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AAS: The ‘sad truth’ about suicide risk assessment scales
ATLANTA – Don’t – repeat, don’t – use risk assessment tools and scales in an effort to predict future suicide in patients who’ve committed intentional self-harm, Dr. Keith Hawton urged at the annual conference of the American Association of Suicidology.
He noted this isn’t simply a matter of his personal opinion; it’s also a strongly worded recommendation in the current U.K. NICE (National Institute for Health and Care Excellence) guidelines on the long-term management of patients who’ve committed self-harm. The various NICE guidelines, which address numerous areas of medical practice and are used to determine what’s reimbursable through the U.K.’s National Health Service, are famously evidence based and concerned with cost-effectiveness.
The NICE guidelines on management of self-harm further advise: “Do not use risk assessment tools and scales to determine who should and should not be offered treatment or who should be discharged from hospital.”
“Those are some fairly contentious statements about risk assessment scales. But those statements are based upon review of the evidence about the effectiveness of risk assessment scales,” according to Dr. Hawton, professor of psychiatry and director of the Centre for Suicide Research at the University of Oxford (England).
“In our country, hospitals have become obsessed with risk assessment. And usually it seems to be about protecting the organization rather than the patient, because so often the results aren’t linked to risk management, which is what we should be talking about,” he observed.
Dr. Hawton and his colleagues provided some of the evidence that led to the NICE guideline committee’s thumbs-down on the use of suicide risk assessment scales in patients who’ve engaged in intentional self-harm. In a study provocatively titled “The sad truth about the SADPERSONS scale,” he and his coinvestigators essentially dismantled SADPERSONS, a widely used screening tool for suicide risk, concluding that it is without value.
The acronym stands for Sex (male), Age (<19 or >45), Depression, Previous attempts, Ethanol abuse, Rational thinking loss, Social supports lacking, Organized plan, No spouse, and Sickness. One point is given for each. Patients who score 7-10 are to be hospitalized, and those with a total of 5 or 6 points should be strongly considered for hospitalization.
Dr. Hawton and coinvestigators tracked 126 consecutive patients who were evaluated for self-harm using the SADPERSONS scale in a general hospital emergency department and then followed them for 6 months. SADPERSONS performed miserably in predicting clinical management outcomes, such as admission to a psychiatric hospital or repetition of self-harm within 6 months. Indeed, the test failed to identify 4 of the 5 patients admitted to a psychiatric hospital, 65 of 70 who were referred from the ED to community psychiatric aftercare, and 28 of 31 who repeated self-harm within 6 months. Thus, its sensitivity as a predictor of repetition of self-harm was a lowly 6.6% (Emerg. Med. J. 2014;31:796-8).
And yet, a 32-hospital U.K. national study conducted by Dr. Hawton and others found that SADPERSONS was the most widely used scale in EDs for risk assessment following self-harm (BMJ Open. 2014 May 2;4:e004732 [doi:10.1136/bmjopen-2013-004732]).
“It’s a very crude tool,” Dr. Hawton said. “How it found its way into common use in clinical practice is beyond me.”
ATLANTA – Don’t – repeat, don’t – use risk assessment tools and scales in an effort to predict future suicide in patients who’ve committed intentional self-harm, Dr. Keith Hawton urged at the annual conference of the American Association of Suicidology.
He noted this isn’t simply a matter of his personal opinion; it’s also a strongly worded recommendation in the current U.K. NICE (National Institute for Health and Care Excellence) guidelines on the long-term management of patients who’ve committed self-harm. The various NICE guidelines, which address numerous areas of medical practice and are used to determine what’s reimbursable through the U.K.’s National Health Service, are famously evidence based and concerned with cost-effectiveness.
The NICE guidelines on management of self-harm further advise: “Do not use risk assessment tools and scales to determine who should and should not be offered treatment or who should be discharged from hospital.”
“Those are some fairly contentious statements about risk assessment scales. But those statements are based upon review of the evidence about the effectiveness of risk assessment scales,” according to Dr. Hawton, professor of psychiatry and director of the Centre for Suicide Research at the University of Oxford (England).
“In our country, hospitals have become obsessed with risk assessment. And usually it seems to be about protecting the organization rather than the patient, because so often the results aren’t linked to risk management, which is what we should be talking about,” he observed.
Dr. Hawton and his colleagues provided some of the evidence that led to the NICE guideline committee’s thumbs-down on the use of suicide risk assessment scales in patients who’ve engaged in intentional self-harm. In a study provocatively titled “The sad truth about the SADPERSONS scale,” he and his coinvestigators essentially dismantled SADPERSONS, a widely used screening tool for suicide risk, concluding that it is without value.
The acronym stands for Sex (male), Age (<19 or >45), Depression, Previous attempts, Ethanol abuse, Rational thinking loss, Social supports lacking, Organized plan, No spouse, and Sickness. One point is given for each. Patients who score 7-10 are to be hospitalized, and those with a total of 5 or 6 points should be strongly considered for hospitalization.
Dr. Hawton and coinvestigators tracked 126 consecutive patients who were evaluated for self-harm using the SADPERSONS scale in a general hospital emergency department and then followed them for 6 months. SADPERSONS performed miserably in predicting clinical management outcomes, such as admission to a psychiatric hospital or repetition of self-harm within 6 months. Indeed, the test failed to identify 4 of the 5 patients admitted to a psychiatric hospital, 65 of 70 who were referred from the ED to community psychiatric aftercare, and 28 of 31 who repeated self-harm within 6 months. Thus, its sensitivity as a predictor of repetition of self-harm was a lowly 6.6% (Emerg. Med. J. 2014;31:796-8).
And yet, a 32-hospital U.K. national study conducted by Dr. Hawton and others found that SADPERSONS was the most widely used scale in EDs for risk assessment following self-harm (BMJ Open. 2014 May 2;4:e004732 [doi:10.1136/bmjopen-2013-004732]).
“It’s a very crude tool,” Dr. Hawton said. “How it found its way into common use in clinical practice is beyond me.”
ATLANTA – Don’t – repeat, don’t – use risk assessment tools and scales in an effort to predict future suicide in patients who’ve committed intentional self-harm, Dr. Keith Hawton urged at the annual conference of the American Association of Suicidology.
He noted this isn’t simply a matter of his personal opinion; it’s also a strongly worded recommendation in the current U.K. NICE (National Institute for Health and Care Excellence) guidelines on the long-term management of patients who’ve committed self-harm. The various NICE guidelines, which address numerous areas of medical practice and are used to determine what’s reimbursable through the U.K.’s National Health Service, are famously evidence based and concerned with cost-effectiveness.
The NICE guidelines on management of self-harm further advise: “Do not use risk assessment tools and scales to determine who should and should not be offered treatment or who should be discharged from hospital.”
“Those are some fairly contentious statements about risk assessment scales. But those statements are based upon review of the evidence about the effectiveness of risk assessment scales,” according to Dr. Hawton, professor of psychiatry and director of the Centre for Suicide Research at the University of Oxford (England).
“In our country, hospitals have become obsessed with risk assessment. And usually it seems to be about protecting the organization rather than the patient, because so often the results aren’t linked to risk management, which is what we should be talking about,” he observed.
Dr. Hawton and his colleagues provided some of the evidence that led to the NICE guideline committee’s thumbs-down on the use of suicide risk assessment scales in patients who’ve engaged in intentional self-harm. In a study provocatively titled “The sad truth about the SADPERSONS scale,” he and his coinvestigators essentially dismantled SADPERSONS, a widely used screening tool for suicide risk, concluding that it is without value.
The acronym stands for Sex (male), Age (<19 or >45), Depression, Previous attempts, Ethanol abuse, Rational thinking loss, Social supports lacking, Organized plan, No spouse, and Sickness. One point is given for each. Patients who score 7-10 are to be hospitalized, and those with a total of 5 or 6 points should be strongly considered for hospitalization.
Dr. Hawton and coinvestigators tracked 126 consecutive patients who were evaluated for self-harm using the SADPERSONS scale in a general hospital emergency department and then followed them for 6 months. SADPERSONS performed miserably in predicting clinical management outcomes, such as admission to a psychiatric hospital or repetition of self-harm within 6 months. Indeed, the test failed to identify 4 of the 5 patients admitted to a psychiatric hospital, 65 of 70 who were referred from the ED to community psychiatric aftercare, and 28 of 31 who repeated self-harm within 6 months. Thus, its sensitivity as a predictor of repetition of self-harm was a lowly 6.6% (Emerg. Med. J. 2014;31:796-8).
And yet, a 32-hospital U.K. national study conducted by Dr. Hawton and others found that SADPERSONS was the most widely used scale in EDs for risk assessment following self-harm (BMJ Open. 2014 May 2;4:e004732 [doi:10.1136/bmjopen-2013-004732]).
“It’s a very crude tool,” Dr. Hawton said. “How it found its way into common use in clinical practice is beyond me.”
EXPERT ANALYSIS FROM THE ANNUAL AAS CONFERENCE
Is azithromycin a good alternative to erythromycin for PPROM prophylaxis?
The objective of this investigation by Pierson and colleagues was to determine if there was any significant difference between erythyromycin and azithromycin, used in combination with ampicillin, for prophylaxis in women with PPROM.
Details of the study
The authors conducted a retrospective study of 168 women at 24 to 34 weeks’ gestation. At the discretion of the attending physician, patients received either ampicillin plus erythromycin or ampicillin plus azithromycin as their prophylactic antibiotic regimen. Patients were excluded from the study if they had a cerclage, a multiple gestation, a history of amniocentesis or fetal surgery, a history of abdominal trauma, or if they had a fetus with a lethal anomaly.
The primary study end point was the duration of the latency period between rupture of membranes and onset of labor. The secondary outcomes were gestational age at delivery, adverse drug effects, neonatal birth weight, Apgar scores, and rates of neonatal death, respiratory distress syndrome, and sepsis.
The mean (SD) duration of the latent period was 9.4 (10.4) days in the azithromycin group and 9.6 (13.2) days in the erythromycin group (P = .4). There also were no significant differences in any of the secondary outcome measures. Accordingly, the authors concluded that azithromycin was an acceptable alternative to erythromycin in the prophylactic antibiotic regimen for patients with PPROM.
Several factors make azithromycin the favored PPROM prophylactic option
In the original Maternal-Fetal Medicine Network trial of prophylactic antibiotics for PPROM, Mercer and colleagues1 used the combination regimen of ampicillin plus erythromycin. In this regimen, ampicillin primarily targets group B streptococci and Escherichia coli. Erythromycin specifically targets mycoplasma organisms, which can be part of the polymicrobial flora that causes chorioamnionitis. The drug also is effective against chlamydia.
However, erythromycin may cause troublesome gastrointestinal adverse effects, notably diarrhea, in some patients. Therefore, in recent years, several investigators have advocated use of azithromycin in lieu of erythromycin. Azithromycin has a similar spectrum of activity as erythromycin, but it has a more favorable pharmacokinetic profile. When given in a single oral dose of 1,000 mg, it has a half-life of 68 hours, compared with erythromycin’s half-life of 1.6 hours. Thus, it is much easier to administer. Moreover, it is usually much better tolerated than erythromycin and, now that generic versions of the drug are available, it is relatively inexpensive.
WHAT THIS EVIDENCE MEANS FOR PRACTICE
Although this study is retrospective (Level II evidence), it is the first to demonstrate that, from the perspective of clinical effectiveness, azithromycin is comparable to erythromycin when used in combination with ampicillin for prophylaxis in patients with PPROM. For the reasons outlined above, I strongly favor azithromycin in lieu of erythromycin.
At our center we administer the drug in a single 1,000-mg oral dose. If the patient cannot tolerate oral medication at the time of admission, the drug can be administered intravenously.
Share your thoughts on this article! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.
Reference
- Mercer BM, Miodovnik M, Thurnau GR, et al. Antibiotic therapy for reduction of infant morbidity after preterm premature rupture of the membranes. A randomized controlled trial. National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. JAMA. 1997;278(12):989–995.
The objective of this investigation by Pierson and colleagues was to determine if there was any significant difference between erythyromycin and azithromycin, used in combination with ampicillin, for prophylaxis in women with PPROM.
Details of the study
The authors conducted a retrospective study of 168 women at 24 to 34 weeks’ gestation. At the discretion of the attending physician, patients received either ampicillin plus erythromycin or ampicillin plus azithromycin as their prophylactic antibiotic regimen. Patients were excluded from the study if they had a cerclage, a multiple gestation, a history of amniocentesis or fetal surgery, a history of abdominal trauma, or if they had a fetus with a lethal anomaly.
The primary study end point was the duration of the latency period between rupture of membranes and onset of labor. The secondary outcomes were gestational age at delivery, adverse drug effects, neonatal birth weight, Apgar scores, and rates of neonatal death, respiratory distress syndrome, and sepsis.
The mean (SD) duration of the latent period was 9.4 (10.4) days in the azithromycin group and 9.6 (13.2) days in the erythromycin group (P = .4). There also were no significant differences in any of the secondary outcome measures. Accordingly, the authors concluded that azithromycin was an acceptable alternative to erythromycin in the prophylactic antibiotic regimen for patients with PPROM.
Several factors make azithromycin the favored PPROM prophylactic option
In the original Maternal-Fetal Medicine Network trial of prophylactic antibiotics for PPROM, Mercer and colleagues1 used the combination regimen of ampicillin plus erythromycin. In this regimen, ampicillin primarily targets group B streptococci and Escherichia coli. Erythromycin specifically targets mycoplasma organisms, which can be part of the polymicrobial flora that causes chorioamnionitis. The drug also is effective against chlamydia.
However, erythromycin may cause troublesome gastrointestinal adverse effects, notably diarrhea, in some patients. Therefore, in recent years, several investigators have advocated use of azithromycin in lieu of erythromycin. Azithromycin has a similar spectrum of activity as erythromycin, but it has a more favorable pharmacokinetic profile. When given in a single oral dose of 1,000 mg, it has a half-life of 68 hours, compared with erythromycin’s half-life of 1.6 hours. Thus, it is much easier to administer. Moreover, it is usually much better tolerated than erythromycin and, now that generic versions of the drug are available, it is relatively inexpensive.
WHAT THIS EVIDENCE MEANS FOR PRACTICE
Although this study is retrospective (Level II evidence), it is the first to demonstrate that, from the perspective of clinical effectiveness, azithromycin is comparable to erythromycin when used in combination with ampicillin for prophylaxis in patients with PPROM. For the reasons outlined above, I strongly favor azithromycin in lieu of erythromycin.
At our center we administer the drug in a single 1,000-mg oral dose. If the patient cannot tolerate oral medication at the time of admission, the drug can be administered intravenously.
Share your thoughts on this article! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.
The objective of this investigation by Pierson and colleagues was to determine if there was any significant difference between erythyromycin and azithromycin, used in combination with ampicillin, for prophylaxis in women with PPROM.
Details of the study
The authors conducted a retrospective study of 168 women at 24 to 34 weeks’ gestation. At the discretion of the attending physician, patients received either ampicillin plus erythromycin or ampicillin plus azithromycin as their prophylactic antibiotic regimen. Patients were excluded from the study if they had a cerclage, a multiple gestation, a history of amniocentesis or fetal surgery, a history of abdominal trauma, or if they had a fetus with a lethal anomaly.
The primary study end point was the duration of the latency period between rupture of membranes and onset of labor. The secondary outcomes were gestational age at delivery, adverse drug effects, neonatal birth weight, Apgar scores, and rates of neonatal death, respiratory distress syndrome, and sepsis.
The mean (SD) duration of the latent period was 9.4 (10.4) days in the azithromycin group and 9.6 (13.2) days in the erythromycin group (P = .4). There also were no significant differences in any of the secondary outcome measures. Accordingly, the authors concluded that azithromycin was an acceptable alternative to erythromycin in the prophylactic antibiotic regimen for patients with PPROM.
Several factors make azithromycin the favored PPROM prophylactic option
In the original Maternal-Fetal Medicine Network trial of prophylactic antibiotics for PPROM, Mercer and colleagues1 used the combination regimen of ampicillin plus erythromycin. In this regimen, ampicillin primarily targets group B streptococci and Escherichia coli. Erythromycin specifically targets mycoplasma organisms, which can be part of the polymicrobial flora that causes chorioamnionitis. The drug also is effective against chlamydia.
However, erythromycin may cause troublesome gastrointestinal adverse effects, notably diarrhea, in some patients. Therefore, in recent years, several investigators have advocated use of azithromycin in lieu of erythromycin. Azithromycin has a similar spectrum of activity as erythromycin, but it has a more favorable pharmacokinetic profile. When given in a single oral dose of 1,000 mg, it has a half-life of 68 hours, compared with erythromycin’s half-life of 1.6 hours. Thus, it is much easier to administer. Moreover, it is usually much better tolerated than erythromycin and, now that generic versions of the drug are available, it is relatively inexpensive.
WHAT THIS EVIDENCE MEANS FOR PRACTICE
Although this study is retrospective (Level II evidence), it is the first to demonstrate that, from the perspective of clinical effectiveness, azithromycin is comparable to erythromycin when used in combination with ampicillin for prophylaxis in patients with PPROM. For the reasons outlined above, I strongly favor azithromycin in lieu of erythromycin.
At our center we administer the drug in a single 1,000-mg oral dose. If the patient cannot tolerate oral medication at the time of admission, the drug can be administered intravenously.
Share your thoughts on this article! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.
Reference
- Mercer BM, Miodovnik M, Thurnau GR, et al. Antibiotic therapy for reduction of infant morbidity after preterm premature rupture of the membranes. A randomized controlled trial. National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. JAMA. 1997;278(12):989–995.
Reference
- Mercer BM, Miodovnik M, Thurnau GR, et al. Antibiotic therapy for reduction of infant morbidity after preterm premature rupture of the membranes. A randomized controlled trial. National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. JAMA. 1997;278(12):989–995.
3 clear dos, and 3 specific don'ts, of vacuum extraction
A survey of liability claims against obstetric providers highlights major areas of contention
An analysis of 882 obstetric claims closed between 2007 and 2014 highlighted 3 common patient allegations:
- a delay in treatment of fetal distress (22%). The term fetal distress remains a common allegation in malpractice claims. Cases in this category most often reflected a delay or failure to act in the face of Category II or III fetal heart-rate tracings.
- improper performance of vaginal delivery (20%). Almost half of the cases in this category involved brachial plexus injuries linked to shoulder dystocia. Patients alleged that improper maneuvers were used to resolve the dystocia. The remainder of cases in this category involved forceps and vacuum extraction deliveries.
- improper management of pregnancy (17%). Among the allegations were a failure to test for fetal abnormalities, failure to recognize complications of pregnancy, and failure to address abnormal findings.
Together, these 3 allegations accounted for 59% of claims. Other allegations included diagnosis-related claims, delay in delivery, improper performance of operative delivery, retained foreign bodies, and improper choice of delivery method.1
The Obstetrics Closed Claims Study findings were released earlier this spring by the Napa, California−based Doctors Company, the nation’s largest physician-owned medical malpractice insurer.1 Susan Mann, MD, a spokesperson for the company, provided expert commentary on the study at the 2015 Annual Clinical Meeting of the American College of Obstetricians and Gynecologists in San Francisco. (Listen to this accompanying audiocast featuring her comments.) Dr. Mann practices obstetrics and gynecology in Brookline, Massachusetts, and at Beth Israel Deaconess Medical Center in Boston. She is president of the QualBridge Institute, a consulting firm focused on issues of quality and safety.
Top 7 factors contributing to patient injury
The Doctors Company identified specific factors that contributed to patient injury in the closed claims:
1. Selection and management of therapy (34%). Among the issues here were decisions involving augmentation of labor, route of delivery, and the timing of interventions. This factor also related to medications—for example, a failure to order antibiotics for Group A and Group B strep, a failure to order Rho(D) immune globulin for Rh-negative mothers, and a failure to provide magnesium sulfate for women with eclampsia.
2. Patient-assessment issues (32%). The Doctors Company reviewers found that physicians frequently failed to consider information that was available, or overlooked abnormal findings.
3. Technical performance (18%). This factor involved problems associated with known risks of various procedures, such as postpartum hemorrhage and brachial plexus injuries. It also included poor technique.
4. Communication among providers (17%)
5. Patient factors (16%). These factors included a failure to comply with therapy or to show up for appointments.
6. Insufficient or lack of documentation (14%)
7. Communication between patient/family and provider (14%).
“Studying obstetrical medical malpractice claims sheds light on the wide array of problems that may arise during pregnancy and in labor and delivery,” the study authors conclude. “Many of these cases reflect unusual maternal or neonatal conditions that can be diagnosed only with vigilance. Examples include protein deficiencies, clotting abnormalities, placental abruptions, infections, and genetic abnormalities. More common conditions should be identified with close attention to vital signs, laboratory studies, changes to maternal and neonatal conditions, and patient complaints.”
“Obstetric departments must plan for clinical emergencies by developing and maintaining physician and staff competencies through mock drills and simulations that reduce the likelihood of injuries to mothers and their infants,” the study authors conclude.
Tips for reducing malpractice claims in obstetrics
The Obstetrics Closed Claim Study identified a number of “underlying vulnerabilities” that place patients at risk and increase liability for clinicians. The Doctors Company offers the following tips to help reduce these claims:
• Require periodic training and certification for physicians and nurses to maintain competency and facilitate conversations about fetal heart-rate (FHR) tracing interpretation. Both parties should use the same terminology when discussing the strips.
• Use technology that allows physicians to review FHR patterns from remote locations so that physicians and nurses are able to see the same information when discussing next steps.
• When operative vaginal delivery is attempted in the face of a Category III FHR tracing, a contingency team should be available for possible emergent cesarean delivery.
• Foster a culture in which caregivers feel comfortable speaking up if they have a concern. Ensure that the organization has a well-defined escalation guideline.
Share your thoughts on this article! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.
Reference
- The Doctors Company. Obstetrics Closed Claim Study. http://www.thedoctors.com/KnowledgeCenter/PatientSafety/articles/CON_ID_011803. Published April 2015. Accessed May 6, 2015.
An analysis of 882 obstetric claims closed between 2007 and 2014 highlighted 3 common patient allegations:
- a delay in treatment of fetal distress (22%). The term fetal distress remains a common allegation in malpractice claims. Cases in this category most often reflected a delay or failure to act in the face of Category II or III fetal heart-rate tracings.
- improper performance of vaginal delivery (20%). Almost half of the cases in this category involved brachial plexus injuries linked to shoulder dystocia. Patients alleged that improper maneuvers were used to resolve the dystocia. The remainder of cases in this category involved forceps and vacuum extraction deliveries.
- improper management of pregnancy (17%). Among the allegations were a failure to test for fetal abnormalities, failure to recognize complications of pregnancy, and failure to address abnormal findings.
Together, these 3 allegations accounted for 59% of claims. Other allegations included diagnosis-related claims, delay in delivery, improper performance of operative delivery, retained foreign bodies, and improper choice of delivery method.1
The Obstetrics Closed Claims Study findings were released earlier this spring by the Napa, California−based Doctors Company, the nation’s largest physician-owned medical malpractice insurer.1 Susan Mann, MD, a spokesperson for the company, provided expert commentary on the study at the 2015 Annual Clinical Meeting of the American College of Obstetricians and Gynecologists in San Francisco. (Listen to this accompanying audiocast featuring her comments.) Dr. Mann practices obstetrics and gynecology in Brookline, Massachusetts, and at Beth Israel Deaconess Medical Center in Boston. She is president of the QualBridge Institute, a consulting firm focused on issues of quality and safety.
Top 7 factors contributing to patient injury
The Doctors Company identified specific factors that contributed to patient injury in the closed claims:
1. Selection and management of therapy (34%). Among the issues here were decisions involving augmentation of labor, route of delivery, and the timing of interventions. This factor also related to medications—for example, a failure to order antibiotics for Group A and Group B strep, a failure to order Rho(D) immune globulin for Rh-negative mothers, and a failure to provide magnesium sulfate for women with eclampsia.
2. Patient-assessment issues (32%). The Doctors Company reviewers found that physicians frequently failed to consider information that was available, or overlooked abnormal findings.
3. Technical performance (18%). This factor involved problems associated with known risks of various procedures, such as postpartum hemorrhage and brachial plexus injuries. It also included poor technique.
4. Communication among providers (17%)
5. Patient factors (16%). These factors included a failure to comply with therapy or to show up for appointments.
6. Insufficient or lack of documentation (14%)
7. Communication between patient/family and provider (14%).
“Studying obstetrical medical malpractice claims sheds light on the wide array of problems that may arise during pregnancy and in labor and delivery,” the study authors conclude. “Many of these cases reflect unusual maternal or neonatal conditions that can be diagnosed only with vigilance. Examples include protein deficiencies, clotting abnormalities, placental abruptions, infections, and genetic abnormalities. More common conditions should be identified with close attention to vital signs, laboratory studies, changes to maternal and neonatal conditions, and patient complaints.”
“Obstetric departments must plan for clinical emergencies by developing and maintaining physician and staff competencies through mock drills and simulations that reduce the likelihood of injuries to mothers and their infants,” the study authors conclude.
Tips for reducing malpractice claims in obstetrics
The Obstetrics Closed Claim Study identified a number of “underlying vulnerabilities” that place patients at risk and increase liability for clinicians. The Doctors Company offers the following tips to help reduce these claims:
• Require periodic training and certification for physicians and nurses to maintain competency and facilitate conversations about fetal heart-rate (FHR) tracing interpretation. Both parties should use the same terminology when discussing the strips.
• Use technology that allows physicians to review FHR patterns from remote locations so that physicians and nurses are able to see the same information when discussing next steps.
• When operative vaginal delivery is attempted in the face of a Category III FHR tracing, a contingency team should be available for possible emergent cesarean delivery.
• Foster a culture in which caregivers feel comfortable speaking up if they have a concern. Ensure that the organization has a well-defined escalation guideline.
Share your thoughts on this article! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.
An analysis of 882 obstetric claims closed between 2007 and 2014 highlighted 3 common patient allegations:
- a delay in treatment of fetal distress (22%). The term fetal distress remains a common allegation in malpractice claims. Cases in this category most often reflected a delay or failure to act in the face of Category II or III fetal heart-rate tracings.
- improper performance of vaginal delivery (20%). Almost half of the cases in this category involved brachial plexus injuries linked to shoulder dystocia. Patients alleged that improper maneuvers were used to resolve the dystocia. The remainder of cases in this category involved forceps and vacuum extraction deliveries.
- improper management of pregnancy (17%). Among the allegations were a failure to test for fetal abnormalities, failure to recognize complications of pregnancy, and failure to address abnormal findings.
Together, these 3 allegations accounted for 59% of claims. Other allegations included diagnosis-related claims, delay in delivery, improper performance of operative delivery, retained foreign bodies, and improper choice of delivery method.1
The Obstetrics Closed Claims Study findings were released earlier this spring by the Napa, California−based Doctors Company, the nation’s largest physician-owned medical malpractice insurer.1 Susan Mann, MD, a spokesperson for the company, provided expert commentary on the study at the 2015 Annual Clinical Meeting of the American College of Obstetricians and Gynecologists in San Francisco. (Listen to this accompanying audiocast featuring her comments.) Dr. Mann practices obstetrics and gynecology in Brookline, Massachusetts, and at Beth Israel Deaconess Medical Center in Boston. She is president of the QualBridge Institute, a consulting firm focused on issues of quality and safety.
Top 7 factors contributing to patient injury
The Doctors Company identified specific factors that contributed to patient injury in the closed claims:
1. Selection and management of therapy (34%). Among the issues here were decisions involving augmentation of labor, route of delivery, and the timing of interventions. This factor also related to medications—for example, a failure to order antibiotics for Group A and Group B strep, a failure to order Rho(D) immune globulin for Rh-negative mothers, and a failure to provide magnesium sulfate for women with eclampsia.
2. Patient-assessment issues (32%). The Doctors Company reviewers found that physicians frequently failed to consider information that was available, or overlooked abnormal findings.
3. Technical performance (18%). This factor involved problems associated with known risks of various procedures, such as postpartum hemorrhage and brachial plexus injuries. It also included poor technique.
4. Communication among providers (17%)
5. Patient factors (16%). These factors included a failure to comply with therapy or to show up for appointments.
6. Insufficient or lack of documentation (14%)
7. Communication between patient/family and provider (14%).
“Studying obstetrical medical malpractice claims sheds light on the wide array of problems that may arise during pregnancy and in labor and delivery,” the study authors conclude. “Many of these cases reflect unusual maternal or neonatal conditions that can be diagnosed only with vigilance. Examples include protein deficiencies, clotting abnormalities, placental abruptions, infections, and genetic abnormalities. More common conditions should be identified with close attention to vital signs, laboratory studies, changes to maternal and neonatal conditions, and patient complaints.”
“Obstetric departments must plan for clinical emergencies by developing and maintaining physician and staff competencies through mock drills and simulations that reduce the likelihood of injuries to mothers and their infants,” the study authors conclude.
Tips for reducing malpractice claims in obstetrics
The Obstetrics Closed Claim Study identified a number of “underlying vulnerabilities” that place patients at risk and increase liability for clinicians. The Doctors Company offers the following tips to help reduce these claims:
• Require periodic training and certification for physicians and nurses to maintain competency and facilitate conversations about fetal heart-rate (FHR) tracing interpretation. Both parties should use the same terminology when discussing the strips.
• Use technology that allows physicians to review FHR patterns from remote locations so that physicians and nurses are able to see the same information when discussing next steps.
• When operative vaginal delivery is attempted in the face of a Category III FHR tracing, a contingency team should be available for possible emergent cesarean delivery.
• Foster a culture in which caregivers feel comfortable speaking up if they have a concern. Ensure that the organization has a well-defined escalation guideline.
Share your thoughts on this article! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.
Reference
- The Doctors Company. Obstetrics Closed Claim Study. http://www.thedoctors.com/KnowledgeCenter/PatientSafety/articles/CON_ID_011803. Published April 2015. Accessed May 6, 2015.
Reference
- The Doctors Company. Obstetrics Closed Claim Study. http://www.thedoctors.com/KnowledgeCenter/PatientSafety/articles/CON_ID_011803. Published April 2015. Accessed May 6, 2015.
Dr. Michael Krychman details new and in-the-pipeline treatment options for vulvovaginal atrophy
In an audiocast summarizing his Sunday Lunch Talk at the Annual Clinical Meeting of the American College of Obstetricians and Gynecologists (ACOG) on May 3, 2015, Dr. Michael L. Krychman discusses new treatment options for vulvar and vaginal atrophy (VVA), including over-the-counter and prescription products and procedures. He emphasizes that a better understanding of the physical and anatomic changes in menopause has led to these improved options.
Dr. Krychman also recommends the use of "genitourinary syndrome of menopause" (GSM), new terminology for VVA suggested by the International Society for the Study of Women's Sexual Health and the North American Menopause Society.1
Among the products Dr. Krychman details are neogyn® Feminine Soothing Cream (neogyn, inc., Switzerland); RepHresh™ Vaginal Gel (Church & Dwight Co., Inc., Princeton, New Jersey); Replens™ Long-Lasting Vaginal Moisturizer (Church & Dwight); silicone- and water-based lubricants (Replens™ Silky Smooth Lubricant [Church & Dwight]; JuvaGyn® Feminine Moisturizer [neogyn, inc.]); and ospemifene (Osphena®, Shionogi Inc., Florham Park, New Jersey).
Dr. Krychman is interested in a new laser procedure for VVA/GSM, but comments that more study is needed before he can recommend its general use. He also talks about other exciting alternatives in the pipeline.
- Portman DJ, Gass ML; Vulvovaginal Atrophy Terminology Consensus Conference Panel. Genitourinary syndrome of menopause: new terminology for vulvovaginal atrophy from the International Society for the Study of Women’s Sexual Health and the North American Menopause Society. Menopause. 2014;11(12):2865–2872.
In an audiocast summarizing his Sunday Lunch Talk at the Annual Clinical Meeting of the American College of Obstetricians and Gynecologists (ACOG) on May 3, 2015, Dr. Michael L. Krychman discusses new treatment options for vulvar and vaginal atrophy (VVA), including over-the-counter and prescription products and procedures. He emphasizes that a better understanding of the physical and anatomic changes in menopause has led to these improved options.
Dr. Krychman also recommends the use of "genitourinary syndrome of menopause" (GSM), new terminology for VVA suggested by the International Society for the Study of Women's Sexual Health and the North American Menopause Society.1
Among the products Dr. Krychman details are neogyn® Feminine Soothing Cream (neogyn, inc., Switzerland); RepHresh™ Vaginal Gel (Church & Dwight Co., Inc., Princeton, New Jersey); Replens™ Long-Lasting Vaginal Moisturizer (Church & Dwight); silicone- and water-based lubricants (Replens™ Silky Smooth Lubricant [Church & Dwight]; JuvaGyn® Feminine Moisturizer [neogyn, inc.]); and ospemifene (Osphena®, Shionogi Inc., Florham Park, New Jersey).
Dr. Krychman is interested in a new laser procedure for VVA/GSM, but comments that more study is needed before he can recommend its general use. He also talks about other exciting alternatives in the pipeline.
In an audiocast summarizing his Sunday Lunch Talk at the Annual Clinical Meeting of the American College of Obstetricians and Gynecologists (ACOG) on May 3, 2015, Dr. Michael L. Krychman discusses new treatment options for vulvar and vaginal atrophy (VVA), including over-the-counter and prescription products and procedures. He emphasizes that a better understanding of the physical and anatomic changes in menopause has led to these improved options.
Dr. Krychman also recommends the use of "genitourinary syndrome of menopause" (GSM), new terminology for VVA suggested by the International Society for the Study of Women's Sexual Health and the North American Menopause Society.1
Among the products Dr. Krychman details are neogyn® Feminine Soothing Cream (neogyn, inc., Switzerland); RepHresh™ Vaginal Gel (Church & Dwight Co., Inc., Princeton, New Jersey); Replens™ Long-Lasting Vaginal Moisturizer (Church & Dwight); silicone- and water-based lubricants (Replens™ Silky Smooth Lubricant [Church & Dwight]; JuvaGyn® Feminine Moisturizer [neogyn, inc.]); and ospemifene (Osphena®, Shionogi Inc., Florham Park, New Jersey).
Dr. Krychman is interested in a new laser procedure for VVA/GSM, but comments that more study is needed before he can recommend its general use. He also talks about other exciting alternatives in the pipeline.
- Portman DJ, Gass ML; Vulvovaginal Atrophy Terminology Consensus Conference Panel. Genitourinary syndrome of menopause: new terminology for vulvovaginal atrophy from the International Society for the Study of Women’s Sexual Health and the North American Menopause Society. Menopause. 2014;11(12):2865–2872.
- Portman DJ, Gass ML; Vulvovaginal Atrophy Terminology Consensus Conference Panel. Genitourinary syndrome of menopause: new terminology for vulvovaginal atrophy from the International Society for the Study of Women’s Sexual Health and the North American Menopause Society. Menopause. 2014;11(12):2865–2872.
Care of the transgender patient: What is the gynecologist's role?
Although precise data are unavailable, it was estimated in 2011 that there were nearly 700,000 transgendered persons in the United States.1 This means that gynecologists in certain locales regularly encounter transgender patients in clinical practice.
At the 2015 Annual Clinical Meeting of the American College of Obstetricians and Gynecologists (ACOG), held May 2-6 in San Francisco, California, Dr. Cecile A. Unger discussed the role of the gynecologist in the care of transgender patients.
In this interview with OBG Management, Dr. Unger discusses:
- pertinent terminology, including gender dysphoria, and important clinical aspects of examining and treating a transgender patient
- what a clinician be screening for in general, as well as specifically, in the transgender population, including considerations for when a patient is undergoing hormone therapy
- the importance of developing trust and how that can be accomplished.
Reference
- Gates GJ. How many people are lesbian, gay, bisexual, and transgender? The Williams Institute Web site. http://williamsinstitute.law.ucla.edu/wp-content/uploads/Gates-How-Many-People-LGBT-Apr-2011.pdf. Published April 2011. Accessed May 5, 2015.
Although precise data are unavailable, it was estimated in 2011 that there were nearly 700,000 transgendered persons in the United States.1 This means that gynecologists in certain locales regularly encounter transgender patients in clinical practice.
At the 2015 Annual Clinical Meeting of the American College of Obstetricians and Gynecologists (ACOG), held May 2-6 in San Francisco, California, Dr. Cecile A. Unger discussed the role of the gynecologist in the care of transgender patients.
In this interview with OBG Management, Dr. Unger discusses:
- pertinent terminology, including gender dysphoria, and important clinical aspects of examining and treating a transgender patient
- what a clinician be screening for in general, as well as specifically, in the transgender population, including considerations for when a patient is undergoing hormone therapy
- the importance of developing trust and how that can be accomplished.
Although precise data are unavailable, it was estimated in 2011 that there were nearly 700,000 transgendered persons in the United States.1 This means that gynecologists in certain locales regularly encounter transgender patients in clinical practice.
At the 2015 Annual Clinical Meeting of the American College of Obstetricians and Gynecologists (ACOG), held May 2-6 in San Francisco, California, Dr. Cecile A. Unger discussed the role of the gynecologist in the care of transgender patients.
In this interview with OBG Management, Dr. Unger discusses:
- pertinent terminology, including gender dysphoria, and important clinical aspects of examining and treating a transgender patient
- what a clinician be screening for in general, as well as specifically, in the transgender population, including considerations for when a patient is undergoing hormone therapy
- the importance of developing trust and how that can be accomplished.
Reference
- Gates GJ. How many people are lesbian, gay, bisexual, and transgender? The Williams Institute Web site. http://williamsinstitute.law.ucla.edu/wp-content/uploads/Gates-How-Many-People-LGBT-Apr-2011.pdf. Published April 2011. Accessed May 5, 2015.
Reference
- Gates GJ. How many people are lesbian, gay, bisexual, and transgender? The Williams Institute Web site. http://williamsinstitute.law.ucla.edu/wp-content/uploads/Gates-How-Many-People-LGBT-Apr-2011.pdf. Published April 2011. Accessed May 5, 2015.
AAS: Experts say suicide research needs a reboot
ATLANTA– Progress has stalled in understanding the predictors and prevention of suicide, and it’s time for researchers to step up their game, experts agreed at the annual conference of the American Association of Suicidology.
“In the past couple of decades we’ve learned a fair amount about suicidal behavior. However, I think progress has been fairly slow – some might even say a little stagnant – in our pushing things forward and improving our understanding,” Matthew K. Nock, Ph.D., said in the meeting’s opening plenary talk.
He cited a soon-to-be-published meta-analysis led by his post-doctoral fellow Joseph C. Franklin, Ph.D., which evaluated all of the studies of predictors of suicide attempts and completed suicides published during the last 5 decades. The eye opening finding: The predictive odds ratios for the standard risk factors have remained essentially the same – namely, weak – for the past 50 years.
“In general, we’re not getting better in our ability to predict suicidal behavior – and that’s a serious problem for us. We still have enormous gaps in our understanding and in our ability to predict and prevent these outcomes,” declared Dr. Nock, professor of psychology at Harvard University, Boston.
The necessity for a fresh approach to suicide and suicide risk also was emphasized by E. David Klonsky, Ph.D., in his Edwin Shneidman Award Lecture.
“Despite what seems like a very large body of knowledge, suicide rates in the U.S. have increased for numerous consecutive years, and the same is true worldwide,” observed Dr. Klonsky, a psychologist at the University of British Columbia, Vancouver.
“What’s really hard to wrap our heads around is that we’re still only at a 1960s level in our ability to predict suicide. And the main reason for that is our risk factors don’t tell us what we think they do,” he continued.
This was first demonstrated in a 1999 study by Dr. Ronald C. Kessler of Harvard Medical School and coworkers (Arch. Gen. Psychiatry 1999;56:617-26).
They showed that the widely accepted suicide risk factors -- including any mood or anxiety disorder or substance disorders -- are strong predictors of suicidal ideation, but not significant predictors of who will transition from ideation to suicidal action. This finding has subsequently been confirmed by Dr. Nock and others in both adults and adolescents in a massive World Health Organization-sponsored project. Yet to date the concept hasn’t really sunk in broadly in the mental health and medical fields, according to Dr. Klonsky.
In his plenary talk, Dr. Nock focused on four key gaps in the current understanding of how to predict and prevent suicide and outlined how he and others are addressing these needs:
The need for objective markers of suicidal risk: Historically, nearly all patient assessments have relied upon self-report and cross-sectional surveys. That has an obvious limitation, since people are often motivated to conceal their thoughts of suicide. For example, one study found that 78% of patients who died by suicide while in a psychiatric hospital denied suicidal thoughts or intent in their last assessment.
The emerging emphasis is on creating brief computerized tests of memory and reaction time to gain a window into people’s implicit cognitions. Dr. Nock and colleagues have developed one such test, the Implicit Association Test. They had patients who presented to a psychiatric emergency department take the 5-minute word association test and demonstrated that those who scored high for implicit associations between death and suicide were six-fold more likely to make a suicide attempt in the next 6 months (Psychol. Sci. 2010;21:511-7). These findings have since been confirmed by a Canadian group (Psychol. Assess. 2013;25:714-21). The test is available online (www.ImplicitMentalHealth.com) with expert feedback provided as a public education tool and as a means for Dr. Nock and coinvestigators to gather large quantities of data.
Other objective tests for suicide risk that measure physiologic and neural responses to suicide-related stimuli include the Suicide Stroop and Affect Misattribution Procedure.
The need for better predictors of the transition from ideation to attempt: There are a few early leads on such predictors from the WHO dataset and other large studies. These include disorders characterized by aggression, agitation, and/or anxiety, such as conduct disorder, bipolar disorder, and a history of physical or sexual abuse. In a large study in the U.S. Army, the number-one predictor is intermittent explosive disorder.
The need for methods of combining risk factor data: Nearly all studies of suicide risk factors have utilized bivariate analysis -- that is, they examine risk based upon the presence or absence of an individual risk factor, such as a personal history of a mental disorder. But in a study led by Guilherme Borges, Sc.D., of the National Institute of Psychiatry in Mexico City, a group including Dr. Nock showed using National Comorbidity Survey Replication data that by simply together individual risk factors to create a 0-11 scale it became possible to identify a high-risk subgroup consisting of 13.7% of survey participants. This subgroup accounted for 67% of all suicide attempts within the next 12 months (Psychol. Med. 2006;36:1747-57).
The investigators have gone on to validate this approach in more than 108,000 subjects in 21 countries participating in the World Health Organization mental health project (J. Clin. Psychiatry 2010;71:1617-28).
Simple addition of suicidality risk factors, while a big step forward in risk assessment, is still a relatively crude predictive tool. More recently, Dr. Kessler, collaborating with Dr. Nock and others, has developed a much more sophisticated actuarial risk algorithm and applied it to more than 54,000 U.S. Army soldiers hospitalized for psychiatric disorders. They found that subjects who scored in the top 5% in terms of predicted suicide risk accounted for 53% of all suicides that occurred within the next 12 months. The suicide rate in this highest-risk group was massive: 3,624 per 100,000 per year as compared to a background rate of 18.5/100,000/year in the Army overall.
Moreover, nearly one-half of soldiers with a risk score in the top 5% had a 12-month composite adverse outcome, defined as another suicide attempt, death by suicide, accidental death, or psychiatric rehospitalization (JAMA Psychiatry 2015;72:49-57).
The need for data on imminent risk: Dr. Nock called this the biggest unmet need in suicidology; it’s what clinicians and family members desperately want but don’t have. At present there is “approximately zero data” on how to predict suicidal behavior in the hours, days, or weeks before it occurs, Dr. Nock said. Indeed, Dr. Franklin’s meta-analysis showed that in the past 50 years more than three-quarters of studies examining suicide risk have looked at risk a year or more in the future. Only 2% of studies have looked at risk during the window of the next month or so.
Numerous groups are now looking at real-time patient monitoring using cell phones and smart watches as a means of developing short-term risk predictors. These tools enable investigators to monitor changes in mood, thoughts, behavior, and physiology in large populations in order to see what leads up to a suicide attempt. Dr. Nock’s group is collaborating with information scientists at Massachusetts Intitute of Technology on such projects.
This technology also shows promise for therapeutic intervention. Dr. Franklin and coworkers have developed a brief, game-like mobile app to administer what he calls Therapeutic Evaluative Conditioning. In three soon-to-be-published randomized controlled trials, he has shown that this simple intervention – essentially, playing a game on a cell phone – resulted in reductions of 42%-49% in self-cutting and other nonsuicidal self-injury, 21%-64% reductions in suicidal planning, and 20%-57% decreases in suicidal behaviors, according to Dr. Nock.
Dr. Nock’s research is funded chiefly by the National Institute of Mental Health, the World Health Organization, and the Department of Defense; he reported having no financial conflicts. Dr. Klonsky’s research is largely supported by the American Foundation for Suicide Prevention.
ATLANTA– Progress has stalled in understanding the predictors and prevention of suicide, and it’s time for researchers to step up their game, experts agreed at the annual conference of the American Association of Suicidology.
“In the past couple of decades we’ve learned a fair amount about suicidal behavior. However, I think progress has been fairly slow – some might even say a little stagnant – in our pushing things forward and improving our understanding,” Matthew K. Nock, Ph.D., said in the meeting’s opening plenary talk.
He cited a soon-to-be-published meta-analysis led by his post-doctoral fellow Joseph C. Franklin, Ph.D., which evaluated all of the studies of predictors of suicide attempts and completed suicides published during the last 5 decades. The eye opening finding: The predictive odds ratios for the standard risk factors have remained essentially the same – namely, weak – for the past 50 years.
“In general, we’re not getting better in our ability to predict suicidal behavior – and that’s a serious problem for us. We still have enormous gaps in our understanding and in our ability to predict and prevent these outcomes,” declared Dr. Nock, professor of psychology at Harvard University, Boston.
The necessity for a fresh approach to suicide and suicide risk also was emphasized by E. David Klonsky, Ph.D., in his Edwin Shneidman Award Lecture.
“Despite what seems like a very large body of knowledge, suicide rates in the U.S. have increased for numerous consecutive years, and the same is true worldwide,” observed Dr. Klonsky, a psychologist at the University of British Columbia, Vancouver.
“What’s really hard to wrap our heads around is that we’re still only at a 1960s level in our ability to predict suicide. And the main reason for that is our risk factors don’t tell us what we think they do,” he continued.
This was first demonstrated in a 1999 study by Dr. Ronald C. Kessler of Harvard Medical School and coworkers (Arch. Gen. Psychiatry 1999;56:617-26).
They showed that the widely accepted suicide risk factors -- including any mood or anxiety disorder or substance disorders -- are strong predictors of suicidal ideation, but not significant predictors of who will transition from ideation to suicidal action. This finding has subsequently been confirmed by Dr. Nock and others in both adults and adolescents in a massive World Health Organization-sponsored project. Yet to date the concept hasn’t really sunk in broadly in the mental health and medical fields, according to Dr. Klonsky.
In his plenary talk, Dr. Nock focused on four key gaps in the current understanding of how to predict and prevent suicide and outlined how he and others are addressing these needs:
The need for objective markers of suicidal risk: Historically, nearly all patient assessments have relied upon self-report and cross-sectional surveys. That has an obvious limitation, since people are often motivated to conceal their thoughts of suicide. For example, one study found that 78% of patients who died by suicide while in a psychiatric hospital denied suicidal thoughts or intent in their last assessment.
The emerging emphasis is on creating brief computerized tests of memory and reaction time to gain a window into people’s implicit cognitions. Dr. Nock and colleagues have developed one such test, the Implicit Association Test. They had patients who presented to a psychiatric emergency department take the 5-minute word association test and demonstrated that those who scored high for implicit associations between death and suicide were six-fold more likely to make a suicide attempt in the next 6 months (Psychol. Sci. 2010;21:511-7). These findings have since been confirmed by a Canadian group (Psychol. Assess. 2013;25:714-21). The test is available online (www.ImplicitMentalHealth.com) with expert feedback provided as a public education tool and as a means for Dr. Nock and coinvestigators to gather large quantities of data.
Other objective tests for suicide risk that measure physiologic and neural responses to suicide-related stimuli include the Suicide Stroop and Affect Misattribution Procedure.
The need for better predictors of the transition from ideation to attempt: There are a few early leads on such predictors from the WHO dataset and other large studies. These include disorders characterized by aggression, agitation, and/or anxiety, such as conduct disorder, bipolar disorder, and a history of physical or sexual abuse. In a large study in the U.S. Army, the number-one predictor is intermittent explosive disorder.
The need for methods of combining risk factor data: Nearly all studies of suicide risk factors have utilized bivariate analysis -- that is, they examine risk based upon the presence or absence of an individual risk factor, such as a personal history of a mental disorder. But in a study led by Guilherme Borges, Sc.D., of the National Institute of Psychiatry in Mexico City, a group including Dr. Nock showed using National Comorbidity Survey Replication data that by simply together individual risk factors to create a 0-11 scale it became possible to identify a high-risk subgroup consisting of 13.7% of survey participants. This subgroup accounted for 67% of all suicide attempts within the next 12 months (Psychol. Med. 2006;36:1747-57).
The investigators have gone on to validate this approach in more than 108,000 subjects in 21 countries participating in the World Health Organization mental health project (J. Clin. Psychiatry 2010;71:1617-28).
Simple addition of suicidality risk factors, while a big step forward in risk assessment, is still a relatively crude predictive tool. More recently, Dr. Kessler, collaborating with Dr. Nock and others, has developed a much more sophisticated actuarial risk algorithm and applied it to more than 54,000 U.S. Army soldiers hospitalized for psychiatric disorders. They found that subjects who scored in the top 5% in terms of predicted suicide risk accounted for 53% of all suicides that occurred within the next 12 months. The suicide rate in this highest-risk group was massive: 3,624 per 100,000 per year as compared to a background rate of 18.5/100,000/year in the Army overall.
Moreover, nearly one-half of soldiers with a risk score in the top 5% had a 12-month composite adverse outcome, defined as another suicide attempt, death by suicide, accidental death, or psychiatric rehospitalization (JAMA Psychiatry 2015;72:49-57).
The need for data on imminent risk: Dr. Nock called this the biggest unmet need in suicidology; it’s what clinicians and family members desperately want but don’t have. At present there is “approximately zero data” on how to predict suicidal behavior in the hours, days, or weeks before it occurs, Dr. Nock said. Indeed, Dr. Franklin’s meta-analysis showed that in the past 50 years more than three-quarters of studies examining suicide risk have looked at risk a year or more in the future. Only 2% of studies have looked at risk during the window of the next month or so.
Numerous groups are now looking at real-time patient monitoring using cell phones and smart watches as a means of developing short-term risk predictors. These tools enable investigators to monitor changes in mood, thoughts, behavior, and physiology in large populations in order to see what leads up to a suicide attempt. Dr. Nock’s group is collaborating with information scientists at Massachusetts Intitute of Technology on such projects.
This technology also shows promise for therapeutic intervention. Dr. Franklin and coworkers have developed a brief, game-like mobile app to administer what he calls Therapeutic Evaluative Conditioning. In three soon-to-be-published randomized controlled trials, he has shown that this simple intervention – essentially, playing a game on a cell phone – resulted in reductions of 42%-49% in self-cutting and other nonsuicidal self-injury, 21%-64% reductions in suicidal planning, and 20%-57% decreases in suicidal behaviors, according to Dr. Nock.
Dr. Nock’s research is funded chiefly by the National Institute of Mental Health, the World Health Organization, and the Department of Defense; he reported having no financial conflicts. Dr. Klonsky’s research is largely supported by the American Foundation for Suicide Prevention.
ATLANTA– Progress has stalled in understanding the predictors and prevention of suicide, and it’s time for researchers to step up their game, experts agreed at the annual conference of the American Association of Suicidology.
“In the past couple of decades we’ve learned a fair amount about suicidal behavior. However, I think progress has been fairly slow – some might even say a little stagnant – in our pushing things forward and improving our understanding,” Matthew K. Nock, Ph.D., said in the meeting’s opening plenary talk.
He cited a soon-to-be-published meta-analysis led by his post-doctoral fellow Joseph C. Franklin, Ph.D., which evaluated all of the studies of predictors of suicide attempts and completed suicides published during the last 5 decades. The eye opening finding: The predictive odds ratios for the standard risk factors have remained essentially the same – namely, weak – for the past 50 years.
“In general, we’re not getting better in our ability to predict suicidal behavior – and that’s a serious problem for us. We still have enormous gaps in our understanding and in our ability to predict and prevent these outcomes,” declared Dr. Nock, professor of psychology at Harvard University, Boston.
The necessity for a fresh approach to suicide and suicide risk also was emphasized by E. David Klonsky, Ph.D., in his Edwin Shneidman Award Lecture.
“Despite what seems like a very large body of knowledge, suicide rates in the U.S. have increased for numerous consecutive years, and the same is true worldwide,” observed Dr. Klonsky, a psychologist at the University of British Columbia, Vancouver.
“What’s really hard to wrap our heads around is that we’re still only at a 1960s level in our ability to predict suicide. And the main reason for that is our risk factors don’t tell us what we think they do,” he continued.
This was first demonstrated in a 1999 study by Dr. Ronald C. Kessler of Harvard Medical School and coworkers (Arch. Gen. Psychiatry 1999;56:617-26).
They showed that the widely accepted suicide risk factors -- including any mood or anxiety disorder or substance disorders -- are strong predictors of suicidal ideation, but not significant predictors of who will transition from ideation to suicidal action. This finding has subsequently been confirmed by Dr. Nock and others in both adults and adolescents in a massive World Health Organization-sponsored project. Yet to date the concept hasn’t really sunk in broadly in the mental health and medical fields, according to Dr. Klonsky.
In his plenary talk, Dr. Nock focused on four key gaps in the current understanding of how to predict and prevent suicide and outlined how he and others are addressing these needs:
The need for objective markers of suicidal risk: Historically, nearly all patient assessments have relied upon self-report and cross-sectional surveys. That has an obvious limitation, since people are often motivated to conceal their thoughts of suicide. For example, one study found that 78% of patients who died by suicide while in a psychiatric hospital denied suicidal thoughts or intent in their last assessment.
The emerging emphasis is on creating brief computerized tests of memory and reaction time to gain a window into people’s implicit cognitions. Dr. Nock and colleagues have developed one such test, the Implicit Association Test. They had patients who presented to a psychiatric emergency department take the 5-minute word association test and demonstrated that those who scored high for implicit associations between death and suicide were six-fold more likely to make a suicide attempt in the next 6 months (Psychol. Sci. 2010;21:511-7). These findings have since been confirmed by a Canadian group (Psychol. Assess. 2013;25:714-21). The test is available online (www.ImplicitMentalHealth.com) with expert feedback provided as a public education tool and as a means for Dr. Nock and coinvestigators to gather large quantities of data.
Other objective tests for suicide risk that measure physiologic and neural responses to suicide-related stimuli include the Suicide Stroop and Affect Misattribution Procedure.
The need for better predictors of the transition from ideation to attempt: There are a few early leads on such predictors from the WHO dataset and other large studies. These include disorders characterized by aggression, agitation, and/or anxiety, such as conduct disorder, bipolar disorder, and a history of physical or sexual abuse. In a large study in the U.S. Army, the number-one predictor is intermittent explosive disorder.
The need for methods of combining risk factor data: Nearly all studies of suicide risk factors have utilized bivariate analysis -- that is, they examine risk based upon the presence or absence of an individual risk factor, such as a personal history of a mental disorder. But in a study led by Guilherme Borges, Sc.D., of the National Institute of Psychiatry in Mexico City, a group including Dr. Nock showed using National Comorbidity Survey Replication data that by simply together individual risk factors to create a 0-11 scale it became possible to identify a high-risk subgroup consisting of 13.7% of survey participants. This subgroup accounted for 67% of all suicide attempts within the next 12 months (Psychol. Med. 2006;36:1747-57).
The investigators have gone on to validate this approach in more than 108,000 subjects in 21 countries participating in the World Health Organization mental health project (J. Clin. Psychiatry 2010;71:1617-28).
Simple addition of suicidality risk factors, while a big step forward in risk assessment, is still a relatively crude predictive tool. More recently, Dr. Kessler, collaborating with Dr. Nock and others, has developed a much more sophisticated actuarial risk algorithm and applied it to more than 54,000 U.S. Army soldiers hospitalized for psychiatric disorders. They found that subjects who scored in the top 5% in terms of predicted suicide risk accounted for 53% of all suicides that occurred within the next 12 months. The suicide rate in this highest-risk group was massive: 3,624 per 100,000 per year as compared to a background rate of 18.5/100,000/year in the Army overall.
Moreover, nearly one-half of soldiers with a risk score in the top 5% had a 12-month composite adverse outcome, defined as another suicide attempt, death by suicide, accidental death, or psychiatric rehospitalization (JAMA Psychiatry 2015;72:49-57).
The need for data on imminent risk: Dr. Nock called this the biggest unmet need in suicidology; it’s what clinicians and family members desperately want but don’t have. At present there is “approximately zero data” on how to predict suicidal behavior in the hours, days, or weeks before it occurs, Dr. Nock said. Indeed, Dr. Franklin’s meta-analysis showed that in the past 50 years more than three-quarters of studies examining suicide risk have looked at risk a year or more in the future. Only 2% of studies have looked at risk during the window of the next month or so.
Numerous groups are now looking at real-time patient monitoring using cell phones and smart watches as a means of developing short-term risk predictors. These tools enable investigators to monitor changes in mood, thoughts, behavior, and physiology in large populations in order to see what leads up to a suicide attempt. Dr. Nock’s group is collaborating with information scientists at Massachusetts Intitute of Technology on such projects.
This technology also shows promise for therapeutic intervention. Dr. Franklin and coworkers have developed a brief, game-like mobile app to administer what he calls Therapeutic Evaluative Conditioning. In three soon-to-be-published randomized controlled trials, he has shown that this simple intervention – essentially, playing a game on a cell phone – resulted in reductions of 42%-49% in self-cutting and other nonsuicidal self-injury, 21%-64% reductions in suicidal planning, and 20%-57% decreases in suicidal behaviors, according to Dr. Nock.
Dr. Nock’s research is funded chiefly by the National Institute of Mental Health, the World Health Organization, and the Department of Defense; he reported having no financial conflicts. Dr. Klonsky’s research is largely supported by the American Foundation for Suicide Prevention.
EXPERT ANALYSIS FROM THE ANNUAL AAS CONFERENCE
LISTEN NOW: Win Whitcomb, MD, MHM, talks about practice management in an ever-changing healthcare landscape
SHM founder Win Whitcomb, MD, MHM, chief medical officer of Remedy Partners of Darien, Conn., talks about the annual practice management pre-course in an ever-changing healthcare landscape.
SHM founder Win Whitcomb, MD, MHM, chief medical officer of Remedy Partners of Darien, Conn., talks about the annual practice management pre-course in an ever-changing healthcare landscape.
SHM founder Win Whitcomb, MD, MHM, chief medical officer of Remedy Partners of Darien, Conn., talks about the annual practice management pre-course in an ever-changing healthcare landscape.
Is it time to revive rotational forceps?
The relative safety of instrumental rotations in the second stage of labor remains controversial. Older reports suggest an unacceptable risk of fetal injury, while recent studies demonstrate more favorable outcomes without significant fetal or maternal morbidity. This study by Aiken and colleagues goes one step further by using propensity analysis to adjust for the likelihood of receiving an attempted instrumental rotation.
Details of the study
With a cohort of 833 women with second-stage positional abnormalities, Aiken and colleagues compared maternal and newborn outcomes associated with cesarean delivery (n = 534) with those of an attempted rotational procedure (n = 334). Among the attempted instrumental rotations, 299 (90%) were successful. By intention to treat, failed attempts at rotation and vaginal delivery were included in the instrumental rotation group. The authors relied on propensity analysis to adjust for selection bias.
Strengths and weaknesses
The main strengths of this study are the relatively large sample size, the inclusion of failed procedures in the forceps group based on intention to treat, the robust approach to adjusting for the likelihood of undergoing an attempted rotation, and the contemporary nature of the cohort.
However, the study has 4 important limitations:
- More than 30% of rotations were attempted with vacuum devices. Many clinicians, including me, eschew vacuum deliveries for rotation due to reported higher failure rates and more scalp lacerations or other trauma. The analysis was not stratified by whether the rotation was attempted with a vacuum or Kielland forceps.
- Information about maternal pelvic features, critical in determining the safety of any operative vaginal delivery, was not included. When the pelvis has anthropoid features, such as more room in the posterior segment, rotation is not needed and may be counterproductive. Android features raise the likelihood of dangerous outlet obstruction and generally suggest the need for cesarean delivery.
- As Aiken and colleagues note, manual rotations followed by instrumental delivery from an occiput anterior position were not included.
- The study was not stratified by whether the abnormal position was occiput posterior (OP) or occiput transverse (OT). Although the degree of rotation is greater with OP position, operative vaginal delivery from OT can be far more challenging.
What this evidence means for practice
Although this study does have limitations, it adds to the increasing number of contemporary reports suggesting that instrumental rotational procedures are safe. Though it is not without challenges, training in rotational forceps should continue.
— William H. Barth Jr, MD
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.
The relative safety of instrumental rotations in the second stage of labor remains controversial. Older reports suggest an unacceptable risk of fetal injury, while recent studies demonstrate more favorable outcomes without significant fetal or maternal morbidity. This study by Aiken and colleagues goes one step further by using propensity analysis to adjust for the likelihood of receiving an attempted instrumental rotation.
Details of the study
With a cohort of 833 women with second-stage positional abnormalities, Aiken and colleagues compared maternal and newborn outcomes associated with cesarean delivery (n = 534) with those of an attempted rotational procedure (n = 334). Among the attempted instrumental rotations, 299 (90%) were successful. By intention to treat, failed attempts at rotation and vaginal delivery were included in the instrumental rotation group. The authors relied on propensity analysis to adjust for selection bias.
Strengths and weaknesses
The main strengths of this study are the relatively large sample size, the inclusion of failed procedures in the forceps group based on intention to treat, the robust approach to adjusting for the likelihood of undergoing an attempted rotation, and the contemporary nature of the cohort.
However, the study has 4 important limitations:
- More than 30% of rotations were attempted with vacuum devices. Many clinicians, including me, eschew vacuum deliveries for rotation due to reported higher failure rates and more scalp lacerations or other trauma. The analysis was not stratified by whether the rotation was attempted with a vacuum or Kielland forceps.
- Information about maternal pelvic features, critical in determining the safety of any operative vaginal delivery, was not included. When the pelvis has anthropoid features, such as more room in the posterior segment, rotation is not needed and may be counterproductive. Android features raise the likelihood of dangerous outlet obstruction and generally suggest the need for cesarean delivery.
- As Aiken and colleagues note, manual rotations followed by instrumental delivery from an occiput anterior position were not included.
- The study was not stratified by whether the abnormal position was occiput posterior (OP) or occiput transverse (OT). Although the degree of rotation is greater with OP position, operative vaginal delivery from OT can be far more challenging.
What this evidence means for practice
Although this study does have limitations, it adds to the increasing number of contemporary reports suggesting that instrumental rotational procedures are safe. Though it is not without challenges, training in rotational forceps should continue.
— William H. Barth Jr, MD
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.
The relative safety of instrumental rotations in the second stage of labor remains controversial. Older reports suggest an unacceptable risk of fetal injury, while recent studies demonstrate more favorable outcomes without significant fetal or maternal morbidity. This study by Aiken and colleagues goes one step further by using propensity analysis to adjust for the likelihood of receiving an attempted instrumental rotation.
Details of the study
With a cohort of 833 women with second-stage positional abnormalities, Aiken and colleagues compared maternal and newborn outcomes associated with cesarean delivery (n = 534) with those of an attempted rotational procedure (n = 334). Among the attempted instrumental rotations, 299 (90%) were successful. By intention to treat, failed attempts at rotation and vaginal delivery were included in the instrumental rotation group. The authors relied on propensity analysis to adjust for selection bias.
Strengths and weaknesses
The main strengths of this study are the relatively large sample size, the inclusion of failed procedures in the forceps group based on intention to treat, the robust approach to adjusting for the likelihood of undergoing an attempted rotation, and the contemporary nature of the cohort.
However, the study has 4 important limitations:
- More than 30% of rotations were attempted with vacuum devices. Many clinicians, including me, eschew vacuum deliveries for rotation due to reported higher failure rates and more scalp lacerations or other trauma. The analysis was not stratified by whether the rotation was attempted with a vacuum or Kielland forceps.
- Information about maternal pelvic features, critical in determining the safety of any operative vaginal delivery, was not included. When the pelvis has anthropoid features, such as more room in the posterior segment, rotation is not needed and may be counterproductive. Android features raise the likelihood of dangerous outlet obstruction and generally suggest the need for cesarean delivery.
- As Aiken and colleagues note, manual rotations followed by instrumental delivery from an occiput anterior position were not included.
- The study was not stratified by whether the abnormal position was occiput posterior (OP) or occiput transverse (OT). Although the degree of rotation is greater with OP position, operative vaginal delivery from OT can be far more challenging.
What this evidence means for practice
Although this study does have limitations, it adds to the increasing number of contemporary reports suggesting that instrumental rotational procedures are safe. Though it is not without challenges, training in rotational forceps should continue.
— William H. Barth Jr, MD
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.
Is the levonorgestrel-releasing intrauterine system more effective than the copper IUD at preventing pregnancy?
Both the LNG-IUS and the copper IUD are highly effective at pregnancy prevention. However, large-scale comparative studies are lacking. These findings from the European Active Surveillance Study for Intrauterine Devices (EURAS IUD), an investigation of new users of the LNG-IUS (20 µg/day) and copper IUD (>30 different types) in Austria, Finland, Germany, Poland, Sweden, and the United Kingdom, confirm the low contraceptive failure rate for both devices.
The primary objective of this trial was to compare uterine perforation rates,1 but the results of a planned secondary analysis comparing contraceptive effectiveness may be of more interest to patients and providers.
Details of the study
Women who had a newly inserted IUD during the study period were eligible for recruitment. These women and their inserting health care provider then completed a follow-up questionnaire 12 months after enrollment to assess for pregnancy or any potential IUD complication.
In total, 61,448 women were enrolled, and 58,324 patients (41,001 using the LNG-IUS and 17,323 using the copper IUD) were included in the analysis. Only 1.7% of LNG-IUS users and 2.8% of copper IUD users were lost to follow-up. Women using the LNG-IUS were older than those using the copper IUD (mean age of 37.4 vs 33.3 years, respectively). About 43% and 24% of LNG-IUS and copper IUD users, respectively, were age 40 or older at the time of IUD insertion.
Strengths and limitations
The large sample size and low number of women lost to follow-up are strengths of this study. A major weakness: The indication for IUD insertion was not recorded. Nor was the risk of pregnancy assessed at enrollment.
Overall, the age of the study population was older than is typically found in a contraceptive efficacy trial, which generally covers the age range of 18 to 35 years.
Because women chose their type of IUD (as opposed to random allocation), variations in underlying fertility, age, and other confounders of efficacy cannot be accounted for fully with statistical analyses. The variation in age strongly suggests that women may have chosen the LNG-IUS for reasons other than contraception.
Furthermore, more than 30 types of copper IUDs were inserted during the study period, and small variations in contraceptive efficacy from one type to another may contribute to the overall difference in failure rates between the LNG-IUS and copper IUD. Although Heinemann and colleagues did perform an analysis of failure rates by copper content and found no differences between users of IUDs with less than 300 mm2 and those with at least 300 mm2 of copper, earlier prospective randomized trials show differences in contraceptive efficacy by device type and amount of copper.2
What this evidence means for practice
The LNG-IUS may be a more effective contraceptive than the copper IUD, but both possess excellent contraceptive efficacy. Prospective randomized trials, although much smaller than this nonrandomized cohort study, do not demonstrate differences in contraceptive efficacy between the LNG-IUS and copper IUD.3 The small difference in contraceptive failure rates (less than 1 in 200 women), if real, should not be the deciding factor for choosing one IUD over the other.
— Melissa J. Chen, MD, MPH, and Mitchell D. Creinin, MDShare your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.
1. Heinemann K, Reed S, Moehner S, Do Minh T. Risk of uterine perforation with levonorgestrel-releasing and copper intrauterine devices in the European Active Surveillance Study on Intrauterine Devices. Contraception. 2015;91(4):274–279.
2. Thonneau PF, Almont T. Contraceptive efficacy of intrauterine devices. Am J Obstet Gynecol. 2008;198(3):248–253.
3. Sivin I, el Mahgoub S, McCarthy T, et al. Long-term contraception with the levonorgestrel 20 mcg/day (LNg 20) and the copper T380Ag intrauterine devices: a five-year randomized study. Contraception. 1990;42(4):361–378.
Both the LNG-IUS and the copper IUD are highly effective at pregnancy prevention. However, large-scale comparative studies are lacking. These findings from the European Active Surveillance Study for Intrauterine Devices (EURAS IUD), an investigation of new users of the LNG-IUS (20 µg/day) and copper IUD (>30 different types) in Austria, Finland, Germany, Poland, Sweden, and the United Kingdom, confirm the low contraceptive failure rate for both devices.
The primary objective of this trial was to compare uterine perforation rates,1 but the results of a planned secondary analysis comparing contraceptive effectiveness may be of more interest to patients and providers.
Details of the study
Women who had a newly inserted IUD during the study period were eligible for recruitment. These women and their inserting health care provider then completed a follow-up questionnaire 12 months after enrollment to assess for pregnancy or any potential IUD complication.
In total, 61,448 women were enrolled, and 58,324 patients (41,001 using the LNG-IUS and 17,323 using the copper IUD) were included in the analysis. Only 1.7% of LNG-IUS users and 2.8% of copper IUD users were lost to follow-up. Women using the LNG-IUS were older than those using the copper IUD (mean age of 37.4 vs 33.3 years, respectively). About 43% and 24% of LNG-IUS and copper IUD users, respectively, were age 40 or older at the time of IUD insertion.
Strengths and limitations
The large sample size and low number of women lost to follow-up are strengths of this study. A major weakness: The indication for IUD insertion was not recorded. Nor was the risk of pregnancy assessed at enrollment.
Overall, the age of the study population was older than is typically found in a contraceptive efficacy trial, which generally covers the age range of 18 to 35 years.
Because women chose their type of IUD (as opposed to random allocation), variations in underlying fertility, age, and other confounders of efficacy cannot be accounted for fully with statistical analyses. The variation in age strongly suggests that women may have chosen the LNG-IUS for reasons other than contraception.
Furthermore, more than 30 types of copper IUDs were inserted during the study period, and small variations in contraceptive efficacy from one type to another may contribute to the overall difference in failure rates between the LNG-IUS and copper IUD. Although Heinemann and colleagues did perform an analysis of failure rates by copper content and found no differences between users of IUDs with less than 300 mm2 and those with at least 300 mm2 of copper, earlier prospective randomized trials show differences in contraceptive efficacy by device type and amount of copper.2
What this evidence means for practice
The LNG-IUS may be a more effective contraceptive than the copper IUD, but both possess excellent contraceptive efficacy. Prospective randomized trials, although much smaller than this nonrandomized cohort study, do not demonstrate differences in contraceptive efficacy between the LNG-IUS and copper IUD.3 The small difference in contraceptive failure rates (less than 1 in 200 women), if real, should not be the deciding factor for choosing one IUD over the other.
— Melissa J. Chen, MD, MPH, and Mitchell D. Creinin, MDShare your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.
Both the LNG-IUS and the copper IUD are highly effective at pregnancy prevention. However, large-scale comparative studies are lacking. These findings from the European Active Surveillance Study for Intrauterine Devices (EURAS IUD), an investigation of new users of the LNG-IUS (20 µg/day) and copper IUD (>30 different types) in Austria, Finland, Germany, Poland, Sweden, and the United Kingdom, confirm the low contraceptive failure rate for both devices.
The primary objective of this trial was to compare uterine perforation rates,1 but the results of a planned secondary analysis comparing contraceptive effectiveness may be of more interest to patients and providers.
Details of the study
Women who had a newly inserted IUD during the study period were eligible for recruitment. These women and their inserting health care provider then completed a follow-up questionnaire 12 months after enrollment to assess for pregnancy or any potential IUD complication.
In total, 61,448 women were enrolled, and 58,324 patients (41,001 using the LNG-IUS and 17,323 using the copper IUD) were included in the analysis. Only 1.7% of LNG-IUS users and 2.8% of copper IUD users were lost to follow-up. Women using the LNG-IUS were older than those using the copper IUD (mean age of 37.4 vs 33.3 years, respectively). About 43% and 24% of LNG-IUS and copper IUD users, respectively, were age 40 or older at the time of IUD insertion.
Strengths and limitations
The large sample size and low number of women lost to follow-up are strengths of this study. A major weakness: The indication for IUD insertion was not recorded. Nor was the risk of pregnancy assessed at enrollment.
Overall, the age of the study population was older than is typically found in a contraceptive efficacy trial, which generally covers the age range of 18 to 35 years.
Because women chose their type of IUD (as opposed to random allocation), variations in underlying fertility, age, and other confounders of efficacy cannot be accounted for fully with statistical analyses. The variation in age strongly suggests that women may have chosen the LNG-IUS for reasons other than contraception.
Furthermore, more than 30 types of copper IUDs were inserted during the study period, and small variations in contraceptive efficacy from one type to another may contribute to the overall difference in failure rates between the LNG-IUS and copper IUD. Although Heinemann and colleagues did perform an analysis of failure rates by copper content and found no differences between users of IUDs with less than 300 mm2 and those with at least 300 mm2 of copper, earlier prospective randomized trials show differences in contraceptive efficacy by device type and amount of copper.2
What this evidence means for practice
The LNG-IUS may be a more effective contraceptive than the copper IUD, but both possess excellent contraceptive efficacy. Prospective randomized trials, although much smaller than this nonrandomized cohort study, do not demonstrate differences in contraceptive efficacy between the LNG-IUS and copper IUD.3 The small difference in contraceptive failure rates (less than 1 in 200 women), if real, should not be the deciding factor for choosing one IUD over the other.
— Melissa J. Chen, MD, MPH, and Mitchell D. Creinin, MDShare your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.
1. Heinemann K, Reed S, Moehner S, Do Minh T. Risk of uterine perforation with levonorgestrel-releasing and copper intrauterine devices in the European Active Surveillance Study on Intrauterine Devices. Contraception. 2015;91(4):274–279.
2. Thonneau PF, Almont T. Contraceptive efficacy of intrauterine devices. Am J Obstet Gynecol. 2008;198(3):248–253.
3. Sivin I, el Mahgoub S, McCarthy T, et al. Long-term contraception with the levonorgestrel 20 mcg/day (LNg 20) and the copper T380Ag intrauterine devices: a five-year randomized study. Contraception. 1990;42(4):361–378.
1. Heinemann K, Reed S, Moehner S, Do Minh T. Risk of uterine perforation with levonorgestrel-releasing and copper intrauterine devices in the European Active Surveillance Study on Intrauterine Devices. Contraception. 2015;91(4):274–279.
2. Thonneau PF, Almont T. Contraceptive efficacy of intrauterine devices. Am J Obstet Gynecol. 2008;198(3):248–253.
3. Sivin I, el Mahgoub S, McCarthy T, et al. Long-term contraception with the levonorgestrel 20 mcg/day (LNg 20) and the copper T380Ag intrauterine devices: a five-year randomized study. Contraception. 1990;42(4):361–378.




