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The perils of the National Practitioner Data Bank
Question: With reference to the National Practitioner Data Bank (NPDB), which of the following statements is incorrect?
A. Both court judgments and out-of-court settlements are reportable to the NPDB.
B. Adverse actions by a hospital against a physician are reportable within 15 days.
C. In states with “Disclosure, Apology, and Offer” laws, a prompt settlement through mediation need not be reported.
D. Hospitals, state licensing boards, medical organizations, and the physician himself/herself can access the NPDB.
E. A plaintiff’s attorney cannot access the NPDB for information regarding a defendant.
Answer: C. Congress implemented the NPDB to collect information about an individual doctor’s malpractice and disciplinary histories, with the objective of restricting errant doctors from moving from one state to another.1
Federal law requires medical liability payments stemming from either a court judgment or an out-of-court settlement be reported to the NPDB. An institution’s disciplinary actions against a medical staff member must also be reported. In turn, the NPDB is obligated to make its information available to hospitals, state licensure boards, and legitimate medical organizations charged with granting privileges or membership. A physician also can ask to see his or her own records, but a plaintiff’s attorney cannot access the NPDB unless there is evidence that a hospital failed to query the NPDB as part of its credentialing process.
Some observers have claimed that the NPDB’s existence has hindered settlement negotiations, because many doctors fear being listed in the NPDB, thus significantly diminishing the likelihood of payments to satisfy a claim. It has been stated that within 6 years of NPDB’s inception, the probability that an injured patient’s claim would receive payment had fallen to 59% of the pre-NPDB level.
Many states have enacted so-called “apology laws” that promote full disclosure of medical errors and prompt out-of-court settlements, if warranted. However, the federal Department of Health and Human Services has ruled that all written demands for payment must be reported, even if the cases are resolved under state programs designed for early out-of-court resolution.
For example, a provision in the Oregon law asserts that a payment under the measure’s mediation mechanism “is not a payment resulting from a written claim or demand for payment.” The HHS has rejected this as “explicitly designed to avoid medical malpractice reporting to the NPDB for any claims that are part of the new process that do not proceed to litigation.”
Massachusetts’ 2012 apology law had proposed reporting only those cases where it was determined that a practitioner failed to meet the standard of care. The HHS responded by indicating that all cases had to be reported, regardless of whether care was determined to be up to standards, and that the state’s prelitigation notice to initiate the meditation process qualified as a reportable “written claim.”
Physicians can be impacted greatly by the NPDB. How much of an impact depends in large part on the underlying events and the wording of the report.
An NPDB account of a medical malpractice payment doesn’t necessarily affect a physician’s ability to practice, while those – especially when “severely-worded” – involving denial or restriction of privileges are taken more seriously by state licensing boards and employers. Physicians should therefore play an active role whenever a report to the NPDB appears likely.
The dispute review process is highly technical and requires the knowledge and skill of an experienced health law attorney. To start out, consider making a request to the reporting entity to correct or vacate the report due to error. If the reporting entity declines, the physician may request a review by the HHS and file an accompanying statement seeking to explain the report.
Yet, out of more than 800,000 total reports for all practitioner types captured in the system, apparently only 44,273 included accompanying clarifying statements by the physician. Risk managers have urged vigilance.
For example, it may be that multiple reports involved a single incident, leading to a “piling on” effect. If an adverse decision at one hospital caused a physician’s clinical privileges to be terminated, this might lead the state medical board to restrict the physician’s license. It is necessary to explain that both of these NPDB-reportable events involved the same incident, and that the state board did not have any independent knowledge of anything that was wrong.
Others have advised that one should always clarify one’s involvement, e.g., “I was not the main doctor in the case.” And if dismissed in a malpractice lawsuit, be sure your name or identifying information isn’t included in the judgment or settlement agreement.
Hospital disciplinary actions being far more serious, physicians would do well to familiarize themselves with medical staff bylaws dealing with peer review and investigations. To avoid being reported to the NPDB, physicians must resist adverse actions that would be in effect for more than 30 days and fight attempts to place restrictions or sanctions on their licenses by the hospital or professional societies. Don’t withdraw applications for privileges during an investigation.
The 2015 NPDB Guidebook, the first update in more than 10 years, contains important changes pertaining to hospital adverse actions.2 The regulations now require any “surrender” of privileges while the physician is a subject of an investigation to be a reportable event. Previously, physicians sought to avoid being reported by simply giving up their privileges when an adverse decision appeared imminent.
Surrender includes not renewing one’s hospital privileges or the taking of a leave of absence, and “investigation” is widely defined to include any formal inquiry into a physician’s competence or conduct. And there need not be any “nexus,” i.e., connection, between what is being investigated and the privileges surrendered, in order to be reportable.
Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii. This article is meant to be educational and does not constitute medical, ethical, or legal advice. For additional information, readers may contact the author at [email protected].
References
1. Health Care Quality Improvement Act of 1986, 42 U.S.C. 11101 et seq.
2. 2015 NPDB e-Guidebook, available at www.npdb.hrsa.gov/resources/aboutGuidebooks.jsp.
Question: With reference to the National Practitioner Data Bank (NPDB), which of the following statements is incorrect?
A. Both court judgments and out-of-court settlements are reportable to the NPDB.
B. Adverse actions by a hospital against a physician are reportable within 15 days.
C. In states with “Disclosure, Apology, and Offer” laws, a prompt settlement through mediation need not be reported.
D. Hospitals, state licensing boards, medical organizations, and the physician himself/herself can access the NPDB.
E. A plaintiff’s attorney cannot access the NPDB for information regarding a defendant.
Answer: C. Congress implemented the NPDB to collect information about an individual doctor’s malpractice and disciplinary histories, with the objective of restricting errant doctors from moving from one state to another.1
Federal law requires medical liability payments stemming from either a court judgment or an out-of-court settlement be reported to the NPDB. An institution’s disciplinary actions against a medical staff member must also be reported. In turn, the NPDB is obligated to make its information available to hospitals, state licensure boards, and legitimate medical organizations charged with granting privileges or membership. A physician also can ask to see his or her own records, but a plaintiff’s attorney cannot access the NPDB unless there is evidence that a hospital failed to query the NPDB as part of its credentialing process.
Some observers have claimed that the NPDB’s existence has hindered settlement negotiations, because many doctors fear being listed in the NPDB, thus significantly diminishing the likelihood of payments to satisfy a claim. It has been stated that within 6 years of NPDB’s inception, the probability that an injured patient’s claim would receive payment had fallen to 59% of the pre-NPDB level.
Many states have enacted so-called “apology laws” that promote full disclosure of medical errors and prompt out-of-court settlements, if warranted. However, the federal Department of Health and Human Services has ruled that all written demands for payment must be reported, even if the cases are resolved under state programs designed for early out-of-court resolution.
For example, a provision in the Oregon law asserts that a payment under the measure’s mediation mechanism “is not a payment resulting from a written claim or demand for payment.” The HHS has rejected this as “explicitly designed to avoid medical malpractice reporting to the NPDB for any claims that are part of the new process that do not proceed to litigation.”
Massachusetts’ 2012 apology law had proposed reporting only those cases where it was determined that a practitioner failed to meet the standard of care. The HHS responded by indicating that all cases had to be reported, regardless of whether care was determined to be up to standards, and that the state’s prelitigation notice to initiate the meditation process qualified as a reportable “written claim.”
Physicians can be impacted greatly by the NPDB. How much of an impact depends in large part on the underlying events and the wording of the report.
An NPDB account of a medical malpractice payment doesn’t necessarily affect a physician’s ability to practice, while those – especially when “severely-worded” – involving denial or restriction of privileges are taken more seriously by state licensing boards and employers. Physicians should therefore play an active role whenever a report to the NPDB appears likely.
The dispute review process is highly technical and requires the knowledge and skill of an experienced health law attorney. To start out, consider making a request to the reporting entity to correct or vacate the report due to error. If the reporting entity declines, the physician may request a review by the HHS and file an accompanying statement seeking to explain the report.
Yet, out of more than 800,000 total reports for all practitioner types captured in the system, apparently only 44,273 included accompanying clarifying statements by the physician. Risk managers have urged vigilance.
For example, it may be that multiple reports involved a single incident, leading to a “piling on” effect. If an adverse decision at one hospital caused a physician’s clinical privileges to be terminated, this might lead the state medical board to restrict the physician’s license. It is necessary to explain that both of these NPDB-reportable events involved the same incident, and that the state board did not have any independent knowledge of anything that was wrong.
Others have advised that one should always clarify one’s involvement, e.g., “I was not the main doctor in the case.” And if dismissed in a malpractice lawsuit, be sure your name or identifying information isn’t included in the judgment or settlement agreement.
Hospital disciplinary actions being far more serious, physicians would do well to familiarize themselves with medical staff bylaws dealing with peer review and investigations. To avoid being reported to the NPDB, physicians must resist adverse actions that would be in effect for more than 30 days and fight attempts to place restrictions or sanctions on their licenses by the hospital or professional societies. Don’t withdraw applications for privileges during an investigation.
The 2015 NPDB Guidebook, the first update in more than 10 years, contains important changes pertaining to hospital adverse actions.2 The regulations now require any “surrender” of privileges while the physician is a subject of an investigation to be a reportable event. Previously, physicians sought to avoid being reported by simply giving up their privileges when an adverse decision appeared imminent.
Surrender includes not renewing one’s hospital privileges or the taking of a leave of absence, and “investigation” is widely defined to include any formal inquiry into a physician’s competence or conduct. And there need not be any “nexus,” i.e., connection, between what is being investigated and the privileges surrendered, in order to be reportable.
Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii. This article is meant to be educational and does not constitute medical, ethical, or legal advice. For additional information, readers may contact the author at [email protected].
References
1. Health Care Quality Improvement Act of 1986, 42 U.S.C. 11101 et seq.
2. 2015 NPDB e-Guidebook, available at www.npdb.hrsa.gov/resources/aboutGuidebooks.jsp.
Question: With reference to the National Practitioner Data Bank (NPDB), which of the following statements is incorrect?
A. Both court judgments and out-of-court settlements are reportable to the NPDB.
B. Adverse actions by a hospital against a physician are reportable within 15 days.
C. In states with “Disclosure, Apology, and Offer” laws, a prompt settlement through mediation need not be reported.
D. Hospitals, state licensing boards, medical organizations, and the physician himself/herself can access the NPDB.
E. A plaintiff’s attorney cannot access the NPDB for information regarding a defendant.
Answer: C. Congress implemented the NPDB to collect information about an individual doctor’s malpractice and disciplinary histories, with the objective of restricting errant doctors from moving from one state to another.1
Federal law requires medical liability payments stemming from either a court judgment or an out-of-court settlement be reported to the NPDB. An institution’s disciplinary actions against a medical staff member must also be reported. In turn, the NPDB is obligated to make its information available to hospitals, state licensure boards, and legitimate medical organizations charged with granting privileges or membership. A physician also can ask to see his or her own records, but a plaintiff’s attorney cannot access the NPDB unless there is evidence that a hospital failed to query the NPDB as part of its credentialing process.
Some observers have claimed that the NPDB’s existence has hindered settlement negotiations, because many doctors fear being listed in the NPDB, thus significantly diminishing the likelihood of payments to satisfy a claim. It has been stated that within 6 years of NPDB’s inception, the probability that an injured patient’s claim would receive payment had fallen to 59% of the pre-NPDB level.
Many states have enacted so-called “apology laws” that promote full disclosure of medical errors and prompt out-of-court settlements, if warranted. However, the federal Department of Health and Human Services has ruled that all written demands for payment must be reported, even if the cases are resolved under state programs designed for early out-of-court resolution.
For example, a provision in the Oregon law asserts that a payment under the measure’s mediation mechanism “is not a payment resulting from a written claim or demand for payment.” The HHS has rejected this as “explicitly designed to avoid medical malpractice reporting to the NPDB for any claims that are part of the new process that do not proceed to litigation.”
Massachusetts’ 2012 apology law had proposed reporting only those cases where it was determined that a practitioner failed to meet the standard of care. The HHS responded by indicating that all cases had to be reported, regardless of whether care was determined to be up to standards, and that the state’s prelitigation notice to initiate the meditation process qualified as a reportable “written claim.”
Physicians can be impacted greatly by the NPDB. How much of an impact depends in large part on the underlying events and the wording of the report.
An NPDB account of a medical malpractice payment doesn’t necessarily affect a physician’s ability to practice, while those – especially when “severely-worded” – involving denial or restriction of privileges are taken more seriously by state licensing boards and employers. Physicians should therefore play an active role whenever a report to the NPDB appears likely.
The dispute review process is highly technical and requires the knowledge and skill of an experienced health law attorney. To start out, consider making a request to the reporting entity to correct or vacate the report due to error. If the reporting entity declines, the physician may request a review by the HHS and file an accompanying statement seeking to explain the report.
Yet, out of more than 800,000 total reports for all practitioner types captured in the system, apparently only 44,273 included accompanying clarifying statements by the physician. Risk managers have urged vigilance.
For example, it may be that multiple reports involved a single incident, leading to a “piling on” effect. If an adverse decision at one hospital caused a physician’s clinical privileges to be terminated, this might lead the state medical board to restrict the physician’s license. It is necessary to explain that both of these NPDB-reportable events involved the same incident, and that the state board did not have any independent knowledge of anything that was wrong.
Others have advised that one should always clarify one’s involvement, e.g., “I was not the main doctor in the case.” And if dismissed in a malpractice lawsuit, be sure your name or identifying information isn’t included in the judgment or settlement agreement.
Hospital disciplinary actions being far more serious, physicians would do well to familiarize themselves with medical staff bylaws dealing with peer review and investigations. To avoid being reported to the NPDB, physicians must resist adverse actions that would be in effect for more than 30 days and fight attempts to place restrictions or sanctions on their licenses by the hospital or professional societies. Don’t withdraw applications for privileges during an investigation.
The 2015 NPDB Guidebook, the first update in more than 10 years, contains important changes pertaining to hospital adverse actions.2 The regulations now require any “surrender” of privileges while the physician is a subject of an investigation to be a reportable event. Previously, physicians sought to avoid being reported by simply giving up their privileges when an adverse decision appeared imminent.
Surrender includes not renewing one’s hospital privileges or the taking of a leave of absence, and “investigation” is widely defined to include any formal inquiry into a physician’s competence or conduct. And there need not be any “nexus,” i.e., connection, between what is being investigated and the privileges surrendered, in order to be reportable.
Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii. This article is meant to be educational and does not constitute medical, ethical, or legal advice. For additional information, readers may contact the author at [email protected].
References
1. Health Care Quality Improvement Act of 1986, 42 U.S.C. 11101 et seq.
2. 2015 NPDB e-Guidebook, available at www.npdb.hrsa.gov/resources/aboutGuidebooks.jsp.
Study sheds light on pregnancy outcomes following ocrelizumab treatment
NEW ORLEANS – Data from the ocrelizumab clinical development program gives clinicians a first look at pregnancy outcomes after exposure to the drug, but the small size limits the ability to draw firm conclusions.
In the United States, prescribing information for ocrelizumab states that women of childbearing potential should use contraception while receiving ocrelizumab and for 6 months after the last infusion. At the annual meeting of the Consortium of Multiple Sclerosis Centers, researchers led by Sibyl Wray, MD, set out to assess the pregnancy, fetal, neonatal and infant outcomes in patients who became pregnant during ocrelizumab trials in MS, rheumatoid arthritis (RA), and systemic lupus erythematosus (SLE) through Sept. 15, 2015.
The analysis included ocrelizumab-exposed women in primarily European-based clinical trials in patients with MS, RA, or SLE, in whom doses ranged from 20 mg to 2,000 mg. These included three randomized trials of its use in MS, totaling 1,876 patients with a mean age of 40 years; four trials of its use in RA, totaling 2,759 patients with a mean age of 53 years; and one trial of its use in SLE, totaling 381 patients with a mean age of 31 years. Between 2008 and Sept. 14, 2015, a total of 48 women who were enrolled in the trials reported pregnancies.
MS data
Of the 15 pregnancies in the MS trials, three involved the delivery of full term, healthy newborns. In one case, the last ocrelizumab infusion was given 28 months before conception. In the second case, an infusion was given 20 weeks before conception, and a further infusion was given 17 days after conception. In the third case, the last ocrelizumab infusion was given 26.5 weeks before conception.
One live term birth occurred with an abnormal finding. In this case, the last infusion of ocrelizumab was 23 weeks prior to the last menstrual period or about 6 months prior to conception. The embryo/fetus was not exposed to the drug in utero. The researchers also found that seven elective terminations occurred among MS patients and that four pregnancies were ongoing at the time of this report.
“We have to be cautious because we don’t have enough data yet to know, but it’s encouraging to see that, if you follow the guidelines, the patient population and the newborns seem to be healthy in these exposed individuals,” Dr. Wray said.
RA data
Data from the RA clinical trials revealed 22 pregnancies in 21 patients exposed to ocrelizumab. Of these, eight pregnancies resulted in healthy term babies; four resulted in live births with abnormal findings (structural malformation, growth abnormality) or preterm birth; and eight pregnancies in seven women resulted in spontaneous abortion (one patient experienced a spontaneous abortion on two occasions), missed abortion, or an embryonic pregnancy. One pregnancy was lost to follow-up and another resulted in elective termination.
SLE data
During the SLE trials, 11 pregnancies occurred in 10 patients. Three pregnancies in two women resulted in healthy term babies. Three other pregnancies resulted in live births with an abnormal finding (structural malformation, functional deficit, growth abnormality) and/or preterm birth. Two pregnancies resulted in spontaneous/missed abortion. One pregnancy resulted in fetal death at 7.5 months’ gestation secondary to fatal pulmonary embolism in the mother; one pregnancy resulted in elective termination; and one pregnancy resulted in a healthy baby born at an unknown gestational week.
Dr. Wray emphasized that the small numbers of patients studied make it difficult to draw conclusions about pregnancy outcomes following ocrelizumab in patients with MS and other autoimmune diseases. “We need to pay attention to the half-life of this drug, the time it takes to clear, and how to plan pregnancies around that,” she said. She noted that pregnancy outcomes in ongoing ocrelizumab studies and postmarketing experiences will continue to be collected and assessed.
The study was funded by Roche, Basel, Switzerland. Dr. Wray reported that she has received honoraria and/or research funding from Actelion, Alkermes, Biogen, Celgene, EMD Serono, Genentech/Roche, Genzyme/Sanofi, Novartis, and TG Therapeutics.
NEW ORLEANS – Data from the ocrelizumab clinical development program gives clinicians a first look at pregnancy outcomes after exposure to the drug, but the small size limits the ability to draw firm conclusions.
In the United States, prescribing information for ocrelizumab states that women of childbearing potential should use contraception while receiving ocrelizumab and for 6 months after the last infusion. At the annual meeting of the Consortium of Multiple Sclerosis Centers, researchers led by Sibyl Wray, MD, set out to assess the pregnancy, fetal, neonatal and infant outcomes in patients who became pregnant during ocrelizumab trials in MS, rheumatoid arthritis (RA), and systemic lupus erythematosus (SLE) through Sept. 15, 2015.
The analysis included ocrelizumab-exposed women in primarily European-based clinical trials in patients with MS, RA, or SLE, in whom doses ranged from 20 mg to 2,000 mg. These included three randomized trials of its use in MS, totaling 1,876 patients with a mean age of 40 years; four trials of its use in RA, totaling 2,759 patients with a mean age of 53 years; and one trial of its use in SLE, totaling 381 patients with a mean age of 31 years. Between 2008 and Sept. 14, 2015, a total of 48 women who were enrolled in the trials reported pregnancies.
MS data
Of the 15 pregnancies in the MS trials, three involved the delivery of full term, healthy newborns. In one case, the last ocrelizumab infusion was given 28 months before conception. In the second case, an infusion was given 20 weeks before conception, and a further infusion was given 17 days after conception. In the third case, the last ocrelizumab infusion was given 26.5 weeks before conception.
One live term birth occurred with an abnormal finding. In this case, the last infusion of ocrelizumab was 23 weeks prior to the last menstrual period or about 6 months prior to conception. The embryo/fetus was not exposed to the drug in utero. The researchers also found that seven elective terminations occurred among MS patients and that four pregnancies were ongoing at the time of this report.
“We have to be cautious because we don’t have enough data yet to know, but it’s encouraging to see that, if you follow the guidelines, the patient population and the newborns seem to be healthy in these exposed individuals,” Dr. Wray said.
RA data
Data from the RA clinical trials revealed 22 pregnancies in 21 patients exposed to ocrelizumab. Of these, eight pregnancies resulted in healthy term babies; four resulted in live births with abnormal findings (structural malformation, growth abnormality) or preterm birth; and eight pregnancies in seven women resulted in spontaneous abortion (one patient experienced a spontaneous abortion on two occasions), missed abortion, or an embryonic pregnancy. One pregnancy was lost to follow-up and another resulted in elective termination.
SLE data
During the SLE trials, 11 pregnancies occurred in 10 patients. Three pregnancies in two women resulted in healthy term babies. Three other pregnancies resulted in live births with an abnormal finding (structural malformation, functional deficit, growth abnormality) and/or preterm birth. Two pregnancies resulted in spontaneous/missed abortion. One pregnancy resulted in fetal death at 7.5 months’ gestation secondary to fatal pulmonary embolism in the mother; one pregnancy resulted in elective termination; and one pregnancy resulted in a healthy baby born at an unknown gestational week.
Dr. Wray emphasized that the small numbers of patients studied make it difficult to draw conclusions about pregnancy outcomes following ocrelizumab in patients with MS and other autoimmune diseases. “We need to pay attention to the half-life of this drug, the time it takes to clear, and how to plan pregnancies around that,” she said. She noted that pregnancy outcomes in ongoing ocrelizumab studies and postmarketing experiences will continue to be collected and assessed.
The study was funded by Roche, Basel, Switzerland. Dr. Wray reported that she has received honoraria and/or research funding from Actelion, Alkermes, Biogen, Celgene, EMD Serono, Genentech/Roche, Genzyme/Sanofi, Novartis, and TG Therapeutics.
NEW ORLEANS – Data from the ocrelizumab clinical development program gives clinicians a first look at pregnancy outcomes after exposure to the drug, but the small size limits the ability to draw firm conclusions.
In the United States, prescribing information for ocrelizumab states that women of childbearing potential should use contraception while receiving ocrelizumab and for 6 months after the last infusion. At the annual meeting of the Consortium of Multiple Sclerosis Centers, researchers led by Sibyl Wray, MD, set out to assess the pregnancy, fetal, neonatal and infant outcomes in patients who became pregnant during ocrelizumab trials in MS, rheumatoid arthritis (RA), and systemic lupus erythematosus (SLE) through Sept. 15, 2015.
The analysis included ocrelizumab-exposed women in primarily European-based clinical trials in patients with MS, RA, or SLE, in whom doses ranged from 20 mg to 2,000 mg. These included three randomized trials of its use in MS, totaling 1,876 patients with a mean age of 40 years; four trials of its use in RA, totaling 2,759 patients with a mean age of 53 years; and one trial of its use in SLE, totaling 381 patients with a mean age of 31 years. Between 2008 and Sept. 14, 2015, a total of 48 women who were enrolled in the trials reported pregnancies.
MS data
Of the 15 pregnancies in the MS trials, three involved the delivery of full term, healthy newborns. In one case, the last ocrelizumab infusion was given 28 months before conception. In the second case, an infusion was given 20 weeks before conception, and a further infusion was given 17 days after conception. In the third case, the last ocrelizumab infusion was given 26.5 weeks before conception.
One live term birth occurred with an abnormal finding. In this case, the last infusion of ocrelizumab was 23 weeks prior to the last menstrual period or about 6 months prior to conception. The embryo/fetus was not exposed to the drug in utero. The researchers also found that seven elective terminations occurred among MS patients and that four pregnancies were ongoing at the time of this report.
“We have to be cautious because we don’t have enough data yet to know, but it’s encouraging to see that, if you follow the guidelines, the patient population and the newborns seem to be healthy in these exposed individuals,” Dr. Wray said.
RA data
Data from the RA clinical trials revealed 22 pregnancies in 21 patients exposed to ocrelizumab. Of these, eight pregnancies resulted in healthy term babies; four resulted in live births with abnormal findings (structural malformation, growth abnormality) or preterm birth; and eight pregnancies in seven women resulted in spontaneous abortion (one patient experienced a spontaneous abortion on two occasions), missed abortion, or an embryonic pregnancy. One pregnancy was lost to follow-up and another resulted in elective termination.
SLE data
During the SLE trials, 11 pregnancies occurred in 10 patients. Three pregnancies in two women resulted in healthy term babies. Three other pregnancies resulted in live births with an abnormal finding (structural malformation, functional deficit, growth abnormality) and/or preterm birth. Two pregnancies resulted in spontaneous/missed abortion. One pregnancy resulted in fetal death at 7.5 months’ gestation secondary to fatal pulmonary embolism in the mother; one pregnancy resulted in elective termination; and one pregnancy resulted in a healthy baby born at an unknown gestational week.
Dr. Wray emphasized that the small numbers of patients studied make it difficult to draw conclusions about pregnancy outcomes following ocrelizumab in patients with MS and other autoimmune diseases. “We need to pay attention to the half-life of this drug, the time it takes to clear, and how to plan pregnancies around that,” she said. She noted that pregnancy outcomes in ongoing ocrelizumab studies and postmarketing experiences will continue to be collected and assessed.
The study was funded by Roche, Basel, Switzerland. Dr. Wray reported that she has received honoraria and/or research funding from Actelion, Alkermes, Biogen, Celgene, EMD Serono, Genentech/Roche, Genzyme/Sanofi, Novartis, and TG Therapeutics.
AT THE CMSC ANNUAL MEETING
Key clinical point:
Major finding: Of 15 pregnancies in the MS trials, three involved the delivery of three full term, healthy newborns; one live term birth occurred with an abnormal finding; seven elective terminations occurred; and four pregnancies were ongoing.
Data source: A review of 48 pregnancies among women enrolled in clinical trials for ocrelizumab in MS, rheumatoid arthritis, and systemic lupus erythematosus.
Disclosures: The study was funded by Roche, Basel, Switzerland. Dr. Wray reported that she has received honoraria and/or research funding from Actelion, Alkermes, Biogen, Celgene, EMD Serono, Genentech/Roche, Genzyme/Sanofi, Novartis, and TG Therapeutics.
Politics and Planned Parenthood
WHAT LIES AHEAD FOR WOMEN’S HEALTH? CHALLENGES, AND OPPORTUNITIES, AS ACOG AND US LEADERSHIP TRANSITION
LUCIA DIVENERE, MA
Politics and Planned Parenthood
As obstetricians and gynecologists, we are all dedicated to women's health care. Many of us are Pro-Life and resent your unqualified support of Planned Parenthood, the world’s largest provider and supporter of unrestricted abortion. There are many venues to deliver women's health care. We should not be cheerleaders for the Planned Parenthood/Democratic party propaganda. As you stated, we should be truly a-political.
Laurence Burns, DO
Grand Rapids, Michigan
Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.
WHAT LIES AHEAD FOR WOMEN’S HEALTH? CHALLENGES, AND OPPORTUNITIES, AS ACOG AND US LEADERSHIP TRANSITION
LUCIA DIVENERE, MA
Politics and Planned Parenthood
As obstetricians and gynecologists, we are all dedicated to women's health care. Many of us are Pro-Life and resent your unqualified support of Planned Parenthood, the world’s largest provider and supporter of unrestricted abortion. There are many venues to deliver women's health care. We should not be cheerleaders for the Planned Parenthood/Democratic party propaganda. As you stated, we should be truly a-political.
Laurence Burns, DO
Grand Rapids, Michigan
Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.
WHAT LIES AHEAD FOR WOMEN’S HEALTH? CHALLENGES, AND OPPORTUNITIES, AS ACOG AND US LEADERSHIP TRANSITION
LUCIA DIVENERE, MA
Politics and Planned Parenthood
As obstetricians and gynecologists, we are all dedicated to women's health care. Many of us are Pro-Life and resent your unqualified support of Planned Parenthood, the world’s largest provider and supporter of unrestricted abortion. There are many venues to deliver women's health care. We should not be cheerleaders for the Planned Parenthood/Democratic party propaganda. As you stated, we should be truly a-political.
Laurence Burns, DO
Grand Rapids, Michigan
Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.
BMS recalls a lot of Eliquis 5 mg tablets
Bristol-Myers Squibb is recalling one lot of Eliquis (apixaban) tablets, according to a company announcement on the Food and Drug Administration website.
The recall is based on a customer complaint that a bottle labeled as containing 5 mg tablets of Eliquis actually contained 2.5 mg tablets of Eliquis. The lot in question was distributed nationwide to wholesalers and retail pharmacies in February 2017. The recall is voluntary, the company noted.
“There are distinct visible differences between the two tablet strengths, including colors, size, and markings that distinguish the 2.5 mg and 5 mg tablets and decrease the likelihood of an incorrect dose,” Bristol-Myers Squibb noted in the press release.
Find the full Bristol-Myers Squibb press release on the FDA website.
Bristol-Myers Squibb is recalling one lot of Eliquis (apixaban) tablets, according to a company announcement on the Food and Drug Administration website.
The recall is based on a customer complaint that a bottle labeled as containing 5 mg tablets of Eliquis actually contained 2.5 mg tablets of Eliquis. The lot in question was distributed nationwide to wholesalers and retail pharmacies in February 2017. The recall is voluntary, the company noted.
“There are distinct visible differences between the two tablet strengths, including colors, size, and markings that distinguish the 2.5 mg and 5 mg tablets and decrease the likelihood of an incorrect dose,” Bristol-Myers Squibb noted in the press release.
Find the full Bristol-Myers Squibb press release on the FDA website.
Bristol-Myers Squibb is recalling one lot of Eliquis (apixaban) tablets, according to a company announcement on the Food and Drug Administration website.
The recall is based on a customer complaint that a bottle labeled as containing 5 mg tablets of Eliquis actually contained 2.5 mg tablets of Eliquis. The lot in question was distributed nationwide to wholesalers and retail pharmacies in February 2017. The recall is voluntary, the company noted.
“There are distinct visible differences between the two tablet strengths, including colors, size, and markings that distinguish the 2.5 mg and 5 mg tablets and decrease the likelihood of an incorrect dose,” Bristol-Myers Squibb noted in the press release.
Find the full Bristol-Myers Squibb press release on the FDA website.
Whole blood PCR improves diagnosis of pediatric bacterial sepsis
MADRID – Whole blood multiplex polymerase chain reaction (PCR) holds considerable promise as a rapid noninvasive test to improve diagnosis of life-threatening bacterial infections in children with suspected sepsis yet negative blood cultures, Clare Thakker, MD, reported at the annual meeting of the European Society for Paediatric Infectious Diseases.
There are several disadvantages with blood cultures – the current diagnostic standard. The turnaround time is 48 hours or longer. Moreover, false-negative culture results are common because of prior antibiotic therapy. And blood cultures require a considerable amount of blood, which becomes an issue in younger children with small blood volumes. Whole blood PCR is unfettered by these limitations, and it could reduce the need for invasive sampling, such as pleural or joint aspiration or CSF sampling, in blood culture–negative children, observed Dr. Thakker of Imperial College London.
The challenge posed by febrile children is that even though the vast majority will turn out to have a self-limited viral illness, a small proportion will have a life-threatening bacterial infection. And distinguishing between the two groups in timely fashion often remains difficult today, the pediatrician said.
Dr. Thakker reported on 504 EUCLIDS participants with suspected sepsis who had blood cultures and whole blood PCR testing done on the same day. The multiplex PCR, developed by Micropathology of Coventry, England, was set up to test simultaneously for five clinically important bacterial pathogens: Neisseria meningitidis, Streptococcus pneumoniae, S. pyogenes, Staphylococcus aureus, and Haemophilus influenzae. Prior to testing, the blood samples underwent lysozyme/lysostaphin digestion and silica bead disruption in order to break down cell walls and facilitate nucleic acid extraction.
Of the 504 children with suspected sepsis, 438 (87%) had negative blood cultures, among whom were 326 patients (74%) with clinically suspected or definite bacterial infection. The PCR test identified one of the five target pathogens in 25 of the 326 patients (8%) where physicians suspected bacterial sepsis despite negative cultures. Ten blood culture-negative patients (40%) were whole blood PCR positive for N. meningitidis, 6 (24%) for H. influenzae, 5 (20%) for S. pneumoniae, 3 (12%) for S. aureus, and 1 (4%) for S. pyogenes. Three of the 25 positive tests showed poor clinical correlation consistent with environmental contamination. The other 22 positive PCR results were consistent with the patient’s clinical syndrome – for example, N. meningitidis being found in the blood of a child with meningeal encephalitis – or concordant with the results of a culture obtained invasively at a sterile body site.
Ninety-two patients with negative blood cultures were culture positive for a causative bacterial pathogen obtained by invasive sampling of a sterile body site such as the CSF. In 68 of these 92 cases (74%), the pathogen was among those on the multiplex PCR panel.
“Our study results bring into question whether blood culture should be the gold standard; clearly, blood culture is not capturing everything. Our findings also highlight the need for developing additional diagnostic markers, maybe based upon the host inflammatory response, to delineate which of these detections are pathogens and which are passengers,” Dr. Thakker said.
She reported having no relevant financial conflicts regarding the European Union–sponsored study.
MADRID – Whole blood multiplex polymerase chain reaction (PCR) holds considerable promise as a rapid noninvasive test to improve diagnosis of life-threatening bacterial infections in children with suspected sepsis yet negative blood cultures, Clare Thakker, MD, reported at the annual meeting of the European Society for Paediatric Infectious Diseases.
There are several disadvantages with blood cultures – the current diagnostic standard. The turnaround time is 48 hours or longer. Moreover, false-negative culture results are common because of prior antibiotic therapy. And blood cultures require a considerable amount of blood, which becomes an issue in younger children with small blood volumes. Whole blood PCR is unfettered by these limitations, and it could reduce the need for invasive sampling, such as pleural or joint aspiration or CSF sampling, in blood culture–negative children, observed Dr. Thakker of Imperial College London.
The challenge posed by febrile children is that even though the vast majority will turn out to have a self-limited viral illness, a small proportion will have a life-threatening bacterial infection. And distinguishing between the two groups in timely fashion often remains difficult today, the pediatrician said.
Dr. Thakker reported on 504 EUCLIDS participants with suspected sepsis who had blood cultures and whole blood PCR testing done on the same day. The multiplex PCR, developed by Micropathology of Coventry, England, was set up to test simultaneously for five clinically important bacterial pathogens: Neisseria meningitidis, Streptococcus pneumoniae, S. pyogenes, Staphylococcus aureus, and Haemophilus influenzae. Prior to testing, the blood samples underwent lysozyme/lysostaphin digestion and silica bead disruption in order to break down cell walls and facilitate nucleic acid extraction.
Of the 504 children with suspected sepsis, 438 (87%) had negative blood cultures, among whom were 326 patients (74%) with clinically suspected or definite bacterial infection. The PCR test identified one of the five target pathogens in 25 of the 326 patients (8%) where physicians suspected bacterial sepsis despite negative cultures. Ten blood culture-negative patients (40%) were whole blood PCR positive for N. meningitidis, 6 (24%) for H. influenzae, 5 (20%) for S. pneumoniae, 3 (12%) for S. aureus, and 1 (4%) for S. pyogenes. Three of the 25 positive tests showed poor clinical correlation consistent with environmental contamination. The other 22 positive PCR results were consistent with the patient’s clinical syndrome – for example, N. meningitidis being found in the blood of a child with meningeal encephalitis – or concordant with the results of a culture obtained invasively at a sterile body site.
Ninety-two patients with negative blood cultures were culture positive for a causative bacterial pathogen obtained by invasive sampling of a sterile body site such as the CSF. In 68 of these 92 cases (74%), the pathogen was among those on the multiplex PCR panel.
“Our study results bring into question whether blood culture should be the gold standard; clearly, blood culture is not capturing everything. Our findings also highlight the need for developing additional diagnostic markers, maybe based upon the host inflammatory response, to delineate which of these detections are pathogens and which are passengers,” Dr. Thakker said.
She reported having no relevant financial conflicts regarding the European Union–sponsored study.
MADRID – Whole blood multiplex polymerase chain reaction (PCR) holds considerable promise as a rapid noninvasive test to improve diagnosis of life-threatening bacterial infections in children with suspected sepsis yet negative blood cultures, Clare Thakker, MD, reported at the annual meeting of the European Society for Paediatric Infectious Diseases.
There are several disadvantages with blood cultures – the current diagnostic standard. The turnaround time is 48 hours or longer. Moreover, false-negative culture results are common because of prior antibiotic therapy. And blood cultures require a considerable amount of blood, which becomes an issue in younger children with small blood volumes. Whole blood PCR is unfettered by these limitations, and it could reduce the need for invasive sampling, such as pleural or joint aspiration or CSF sampling, in blood culture–negative children, observed Dr. Thakker of Imperial College London.
The challenge posed by febrile children is that even though the vast majority will turn out to have a self-limited viral illness, a small proportion will have a life-threatening bacterial infection. And distinguishing between the two groups in timely fashion often remains difficult today, the pediatrician said.
Dr. Thakker reported on 504 EUCLIDS participants with suspected sepsis who had blood cultures and whole blood PCR testing done on the same day. The multiplex PCR, developed by Micropathology of Coventry, England, was set up to test simultaneously for five clinically important bacterial pathogens: Neisseria meningitidis, Streptococcus pneumoniae, S. pyogenes, Staphylococcus aureus, and Haemophilus influenzae. Prior to testing, the blood samples underwent lysozyme/lysostaphin digestion and silica bead disruption in order to break down cell walls and facilitate nucleic acid extraction.
Of the 504 children with suspected sepsis, 438 (87%) had negative blood cultures, among whom were 326 patients (74%) with clinically suspected or definite bacterial infection. The PCR test identified one of the five target pathogens in 25 of the 326 patients (8%) where physicians suspected bacterial sepsis despite negative cultures. Ten blood culture-negative patients (40%) were whole blood PCR positive for N. meningitidis, 6 (24%) for H. influenzae, 5 (20%) for S. pneumoniae, 3 (12%) for S. aureus, and 1 (4%) for S. pyogenes. Three of the 25 positive tests showed poor clinical correlation consistent with environmental contamination. The other 22 positive PCR results were consistent with the patient’s clinical syndrome – for example, N. meningitidis being found in the blood of a child with meningeal encephalitis – or concordant with the results of a culture obtained invasively at a sterile body site.
Ninety-two patients with negative blood cultures were culture positive for a causative bacterial pathogen obtained by invasive sampling of a sterile body site such as the CSF. In 68 of these 92 cases (74%), the pathogen was among those on the multiplex PCR panel.
“Our study results bring into question whether blood culture should be the gold standard; clearly, blood culture is not capturing everything. Our findings also highlight the need for developing additional diagnostic markers, maybe based upon the host inflammatory response, to delineate which of these detections are pathogens and which are passengers,” Dr. Thakker said.
She reported having no relevant financial conflicts regarding the European Union–sponsored study.
AT ESPID 2017
Key clinical point:
Major finding: Twenty-five of 326 children (8%) clinically suspected of having bacterial sepsis despite negative blood cultures proved positive for one of five important bacterial pathogens upon whole blood multiplex PCR testing .
Data source: EUCLIDS, a large, ongoing, 5-year international genomic study aimed at learning why some children with a bacterial infection develop serious illness while others do not.
Disclosures: The European Union sponsored the study. Dr. Thakker reported having no relevant financial conflicts.
Identifying type 1 diabetes drivers at risk of mishaps
A risk assessment score could help identify individuals with type 1 diabetes who are at higher risk of driving mishaps and who may benefit from interventions to reduce their risk, a new study suggests.
Writing in the June edition of Diabetes Care, Daniel J. Cox, MD, of the University of Virginia, Charlottesville, and his coauthors reported on their efforts to develop and validate a “Risk Assessment of Diabetic Drivers” (RADD) scoring system.
In the first part of the two-part study, 1,371 drivers with type 1 diabetes filled out a series of questionnaires about diabetes and driving, then recorded their driving mishaps over the subsequent year (Diabetes Care. 2017;40:742-50).
This revealed that annual driving distance, peripheral neuropathy, number of past hypoglycemia-related driving mishaps, and the degree to which the individual is bothered by hypoglycemia in general were all significantly associated with a risk of future driving incidents.
Based on this, the authors developed a scoring system using these factors and identified the optimum cut-off point for maximum sensitivity and specificity.
“The area under the curve, a global measure of model performance, was estimated to be 0.73, indicating that the model performed better than chance at classifying participants into the two risk categories,” the authors wrote.
When applied to the original participants, the model classified 37.5% of them as being high-risk. This group had an average of 3.03 driving mishaps over the 12-month follow-up, compared with 0.87 mishaps in the participants who fell into the lowest 37.5% of risk (P = .002).
In the second part of the study, 1,737 drivers with type 1 diabetes completed a version of the scoring questionnaire online, and 118 low-risk and 372 high-risk individuals were recruited.
The high-risk individuals were randomized either to a 2-month online intervention that aimed at helping people with type 1 diabetes anticipate, prevent, detect, and treat hypoglycemia while driving, as well as a program of motivational interviewing, the online intervention alone, or routine care, with 12 months of follow-up. The low-risk individuals all received routine care only.
As with the first part of the study, researchers saw a significantly lower number of driving mishaps in the low-risk participants, compared with the high-risk participants (1.65 mishaps per driver per year vs. 4.26 mishaps per driver per year; P less than .001).
After adjusting for other factors such as age, sex, method of insulin delivery, and hypoglycemia awareness, the rate of mishaps was still 2.83 times higher in the high-risk group, compared with the low-risk group (P less than .001).
The authors noted that their RADD scoring system did have a false-negative rate of 24%, classifying people as low-risk even though they reported more than one driving mishap in the following 12 months.
“This illustrates that any driver has a risk of being involved in a collision or receiving a citation, and any driver with type 1 diabetes has the additional risk of experiencing disruptive extreme [blood glucose (BG)] that can result in a mishap while driving,” they wrote. “While, ideally, all drivers with type 1 diabetes should measure their BG before driving, they should at least be counseled that, whenever they take more insulin, eat fewer carbohydrates, or engage in more physical activity than usual, they should measure their BG before driving.”
With respect to the impact of the intervention and motivational interviewing, researchers found no significant differences in the rate of mishaps between the groups who received intervention plus interview and those who received the intervention alone, and, as a result, combined these two groups into one.
The high-risk group who underwent the online intervention had fewer driving mishaps than did the high-risk group who received routine care. However, they still had 1.58 times more incidents than did the low-risk individuals who received routine care.
The intervention decreased the risk of mishaps associated with hypoglycemia in high-risk individuals, compared with that in those who recieved routine care, but these individuals still had a higher incidence of hypoglycemia-associated mishaps, compared with the low-risk individuals.
“It is also important to note that [the online intervention] only affected hypoglycemia-related driving mishaps, not hyperglycemia- or nondiabetes-related mishaps,” the authors wrote.
The study was funded by the National Institutes of Health and supported in-kind by LifeScan, Abbott Laboratories, MyGlu.com, dLife.com, and Dex4.com.
A risk assessment score could help identify individuals with type 1 diabetes who are at higher risk of driving mishaps and who may benefit from interventions to reduce their risk, a new study suggests.
Writing in the June edition of Diabetes Care, Daniel J. Cox, MD, of the University of Virginia, Charlottesville, and his coauthors reported on their efforts to develop and validate a “Risk Assessment of Diabetic Drivers” (RADD) scoring system.
In the first part of the two-part study, 1,371 drivers with type 1 diabetes filled out a series of questionnaires about diabetes and driving, then recorded their driving mishaps over the subsequent year (Diabetes Care. 2017;40:742-50).
This revealed that annual driving distance, peripheral neuropathy, number of past hypoglycemia-related driving mishaps, and the degree to which the individual is bothered by hypoglycemia in general were all significantly associated with a risk of future driving incidents.
Based on this, the authors developed a scoring system using these factors and identified the optimum cut-off point for maximum sensitivity and specificity.
“The area under the curve, a global measure of model performance, was estimated to be 0.73, indicating that the model performed better than chance at classifying participants into the two risk categories,” the authors wrote.
When applied to the original participants, the model classified 37.5% of them as being high-risk. This group had an average of 3.03 driving mishaps over the 12-month follow-up, compared with 0.87 mishaps in the participants who fell into the lowest 37.5% of risk (P = .002).
In the second part of the study, 1,737 drivers with type 1 diabetes completed a version of the scoring questionnaire online, and 118 low-risk and 372 high-risk individuals were recruited.
The high-risk individuals were randomized either to a 2-month online intervention that aimed at helping people with type 1 diabetes anticipate, prevent, detect, and treat hypoglycemia while driving, as well as a program of motivational interviewing, the online intervention alone, or routine care, with 12 months of follow-up. The low-risk individuals all received routine care only.
As with the first part of the study, researchers saw a significantly lower number of driving mishaps in the low-risk participants, compared with the high-risk participants (1.65 mishaps per driver per year vs. 4.26 mishaps per driver per year; P less than .001).
After adjusting for other factors such as age, sex, method of insulin delivery, and hypoglycemia awareness, the rate of mishaps was still 2.83 times higher in the high-risk group, compared with the low-risk group (P less than .001).
The authors noted that their RADD scoring system did have a false-negative rate of 24%, classifying people as low-risk even though they reported more than one driving mishap in the following 12 months.
“This illustrates that any driver has a risk of being involved in a collision or receiving a citation, and any driver with type 1 diabetes has the additional risk of experiencing disruptive extreme [blood glucose (BG)] that can result in a mishap while driving,” they wrote. “While, ideally, all drivers with type 1 diabetes should measure their BG before driving, they should at least be counseled that, whenever they take more insulin, eat fewer carbohydrates, or engage in more physical activity than usual, they should measure their BG before driving.”
With respect to the impact of the intervention and motivational interviewing, researchers found no significant differences in the rate of mishaps between the groups who received intervention plus interview and those who received the intervention alone, and, as a result, combined these two groups into one.
The high-risk group who underwent the online intervention had fewer driving mishaps than did the high-risk group who received routine care. However, they still had 1.58 times more incidents than did the low-risk individuals who received routine care.
The intervention decreased the risk of mishaps associated with hypoglycemia in high-risk individuals, compared with that in those who recieved routine care, but these individuals still had a higher incidence of hypoglycemia-associated mishaps, compared with the low-risk individuals.
“It is also important to note that [the online intervention] only affected hypoglycemia-related driving mishaps, not hyperglycemia- or nondiabetes-related mishaps,” the authors wrote.
The study was funded by the National Institutes of Health and supported in-kind by LifeScan, Abbott Laboratories, MyGlu.com, dLife.com, and Dex4.com.
A risk assessment score could help identify individuals with type 1 diabetes who are at higher risk of driving mishaps and who may benefit from interventions to reduce their risk, a new study suggests.
Writing in the June edition of Diabetes Care, Daniel J. Cox, MD, of the University of Virginia, Charlottesville, and his coauthors reported on their efforts to develop and validate a “Risk Assessment of Diabetic Drivers” (RADD) scoring system.
In the first part of the two-part study, 1,371 drivers with type 1 diabetes filled out a series of questionnaires about diabetes and driving, then recorded their driving mishaps over the subsequent year (Diabetes Care. 2017;40:742-50).
This revealed that annual driving distance, peripheral neuropathy, number of past hypoglycemia-related driving mishaps, and the degree to which the individual is bothered by hypoglycemia in general were all significantly associated with a risk of future driving incidents.
Based on this, the authors developed a scoring system using these factors and identified the optimum cut-off point for maximum sensitivity and specificity.
“The area under the curve, a global measure of model performance, was estimated to be 0.73, indicating that the model performed better than chance at classifying participants into the two risk categories,” the authors wrote.
When applied to the original participants, the model classified 37.5% of them as being high-risk. This group had an average of 3.03 driving mishaps over the 12-month follow-up, compared with 0.87 mishaps in the participants who fell into the lowest 37.5% of risk (P = .002).
In the second part of the study, 1,737 drivers with type 1 diabetes completed a version of the scoring questionnaire online, and 118 low-risk and 372 high-risk individuals were recruited.
The high-risk individuals were randomized either to a 2-month online intervention that aimed at helping people with type 1 diabetes anticipate, prevent, detect, and treat hypoglycemia while driving, as well as a program of motivational interviewing, the online intervention alone, or routine care, with 12 months of follow-up. The low-risk individuals all received routine care only.
As with the first part of the study, researchers saw a significantly lower number of driving mishaps in the low-risk participants, compared with the high-risk participants (1.65 mishaps per driver per year vs. 4.26 mishaps per driver per year; P less than .001).
After adjusting for other factors such as age, sex, method of insulin delivery, and hypoglycemia awareness, the rate of mishaps was still 2.83 times higher in the high-risk group, compared with the low-risk group (P less than .001).
The authors noted that their RADD scoring system did have a false-negative rate of 24%, classifying people as low-risk even though they reported more than one driving mishap in the following 12 months.
“This illustrates that any driver has a risk of being involved in a collision or receiving a citation, and any driver with type 1 diabetes has the additional risk of experiencing disruptive extreme [blood glucose (BG)] that can result in a mishap while driving,” they wrote. “While, ideally, all drivers with type 1 diabetes should measure their BG before driving, they should at least be counseled that, whenever they take more insulin, eat fewer carbohydrates, or engage in more physical activity than usual, they should measure their BG before driving.”
With respect to the impact of the intervention and motivational interviewing, researchers found no significant differences in the rate of mishaps between the groups who received intervention plus interview and those who received the intervention alone, and, as a result, combined these two groups into one.
The high-risk group who underwent the online intervention had fewer driving mishaps than did the high-risk group who received routine care. However, they still had 1.58 times more incidents than did the low-risk individuals who received routine care.
The intervention decreased the risk of mishaps associated with hypoglycemia in high-risk individuals, compared with that in those who recieved routine care, but these individuals still had a higher incidence of hypoglycemia-associated mishaps, compared with the low-risk individuals.
“It is also important to note that [the online intervention] only affected hypoglycemia-related driving mishaps, not hyperglycemia- or nondiabetes-related mishaps,” the authors wrote.
The study was funded by the National Institutes of Health and supported in-kind by LifeScan, Abbott Laboratories, MyGlu.com, dLife.com, and Dex4.com.
FROM DIABETES CARE
Key clinical point: A scoring questionnaire could help identify drivers with type 1 diabetes at greater risk of driving mishaps and those who could benefit from an intervention to reduce their risk.
Major finding: Individuals with type 1 diabetes who were classified as high-risk according to a scoring system had a more than threefold greater incidence of driving mishaps than those classified as low-risk.
Data source: A two-part study in 1,371 and 1,737 drivers with type 1 diabetes.
Disclosures: The study was funded by the National Institutes of Health and supported in-kind by LifeScan, Abbott Laboratories, MyGlu.com, dLife.com, and Dex4.com.
Earlier childhood measles vaccination elevates the risk of vaccine failure
of age or younger, compared with 15 months of age or older, said Sara Carazo Perez, MD, PhD, of Laval University, Quebec City, and her associates.
Studies suggest that measles elimination “requires the maintenance of population immunity above 92%-94%.” So, “the additional protection of 3%-5% of vaccinated children against secondary vaccine failures by postponing the first dose from 12 to 15 months of age would be significant, and the risk would be minimal in countries that achieved elimination” of measles, said Dr. Perez and her colleagues.
The percentage of children who were seronegative for measles after being vaccinated decreased significantly with older age at the first dose, from 8.5% in children vaccinated at 11 months to 3.2%, 2.4%, and 1.5% with vaccination at 12 months, 13-14 months, and 15-22 months, respectively (P less than .001).
Geometric mean concentrations (GMC) after the second dose were highly correlated with GMCs after the first dose.
The investigators then performed multivariable analysis, adjusting for the type of vaccine, the country, and the study. GMCs rose significantly with older age at first dose. Children vaccinated at 11 months had a 23% lower GMC and 30% increased risk of seronegativity than children vaccinated at 12 months.
In children first vaccinated at 13-14 months or 15-22 months, GMCs were 1.21 and 1.37 times greater than in children vaccinated at 12 months, respectively, and their risks for seronegativity were 49% and 71% lower, respectively.
“After two doses, the association between the age at first dose and the GMC was slightly weaker but still significant,” the researchers said.
Read more in the journal Clinical Infectious Diseases (2017 Jun 8. doi: 10.1093/cid/cix510).
of age or younger, compared with 15 months of age or older, said Sara Carazo Perez, MD, PhD, of Laval University, Quebec City, and her associates.
Studies suggest that measles elimination “requires the maintenance of population immunity above 92%-94%.” So, “the additional protection of 3%-5% of vaccinated children against secondary vaccine failures by postponing the first dose from 12 to 15 months of age would be significant, and the risk would be minimal in countries that achieved elimination” of measles, said Dr. Perez and her colleagues.
The percentage of children who were seronegative for measles after being vaccinated decreased significantly with older age at the first dose, from 8.5% in children vaccinated at 11 months to 3.2%, 2.4%, and 1.5% with vaccination at 12 months, 13-14 months, and 15-22 months, respectively (P less than .001).
Geometric mean concentrations (GMC) after the second dose were highly correlated with GMCs after the first dose.
The investigators then performed multivariable analysis, adjusting for the type of vaccine, the country, and the study. GMCs rose significantly with older age at first dose. Children vaccinated at 11 months had a 23% lower GMC and 30% increased risk of seronegativity than children vaccinated at 12 months.
In children first vaccinated at 13-14 months or 15-22 months, GMCs were 1.21 and 1.37 times greater than in children vaccinated at 12 months, respectively, and their risks for seronegativity were 49% and 71% lower, respectively.
“After two doses, the association between the age at first dose and the GMC was slightly weaker but still significant,” the researchers said.
Read more in the journal Clinical Infectious Diseases (2017 Jun 8. doi: 10.1093/cid/cix510).
of age or younger, compared with 15 months of age or older, said Sara Carazo Perez, MD, PhD, of Laval University, Quebec City, and her associates.
Studies suggest that measles elimination “requires the maintenance of population immunity above 92%-94%.” So, “the additional protection of 3%-5% of vaccinated children against secondary vaccine failures by postponing the first dose from 12 to 15 months of age would be significant, and the risk would be minimal in countries that achieved elimination” of measles, said Dr. Perez and her colleagues.
The percentage of children who were seronegative for measles after being vaccinated decreased significantly with older age at the first dose, from 8.5% in children vaccinated at 11 months to 3.2%, 2.4%, and 1.5% with vaccination at 12 months, 13-14 months, and 15-22 months, respectively (P less than .001).
Geometric mean concentrations (GMC) after the second dose were highly correlated with GMCs after the first dose.
The investigators then performed multivariable analysis, adjusting for the type of vaccine, the country, and the study. GMCs rose significantly with older age at first dose. Children vaccinated at 11 months had a 23% lower GMC and 30% increased risk of seronegativity than children vaccinated at 12 months.
In children first vaccinated at 13-14 months or 15-22 months, GMCs were 1.21 and 1.37 times greater than in children vaccinated at 12 months, respectively, and their risks for seronegativity were 49% and 71% lower, respectively.
“After two doses, the association between the age at first dose and the GMC was slightly weaker but still significant,” the researchers said.
Read more in the journal Clinical Infectious Diseases (2017 Jun 8. doi: 10.1093/cid/cix510).
FROM CLINICAL INFECTIOUS DISEASES
See one, do one ...
It rolls off your tongue so easily. See-one, do-one, teach-one has been the mantra recited to doctors-in-training for hundreds of years. It purports to characterize the process by which technical skills are passed from one generation of physicians to the next. However, you know as well as I do that the process of learning a skill such as performing a lumbar puncture on a squirming 6-month-old almost never conforms to the see-one, do-one, teach-one dictum.
Although I recall that it was not until my 7th birthday that I could consistently and confidently tie my own shoes, I consider myself reasonably dexterous. As a woodcarver, I was comfortable around sharp instruments, but that comfort zone quickly disappeared when it came to poking and cutting another human being who had nerves and blood vessels.
In a Pediatric Perspective in the June 2017 issue of Pediatrics, two anesthesiologists at Texas Children’s Hospital in Houston and the Children’s Hospital of Philadelphia address that question of, How many tries is reasonable for a physician attempting to learn a new technique (“When Should Trainees Call for Help with Invasive Procedures?” Pediatrics. 2017, June. doi: 10.1542/peds.2016-3673)? They illustrate their insightful discussion with the gruesome image of the wrist of an infant who had endured 21 attempts at percutaneous arterial line placement.
In addition to direct supervision, the authors recommend that instructors engage the trainee in a preprocedure discussion that includes setting a predetermined number of unsuccessful attempts at which the trainee will stop and ask for help. They suggest that the “trainee should be taught the self-insight to summon a more experienced provider or perhaps just a fresh pair of hands.”
For the general pediatrician or family physician, many of the technical skills we learned in training are likely to fade from disuse in the real world of office practice. However, learning when and how to step back in the face of multiple failures is a skill that every physician will continue to use regardless of where he or she is on his or her professional trajectory.
It isn’t always easy. It challenges our egos to ask for help when we have failed at making the diagnosis or not chosen the most effective therapy. At a minimum, stepping back and taking a deep breath (or three) may allow us a window through which we can finally see outside the box we find ourselves in.
Persistence is an attribute that allowed us to navigate the long and challenging path of our medical education. But, there are situations when it gets in the way of good medical care.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at [email protected].
It rolls off your tongue so easily. See-one, do-one, teach-one has been the mantra recited to doctors-in-training for hundreds of years. It purports to characterize the process by which technical skills are passed from one generation of physicians to the next. However, you know as well as I do that the process of learning a skill such as performing a lumbar puncture on a squirming 6-month-old almost never conforms to the see-one, do-one, teach-one dictum.
Although I recall that it was not until my 7th birthday that I could consistently and confidently tie my own shoes, I consider myself reasonably dexterous. As a woodcarver, I was comfortable around sharp instruments, but that comfort zone quickly disappeared when it came to poking and cutting another human being who had nerves and blood vessels.
In a Pediatric Perspective in the June 2017 issue of Pediatrics, two anesthesiologists at Texas Children’s Hospital in Houston and the Children’s Hospital of Philadelphia address that question of, How many tries is reasonable for a physician attempting to learn a new technique (“When Should Trainees Call for Help with Invasive Procedures?” Pediatrics. 2017, June. doi: 10.1542/peds.2016-3673)? They illustrate their insightful discussion with the gruesome image of the wrist of an infant who had endured 21 attempts at percutaneous arterial line placement.
In addition to direct supervision, the authors recommend that instructors engage the trainee in a preprocedure discussion that includes setting a predetermined number of unsuccessful attempts at which the trainee will stop and ask for help. They suggest that the “trainee should be taught the self-insight to summon a more experienced provider or perhaps just a fresh pair of hands.”
For the general pediatrician or family physician, many of the technical skills we learned in training are likely to fade from disuse in the real world of office practice. However, learning when and how to step back in the face of multiple failures is a skill that every physician will continue to use regardless of where he or she is on his or her professional trajectory.
It isn’t always easy. It challenges our egos to ask for help when we have failed at making the diagnosis or not chosen the most effective therapy. At a minimum, stepping back and taking a deep breath (or three) may allow us a window through which we can finally see outside the box we find ourselves in.
Persistence is an attribute that allowed us to navigate the long and challenging path of our medical education. But, there are situations when it gets in the way of good medical care.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at [email protected].
It rolls off your tongue so easily. See-one, do-one, teach-one has been the mantra recited to doctors-in-training for hundreds of years. It purports to characterize the process by which technical skills are passed from one generation of physicians to the next. However, you know as well as I do that the process of learning a skill such as performing a lumbar puncture on a squirming 6-month-old almost never conforms to the see-one, do-one, teach-one dictum.
Although I recall that it was not until my 7th birthday that I could consistently and confidently tie my own shoes, I consider myself reasonably dexterous. As a woodcarver, I was comfortable around sharp instruments, but that comfort zone quickly disappeared when it came to poking and cutting another human being who had nerves and blood vessels.
In a Pediatric Perspective in the June 2017 issue of Pediatrics, two anesthesiologists at Texas Children’s Hospital in Houston and the Children’s Hospital of Philadelphia address that question of, How many tries is reasonable for a physician attempting to learn a new technique (“When Should Trainees Call for Help with Invasive Procedures?” Pediatrics. 2017, June. doi: 10.1542/peds.2016-3673)? They illustrate their insightful discussion with the gruesome image of the wrist of an infant who had endured 21 attempts at percutaneous arterial line placement.
In addition to direct supervision, the authors recommend that instructors engage the trainee in a preprocedure discussion that includes setting a predetermined number of unsuccessful attempts at which the trainee will stop and ask for help. They suggest that the “trainee should be taught the self-insight to summon a more experienced provider or perhaps just a fresh pair of hands.”
For the general pediatrician or family physician, many of the technical skills we learned in training are likely to fade from disuse in the real world of office practice. However, learning when and how to step back in the face of multiple failures is a skill that every physician will continue to use regardless of where he or she is on his or her professional trajectory.
It isn’t always easy. It challenges our egos to ask for help when we have failed at making the diagnosis or not chosen the most effective therapy. At a minimum, stepping back and taking a deep breath (or three) may allow us a window through which we can finally see outside the box we find ourselves in.
Persistence is an attribute that allowed us to navigate the long and challenging path of our medical education. But, there are situations when it gets in the way of good medical care.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at [email protected].
Use of probiotics in hospitalized adults to prevent Clostridium difficile infection
Clinical Question: Does the use and timing of probiotics in hospitalized adult patients with Clostridium difficile infection (CDI) improve clinical outcomes?
Background: The incidence of CDI in hospitalized patients has increased significantly over the past years, resulting in significant morbidity and mortality. Improved prevention of CDI could have substantial public health benefits.
Study design: Systematic review and metaregression analysis.
Setting: 19 studies meeting inclusion criteria.
Synopsis: Computerized bibliography databases were searched for randomized controlled trials (RCTs) evaluating probiotic effects on CDI in hospitalized adults taking antibiotics.
Comprising 6261 subjects, 19 RCTs were analyzed. The incidence of CDI was lower in the probiotic cohort than in the control group (1.6% vs. 3.9%; P less than 0.001). The pooled relative risk of CDI in probiotic users was 0.42 (95% CI, 0.30-0.57). Metaregression analysis demonstrated that probiotics were significantly more effective if given closer to the first antibiotic dose, with a decrease in efficacy for every day of delay in starting probiotics (P = .04). Probiotics given within 2 days of antibiotic initiation produced a greater reduction of risk for CDI (RR, 0.32; 95% CI, 0.22-0.48) than later administration (RR, 0.70; 95% CI, 0.40-1.23; P = .02). There was no increased risk for adverse events among patients receiving probiotics.
Limitations included high risk of bias because of missing data, attrition, restricted patient population, lack of placebo, and conflict of interest.
Bottom Line: Administration of probiotics soon after the first dose of antibiotic reduces the risk of CDI by more than 50% in hospitalized adults without any increased risk of adverse events.
Reference: Shen NT, Maw A, Tmanova LL et al. Timely use of Probiotics in Hospitalized Adults Prevents Clostridium difficile Infection: A Systematic Review with Meta-Regression Analysis. Gastroenterology. Published on 9 Feb 2017. doi: 10.1053/j.gastro.2017.02.003.
Dr. Martin is clinical professor in the division of hospital medicine, department of medicine, University of California, San Diego.
Clinical Question: Does the use and timing of probiotics in hospitalized adult patients with Clostridium difficile infection (CDI) improve clinical outcomes?
Background: The incidence of CDI in hospitalized patients has increased significantly over the past years, resulting in significant morbidity and mortality. Improved prevention of CDI could have substantial public health benefits.
Study design: Systematic review and metaregression analysis.
Setting: 19 studies meeting inclusion criteria.
Synopsis: Computerized bibliography databases were searched for randomized controlled trials (RCTs) evaluating probiotic effects on CDI in hospitalized adults taking antibiotics.
Comprising 6261 subjects, 19 RCTs were analyzed. The incidence of CDI was lower in the probiotic cohort than in the control group (1.6% vs. 3.9%; P less than 0.001). The pooled relative risk of CDI in probiotic users was 0.42 (95% CI, 0.30-0.57). Metaregression analysis demonstrated that probiotics were significantly more effective if given closer to the first antibiotic dose, with a decrease in efficacy for every day of delay in starting probiotics (P = .04). Probiotics given within 2 days of antibiotic initiation produced a greater reduction of risk for CDI (RR, 0.32; 95% CI, 0.22-0.48) than later administration (RR, 0.70; 95% CI, 0.40-1.23; P = .02). There was no increased risk for adverse events among patients receiving probiotics.
Limitations included high risk of bias because of missing data, attrition, restricted patient population, lack of placebo, and conflict of interest.
Bottom Line: Administration of probiotics soon after the first dose of antibiotic reduces the risk of CDI by more than 50% in hospitalized adults without any increased risk of adverse events.
Reference: Shen NT, Maw A, Tmanova LL et al. Timely use of Probiotics in Hospitalized Adults Prevents Clostridium difficile Infection: A Systematic Review with Meta-Regression Analysis. Gastroenterology. Published on 9 Feb 2017. doi: 10.1053/j.gastro.2017.02.003.
Dr. Martin is clinical professor in the division of hospital medicine, department of medicine, University of California, San Diego.
Clinical Question: Does the use and timing of probiotics in hospitalized adult patients with Clostridium difficile infection (CDI) improve clinical outcomes?
Background: The incidence of CDI in hospitalized patients has increased significantly over the past years, resulting in significant morbidity and mortality. Improved prevention of CDI could have substantial public health benefits.
Study design: Systematic review and metaregression analysis.
Setting: 19 studies meeting inclusion criteria.
Synopsis: Computerized bibliography databases were searched for randomized controlled trials (RCTs) evaluating probiotic effects on CDI in hospitalized adults taking antibiotics.
Comprising 6261 subjects, 19 RCTs were analyzed. The incidence of CDI was lower in the probiotic cohort than in the control group (1.6% vs. 3.9%; P less than 0.001). The pooled relative risk of CDI in probiotic users was 0.42 (95% CI, 0.30-0.57). Metaregression analysis demonstrated that probiotics were significantly more effective if given closer to the first antibiotic dose, with a decrease in efficacy for every day of delay in starting probiotics (P = .04). Probiotics given within 2 days of antibiotic initiation produced a greater reduction of risk for CDI (RR, 0.32; 95% CI, 0.22-0.48) than later administration (RR, 0.70; 95% CI, 0.40-1.23; P = .02). There was no increased risk for adverse events among patients receiving probiotics.
Limitations included high risk of bias because of missing data, attrition, restricted patient population, lack of placebo, and conflict of interest.
Bottom Line: Administration of probiotics soon after the first dose of antibiotic reduces the risk of CDI by more than 50% in hospitalized adults without any increased risk of adverse events.
Reference: Shen NT, Maw A, Tmanova LL et al. Timely use of Probiotics in Hospitalized Adults Prevents Clostridium difficile Infection: A Systematic Review with Meta-Regression Analysis. Gastroenterology. Published on 9 Feb 2017. doi: 10.1053/j.gastro.2017.02.003.
Dr. Martin is clinical professor in the division of hospital medicine, department of medicine, University of California, San Diego.
Sooner may not be better: Study shows no benefit of urgent colonoscopy for lower GI bleeding
Clinical Question: In patients hospitalized for a lower gastrointestinal bleeding (LGIB), does an urgent colonoscopy (less than 24 hours after admission) result in any clinical benefits, compared with waiting for an elective colonoscopy?
Background: LGIB is a common cause of morbidity and mortality, often requiring hospitalization. While colonoscopy is necessary for appropriate work-up and treatment, it remains unclear if time to colonoscopy (urgent vs. elective) confers any clinical benefit in hospitalized patients.
Study Design: Systematic review and meta-analysis.
Setting: Twelve studies meeting inclusion criteria.
Synopsis: Computerized bibliography databases were searched for appropriate studies, and 12 met inclusion criteria, resulting in a total sample size of 10,172 patients in the urgent colonoscopy arm and 14,224 patients in the elective colonoscopy.
Outcome measures included bleeding source identified on colonoscopy, therapeutic endoscopic interventions performed, patients requiring blood transfusions, rebleeding, adverse events, and mortality.
Urgent colonoscopy was associated with increased use of endoscopic therapeutic intervention (relative risk, 1.70; 95% CI, 1.08-2.67). There were no significant differences in bleeding source localization (RR, 1.08; 95% CI, 0.92-1.25), adverse event rates (RR, 1.05; 95% CI, 0.65-1.71), rebleeding rates (RR, 1.14; 95% CI, 0.74-1.78), transfusion requirement (RR, 1.02; 95% CI, 0.73-1.41), or mortality (RR, 1.17; 95% CI, 0.45-3.02) between urgent and elective colonoscopy.
Limitations of the study comprise of inclusion of small number of studies, underpowered statistical analysis, and possible variation in quality assessment of articles evaluated.
Bottom Line: Urgent colonoscopy is safe and usually well tolerated in hospitalized patients with LGIB, but, compared with elective colonoscopy, there is no clear evidence it alters important clinical outcomes.
Reference: Kouanda AM, Somsouk M, Sewell JL, Day LW. Urgent colonoscopy in patients with lower GI bleeding: A systematic review and meta-analysis. Gastrointest Endosc. Published online Feb 4, 2017. doi: 10.1016/j.gie.2017.01.035.
Dr. Martin is clinical professor in the division of hospital medicine, department of medicine, University of California, San Diego.
Clinical Question: In patients hospitalized for a lower gastrointestinal bleeding (LGIB), does an urgent colonoscopy (less than 24 hours after admission) result in any clinical benefits, compared with waiting for an elective colonoscopy?
Background: LGIB is a common cause of morbidity and mortality, often requiring hospitalization. While colonoscopy is necessary for appropriate work-up and treatment, it remains unclear if time to colonoscopy (urgent vs. elective) confers any clinical benefit in hospitalized patients.
Study Design: Systematic review and meta-analysis.
Setting: Twelve studies meeting inclusion criteria.
Synopsis: Computerized bibliography databases were searched for appropriate studies, and 12 met inclusion criteria, resulting in a total sample size of 10,172 patients in the urgent colonoscopy arm and 14,224 patients in the elective colonoscopy.
Outcome measures included bleeding source identified on colonoscopy, therapeutic endoscopic interventions performed, patients requiring blood transfusions, rebleeding, adverse events, and mortality.
Urgent colonoscopy was associated with increased use of endoscopic therapeutic intervention (relative risk, 1.70; 95% CI, 1.08-2.67). There were no significant differences in bleeding source localization (RR, 1.08; 95% CI, 0.92-1.25), adverse event rates (RR, 1.05; 95% CI, 0.65-1.71), rebleeding rates (RR, 1.14; 95% CI, 0.74-1.78), transfusion requirement (RR, 1.02; 95% CI, 0.73-1.41), or mortality (RR, 1.17; 95% CI, 0.45-3.02) between urgent and elective colonoscopy.
Limitations of the study comprise of inclusion of small number of studies, underpowered statistical analysis, and possible variation in quality assessment of articles evaluated.
Bottom Line: Urgent colonoscopy is safe and usually well tolerated in hospitalized patients with LGIB, but, compared with elective colonoscopy, there is no clear evidence it alters important clinical outcomes.
Reference: Kouanda AM, Somsouk M, Sewell JL, Day LW. Urgent colonoscopy in patients with lower GI bleeding: A systematic review and meta-analysis. Gastrointest Endosc. Published online Feb 4, 2017. doi: 10.1016/j.gie.2017.01.035.
Dr. Martin is clinical professor in the division of hospital medicine, department of medicine, University of California, San Diego.
Clinical Question: In patients hospitalized for a lower gastrointestinal bleeding (LGIB), does an urgent colonoscopy (less than 24 hours after admission) result in any clinical benefits, compared with waiting for an elective colonoscopy?
Background: LGIB is a common cause of morbidity and mortality, often requiring hospitalization. While colonoscopy is necessary for appropriate work-up and treatment, it remains unclear if time to colonoscopy (urgent vs. elective) confers any clinical benefit in hospitalized patients.
Study Design: Systematic review and meta-analysis.
Setting: Twelve studies meeting inclusion criteria.
Synopsis: Computerized bibliography databases were searched for appropriate studies, and 12 met inclusion criteria, resulting in a total sample size of 10,172 patients in the urgent colonoscopy arm and 14,224 patients in the elective colonoscopy.
Outcome measures included bleeding source identified on colonoscopy, therapeutic endoscopic interventions performed, patients requiring blood transfusions, rebleeding, adverse events, and mortality.
Urgent colonoscopy was associated with increased use of endoscopic therapeutic intervention (relative risk, 1.70; 95% CI, 1.08-2.67). There were no significant differences in bleeding source localization (RR, 1.08; 95% CI, 0.92-1.25), adverse event rates (RR, 1.05; 95% CI, 0.65-1.71), rebleeding rates (RR, 1.14; 95% CI, 0.74-1.78), transfusion requirement (RR, 1.02; 95% CI, 0.73-1.41), or mortality (RR, 1.17; 95% CI, 0.45-3.02) between urgent and elective colonoscopy.
Limitations of the study comprise of inclusion of small number of studies, underpowered statistical analysis, and possible variation in quality assessment of articles evaluated.
Bottom Line: Urgent colonoscopy is safe and usually well tolerated in hospitalized patients with LGIB, but, compared with elective colonoscopy, there is no clear evidence it alters important clinical outcomes.
Reference: Kouanda AM, Somsouk M, Sewell JL, Day LW. Urgent colonoscopy in patients with lower GI bleeding: A systematic review and meta-analysis. Gastrointest Endosc. Published online Feb 4, 2017. doi: 10.1016/j.gie.2017.01.035.
Dr. Martin is clinical professor in the division of hospital medicine, department of medicine, University of California, San Diego.