount that is equivalent to that of being legally drunk.”

Research shows that resident physicians working in intensive care units make 36% more serious medical errors on patients whom they are treating while working marathon extended duration shifts, Dr. Czeisler said. In addition, physicians have a 460% higher risk of diagnostic errors when working extended shifts, he added. Stressing this evidence, Public Citizen and others have called on ACGME to reject scaling back its 16-hour work-shift limit for first-year residents.

But restricting physician work hours to improve patient safety and care quality is not as straightforward as it seems, said Patrick C. Alguire, MD, senior vice president for medical education at the American College of Physicians. Physician-scientists who study the process have found unintended consequences of restricted working hours and unfulfilled expectations, Dr. Alguire said in an interview.

“The weight of the evidence does not demonstrate improvement in patient outcomes such as mortality or safety, consistent positive impact on resident wellness, or even meaningful gains in resident sleep,” he said. “Moreover, restrictive scheduling assignments shorten the time for residents to complete their work, resulting in heightened work intensity and resident stress and inability to balance work and educational responsibilities. Scheduling restrictions have also increased the proportion of night float rotations and ACP finds these of less educational value than daytime rotations.”

Most concerning is that scheduling restrictions increase the opportunity for errors due to the frequency of handoffs from one team to another, Dr. Alguire said. The ACP recommends that ACGME undertake a critical review of scheduling restrictions focusing on added flexibility that takes into account patient care complexity, intensity, and acuity, as well as local factors, he added.

“It is ACP’s opinion that the ACGME should allow deviations from the existing schedule limitations within the context of approved studies, the results of which will provide the ACGME with a firmer evidence base upon which to optimize the inpatient clinical learning environment and the safety and well-being of both residents and patients,” Dr. Alguire said.

[email protected]

On Twitter @legal_med

The majority of patients support work-hour limits for medical residents and want tighter shift caps for second-year residents and above, according to a national poll published Sept. 13 by Public Citizen.

The survey of 500 consumers by Lake Research Partners found that 86% of respondents were opposed to eliminating the Accreditation Council for Graduate Medical Education’s (ACGME) current 16-hour shift limit for first-year residents. Most respondents (80%) also favor decreasing the shift limit from 28 hours to 16 hours for second-year residents and above. More than three-quarters of respondents said hospital patients should be informed if a medical resident treating them has been working more than 16 hours without sleep.

“The public’s apprehension about resident shifts longer than 16 hours comports with the long-standing evidence on the risks of long resident work shifts for both the residents and their patients,” Michael Carome, MD, director of Public Citizen’s Health Research Group, said during a press conference. “Medical residents are not superhuman and, when sleep-deprived, put themselves, their patients, and others in harm’s way. This is not a partisan political issue, but one of public health and safety.”

But some physicians called the findings “obvious” and said they fail to address the full picture of work-hour limitations for residents. Evaluating only one aspect of a complex problem risks causing harm through unintended consequences, said Sharmila Dissanaike, MD, Peter C. Canizaro Chair of Surgery at Texas Tech University Health Sciences Center in Lubbock.

“The poll reflects that the public would prefer a well-rested physician over a sleep-deprived one – an obvious finding – since we would all prefer our physicians, nurses, police officers, firemen, and anyone who provides essential care or services to us to be well rested,” Dr. Dissanaike said in an interview. “However, interpreting this result as a mandate from the public to increase restrictions on resident duty hours, while well intentioned, is shortsighted and neglects many salient aspects of the problem, including the high risk of increased handoffs and adverse impact on GME training as a whole.”

The poll is the latest development in an ongoing debate about resident work hours and whether cutting shift time for new doctors aids or undermines patient safety. Earlier this year, a host of physician associations called on ACGME to roll back its work limits on first-year residents. The medical associations say current duty-hour restrictions are not improving care, and that the limits are negatively impacting physician training. The American College of Surgeons (ACS) for example, recommends the only restrictions on resident duty hours be a total of 80 hours per week, averaged over a 4-week period, with no other limitations.

The physician associations note a recent landmark study of 117 general surgery residency programs that found longer shifts have not markedly affected patient outcomes. The Flexibility in Duty Hour Requirements for Surgical Trainees (FIRST) Trial, published Feb. 25 in the New England Journal of Medicine, showed extended work hours for residents are not associated with a greater risk of early serious postoperative complications or death (N Engl J Med. 2016;374:713-27). Other studies have found similar results.

During a Sept. 13 press conference, Public Citizen representatives called the FIRST study and ongoing iCOMPARE trials “unethical.” The studies have forced some first-year residents to work shifts of 28 consecutive hours or more without their consent or the consent of patients, Dr. Carome said. When polled, 84% of survey respondents said if admitted to a hospital, they would want to know if their health provider was participating in such trials. Public Citizen and the American Medical Student Association have requested prompt investigation and suspension of the trials by the Office for Human Research Protections and have urged ACGME not to allow the trials to continue.

Sleep-deprived physicians are more prone to making errors, injuring themselves, and incurring chronic health ailments, said Charles A. Czeisler, PhD, MD, chief of the division of sleep and circadian disorders at Brigham & Women’s Hospital and director of the division of sleep medicine at Harvard University School of Medicine, Boston.

“One of the concerns of the extended-duration shifts that resident physicians work is the impairment of performance,” Dr. Czeisler said during the press conference. “We know when an individual is awake for more than 24 hours, their performance is impaired by an amount that is equivalent to that of being legally drunk.”

Research shows that resident physicians working in intensive care units make 36% more serious medical errors on patients whom they are treating while working marathon extended duration shifts, Dr. Czeisler said. In addition, physicians have a 460% higher risk of diagnostic errors when working extended shifts, he added. Stressing this evidence, Public Citizen and others have called on ACGME to reject scaling back its 16-hour work-shift limit for first-year residents.

But restricting physician work hours to improve patient safety and care quality is not as straightforward as it seems, said Patrick C. Alguire, MD, senior vice president for medical education at the American College of Physicians. Physician-scientists who study the process have found unintended consequences of restricted working hours and unfulfilled expectations, Dr. Alguire said in an interview.

“The weight of the evidence does not demonstrate improvement in patient outcomes such as mortality or safety, consistent positive impact on resident wellness, or even meaningful gains in resident sleep,” he said. “Moreover, restrictive scheduling assignments shorten the time for residents to complete their work, resulting in heightened work intensity and resident stress and inability to balance work and educational responsibilities. Scheduling restrictions have also increased the proportion of night float rotations and ACP finds these of less educational value than daytime rotations.”

Most concerning is that scheduling restrictions increase the opportunity for errors due to the frequency of handoffs from one team to another, Dr. Alguire said. The ACP recommends that ACGME undertake a critical review of scheduling restrictions focusing on added flexibility that takes into account patient care complexity, intensity, and acuity, as well as local factors, he added.

“It is ACP’s opinion that the ACGME should allow deviations from the existing schedule limitations within the context of approved studies, the results of which will provide the ACGME with a firmer evidence base upon which to optimize the inpatient clinical learning environment and the safety and well-being of both residents and patients,” Dr. Alguire said.

[email protected]

On Twitter @legal_med

The majority of patients support work-hour limits for medical residents and want tighter shift caps for second-year residents and above, according to a national poll published Sept. 13 by Public Citizen.

The survey of 500 consumers by Lake Research Partners found that 86% of respondents were opposed to eliminating the Accreditation Council for Graduate Medical Education’s (ACGME) current 16-hour shift limit for first-year residents. Most respondents (80%) also favor decreasing the shift limit from 28 hours to 16 hours for second-year residents and above. More than three-quarters of respondents said hospital patients should be informed if a medical resident treating them has been working more than 16 hours without sleep.

“The public’s apprehension about resident shifts longer than 16 hours comports with the long-standing evidence on the risks of long resident work shifts for both the residents and their patients,” Michael Carome, MD, director of Public Citizen’s Health Research Group, said during a press conference. “Medical residents are not superhuman and, when sleep-deprived, put themselves, their patients, and others in harm’s way. This is not a partisan political issue, but one of public health and safety.”

But some physicians called the findings “obvious” and said they fail to address the full picture of work-hour limitations for residents. Evaluating only one aspect of a complex problem risks causing harm through unintended consequences, said Sharmila Dissanaike, MD, Peter C. Canizaro Chair of Surgery at Texas Tech University Health Sciences Center in Lubbock.

“The poll reflects that the public would prefer a well-rested physician over a sleep-deprived one – an obvious finding – since we would all prefer our physicians, nurses, police officers, firemen, and anyone who provides essential care or services to us to be well rested,” Dr. Dissanaike said in an interview. “However, interpreting this result as a mandate from the public to increase restrictions on resident duty hours, while well intentioned, is shortsighted and neglects many salient aspects of the problem, including the high risk of increased handoffs and adverse impact on GME training as a whole.”

The poll is the latest development in an ongoing debate about resident work hours and whether cutting shift time for new doctors aids or undermines patient safety. Earlier this year, a host of physician associations called on ACGME to roll back its work limits on first-year residents. The medical associations say current duty-hour restrictions are not improving care, and that the limits are negatively impacting physician training. The American College of Surgeons (ACS) for example, recommends the only restrictions on resident duty hours be a total of 80 hours per week, averaged over a 4-week period, with no other limitations.

The physician associations note a recent landmark study of 117 general surgery residency programs that found longer shifts have not markedly affected patient outcomes. The Flexibility in Duty Hour Requirements for Surgical Trainees (FIRST) Trial, published Feb. 25 in the New England Journal of Medicine, showed extended work hours for residents are not associated with a greater risk of early serious postoperative complications or death (N Engl J Med. 2016;374:713-27). Other studies have found similar results.

During a Sept. 13 press conference, Public Citizen representatives called the FIRST study and ongoing iCOMPARE trials “unethical.” The studies have forced some first-year residents to work shifts of 28 consecutive hours or more without their consent or the consent of patients, Dr. Carome said. When polled, 84% of survey respondents said if admitted to a hospital, they would want to know if their health provider was participating in such trials. Public Citizen and the American Medical Student Association have requested prompt investigation and suspension of the trials by the Office for Human Research Protections and have urged ACGME not to allow the trials to continue.

Sleep-deprived physicians are more prone to making errors, injuring themselves, and incurring chronic health ailments, said Charles A. Czeisler, PhD, MD, chief of the division of sleep and circadian disorders at Brigham & Women’s Hospital and director of the division of sleep medicine at Harvard University School of Medicine, Boston.

“One of the concerns of the extended-duration shifts that resident physicians work is the impairment of performance,” Dr. Czeisler said during the press conference. “We know when an individual is awake for more than 24 hours, their performance is impaired by an amount that is equivalent to that of being legally drunk.”

Research shows that resident physicians working in intensive care units make 36% more serious medical errors on patients whom they are treating while working marathon extended duration shifts, Dr. Czeisler said. In addition, physicians have a 460% higher risk of diagnostic errors when working extended shifts, he added. Stressing this evidence, Public Citizen and others have called on ACGME to reject scaling back its 16-hour work-shift limit for first-year residents.

But restricting physician work hours to improve patient safety and care quality is not as straightforward as it seems, said Patrick C. Alguire, MD, senior vice president for medical education at the American College of Physicians. Physician-scientists who study the process have found unintended consequences of restricted working hours and unfulfilled expectations, Dr. Alguire said in an interview.

“The weight of the evidence does not demonstrate improvement in patient outcomes such as mortality or safety, consistent positive impact on resident wellness, or even meaningful gains in resident sleep,” he said. “Moreover, restrictive scheduling assignments shorten the time for residents to complete their work, resulting in heightened work intensity and resident stress and inability to balance work and educational responsibilities. Scheduling restrictions have also increased the proportion of night float rotations and ACP finds these of less educational value than daytime rotations.”

Most concerning is that scheduling restrictions increase the opportunity for errors due to the frequency of handoffs from one team to another, Dr. Alguire said. The ACP recommends that ACGME undertake a critical review of scheduling restrictions focusing on added flexibility that takes into account patient care complexity, intensity, and acuity, as well as local factors, he added.

“It is ACP’s opinion that the ACGME should allow deviations from the existing schedule limitations within the context of approved studies, the results of which will provide the ACGME with a firmer evidence base upon which to optimize the inpatient clinical learning environment and the safety and well-being of both residents and patients,” Dr. Alguire said.

[email protected]

On Twitter @legal_med

WAIKOLOA, HAWAII – The FRAIL scale questionnaire predicts functional status and mortality at 1 year among geriatric trauma patients and is a useful tool for bedside screening by clinicians, results from a single-center study demonstrated.

“Over the past 2 years, the implications of frailty among the geriatric trauma population have gained much attention in the trauma community,” Cathy A. Maxwell, PhD, RN, said in an interview in advance of the annual meeting of the American Association for the Surgery of Trauma. “This work highlights the clinical utility of the FRAIL scale for screening injured older patients who are admitted to trauma centers and other acute care hospitals. Hopefully, it will encourage trauma care providers to use the instrument to identify older patients’ pre-injury/baseline status and to obtain a frailty risk adjustment measure for quality improvement efforts.”

Developed by the International Association of Nutrition and Aging, the validated five-item FRAIL scale requires answers to questions about fatigue, resistance, ambulation, illnesses, and loss of weight (J Nutr Health Aging. 2012;16[7]:601-8). In an effort to examine the influence of pre-injury physical frailty (as measured by FRAIL) on 1-year outcomes, Dr. Maxwell, of the Vanderbilt University, Nashville, Tenn., and her associates evaluated injured patients aged 65 and older who were admitted through the ED between October 2013 and March 2014 and who participated in a prior study (J Trauma Acute Care Surg. 2016;80[2]:195-203). The researchers identified the five items of the FRAIL instrument from that study and created a pre-injury FRAIL score for each patient.

Dr. Maxwell reported results from 188 patients with a median age of 77, a median Injury Severity Score of 10, and a median comorbidity index of 3. Upon admission to the ED, 63 patients (34%) screened as frail (defined as a FRAIL score of 3 or greater), 71 (38%) screened as pre-frail (defined as a FRAIL score of 1-2), and 54 (29%) screened as non-frail (defined as a FRAIL score of zero). Frequencies for components of the FRAIL score were as follows: fatigue (65%), resistance (32%), ambulation (40%), illnesses (27%), and loss of weight (6%).

After the researchers controlled for age, comorbidities, injury severity, and cognitive status via the Ascertain Dementia 8-item Informant Questionnaire (AD8), they found that pre-injury FRAIL scores explained about 13% of the variability in physical function as measured by the Barthel Index (P less than .001). A total of 47 patients (26%) died within 1 year of admission. Logistic regression analysis revealed that after adjustment for these same variables, the higher the pre-injury FRAIL score, the greater the likelihood of mortality within 1 year (odds ratio, 1.74; P = .001).

“The FRAIL scale predicts functional decline and mortality in geriatric trauma patients and is a useful tool for clinicians,” Dr. Maxwell concluded. “Bedside nurses in our trauma unit at Vanderbilt University Medical Center are currently using this instrument to screen our older patients. We have seen an increase in earlier geriatric palliative care consultations as a result of our screening efforts.”

She acknowledged certain limitations of the study, including the fact that it was a secondary analysis. “We created FRAIL scale scores for 188 patients from six different data sources, thus, the created scores may not accurately represent actual prospectively collected FRAIL scores,” Dr. Maxwell said. “That being said, we compared the frailty frequencies from this study with actual FRAIL scale scores (from current bedside FRAIL screens) and we are seeing similar percentages of patients in non-frail, pre-frail and frail categories. This strengthens the findings of this study.”

She reported having no financial disclosures.

[email protected]

WAIKOLOA, HAWAII – The FRAIL scale questionnaire predicts functional status and mortality at 1 year among geriatric trauma patients and is a useful tool for bedside screening by clinicians, results from a single-center study demonstrated.

“Over the past 2 years, the implications of frailty among the geriatric trauma population have gained much attention in the trauma community,” Cathy A. Maxwell, PhD, RN, said in an interview in advance of the annual meeting of the American Association for the Surgery of Trauma. “This work highlights the clinical utility of the FRAIL scale for screening injured older patients who are admitted to trauma centers and other acute care hospitals. Hopefully, it will encourage trauma care providers to use the instrument to identify older patients’ pre-injury/baseline status and to obtain a frailty risk adjustment measure for quality improvement efforts.”

Developed by the International Association of Nutrition and Aging, the validated five-item FRAIL scale requires answers to questions about fatigue, resistance, ambulation, illnesses, and loss of weight (J Nutr Health Aging. 2012;16[7]:601-8). In an effort to examine the influence of pre-injury physical frailty (as measured by FRAIL) on 1-year outcomes, Dr. Maxwell, of the Vanderbilt University, Nashville, Tenn., and her associates evaluated injured patients aged 65 and older who were admitted through the ED between October 2013 and March 2014 and who participated in a prior study (J Trauma Acute Care Surg. 2016;80[2]:195-203). The researchers identified the five items of the FRAIL instrument from that study and created a pre-injury FRAIL score for each patient.

Dr. Maxwell reported results from 188 patients with a median age of 77, a median Injury Severity Score of 10, and a median comorbidity index of 3. Upon admission to the ED, 63 patients (34%) screened as frail (defined as a FRAIL score of 3 or greater), 71 (38%) screened as pre-frail (defined as a FRAIL score of 1-2), and 54 (29%) screened as non-frail (defined as a FRAIL score of zero). Frequencies for components of the FRAIL score were as follows: fatigue (65%), resistance (32%), ambulation (40%), illnesses (27%), and loss of weight (6%).

After the researchers controlled for age, comorbidities, injury severity, and cognitive status via the Ascertain Dementia 8-item Informant Questionnaire (AD8), they found that pre-injury FRAIL scores explained about 13% of the variability in physical function as measured by the Barthel Index (P less than .001). A total of 47 patients (26%) died within 1 year of admission. Logistic regression analysis revealed that after adjustment for these same variables, the higher the pre-injury FRAIL score, the greater the likelihood of mortality within 1 year (odds ratio, 1.74; P = .001).

“The FRAIL scale predicts functional decline and mortality in geriatric trauma patients and is a useful tool for clinicians,” Dr. Maxwell concluded. “Bedside nurses in our trauma unit at Vanderbilt University Medical Center are currently using this instrument to screen our older patients. We have seen an increase in earlier geriatric palliative care consultations as a result of our screening efforts.”

She acknowledged certain limitations of the study, including the fact that it was a secondary analysis. “We created FRAIL scale scores for 188 patients from six different data sources, thus, the created scores may not accurately represent actual prospectively collected FRAIL scores,” Dr. Maxwell said. “That being said, we compared the frailty frequencies from this study with actual FRAIL scale scores (from current bedside FRAIL screens) and we are seeing similar percentages of patients in non-frail, pre-frail and frail categories. This strengthens the findings of this study.”

She reported having no financial disclosures.

[email protected]

WAIKOLOA, HAWAII – The FRAIL scale questionnaire predicts functional status and mortality at 1 year among geriatric trauma patients and is a useful tool for bedside screening by clinicians, results from a single-center study demonstrated.

“Over the past 2 years, the implications of frailty among the geriatric trauma population have gained much attention in the trauma community,” Cathy A. Maxwell, PhD, RN, said in an interview in advance of the annual meeting of the American Association for the Surgery of Trauma. “This work highlights the clinical utility of the FRAIL scale for screening injured older patients who are admitted to trauma centers and other acute care hospitals. Hopefully, it will encourage trauma care providers to use the instrument to identify older patients’ pre-injury/baseline status and to obtain a frailty risk adjustment measure for quality improvement efforts.”

Developed by the International Association of Nutrition and Aging, the validated five-item FRAIL scale requires answers to questions about fatigue, resistance, ambulation, illnesses, and loss of weight (J Nutr Health Aging. 2012;16[7]:601-8). In an effort to examine the influence of pre-injury physical frailty (as measured by FRAIL) on 1-year outcomes, Dr. Maxwell, of the Vanderbilt University, Nashville, Tenn., and her associates evaluated injured patients aged 65 and older who were admitted through the ED between October 2013 and March 2014 and who participated in a prior study (J Trauma Acute Care Surg. 2016;80[2]:195-203). The researchers identified the five items of the FRAIL instrument from that study and created a pre-injury FRAIL score for each patient.

Dr. Maxwell reported results from 188 patients with a median age of 77, a median Injury Severity Score of 10, and a median comorbidity index of 3. Upon admission to the ED, 63 patients (34%) screened as frail (defined as a FRAIL score of 3 or greater), 71 (38%) screened as pre-frail (defined as a FRAIL score of 1-2), and 54 (29%) screened as non-frail (defined as a FRAIL score of zero). Frequencies for components of the FRAIL score were as follows: fatigue (65%), resistance (32%), ambulation (40%), illnesses (27%), and loss of weight (6%).

After the researchers controlled for age, comorbidities, injury severity, and cognitive status via the Ascertain Dementia 8-item Informant Questionnaire (AD8), they found that pre-injury FRAIL scores explained about 13% of the variability in physical function as measured by the Barthel Index (P less than .001). A total of 47 patients (26%) died within 1 year of admission. Logistic regression analysis revealed that after adjustment for these same variables, the higher the pre-injury FRAIL score, the greater the likelihood of mortality within 1 year (odds ratio, 1.74; P = .001).

“The FRAIL scale predicts functional decline and mortality in geriatric trauma patients and is a useful tool for clinicians,” Dr. Maxwell concluded. “Bedside nurses in our trauma unit at Vanderbilt University Medical Center are currently using this instrument to screen our older patients. We have seen an increase in earlier geriatric palliative care consultations as a result of our screening efforts.”

She acknowledged certain limitations of the study, including the fact that it was a secondary analysis. “We created FRAIL scale scores for 188 patients from six different data sources, thus, the created scores may not accurately represent actual prospectively collected FRAIL scores,” Dr. Maxwell said. “That being said, we compared the frailty frequencies from this study with actual FRAIL scale scores (from current bedside FRAIL screens) and we are seeing similar percentages of patients in non-frail, pre-frail and frail categories. This strengthens the findings of this study.”

She reported having no financial disclosures.

[email protected]

In a commentary about the use of DTC teledermatology in the pediatric arena, the Dermatology Foundation outlined a framework of features needed for such services “to appropriately treat pediatric patients.”

The commentary, by Kavita Sarin, MD, of the department of dermatology, Joyce Teng, MD, of the departments of pediatrics and dermatology, and Alexander L. Fogel, MBA, a medical student at Stanford (Calif.) University, was written on behalf of the Dermatology Foundation in response to the lack of uniform standards and policies governing the use of DTC teledermatology services for pediatric patients.

The writers reported the results of their assessment of the pediatric policies of DTC teledermatology websites and smartphone-based services, which included whether a patient’s age and identity were verified, whether the validity of parental consent was confirmed, and whether any coordination with a patient’s primary care physician or with other physicians occurred.

None of the sites performed all of the features they considered necessary for online pediatric care. “Most services have very minor checks on pediatric access, such as a limit on self-reported age, or a click-box to indicate that parental consent for the visit has been given, and few services allow for medical record capture or coordination with other physicians,” they wrote (J Am Acad Dermatol. 2016 Sep 7. doi: 10.1016/j.jaad.2016.08.002).

Describing the situation as “problematic,” they proposed the framework with features needed for DTC pediatric teledermatology services, which could be “implemented through legislation, regulation, or a third-party certification process,” the researchers wrote.

“We recommend an approach that allows for ample data cross-referencing between patient and parent, and with publicly available records,” to verify identification and parental consent, they noted.

Other elements include the use of standard templates for inputting patient’s medical histories, and sending care plans to the physicians indicated by the parents and patients.

DTC teledermatology “has the potential to offer patients substantial benefits,” but “we must insist on high-quality DTC TD[teledermatology]-services that are coordinated, transparent, focused on quality rather than prescription-writing, and consistent with standards of in-person care,” they wrote.

None of the authors declared any conflicts of interest. Dr. Sarin is supported by a Dermatology Foundation Medical Dermatology Career Development Award.

In a commentary about the use of DTC teledermatology in the pediatric arena, the Dermatology Foundation outlined a framework of features needed for such services “to appropriately treat pediatric patients.”

The commentary, by Kavita Sarin, MD, of the department of dermatology, Joyce Teng, MD, of the departments of pediatrics and dermatology, and Alexander L. Fogel, MBA, a medical student at Stanford (Calif.) University, was written on behalf of the Dermatology Foundation in response to the lack of uniform standards and policies governing the use of DTC teledermatology services for pediatric patients.

The writers reported the results of their assessment of the pediatric policies of DTC teledermatology websites and smartphone-based services, which included whether a patient’s age and identity were verified, whether the validity of parental consent was confirmed, and whether any coordination with a patient’s primary care physician or with other physicians occurred.

None of the sites performed all of the features they considered necessary for online pediatric care. “Most services have very minor checks on pediatric access, such as a limit on self-reported age, or a click-box to indicate that parental consent for the visit has been given, and few services allow for medical record capture or coordination with other physicians,” they wrote (J Am Acad Dermatol. 2016 Sep 7. doi: 10.1016/j.jaad.2016.08.002).

Describing the situation as “problematic,” they proposed the framework with features needed for DTC pediatric teledermatology services, which could be “implemented through legislation, regulation, or a third-party certification process,” the researchers wrote.

“We recommend an approach that allows for ample data cross-referencing between patient and parent, and with publicly available records,” to verify identification and parental consent, they noted.

Other elements include the use of standard templates for inputting patient’s medical histories, and sending care plans to the physicians indicated by the parents and patients.

DTC teledermatology “has the potential to offer patients substantial benefits,” but “we must insist on high-quality DTC TD[teledermatology]-services that are coordinated, transparent, focused on quality rather than prescription-writing, and consistent with standards of in-person care,” they wrote.

None of the authors declared any conflicts of interest. Dr. Sarin is supported by a Dermatology Foundation Medical Dermatology Career Development Award.

In a commentary about the use of DTC teledermatology in the pediatric arena, the Dermatology Foundation outlined a framework of features needed for such services “to appropriately treat pediatric patients.”

The commentary, by Kavita Sarin, MD, of the department of dermatology, Joyce Teng, MD, of the departments of pediatrics and dermatology, and Alexander L. Fogel, MBA, a medical student at Stanford (Calif.) University, was written on behalf of the Dermatology Foundation in response to the lack of uniform standards and policies governing the use of DTC teledermatology services for pediatric patients.

The writers reported the results of their assessment of the pediatric policies of DTC teledermatology websites and smartphone-based services, which included whether a patient’s age and identity were verified, whether the validity of parental consent was confirmed, and whether any coordination with a patient’s primary care physician or with other physicians occurred.

None of the sites performed all of the features they considered necessary for online pediatric care. “Most services have very minor checks on pediatric access, such as a limit on self-reported age, or a click-box to indicate that parental consent for the visit has been given, and few services allow for medical record capture or coordination with other physicians,” they wrote (J Am Acad Dermatol. 2016 Sep 7. doi: 10.1016/j.jaad.2016.08.002).

Describing the situation as “problematic,” they proposed the framework with features needed for DTC pediatric teledermatology services, which could be “implemented through legislation, regulation, or a third-party certification process,” the researchers wrote.

“We recommend an approach that allows for ample data cross-referencing between patient and parent, and with publicly available records,” to verify identification and parental consent, they noted.

Other elements include the use of standard templates for inputting patient’s medical histories, and sending care plans to the physicians indicated by the parents and patients.

DTC teledermatology “has the potential to offer patients substantial benefits,” but “we must insist on high-quality DTC TD[teledermatology]-services that are coordinated, transparent, focused on quality rather than prescription-writing, and consistent with standards of in-person care,” they wrote.

None of the authors declared any conflicts of interest. Dr. Sarin is supported by a Dermatology Foundation Medical Dermatology Career Development Award.

LONDON – Having an elevated level of high-density lipoprotein cholesterol (HDL-C) is associated with an increased rate of lung function decline over time, according to results from a cohort analysis of more than 30,000 adults presented at the annual congress of the European Respiratory Society.

For forced expiratory volume in 1 second (FEV₁), “there was a highly statistically significant inverse association for HDL-C for both cross-sectional and longitudinal measures of lung function,” reported Elizabeth C. Oelsner, MD, Columbia University Medical Center, New York. Those in the top quartile for HDL-C, on average, had a 9-mL greater decline in FEV¹, compared with patients in the lowest quartile (P less than .001). To put this in perspective, Dr. Oelsner said this decline is comparable “to a 10-year increment in pack-years of smoking.”

The study, which pooled six population-based cohorts in the United States, included 31,843 adults for whom there were baseline HDL-C levels and at least two longitudinally collected spirometry readings. According to Dr. Oelsner, quality control criteria were rigorously applied. For example, spirometry measures were obtained according to contemporary standards issued by the American Thoracic Society (ATS).

The average age of the study patients was 57 years, and 45% were classified as never smokers. The mean FEV₁ decline over a median follow-up of 5 years was 37 mL per year (range of 22-49 mL/year across the six cohorts). Approximately 15% of individuals had airflow limitation at baseline. There were more than 300,000 total person-years of observation in the pooled data.

In a fully adjusted cross-sectional analysis, each 1 mmol/L increase (38.67 mg/dL) in HDL-C was associated with a 9-mL lower FEV₁, according to Dr. Oelsner. He said the list of adjusted variables included age, gender, pack-years of smoking, weight, and height.

Results were consistent across age groups, presence or absence of smoking history, body mass index, and the presence or absence of airflow limitations at baseline, according to Dr. Oelsner.

HDL-C’s inverse correlation with lung function has been shown in other studies, such as the MESA Lung Study, another population-based analysis, according to Dr. Oelsner. In that study, a 0.4% increase in emphysema on CT lung scans was observed for every 10 mg/dL increase in HDL-C (Am J Respir Crit Care Med. 2010;181:A2878).

In this study, “being in the highest quartile for HDL at baseline was associated with an odds ratio of 1.2 for incident airflow limitation relative to being in the lowest [quartile],” Dr. Oelsner said.

The risk of a decline in airway function from an elevated HDL-C, if confirmed, should be considered in the context of the well-known protective effect exerted by HDL against cardiovascular events, according to Dr. Oelsner. However, she added, these data suggest that “having an excessively high HDL-C may incur risk just as an excessively low HDL may incur risk.” She noted, “there may be a limitation to the good of the good cholesterol.”

When asked after these data were presented whether she would prefer to have a low or high HDL-C, Dr. Oelsner responded, “Everything in moderation.” She also suggested that studies of treatments designed to raise HDL-C to reduce cardiovascular risk should take lung function into consideration. She warned that adverse effects on lung function are a potential “off-target risk” from such therapies.

LONDON – Having an elevated level of high-density lipoprotein cholesterol (HDL-C) is associated with an increased rate of lung function decline over time, according to results from a cohort analysis of more than 30,000 adults presented at the annual congress of the European Respiratory Society.

For forced expiratory volume in 1 second (FEV₁), “there was a highly statistically significant inverse association for HDL-C for both cross-sectional and longitudinal measures of lung function,” reported Elizabeth C. Oelsner, MD, Columbia University Medical Center, New York. Those in the top quartile for HDL-C, on average, had a 9-mL greater decline in FEV¹, compared with patients in the lowest quartile (P less than .001). To put this in perspective, Dr. Oelsner said this decline is comparable “to a 10-year increment in pack-years of smoking.”

The study, which pooled six population-based cohorts in the United States, included 31,843 adults for whom there were baseline HDL-C levels and at least two longitudinally collected spirometry readings. According to Dr. Oelsner, quality control criteria were rigorously applied. For example, spirometry measures were obtained according to contemporary standards issued by the American Thoracic Society (ATS).

The average age of the study patients was 57 years, and 45% were classified as never smokers. The mean FEV₁ decline over a median follow-up of 5 years was 37 mL per year (range of 22-49 mL/year across the six cohorts). Approximately 15% of individuals had airflow limitation at baseline. There were more than 300,000 total person-years of observation in the pooled data.

In a fully adjusted cross-sectional analysis, each 1 mmol/L increase (38.67 mg/dL) in HDL-C was associated with a 9-mL lower FEV₁, according to Dr. Oelsner. He said the list of adjusted variables included age, gender, pack-years of smoking, weight, and height.

Results were consistent across age groups, presence or absence of smoking history, body mass index, and the presence or absence of airflow limitations at baseline, according to Dr. Oelsner.

HDL-C’s inverse correlation with lung function has been shown in other studies, such as the MESA Lung Study, another population-based analysis, according to Dr. Oelsner. In that study, a 0.4% increase in emphysema on CT lung scans was observed for every 10 mg/dL increase in HDL-C (Am J Respir Crit Care Med. 2010;181:A2878).

In this study, “being in the highest quartile for HDL at baseline was associated with an odds ratio of 1.2 for incident airflow limitation relative to being in the lowest [quartile],” Dr. Oelsner said.

The risk of a decline in airway function from an elevated HDL-C, if confirmed, should be considered in the context of the well-known protective effect exerted by HDL against cardiovascular events, according to Dr. Oelsner. However, she added, these data suggest that “having an excessively high HDL-C may incur risk just as an excessively low HDL may incur risk.” She noted, “there may be a limitation to the good of the good cholesterol.”

When asked after these data were presented whether she would prefer to have a low or high HDL-C, Dr. Oelsner responded, “Everything in moderation.” She also suggested that studies of treatments designed to raise HDL-C to reduce cardiovascular risk should take lung function into consideration. She warned that adverse effects on lung function are a potential “off-target risk” from such therapies.

LONDON – Having an elevated level of high-density lipoprotein cholesterol (HDL-C) is associated with an increased rate of lung function decline over time, according to results from a cohort analysis of more than 30,000 adults presented at the annual congress of the European Respiratory Society.

For forced expiratory volume in 1 second (FEV₁), “there was a highly statistically significant inverse association for HDL-C for both cross-sectional and longitudinal measures of lung function,” reported Elizabeth C. Oelsner, MD, Columbia University Medical Center, New York. Those in the top quartile for HDL-C, on average, had a 9-mL greater decline in FEV¹, compared with patients in the lowest quartile (P less than .001). To put this in perspective, Dr. Oelsner said this decline is comparable “to a 10-year increment in pack-years of smoking.”

The study, which pooled six population-based cohorts in the United States, included 31,843 adults for whom there were baseline HDL-C levels and at least two longitudinally collected spirometry readings. According to Dr. Oelsner, quality control criteria were rigorously applied. For example, spirometry measures were obtained according to contemporary standards issued by the American Thoracic Society (ATS).

The average age of the study patients was 57 years, and 45% were classified as never smokers. The mean FEV₁ decline over a median follow-up of 5 years was 37 mL per year (range of 22-49 mL/year across the six cohorts). Approximately 15% of individuals had airflow limitation at baseline. There were more than 300,000 total person-years of observation in the pooled data.

In a fully adjusted cross-sectional analysis, each 1 mmol/L increase (38.67 mg/dL) in HDL-C was associated with a 9-mL lower FEV₁, according to Dr. Oelsner. He said the list of adjusted variables included age, gender, pack-years of smoking, weight, and height.

Results were consistent across age groups, presence or absence of smoking history, body mass index, and the presence or absence of airflow limitations at baseline, according to Dr. Oelsner.

HDL-C’s inverse correlation with lung function has been shown in other studies, such as the MESA Lung Study, another population-based analysis, according to Dr. Oelsner. In that study, a 0.4% increase in emphysema on CT lung scans was observed for every 10 mg/dL increase in HDL-C (Am J Respir Crit Care Med. 2010;181:A2878).

In this study, “being in the highest quartile for HDL at baseline was associated with an odds ratio of 1.2 for incident airflow limitation relative to being in the lowest [quartile],” Dr. Oelsner said.

The risk of a decline in airway function from an elevated HDL-C, if confirmed, should be considered in the context of the well-known protective effect exerted by HDL against cardiovascular events, according to Dr. Oelsner. However, she added, these data suggest that “having an excessively high HDL-C may incur risk just as an excessively low HDL may incur risk.” She noted, “there may be a limitation to the good of the good cholesterol.”

When asked after these data were presented whether she would prefer to have a low or high HDL-C, Dr. Oelsner responded, “Everything in moderation.” She also suggested that studies of treatments designed to raise HDL-C to reduce cardiovascular risk should take lung function into consideration. She warned that adverse effects on lung function are a potential “off-target risk” from such therapies.

Despite its widespread use as a guideline-recommended, first-line agent for the treatment of hypertension, hydrochlorothiazide (HCTZ) may contribute to an increased risk of skin cancer, according to Armand B. Cognetta Jr., MD, and his associates in the division of dermatology, Mohs Micrographic Surgery Unit, Florida State University, Tallahassee.

The common, long-term use of HCTZ for treatment of hypertension, combined with its known photosensitizing effects, makes it a potential candidate for increasing the risk of squamous cell carcinoma (SCC) and other skin cancers.

To further elucidate the association between longterm HCTZ exposure and skin cancer risk, Dr. Cognetta and his associates screened medication lists of 75 patients seen in their Mohs practice over a period of 5 days for lifetime SCCs and HCTZ exposure. For this study, patients with more than 20 lifetime SCCs were considered high risk. They also conducted a literature review of previous studies exploring this relationship, from 1966 to 2015.

Of the 75 patients screened, 4 met the criteria for inclusion in the high risk category. These four patients had a combined lifetime total of 288 SCC and 98 basal cell carcinomas (BCCs), including 10 that were lip SCC. All four patients were non-Hispanic white males and had been taking HCTZ alone or in combination for 3-15 years (Dermatol Surg. 2016 Sep;42[9]:1107-9).

The literature search produced three relevant studies, all of which had large patient populations, published between 2008 and 2012, “demonstrating an increased risk of SCC or lip cancer” associated with HCTZ use, with the highest risk associated with over 5 years of use, the researchers wrote.

“As cutaneous oncologists, it is our duty to look for ‘correctable’ causes of skin cancer,” they noted. “Hydrochlorothiazide, a known photosensitizer, when taken by white non-Hispanic patients with a history of multiple SCC, skin cancers may represent a ‘correctable’ cause.”

In their practice, they screen their high-risk SCC non-Hispanic patients for HCTZ use, “and send a standard letter explaining the association to the primary care provider with a request to change to a different antihypertensive if possible,” they wrote. “Many primary care providers are unaware of the association between HCTZ use and skin cancer,” they observed.

The authors had no disclosures.

Despite its widespread use as a guideline-recommended, first-line agent for the treatment of hypertension, hydrochlorothiazide (HCTZ) may contribute to an increased risk of skin cancer, according to Armand B. Cognetta Jr., MD, and his associates in the division of dermatology, Mohs Micrographic Surgery Unit, Florida State University, Tallahassee.

The common, long-term use of HCTZ for treatment of hypertension, combined with its known photosensitizing effects, makes it a potential candidate for increasing the risk of squamous cell carcinoma (SCC) and other skin cancers.

To further elucidate the association between longterm HCTZ exposure and skin cancer risk, Dr. Cognetta and his associates screened medication lists of 75 patients seen in their Mohs practice over a period of 5 days for lifetime SCCs and HCTZ exposure. For this study, patients with more than 20 lifetime SCCs were considered high risk. They also conducted a literature review of previous studies exploring this relationship, from 1966 to 2015.

Of the 75 patients screened, 4 met the criteria for inclusion in the high risk category. These four patients had a combined lifetime total of 288 SCC and 98 basal cell carcinomas (BCCs), including 10 that were lip SCC. All four patients were non-Hispanic white males and had been taking HCTZ alone or in combination for 3-15 years (Dermatol Surg. 2016 Sep;42[9]:1107-9).

The literature search produced three relevant studies, all of which had large patient populations, published between 2008 and 2012, “demonstrating an increased risk of SCC or lip cancer” associated with HCTZ use, with the highest risk associated with over 5 years of use, the researchers wrote.

“As cutaneous oncologists, it is our duty to look for ‘correctable’ causes of skin cancer,” they noted. “Hydrochlorothiazide, a known photosensitizer, when taken by white non-Hispanic patients with a history of multiple SCC, skin cancers may represent a ‘correctable’ cause.”

In their practice, they screen their high-risk SCC non-Hispanic patients for HCTZ use, “and send a standard letter explaining the association to the primary care provider with a request to change to a different antihypertensive if possible,” they wrote. “Many primary care providers are unaware of the association between HCTZ use and skin cancer,” they observed.

The authors had no disclosures.

Despite its widespread use as a guideline-recommended, first-line agent for the treatment of hypertension, hydrochlorothiazide (HCTZ) may contribute to an increased risk of skin cancer, according to Armand B. Cognetta Jr., MD, and his associates in the division of dermatology, Mohs Micrographic Surgery Unit, Florida State University, Tallahassee.

The common, long-term use of HCTZ for treatment of hypertension, combined with its known photosensitizing effects, makes it a potential candidate for increasing the risk of squamous cell carcinoma (SCC) and other skin cancers.

To further elucidate the association between longterm HCTZ exposure and skin cancer risk, Dr. Cognetta and his associates screened medication lists of 75 patients seen in their Mohs practice over a period of 5 days for lifetime SCCs and HCTZ exposure. For this study, patients with more than 20 lifetime SCCs were considered high risk. They also conducted a literature review of previous studies exploring this relationship, from 1966 to 2015.

Of the 75 patients screened, 4 met the criteria for inclusion in the high risk category. These four patients had a combined lifetime total of 288 SCC and 98 basal cell carcinomas (BCCs), including 10 that were lip SCC. All four patients were non-Hispanic white males and had been taking HCTZ alone or in combination for 3-15 years (Dermatol Surg. 2016 Sep;42[9]:1107-9).

The literature search produced three relevant studies, all of which had large patient populations, published between 2008 and 2012, “demonstrating an increased risk of SCC or lip cancer” associated with HCTZ use, with the highest risk associated with over 5 years of use, the researchers wrote.

“As cutaneous oncologists, it is our duty to look for ‘correctable’ causes of skin cancer,” they noted. “Hydrochlorothiazide, a known photosensitizer, when taken by white non-Hispanic patients with a history of multiple SCC, skin cancers may represent a ‘correctable’ cause.”

In their practice, they screen their high-risk SCC non-Hispanic patients for HCTZ use, “and send a standard letter explaining the association to the primary care provider with a request to change to a different antihypertensive if possible,” they wrote. “Many primary care providers are unaware of the association between HCTZ use and skin cancer,” they observed.

The authors had no disclosures.

Researcher examines

tumor in a test tube

Photo by Rhoda Baer

The US Department of Health and Human Services (HHS) and the National Institutes of Health (NIH) have announced new efforts to increase clinical trial transparency.

The HHS has issued a final rule that expands the legal requirements for registering certain clinical trials on ClinicalTrials.gov and providing summary results of these trials on the website.

The NIH has issued a complementary policy for registering and submitting summary results to ClinicalTrials.gov for all NIH-funded trials, including those not subject to the final rule.

Both the HHS rule and the NIH policy will be effective on January 18, 2017.

“Access to more information about clinical trials is good for patients, the public, and science,” said NIH Director Francis S. Collins, MD, PhD.

“The final rule and NIH policy we have issued today will help maximize the value of clinical trials, whether publicly or privately supported, and help us honor our commitments to trial participants who do so much to help society advance knowledge and improve health.”

About the HHS rule

The final rule specifies how and when information collected in a clinical trial must be submitted to ClinicalTrials.gov. It does not dictate how clinical trials should be designed or conducted, or what data must be collected.

Requirements under the rule apply to most interventional studies of drug, biological, and device products regulated by the US Food and Drug Administration (FDA). The requirements do not apply to phase 1 trials of drug and biological products or small feasibility studies of device products.

Elements of the rule include:

• Providing a checklist for evaluating which clinical trials are subject to the regulations and who is responsible for submitting the required information
• Expanding the scope of trials for which summary results information must be submitted to include trials involving FDA-regulated products that have not yet been approved, licensed, or cleared by the FDA
• Requiring additional registration and summary results information data elements to be submitted to ClinicalTrials.gov, including the race and ethnicity of trial participants, if collected, and the full protocol
• Requiring additional types of adverse event information
• Providing a list of potential legal consequences for non-compliance.

About the NIH policy

The NIH policy mandates that investigators conducting clinical trials funded by NIH (in whole or in part) will ensure that the trials are registered at ClinicalTrials.gov and that summary results of these trials are posted to the website within 12 months of the primary completion date (although this can be delayed for up to 2 years).

The policy applies to all NIH-funded trials, including phase 1 trials of FDA-regulated products and small feasibility device trials, as well as trials of products that are not regulated by the FDA, such as behavioral interventions.

Researcher examines

tumor in a test tube

Photo by Rhoda Baer

The US Department of Health and Human Services (HHS) and the National Institutes of Health (NIH) have announced new efforts to increase clinical trial transparency.

The HHS has issued a final rule that expands the legal requirements for registering certain clinical trials on ClinicalTrials.gov and providing summary results of these trials on the website.

The NIH has issued a complementary policy for registering and submitting summary results to ClinicalTrials.gov for all NIH-funded trials, including those not subject to the final rule.

Both the HHS rule and the NIH policy will be effective on January 18, 2017.

“Access to more information about clinical trials is good for patients, the public, and science,” said NIH Director Francis S. Collins, MD, PhD.

“The final rule and NIH policy we have issued today will help maximize the value of clinical trials, whether publicly or privately supported, and help us honor our commitments to trial participants who do so much to help society advance knowledge and improve health.”

About the HHS rule

The final rule specifies how and when information collected in a clinical trial must be submitted to ClinicalTrials.gov. It does not dictate how clinical trials should be designed or conducted, or what data must be collected.

Requirements under the rule apply to most interventional studies of drug, biological, and device products regulated by the US Food and Drug Administration (FDA). The requirements do not apply to phase 1 trials of drug and biological products or small feasibility studies of device products.

Elements of the rule include:

• Providing a checklist for evaluating which clinical trials are subject to the regulations and who is responsible for submitting the required information
• Expanding the scope of trials for which summary results information must be submitted to include trials involving FDA-regulated products that have not yet been approved, licensed, or cleared by the FDA
• Requiring additional registration and summary results information data elements to be submitted to ClinicalTrials.gov, including the race and ethnicity of trial participants, if collected, and the full protocol
• Requiring additional types of adverse event information
• Providing a list of potential legal consequences for non-compliance.

About the NIH policy

The NIH policy mandates that investigators conducting clinical trials funded by NIH (in whole or in part) will ensure that the trials are registered at ClinicalTrials.gov and that summary results of these trials are posted to the website within 12 months of the primary completion date (although this can be delayed for up to 2 years).

The policy applies to all NIH-funded trials, including phase 1 trials of FDA-regulated products and small feasibility device trials, as well as trials of products that are not regulated by the FDA, such as behavioral interventions.

Researcher examines

tumor in a test tube

Photo by Rhoda Baer

The US Department of Health and Human Services (HHS) and the National Institutes of Health (NIH) have announced new efforts to increase clinical trial transparency.

The HHS has issued a final rule that expands the legal requirements for registering certain clinical trials on ClinicalTrials.gov and providing summary results of these trials on the website.

The NIH has issued a complementary policy for registering and submitting summary results to ClinicalTrials.gov for all NIH-funded trials, including those not subject to the final rule.

Both the HHS rule and the NIH policy will be effective on January 18, 2017.

“Access to more information about clinical trials is good for patients, the public, and science,” said NIH Director Francis S. Collins, MD, PhD.

“The final rule and NIH policy we have issued today will help maximize the value of clinical trials, whether publicly or privately supported, and help us honor our commitments to trial participants who do so much to help society advance knowledge and improve health.”

About the HHS rule

The final rule specifies how and when information collected in a clinical trial must be submitted to ClinicalTrials.gov. It does not dictate how clinical trials should be designed or conducted, or what data must be collected.

Requirements under the rule apply to most interventional studies of drug, biological, and device products regulated by the US Food and Drug Administration (FDA). The requirements do not apply to phase 1 trials of drug and biological products or small feasibility studies of device products.

Elements of the rule include:

• Providing a checklist for evaluating which clinical trials are subject to the regulations and who is responsible for submitting the required information
• Expanding the scope of trials for which summary results information must be submitted to include trials involving FDA-regulated products that have not yet been approved, licensed, or cleared by the FDA
• Requiring additional registration and summary results information data elements to be submitted to ClinicalTrials.gov, including the race and ethnicity of trial participants, if collected, and the full protocol
• Requiring additional types of adverse event information
• Providing a list of potential legal consequences for non-compliance.

About the NIH policy

The NIH policy mandates that investigators conducting clinical trials funded by NIH (in whole or in part) will ensure that the trials are registered at ClinicalTrials.gov and that summary results of these trials are posted to the website within 12 months of the primary completion date (although this can be delayed for up to 2 years).

The policy applies to all NIH-funded trials, including phase 1 trials of FDA-regulated products and small feasibility device trials, as well as trials of products that are not regulated by the FDA, such as behavioral interventions.

WAIKOLOA, HI. – If you openly share your institution’s use of damage control laparotomy, it is possible to safely decrease use of the procedure, according to results from a 2-year, single-center quality improvement project.

“Damage control laparotomy (DCL) is currently overused, both in trauma and general surgery,” John A. Harvin, MD, said in an interview in advance of the annual meeting of the American Association for the Surgery of Trauma. “One of the barriers to discussing the overuse is that no one knows what the ‘right’ rate of DCL should be. The vast majority of papers reporting findings regarding DCL fail to provide a denominator, thus actual rates of DCL across the country are not known. It is only by word of mouth that the overuse comes out.”

In a quality improvement (QI) project designed to decrease the rate of DCL at the University of Texas Health Science Center, Houston, Dr. Harvin and his associates prospectively evaluated all emergent laparotomies performed at the institution from November 2013 to October 2015. During year 1 of the QI project, trauma faculty completed report cards immediately following every DCL. During year 2, the researchers collectively reviewed DCLs every other month to determine which patients may have safely undergone definitive laparotomy. They prospectively compared the morbidity and mortality of patients in the quality improvement group with that of a published historical cohort group of patients who underwent emergent laparotomy between January 2011 and October 2013 (Am. J. Surg. 2016;212[1]:34-9).

Dr. Harvin of the division of acute care surgery at the university, reported that the rate of DCL among the historical control group was 39%. Soon after the QI project was implemented the DCL rate fell to 23% (P less than .05), and it declined further following completion of the project, to 18%. “This was accomplished by open discussion among our faculty on who and why DCL was done,” he said. “Over the course of the 2-year QI project, approximately 70 DCLs were avoided without an increase in complications or mortality.”

Many of the findings surprised the researchers, including the fact that the indications for DCL did not differ before and after implementation of the QI project. “So, surgeons did not necessarily abandon certain indications but used all indications more selectively,” Dr. Harvin noted. “That being said, we were able to identify a few indications for DCL that may or may not be necessary. Lastly, despite a significant reduction in the overall use of DCL, we saw no change in rates of complications. This flies in the face of many papers reporting an association between DCL and all kinds of morbidities.”

He acknowledged certain limitations of the study, including the fact that the researchers identified a Hawthorne effect after implementation of the QI intervention. “Despite this, there was a sustained reduction in the rate of DCL that persisted following termination of the project,” Dr. Harvin said. “Additionally, this is not a randomized clinical trial, but a before and after trial which is subject to the usual methodological flaws such as confounding by temporal change and differences in baseline characteristics of the patient populations.” He reported having no financial disclosures.

[email protected]

WAIKOLOA, HI. – If you openly share your institution’s use of damage control laparotomy, it is possible to safely decrease use of the procedure, according to results from a 2-year, single-center quality improvement project.

“Damage control laparotomy (DCL) is currently overused, both in trauma and general surgery,” John A. Harvin, MD, said in an interview in advance of the annual meeting of the American Association for the Surgery of Trauma. “One of the barriers to discussing the overuse is that no one knows what the ‘right’ rate of DCL should be. The vast majority of papers reporting findings regarding DCL fail to provide a denominator, thus actual rates of DCL across the country are not known. It is only by word of mouth that the overuse comes out.”

In a quality improvement (QI) project designed to decrease the rate of DCL at the University of Texas Health Science Center, Houston, Dr. Harvin and his associates prospectively evaluated all emergent laparotomies performed at the institution from November 2013 to October 2015. During year 1 of the QI project, trauma faculty completed report cards immediately following every DCL. During year 2, the researchers collectively reviewed DCLs every other month to determine which patients may have safely undergone definitive laparotomy. They prospectively compared the morbidity and mortality of patients in the quality improvement group with that of a published historical cohort group of patients who underwent emergent laparotomy between January 2011 and October 2013 (Am. J. Surg. 2016;212[1]:34-9).

Dr. Harvin of the division of acute care surgery at the university, reported that the rate of DCL among the historical control group was 39%. Soon after the QI project was implemented the DCL rate fell to 23% (P less than .05), and it declined further following completion of the project, to 18%. “This was accomplished by open discussion among our faculty on who and why DCL was done,” he said. “Over the course of the 2-year QI project, approximately 70 DCLs were avoided without an increase in complications or mortality.”

Many of the findings surprised the researchers, including the fact that the indications for DCL did not differ before and after implementation of the QI project. “So, surgeons did not necessarily abandon certain indications but used all indications more selectively,” Dr. Harvin noted. “That being said, we were able to identify a few indications for DCL that may or may not be necessary. Lastly, despite a significant reduction in the overall use of DCL, we saw no change in rates of complications. This flies in the face of many papers reporting an association between DCL and all kinds of morbidities.”

He acknowledged certain limitations of the study, including the fact that the researchers identified a Hawthorne effect after implementation of the QI intervention. “Despite this, there was a sustained reduction in the rate of DCL that persisted following termination of the project,” Dr. Harvin said. “Additionally, this is not a randomized clinical trial, but a before and after trial which is subject to the usual methodological flaws such as confounding by temporal change and differences in baseline characteristics of the patient populations.” He reported having no financial disclosures.

[email protected]

WAIKOLOA, HI. – If you openly share your institution’s use of damage control laparotomy, it is possible to safely decrease use of the procedure, according to results from a 2-year, single-center quality improvement project.

“Damage control laparotomy (DCL) is currently overused, both in trauma and general surgery,” John A. Harvin, MD, said in an interview in advance of the annual meeting of the American Association for the Surgery of Trauma. “One of the barriers to discussing the overuse is that no one knows what the ‘right’ rate of DCL should be. The vast majority of papers reporting findings regarding DCL fail to provide a denominator, thus actual rates of DCL across the country are not known. It is only by word of mouth that the overuse comes out.”

In a quality improvement (QI) project designed to decrease the rate of DCL at the University of Texas Health Science Center, Houston, Dr. Harvin and his associates prospectively evaluated all emergent laparotomies performed at the institution from November 2013 to October 2015. During year 1 of the QI project, trauma faculty completed report cards immediately following every DCL. During year 2, the researchers collectively reviewed DCLs every other month to determine which patients may have safely undergone definitive laparotomy. They prospectively compared the morbidity and mortality of patients in the quality improvement group with that of a published historical cohort group of patients who underwent emergent laparotomy between January 2011 and October 2013 (Am. J. Surg. 2016;212[1]:34-9).

Dr. Harvin of the division of acute care surgery at the university, reported that the rate of DCL among the historical control group was 39%. Soon after the QI project was implemented the DCL rate fell to 23% (P less than .05), and it declined further following completion of the project, to 18%. “This was accomplished by open discussion among our faculty on who and why DCL was done,” he said. “Over the course of the 2-year QI project, approximately 70 DCLs were avoided without an increase in complications or mortality.”

Many of the findings surprised the researchers, including the fact that the indications for DCL did not differ before and after implementation of the QI project. “So, surgeons did not necessarily abandon certain indications but used all indications more selectively,” Dr. Harvin noted. “That being said, we were able to identify a few indications for DCL that may or may not be necessary. Lastly, despite a significant reduction in the overall use of DCL, we saw no change in rates of complications. This flies in the face of many papers reporting an association between DCL and all kinds of morbidities.”

He acknowledged certain limitations of the study, including the fact that the researchers identified a Hawthorne effect after implementation of the QI intervention. “Despite this, there was a sustained reduction in the rate of DCL that persisted following termination of the project,” Dr. Harvin said. “Additionally, this is not a randomized clinical trial, but a before and after trial which is subject to the usual methodological flaws such as confounding by temporal change and differences in baseline characteristics of the patient populations.” He reported having no financial disclosures.

[email protected]