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ACOG: Ob.gyns. can help protect pregnant women’s workplace rights
Obstetrician-gynecologists have a central role in helping pregnant patients maintain employment by writing appropriate notes to employers and informing patients of their rights, according to a new committee opinion by the American College of Obstetricians and Gynecologists.
The most common employment issues that pregnant women face include pregnancy-related discrimination, work accommodations that allow continued employment, job-protected leave, and wage replacement while on leave, according to the opinion. After delivery, top employment concerns involve lactation, and accommodations and leave for recovery, bonding, and caring for the infant.
“It’s important that ob.gyns. discuss workplace expectations with their working pregnant patient,” Yasser El-Sayed, MD, vice chair of the ACOG’s committee on obstetric practice said in a statement. “Some women may be unaware of attendant risks to pregnancy at their job, while others may be unaware that their ob.gyn. can offer both support and potential solutions or resources, whether in the form of slight modifications or a formal medical note detailing the need for an accommodation to protect the patient’s health.”
To address these issues, ACOG recommends that ob.gyns. reassure patients that working during pregnancy is generally safe. In the case of high-risk or complicated pregnancy, ob.gyns. should inform patients that work accommodations often can allow for continued safe employment. Appropriately drafted notes by physicians to employers are key, the opinion stresses.
“By writing appropriate notes to employers, obstetrician-gynecologists and other obstetric care providers can be instrumental in obtaining accommodations for their patients who are able to continue working,” the authors wrote. “Accommodations that allow a woman to keep working are the most reliable way to guarantee pay, benefits, and job protection.”
Because the way in which medical certification paperwork is written can greatly affect whether employers comply with medical suggestions, physicians should familiarize themselves with the most effective ways to write such notes, according to ACOG. The recent opinion provides an overview of the necessary structure and contents of medical notes to optimize their effects. The opinion highlights the work of Pregnant@Work, an online note-writing resource developed by the University of California’s Hastings Center for WorkLife Law, San Francisco, that assists health providers in writing legally appropriate work accommodations letters.
Also important for ob.gyns. is knowing the relevant state and federal protections for pregnant patients and new mothers who work or take medical leave. In some instances, it may be necessary for women to consult with a legal counselor in cases in which discrimination has occurred, accommodations are denied, or complex legal questions arise, according to the opinion.
The ACOG opinion is timely because more women than ever before are a part of the workforce, said Rebecca Jackson, MD, a member of ACOG’s committee on obstetric practice and a coauthor of the opinion. Dr. Jackson recently participated in a multidisciplinary work group that addressed legal issues around employment accommodations for pregnant women. Dr. Jackson said she approached ACOG about creating formal guidance on the subject after hearing about the many employment challenges pregnant women experience and how the way physician notes are written can greatly influence accommodations.
“As health care providers responsible for caring for women, it’s essential our guidance addresses the key considerations for maintaining women’s health – this often includes work environments, particularly for pregnant and immediately postpartum women who may have specific health care needs requiring adjustments or accommodations,” Dr. Jackson said in an interview. “Obstetric care providers must be equipped with the necessary and relevant guidance to appropriately support their patients or refer them to additional resources, like legal assistance. This guidance is an important component in building that knowledge among women’s health care providers and ensuring more women can access the care and treatment they need when they need it without compromising their careers or income.”
Obstetrician-gynecologists have a central role in helping pregnant patients maintain employment by writing appropriate notes to employers and informing patients of their rights, according to a new committee opinion by the American College of Obstetricians and Gynecologists.
The most common employment issues that pregnant women face include pregnancy-related discrimination, work accommodations that allow continued employment, job-protected leave, and wage replacement while on leave, according to the opinion. After delivery, top employment concerns involve lactation, and accommodations and leave for recovery, bonding, and caring for the infant.
“It’s important that ob.gyns. discuss workplace expectations with their working pregnant patient,” Yasser El-Sayed, MD, vice chair of the ACOG’s committee on obstetric practice said in a statement. “Some women may be unaware of attendant risks to pregnancy at their job, while others may be unaware that their ob.gyn. can offer both support and potential solutions or resources, whether in the form of slight modifications or a formal medical note detailing the need for an accommodation to protect the patient’s health.”
To address these issues, ACOG recommends that ob.gyns. reassure patients that working during pregnancy is generally safe. In the case of high-risk or complicated pregnancy, ob.gyns. should inform patients that work accommodations often can allow for continued safe employment. Appropriately drafted notes by physicians to employers are key, the opinion stresses.
“By writing appropriate notes to employers, obstetrician-gynecologists and other obstetric care providers can be instrumental in obtaining accommodations for their patients who are able to continue working,” the authors wrote. “Accommodations that allow a woman to keep working are the most reliable way to guarantee pay, benefits, and job protection.”
Because the way in which medical certification paperwork is written can greatly affect whether employers comply with medical suggestions, physicians should familiarize themselves with the most effective ways to write such notes, according to ACOG. The recent opinion provides an overview of the necessary structure and contents of medical notes to optimize their effects. The opinion highlights the work of Pregnant@Work, an online note-writing resource developed by the University of California’s Hastings Center for WorkLife Law, San Francisco, that assists health providers in writing legally appropriate work accommodations letters.
Also important for ob.gyns. is knowing the relevant state and federal protections for pregnant patients and new mothers who work or take medical leave. In some instances, it may be necessary for women to consult with a legal counselor in cases in which discrimination has occurred, accommodations are denied, or complex legal questions arise, according to the opinion.
The ACOG opinion is timely because more women than ever before are a part of the workforce, said Rebecca Jackson, MD, a member of ACOG’s committee on obstetric practice and a coauthor of the opinion. Dr. Jackson recently participated in a multidisciplinary work group that addressed legal issues around employment accommodations for pregnant women. Dr. Jackson said she approached ACOG about creating formal guidance on the subject after hearing about the many employment challenges pregnant women experience and how the way physician notes are written can greatly influence accommodations.
“As health care providers responsible for caring for women, it’s essential our guidance addresses the key considerations for maintaining women’s health – this often includes work environments, particularly for pregnant and immediately postpartum women who may have specific health care needs requiring adjustments or accommodations,” Dr. Jackson said in an interview. “Obstetric care providers must be equipped with the necessary and relevant guidance to appropriately support their patients or refer them to additional resources, like legal assistance. This guidance is an important component in building that knowledge among women’s health care providers and ensuring more women can access the care and treatment they need when they need it without compromising their careers or income.”
Obstetrician-gynecologists have a central role in helping pregnant patients maintain employment by writing appropriate notes to employers and informing patients of their rights, according to a new committee opinion by the American College of Obstetricians and Gynecologists.
The most common employment issues that pregnant women face include pregnancy-related discrimination, work accommodations that allow continued employment, job-protected leave, and wage replacement while on leave, according to the opinion. After delivery, top employment concerns involve lactation, and accommodations and leave for recovery, bonding, and caring for the infant.
“It’s important that ob.gyns. discuss workplace expectations with their working pregnant patient,” Yasser El-Sayed, MD, vice chair of the ACOG’s committee on obstetric practice said in a statement. “Some women may be unaware of attendant risks to pregnancy at their job, while others may be unaware that their ob.gyn. can offer both support and potential solutions or resources, whether in the form of slight modifications or a formal medical note detailing the need for an accommodation to protect the patient’s health.”
To address these issues, ACOG recommends that ob.gyns. reassure patients that working during pregnancy is generally safe. In the case of high-risk or complicated pregnancy, ob.gyns. should inform patients that work accommodations often can allow for continued safe employment. Appropriately drafted notes by physicians to employers are key, the opinion stresses.
“By writing appropriate notes to employers, obstetrician-gynecologists and other obstetric care providers can be instrumental in obtaining accommodations for their patients who are able to continue working,” the authors wrote. “Accommodations that allow a woman to keep working are the most reliable way to guarantee pay, benefits, and job protection.”
Because the way in which medical certification paperwork is written can greatly affect whether employers comply with medical suggestions, physicians should familiarize themselves with the most effective ways to write such notes, according to ACOG. The recent opinion provides an overview of the necessary structure and contents of medical notes to optimize their effects. The opinion highlights the work of Pregnant@Work, an online note-writing resource developed by the University of California’s Hastings Center for WorkLife Law, San Francisco, that assists health providers in writing legally appropriate work accommodations letters.
Also important for ob.gyns. is knowing the relevant state and federal protections for pregnant patients and new mothers who work or take medical leave. In some instances, it may be necessary for women to consult with a legal counselor in cases in which discrimination has occurred, accommodations are denied, or complex legal questions arise, according to the opinion.
The ACOG opinion is timely because more women than ever before are a part of the workforce, said Rebecca Jackson, MD, a member of ACOG’s committee on obstetric practice and a coauthor of the opinion. Dr. Jackson recently participated in a multidisciplinary work group that addressed legal issues around employment accommodations for pregnant women. Dr. Jackson said she approached ACOG about creating formal guidance on the subject after hearing about the many employment challenges pregnant women experience and how the way physician notes are written can greatly influence accommodations.
“As health care providers responsible for caring for women, it’s essential our guidance addresses the key considerations for maintaining women’s health – this often includes work environments, particularly for pregnant and immediately postpartum women who may have specific health care needs requiring adjustments or accommodations,” Dr. Jackson said in an interview. “Obstetric care providers must be equipped with the necessary and relevant guidance to appropriately support their patients or refer them to additional resources, like legal assistance. This guidance is an important component in building that knowledge among women’s health care providers and ensuring more women can access the care and treatment they need when they need it without compromising their careers or income.”
Phase 2 study tests low-dose maintenance therapy for ALL
Researchers at MD Anderson Cancer Center in Houston are studying the safety and clinical effectiveness of low-dose inotuzumab ozogamicin in controlling acute lymphocytic leukemia (ALL).
The phase 2 study (NCT03441061), which was launched on Feb. 15, will include up to 40 adult patients with B-cell ALL who are in complete remission with molecular failure or molecular relapse at any point after 3 months of frontline therapy. The study is looking first at relapse-free survival, and secondarily at overall survival and minimal residual disease negativity rate overall and after the first cycle. In addition, the researchers will consider the safety of the drug in this setting.
Inotuzumab ozogamicin (Besponsa) was approved by the Food and Drug Administration in August 2017 for the treatment of adults with relapsed or refractory B-cell precursor ALL.
During the open-label, single-arm study, patients can receive up to six cycles of the drug and each cycle is 28 (plus or minus 7) days. Eligible patients will receive inotuzumab ozogamicin on days 1,8, and 15 of cycle 1 and days 1 and 8 of cycles 2-6.
If a patient chooses to undergo a stem cell transplant from a donor, that patient will receive only two to three cycles of the drug. Study participants may also be taken off treatment after cycle 2 if the disease has had no response.
The study is being conducted at MD Anderson Cancer Center and is expected to be completed in February 2023. The study is sponsored by Pfizer.
Researchers at MD Anderson Cancer Center in Houston are studying the safety and clinical effectiveness of low-dose inotuzumab ozogamicin in controlling acute lymphocytic leukemia (ALL).
The phase 2 study (NCT03441061), which was launched on Feb. 15, will include up to 40 adult patients with B-cell ALL who are in complete remission with molecular failure or molecular relapse at any point after 3 months of frontline therapy. The study is looking first at relapse-free survival, and secondarily at overall survival and minimal residual disease negativity rate overall and after the first cycle. In addition, the researchers will consider the safety of the drug in this setting.
Inotuzumab ozogamicin (Besponsa) was approved by the Food and Drug Administration in August 2017 for the treatment of adults with relapsed or refractory B-cell precursor ALL.
During the open-label, single-arm study, patients can receive up to six cycles of the drug and each cycle is 28 (plus or minus 7) days. Eligible patients will receive inotuzumab ozogamicin on days 1,8, and 15 of cycle 1 and days 1 and 8 of cycles 2-6.
If a patient chooses to undergo a stem cell transplant from a donor, that patient will receive only two to three cycles of the drug. Study participants may also be taken off treatment after cycle 2 if the disease has had no response.
The study is being conducted at MD Anderson Cancer Center and is expected to be completed in February 2023. The study is sponsored by Pfizer.
Researchers at MD Anderson Cancer Center in Houston are studying the safety and clinical effectiveness of low-dose inotuzumab ozogamicin in controlling acute lymphocytic leukemia (ALL).
The phase 2 study (NCT03441061), which was launched on Feb. 15, will include up to 40 adult patients with B-cell ALL who are in complete remission with molecular failure or molecular relapse at any point after 3 months of frontline therapy. The study is looking first at relapse-free survival, and secondarily at overall survival and minimal residual disease negativity rate overall and after the first cycle. In addition, the researchers will consider the safety of the drug in this setting.
Inotuzumab ozogamicin (Besponsa) was approved by the Food and Drug Administration in August 2017 for the treatment of adults with relapsed or refractory B-cell precursor ALL.
During the open-label, single-arm study, patients can receive up to six cycles of the drug and each cycle is 28 (plus or minus 7) days. Eligible patients will receive inotuzumab ozogamicin on days 1,8, and 15 of cycle 1 and days 1 and 8 of cycles 2-6.
If a patient chooses to undergo a stem cell transplant from a donor, that patient will receive only two to three cycles of the drug. Study participants may also be taken off treatment after cycle 2 if the disease has had no response.
The study is being conducted at MD Anderson Cancer Center and is expected to be completed in February 2023. The study is sponsored by Pfizer.
FROM CLINICALTRIALS.GOV
Multipart collaboration brings data-driven care management tools to patients
One Drop announced on Oct. 31 a multipart collaboration with Fitbit to bring enhanced data-driven care management tools to the diabetes community.
One Drop users will now be able to sync Fitbit intraday data to their One Drop accounts. The first initiative will be to help users better understand the impact of physical activity on blood glucose management. The app software also will analyze user-generated health data points with the goal of gaining deeper insights and improving health outcomes for all people with diabetes worldwide. It can potentially allow users to see how their physical activity impacts blood glucose levels. Users can review these data with their very own Certified Diabetes Educator as they work together to meet personalized health goals.
In a study published in JMIR Diabetes in August 2017, results showed a 1.1%-1.3% absolute reduction in hemoglobin A1C in just 4 months in patients using One Drop. It is noted that this was a more significant reduction than other published research suggested was possible using a mobile care management app.
“By integrating Fitbit data and creating an app for Fitbit Ionic, we will be able to provide our users and their health care providers with more data and deeper insights to better manage their diabetes,” said Jeff Dachis, CEO and founder of One Drop, in a press release.
Read the full press release here.
One Drop announced on Oct. 31 a multipart collaboration with Fitbit to bring enhanced data-driven care management tools to the diabetes community.
One Drop users will now be able to sync Fitbit intraday data to their One Drop accounts. The first initiative will be to help users better understand the impact of physical activity on blood glucose management. The app software also will analyze user-generated health data points with the goal of gaining deeper insights and improving health outcomes for all people with diabetes worldwide. It can potentially allow users to see how their physical activity impacts blood glucose levels. Users can review these data with their very own Certified Diabetes Educator as they work together to meet personalized health goals.
In a study published in JMIR Diabetes in August 2017, results showed a 1.1%-1.3% absolute reduction in hemoglobin A1C in just 4 months in patients using One Drop. It is noted that this was a more significant reduction than other published research suggested was possible using a mobile care management app.
“By integrating Fitbit data and creating an app for Fitbit Ionic, we will be able to provide our users and their health care providers with more data and deeper insights to better manage their diabetes,” said Jeff Dachis, CEO and founder of One Drop, in a press release.
Read the full press release here.
One Drop announced on Oct. 31 a multipart collaboration with Fitbit to bring enhanced data-driven care management tools to the diabetes community.
One Drop users will now be able to sync Fitbit intraday data to their One Drop accounts. The first initiative will be to help users better understand the impact of physical activity on blood glucose management. The app software also will analyze user-generated health data points with the goal of gaining deeper insights and improving health outcomes for all people with diabetes worldwide. It can potentially allow users to see how their physical activity impacts blood glucose levels. Users can review these data with their very own Certified Diabetes Educator as they work together to meet personalized health goals.
In a study published in JMIR Diabetes in August 2017, results showed a 1.1%-1.3% absolute reduction in hemoglobin A1C in just 4 months in patients using One Drop. It is noted that this was a more significant reduction than other published research suggested was possible using a mobile care management app.
“By integrating Fitbit data and creating an app for Fitbit Ionic, we will be able to provide our users and their health care providers with more data and deeper insights to better manage their diabetes,” said Jeff Dachis, CEO and founder of One Drop, in a press release.
Read the full press release here.
CAR T-cell data expected soon in mantle cell lymphoma
Final data collection for primary outcome measures is anticipated in September for ZUMA-2, a Phase II multicenter study of the chimeric antigen receptor (CAR) T-cell product KTE-C19 in patients with relapsed/refractory mantle cell lymphoma.
ZUMA-2 (NCT02601313), with a planned enrollment of 70 patients, is expected to release the overall response rate at 12 months. Secondary outcome measures include duration of response, best objective response, and progression-free survival.
Subjects can have up to five prior regimens, which must include anthracycline or bendamustine-containing chemotherapy, anti-CD20 monoclonal antibody therapy, and ibrutinib. Study subjects cannot have received allogeneic stem cell transplantation, prior CD19 targeted therapy, or prior CAR or other genetically modified T cell therapy.
Trial participants must be adults with an Eastern cooperative oncology group (ECOG) performance status of 0 or 1, an absolute neutrophil count of at least 1000/µL, and a platelet count of at least 50,000/µL. All need to have adequate renal function, defined as a serum creatinine of 1.5 mg/dL or less; adequate hepatic function, defined as a serum ALT/AST of 2.5 the upper limit of normal or less; and a total bilirubin of 1.5 mg/dL or less (except in subjects with Gilbert’s syndrome), and adequate cardiac function, defined as a cardiac ejection fraction of 50% or more with no evidence of pericardial effusion.
Exclusion criteria include a history of another cancer other than nonmelanomatous skin cancer or carcinoma in situ (for example, cervix, bladder, breast) unless disease free for at least 3 years, known infection with HIV or hepatitis B or C virus, metastases in cerebrospinal fluid or brain, and a history of a seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement.
The study is sponsored by Kite Pharma, the makers of KTE-C19.
Final data collection for primary outcome measures is anticipated in September for ZUMA-2, a Phase II multicenter study of the chimeric antigen receptor (CAR) T-cell product KTE-C19 in patients with relapsed/refractory mantle cell lymphoma.
ZUMA-2 (NCT02601313), with a planned enrollment of 70 patients, is expected to release the overall response rate at 12 months. Secondary outcome measures include duration of response, best objective response, and progression-free survival.
Subjects can have up to five prior regimens, which must include anthracycline or bendamustine-containing chemotherapy, anti-CD20 monoclonal antibody therapy, and ibrutinib. Study subjects cannot have received allogeneic stem cell transplantation, prior CD19 targeted therapy, or prior CAR or other genetically modified T cell therapy.
Trial participants must be adults with an Eastern cooperative oncology group (ECOG) performance status of 0 or 1, an absolute neutrophil count of at least 1000/µL, and a platelet count of at least 50,000/µL. All need to have adequate renal function, defined as a serum creatinine of 1.5 mg/dL or less; adequate hepatic function, defined as a serum ALT/AST of 2.5 the upper limit of normal or less; and a total bilirubin of 1.5 mg/dL or less (except in subjects with Gilbert’s syndrome), and adequate cardiac function, defined as a cardiac ejection fraction of 50% or more with no evidence of pericardial effusion.
Exclusion criteria include a history of another cancer other than nonmelanomatous skin cancer or carcinoma in situ (for example, cervix, bladder, breast) unless disease free for at least 3 years, known infection with HIV or hepatitis B or C virus, metastases in cerebrospinal fluid or brain, and a history of a seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement.
The study is sponsored by Kite Pharma, the makers of KTE-C19.
Final data collection for primary outcome measures is anticipated in September for ZUMA-2, a Phase II multicenter study of the chimeric antigen receptor (CAR) T-cell product KTE-C19 in patients with relapsed/refractory mantle cell lymphoma.
ZUMA-2 (NCT02601313), with a planned enrollment of 70 patients, is expected to release the overall response rate at 12 months. Secondary outcome measures include duration of response, best objective response, and progression-free survival.
Subjects can have up to five prior regimens, which must include anthracycline or bendamustine-containing chemotherapy, anti-CD20 monoclonal antibody therapy, and ibrutinib. Study subjects cannot have received allogeneic stem cell transplantation, prior CD19 targeted therapy, or prior CAR or other genetically modified T cell therapy.
Trial participants must be adults with an Eastern cooperative oncology group (ECOG) performance status of 0 or 1, an absolute neutrophil count of at least 1000/µL, and a platelet count of at least 50,000/µL. All need to have adequate renal function, defined as a serum creatinine of 1.5 mg/dL or less; adequate hepatic function, defined as a serum ALT/AST of 2.5 the upper limit of normal or less; and a total bilirubin of 1.5 mg/dL or less (except in subjects with Gilbert’s syndrome), and adequate cardiac function, defined as a cardiac ejection fraction of 50% or more with no evidence of pericardial effusion.
Exclusion criteria include a history of another cancer other than nonmelanomatous skin cancer or carcinoma in situ (for example, cervix, bladder, breast) unless disease free for at least 3 years, known infection with HIV or hepatitis B or C virus, metastases in cerebrospinal fluid or brain, and a history of a seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement.
The study is sponsored by Kite Pharma, the makers of KTE-C19.
SUMMARY FROM CLINICALTRIALS.GOV
Merck Manual available as free app
The Merck Manual professional app is now available for free for use on either Android or Apple devices.
“In today’s mobile world, health care professionals expect critical health information at their fingertips, with or without an Internet connection,” said Robert S. Porter, MD, Merck Manuals’ editor-in-chief.
The app contains more than 1,000 photos and illustrations, and offline content can be stored on the device. A Wi-Fi connection is not needed to access the manual. When a cell phone is connected to the Internet, the app allows access to features such as videos of procedures, quizzes, medical news, editorials, and drug reference information.
The Merck Manual professional app is now available for free for use on either Android or Apple devices.
“In today’s mobile world, health care professionals expect critical health information at their fingertips, with or without an Internet connection,” said Robert S. Porter, MD, Merck Manuals’ editor-in-chief.
The app contains more than 1,000 photos and illustrations, and offline content can be stored on the device. A Wi-Fi connection is not needed to access the manual. When a cell phone is connected to the Internet, the app allows access to features such as videos of procedures, quizzes, medical news, editorials, and drug reference information.
The Merck Manual professional app is now available for free for use on either Android or Apple devices.
“In today’s mobile world, health care professionals expect critical health information at their fingertips, with or without an Internet connection,” said Robert S. Porter, MD, Merck Manuals’ editor-in-chief.
The app contains more than 1,000 photos and illustrations, and offline content can be stored on the device. A Wi-Fi connection is not needed to access the manual. When a cell phone is connected to the Internet, the app allows access to features such as videos of procedures, quizzes, medical news, editorials, and drug reference information.
Tool kit improves communication after an adverse event
The Communication and Optimal Resolution tool kit, offered by the Agency for Healthcare Research and Quality, helps hospitals, health systems, and clinicians respond to patients who are harmed by the care they receive, Andy Bindman, MD, AHRQ director, said in a blog post.
The tool kit is a new addition to AHRQ’s suite of patient safety tools and training materials.
Poor communication can lead to life-and-death mistakes, which can then become legal issues, said Dr. Bindman. The Communication and Optimal Resolution (CANDOR) tool kit uses time as a key factor by disclosing harm to patients and families as soon as it happens.
“It has been estimated that medical errors are the third-leading cause of death in the United States and that the majority of clinicians have experience with a medical error that resulted in harm to a patient. Often these ‘mistakes’ are not the result of poorly trained individuals but the result of the faulty systems we sometimes work in,” Dr. Bindman noted.
“It is also important for us to engage with colleagues to reflect on the mistake and explore the root causes of how it happened. This helps us to learn from the situation and take steps to minimize the chances of a similar mistake happening again to another patient,” he said.
Funding for CANDOR was provided by the AHRQ’s $23 million Patient Safety and Medical Liability grant initiative, launched in 2009. The initiative is the largest federal investment in research linking improved patient safety to reduced medical liability, according to Dr. Bindman.
The Communication and Optimal Resolution tool kit, offered by the Agency for Healthcare Research and Quality, helps hospitals, health systems, and clinicians respond to patients who are harmed by the care they receive, Andy Bindman, MD, AHRQ director, said in a blog post.
The tool kit is a new addition to AHRQ’s suite of patient safety tools and training materials.
Poor communication can lead to life-and-death mistakes, which can then become legal issues, said Dr. Bindman. The Communication and Optimal Resolution (CANDOR) tool kit uses time as a key factor by disclosing harm to patients and families as soon as it happens.
“It has been estimated that medical errors are the third-leading cause of death in the United States and that the majority of clinicians have experience with a medical error that resulted in harm to a patient. Often these ‘mistakes’ are not the result of poorly trained individuals but the result of the faulty systems we sometimes work in,” Dr. Bindman noted.
“It is also important for us to engage with colleagues to reflect on the mistake and explore the root causes of how it happened. This helps us to learn from the situation and take steps to minimize the chances of a similar mistake happening again to another patient,” he said.
Funding for CANDOR was provided by the AHRQ’s $23 million Patient Safety and Medical Liability grant initiative, launched in 2009. The initiative is the largest federal investment in research linking improved patient safety to reduced medical liability, according to Dr. Bindman.
The Communication and Optimal Resolution tool kit, offered by the Agency for Healthcare Research and Quality, helps hospitals, health systems, and clinicians respond to patients who are harmed by the care they receive, Andy Bindman, MD, AHRQ director, said in a blog post.
The tool kit is a new addition to AHRQ’s suite of patient safety tools and training materials.
Poor communication can lead to life-and-death mistakes, which can then become legal issues, said Dr. Bindman. The Communication and Optimal Resolution (CANDOR) tool kit uses time as a key factor by disclosing harm to patients and families as soon as it happens.
“It has been estimated that medical errors are the third-leading cause of death in the United States and that the majority of clinicians have experience with a medical error that resulted in harm to a patient. Often these ‘mistakes’ are not the result of poorly trained individuals but the result of the faulty systems we sometimes work in,” Dr. Bindman noted.
“It is also important for us to engage with colleagues to reflect on the mistake and explore the root causes of how it happened. This helps us to learn from the situation and take steps to minimize the chances of a similar mistake happening again to another patient,” he said.
Funding for CANDOR was provided by the AHRQ’s $23 million Patient Safety and Medical Liability grant initiative, launched in 2009. The initiative is the largest federal investment in research linking improved patient safety to reduced medical liability, according to Dr. Bindman.
BCG slows bladder cancer progression
Bacillus Calmette-Guérin (BCG) is the only intravesical therapy shown to be associated with decreased risk of bladder cancer progression, according to a report by the Agency for Healthcare Research and Quality (AHRQ), but the researchers cautioned that the therapy was associated with a high rate of adverse events.
The Comparative Effectiveness Review, headed by Dr. Roger Chou and based on research by the Pacific Northwest Evidence-Based Practice Center (EPC) under contract to the AHRQ, was conducted as a systematic review of trials identified via electronic databases and conducted from 1990 to 2014.
BCG was associated with a higher rate of local and systemic adverse events (granulomatous cystitis or irritative symptoms in 27%-84% of patients, macroscopic hematuria in 21%-72%, and fever in 27%-44%) when compared with no intravesical therapy, the researchers wrote. BCG was associated with decreased risk of bladder cancer progression, but no intravesical agent was associated with decreased risk of all-cause or bladder cancer mortality.
In addition, fluorescent cystoscopy was associated with decreased risk of subsequent bladder recurrence, compared with white light cystoscopy, but results were inconsistent through many of the trials identified.
Read the full report here.
Bacillus Calmette-Guérin (BCG) is the only intravesical therapy shown to be associated with decreased risk of bladder cancer progression, according to a report by the Agency for Healthcare Research and Quality (AHRQ), but the researchers cautioned that the therapy was associated with a high rate of adverse events.
The Comparative Effectiveness Review, headed by Dr. Roger Chou and based on research by the Pacific Northwest Evidence-Based Practice Center (EPC) under contract to the AHRQ, was conducted as a systematic review of trials identified via electronic databases and conducted from 1990 to 2014.
BCG was associated with a higher rate of local and systemic adverse events (granulomatous cystitis or irritative symptoms in 27%-84% of patients, macroscopic hematuria in 21%-72%, and fever in 27%-44%) when compared with no intravesical therapy, the researchers wrote. BCG was associated with decreased risk of bladder cancer progression, but no intravesical agent was associated with decreased risk of all-cause or bladder cancer mortality.
In addition, fluorescent cystoscopy was associated with decreased risk of subsequent bladder recurrence, compared with white light cystoscopy, but results were inconsistent through many of the trials identified.
Read the full report here.
Bacillus Calmette-Guérin (BCG) is the only intravesical therapy shown to be associated with decreased risk of bladder cancer progression, according to a report by the Agency for Healthcare Research and Quality (AHRQ), but the researchers cautioned that the therapy was associated with a high rate of adverse events.
The Comparative Effectiveness Review, headed by Dr. Roger Chou and based on research by the Pacific Northwest Evidence-Based Practice Center (EPC) under contract to the AHRQ, was conducted as a systematic review of trials identified via electronic databases and conducted from 1990 to 2014.
BCG was associated with a higher rate of local and systemic adverse events (granulomatous cystitis or irritative symptoms in 27%-84% of patients, macroscopic hematuria in 21%-72%, and fever in 27%-44%) when compared with no intravesical therapy, the researchers wrote. BCG was associated with decreased risk of bladder cancer progression, but no intravesical agent was associated with decreased risk of all-cause or bladder cancer mortality.
In addition, fluorescent cystoscopy was associated with decreased risk of subsequent bladder recurrence, compared with white light cystoscopy, but results were inconsistent through many of the trials identified.
Read the full report here.
ADA proposes new standards for students with diabetes
Every student with diabetes should have an individualized Diabetes Medical Management Plan that sets out the specifics of that student’s needs throughout the school day, including information on when and how to monitor blood glucose levels and insulin dosages and instructions on meals and snacks, according to new guidelines from the American Diabetes Association.
The position statement, published in the October issue of Diabetes Care, calls on schools to better accommodate students with diabetes (Diabetes Care. 2015;38[10]:1958-63). The guidelines suggest that school nurses and other staff members undergo training to deal with hypoglycemia and hyperglycemia. The statement also points out the need for reasonable modifications for students with diabetes during special events such as standardized testing, field trips, and school lockdowns.
Also included in the October issue of Diabetes Care is a joint scientific statement from the American Diabetes Association, JDRF, and the Endocrine Society, which proposes a new classification system that outlines three progressive stages of type 1 diabetes, beginning with an asymptomatic stage of beta-cell autoimmunity, leading to a gradual progression to glucose intolerance, and ultimately, symptomatic disease (Diabetes Care. 2015;38[10]1964-74).
A consensus report in the October issue makes the case for designing studies that account for age-related differences in type 1 diabetes (Diabetes Care. 2015;38[10]:1975-85). A perspective focuses on potential solutions to the challenges of developing and gaining marketing approval for new drugs for pediatric type 1 diabetes (Diabetes Care. 2015;38[10]1986-91).
“Given the progress to date and knowledge gained in understanding the pathophysiology of type 1 diabetes, the unique needs of children with diabetes, and the evolving therapeutic landscape, updates to guide our thinking on management and approach to this patient cohort are continually needed,” Dr. William T. Cefalu and Dr. Jane L. Chiang wrote in the issue’s editorial (Diabetes Care. 2015;38[10]1955-7).
Every student with diabetes should have an individualized Diabetes Medical Management Plan that sets out the specifics of that student’s needs throughout the school day, including information on when and how to monitor blood glucose levels and insulin dosages and instructions on meals and snacks, according to new guidelines from the American Diabetes Association.
The position statement, published in the October issue of Diabetes Care, calls on schools to better accommodate students with diabetes (Diabetes Care. 2015;38[10]:1958-63). The guidelines suggest that school nurses and other staff members undergo training to deal with hypoglycemia and hyperglycemia. The statement also points out the need for reasonable modifications for students with diabetes during special events such as standardized testing, field trips, and school lockdowns.
Also included in the October issue of Diabetes Care is a joint scientific statement from the American Diabetes Association, JDRF, and the Endocrine Society, which proposes a new classification system that outlines three progressive stages of type 1 diabetes, beginning with an asymptomatic stage of beta-cell autoimmunity, leading to a gradual progression to glucose intolerance, and ultimately, symptomatic disease (Diabetes Care. 2015;38[10]1964-74).
A consensus report in the October issue makes the case for designing studies that account for age-related differences in type 1 diabetes (Diabetes Care. 2015;38[10]:1975-85). A perspective focuses on potential solutions to the challenges of developing and gaining marketing approval for new drugs for pediatric type 1 diabetes (Diabetes Care. 2015;38[10]1986-91).
“Given the progress to date and knowledge gained in understanding the pathophysiology of type 1 diabetes, the unique needs of children with diabetes, and the evolving therapeutic landscape, updates to guide our thinking on management and approach to this patient cohort are continually needed,” Dr. William T. Cefalu and Dr. Jane L. Chiang wrote in the issue’s editorial (Diabetes Care. 2015;38[10]1955-7).
Every student with diabetes should have an individualized Diabetes Medical Management Plan that sets out the specifics of that student’s needs throughout the school day, including information on when and how to monitor blood glucose levels and insulin dosages and instructions on meals and snacks, according to new guidelines from the American Diabetes Association.
The position statement, published in the October issue of Diabetes Care, calls on schools to better accommodate students with diabetes (Diabetes Care. 2015;38[10]:1958-63). The guidelines suggest that school nurses and other staff members undergo training to deal with hypoglycemia and hyperglycemia. The statement also points out the need for reasonable modifications for students with diabetes during special events such as standardized testing, field trips, and school lockdowns.
Also included in the October issue of Diabetes Care is a joint scientific statement from the American Diabetes Association, JDRF, and the Endocrine Society, which proposes a new classification system that outlines three progressive stages of type 1 diabetes, beginning with an asymptomatic stage of beta-cell autoimmunity, leading to a gradual progression to glucose intolerance, and ultimately, symptomatic disease (Diabetes Care. 2015;38[10]1964-74).
A consensus report in the October issue makes the case for designing studies that account for age-related differences in type 1 diabetes (Diabetes Care. 2015;38[10]:1975-85). A perspective focuses on potential solutions to the challenges of developing and gaining marketing approval for new drugs for pediatric type 1 diabetes (Diabetes Care. 2015;38[10]1986-91).
“Given the progress to date and knowledge gained in understanding the pathophysiology of type 1 diabetes, the unique needs of children with diabetes, and the evolving therapeutic landscape, updates to guide our thinking on management and approach to this patient cohort are continually needed,” Dr. William T. Cefalu and Dr. Jane L. Chiang wrote in the issue’s editorial (Diabetes Care. 2015;38[10]1955-7).
FROM DIABETES CARE
Cardiac biomarkers predict cancer mortality
High circulating levels of six cardiovascular biomarkers predicted cancer mortality even before the start of treatment and regardless of tumor type or stage, according to a study published online Sept. 28 in Heart.
Cancer patients had high levels of these biomarkers even though they had no clinical signs of heart disease or concurrent infections, wrote Noemi Pavo of Medical University of Vienna. The findings suggest that these patients could benefit from enhanced heart failure therapies that go beyond the current focus on preventing cardiotoxic side effects of chemotherapy and radiotherapy, noted Dr. Pavo and her associates.
Cardiovascular hormone and peptide levels can rise during cancer treatment, but whether cancer itself affects these biomarkers has been unclear, the investigators said. Therefore, they prospectively measured levels of five cardiovascular hormones – NT-proBNP, MR-proANP, MR-proADM, CT-pro-ET, and copeptin – in addition to high-sensitive troponin, the proinflammatory markers interleukin 6 and C-reactive protein, and cytokines serum amyloid A, haptoglobin, and fibronectin, in 555 patients with newly diagnosed, as-yet-untreated cancer (Heart 2015 Sep 28. doi:10.1136/heartjnl-2015-307848).
A total of 186 patients (34%) died after an average of 25 months of follow-up, the researchers reported. Levels of all cardiovascular hormones and hsTnT increased with tumor stage progression. After the researchers controlled for age, tumor type, tumor stage, glomerular filtration rate, and cardiac status, rising levels of all five cardiac hormones and hsTnT independently predicted mortality, with adjusted hazard ratios ranging from 1.21 for CT-proET-1 and hsTnT to 1.54 for the natural logarithm of NT-proBNP, and P values ranging from .014 to less than.001.
“All of these markers are strongly related to mortality, implying a direct association with disease progression,” the researchers said. “While our endpoint [was] all-cause mortality, precise information about the percentage of cardiovascular-related death would certainly be of important clinical interest. Since post hoc interpretations of certifications of death are not reliable, the development of a cardiac disease during cancer progression should be documented in longitudinal studies in the future.”
An unrestricted grant from Thermo Fisher funded the study. The researchers declared no competing interests.
This study opens the potential for new management strategies integrating cardiology and oncology. Treating overt and perhaps subclinical cardiac dysfunction may improve outcomes in patients with cancer, and may possibly improve progression-free cancer survival based on optimizing cancer treatment and preventing interruptions. These biomarkers could serve as a surveillance strategy for both cardiologists and oncologists. It would be equally tantalizing to know whether treating the cancer effectively improves cardiac outcomes, but this will be more challenging to unravel if the cancer treatment imparts potential cardiotoxicity.
The key next stage will be to reproduce these findings in a prospectively designed multicenter study with larger numbers to validate the conclusion, collect the mode of death, and also to consider whether serial biomarker assessment adds further predictive power. Pavo et al. should be congratulated on bringing to our attention the widening complexity of biomarker biology and the potential to identify single biomarkers with the unique properties to predict both cardiovascular and oncology outcomes.
Dr. Alexander Lyon is at Imperial College and Royal Brompton Hospital in London. He reported receiving research funding and having consulting and advisory relationships with Pfizer, Onyx Pharmaceuticals, Ferring Pharmaceuticals, and Clinigen Group. These remarks are from his editorial (Heart 2015 Sep. 28. doi:10.1136/heartjnl-2015-308208).
This study opens the potential for new management strategies integrating cardiology and oncology. Treating overt and perhaps subclinical cardiac dysfunction may improve outcomes in patients with cancer, and may possibly improve progression-free cancer survival based on optimizing cancer treatment and preventing interruptions. These biomarkers could serve as a surveillance strategy for both cardiologists and oncologists. It would be equally tantalizing to know whether treating the cancer effectively improves cardiac outcomes, but this will be more challenging to unravel if the cancer treatment imparts potential cardiotoxicity.
The key next stage will be to reproduce these findings in a prospectively designed multicenter study with larger numbers to validate the conclusion, collect the mode of death, and also to consider whether serial biomarker assessment adds further predictive power. Pavo et al. should be congratulated on bringing to our attention the widening complexity of biomarker biology and the potential to identify single biomarkers with the unique properties to predict both cardiovascular and oncology outcomes.
Dr. Alexander Lyon is at Imperial College and Royal Brompton Hospital in London. He reported receiving research funding and having consulting and advisory relationships with Pfizer, Onyx Pharmaceuticals, Ferring Pharmaceuticals, and Clinigen Group. These remarks are from his editorial (Heart 2015 Sep. 28. doi:10.1136/heartjnl-2015-308208).
This study opens the potential for new management strategies integrating cardiology and oncology. Treating overt and perhaps subclinical cardiac dysfunction may improve outcomes in patients with cancer, and may possibly improve progression-free cancer survival based on optimizing cancer treatment and preventing interruptions. These biomarkers could serve as a surveillance strategy for both cardiologists and oncologists. It would be equally tantalizing to know whether treating the cancer effectively improves cardiac outcomes, but this will be more challenging to unravel if the cancer treatment imparts potential cardiotoxicity.
The key next stage will be to reproduce these findings in a prospectively designed multicenter study with larger numbers to validate the conclusion, collect the mode of death, and also to consider whether serial biomarker assessment adds further predictive power. Pavo et al. should be congratulated on bringing to our attention the widening complexity of biomarker biology and the potential to identify single biomarkers with the unique properties to predict both cardiovascular and oncology outcomes.
Dr. Alexander Lyon is at Imperial College and Royal Brompton Hospital in London. He reported receiving research funding and having consulting and advisory relationships with Pfizer, Onyx Pharmaceuticals, Ferring Pharmaceuticals, and Clinigen Group. These remarks are from his editorial (Heart 2015 Sep. 28. doi:10.1136/heartjnl-2015-308208).
High circulating levels of six cardiovascular biomarkers predicted cancer mortality even before the start of treatment and regardless of tumor type or stage, according to a study published online Sept. 28 in Heart.
Cancer patients had high levels of these biomarkers even though they had no clinical signs of heart disease or concurrent infections, wrote Noemi Pavo of Medical University of Vienna. The findings suggest that these patients could benefit from enhanced heart failure therapies that go beyond the current focus on preventing cardiotoxic side effects of chemotherapy and radiotherapy, noted Dr. Pavo and her associates.
Cardiovascular hormone and peptide levels can rise during cancer treatment, but whether cancer itself affects these biomarkers has been unclear, the investigators said. Therefore, they prospectively measured levels of five cardiovascular hormones – NT-proBNP, MR-proANP, MR-proADM, CT-pro-ET, and copeptin – in addition to high-sensitive troponin, the proinflammatory markers interleukin 6 and C-reactive protein, and cytokines serum amyloid A, haptoglobin, and fibronectin, in 555 patients with newly diagnosed, as-yet-untreated cancer (Heart 2015 Sep 28. doi:10.1136/heartjnl-2015-307848).
A total of 186 patients (34%) died after an average of 25 months of follow-up, the researchers reported. Levels of all cardiovascular hormones and hsTnT increased with tumor stage progression. After the researchers controlled for age, tumor type, tumor stage, glomerular filtration rate, and cardiac status, rising levels of all five cardiac hormones and hsTnT independently predicted mortality, with adjusted hazard ratios ranging from 1.21 for CT-proET-1 and hsTnT to 1.54 for the natural logarithm of NT-proBNP, and P values ranging from .014 to less than.001.
“All of these markers are strongly related to mortality, implying a direct association with disease progression,” the researchers said. “While our endpoint [was] all-cause mortality, precise information about the percentage of cardiovascular-related death would certainly be of important clinical interest. Since post hoc interpretations of certifications of death are not reliable, the development of a cardiac disease during cancer progression should be documented in longitudinal studies in the future.”
An unrestricted grant from Thermo Fisher funded the study. The researchers declared no competing interests.
High circulating levels of six cardiovascular biomarkers predicted cancer mortality even before the start of treatment and regardless of tumor type or stage, according to a study published online Sept. 28 in Heart.
Cancer patients had high levels of these biomarkers even though they had no clinical signs of heart disease or concurrent infections, wrote Noemi Pavo of Medical University of Vienna. The findings suggest that these patients could benefit from enhanced heart failure therapies that go beyond the current focus on preventing cardiotoxic side effects of chemotherapy and radiotherapy, noted Dr. Pavo and her associates.
Cardiovascular hormone and peptide levels can rise during cancer treatment, but whether cancer itself affects these biomarkers has been unclear, the investigators said. Therefore, they prospectively measured levels of five cardiovascular hormones – NT-proBNP, MR-proANP, MR-proADM, CT-pro-ET, and copeptin – in addition to high-sensitive troponin, the proinflammatory markers interleukin 6 and C-reactive protein, and cytokines serum amyloid A, haptoglobin, and fibronectin, in 555 patients with newly diagnosed, as-yet-untreated cancer (Heart 2015 Sep 28. doi:10.1136/heartjnl-2015-307848).
A total of 186 patients (34%) died after an average of 25 months of follow-up, the researchers reported. Levels of all cardiovascular hormones and hsTnT increased with tumor stage progression. After the researchers controlled for age, tumor type, tumor stage, glomerular filtration rate, and cardiac status, rising levels of all five cardiac hormones and hsTnT independently predicted mortality, with adjusted hazard ratios ranging from 1.21 for CT-proET-1 and hsTnT to 1.54 for the natural logarithm of NT-proBNP, and P values ranging from .014 to less than.001.
“All of these markers are strongly related to mortality, implying a direct association with disease progression,” the researchers said. “While our endpoint [was] all-cause mortality, precise information about the percentage of cardiovascular-related death would certainly be of important clinical interest. Since post hoc interpretations of certifications of death are not reliable, the development of a cardiac disease during cancer progression should be documented in longitudinal studies in the future.”
An unrestricted grant from Thermo Fisher funded the study. The researchers declared no competing interests.
FROM HEART
Key clinical point: High levels of cardiac hormones and peptides predicted mortality in patients with first-time, as-yet-untreated cancer.
Major finding: Rising levels of all biomarkers significantly predicted mortality, with adjusted hazard ratios ranging from 1.21 to 1.54.
Data source: Prospective observational study of 555 cancer patients.
Disclosures: An unrestricted grant from Thermo Fisher funded the study. The researchers declared no competing interests.
Tool helps patients, clinicians choose depression meds
A new tool, the Depression Medication Choice decision aid, helped adults with moderate to severe depression and their primary care physicians choose appropriate medications together, according to a report published online Sept. 28 in JAMA Internal Medicine.
Researchers developed the Depression Medication Choice (DMC) tool to enhance patient involvement in the decision-making process, in the hope that taking their preferences and circumstances into account would improve adherence and stave off premature discontinuation of antidepressants. The investigators then performed a cluster-randomized trial to assess the usefulness of the decision aid in real-world practice, said Annie LeBlanc, Ph.D., of the Knowledge and Evaluation Research Unit, Mayo Clinic, Rochester ,Minn.
The study involved 297 adults treated during a 2-year period by 117 clinicians in 10 rural, urban, and suburban private practices across Minnesota and Wisconsin. These demographically diverse patients had moderate to severe depression as measured by scores of 10 or higher on the Patent Health Questionnaire–9 and were considering antidepressant therapy. They were randomly assigned to clinicians who chose antidepressant therapy in the usual manner (139 patients in the control group) or to clinicians who used the DMC to choose antidepressant therapy together (158 patients in the intervention group).
The DMC tool comprised several laminated 10-by-25-cm cards that presented general information about antidepressant efficacy and adverse effects “in terms that matter to patients: weight change, sleep, libido, discontinuation, and cost,” as well as a leaflet for patients to take home, Dr. LeBlanc and her associates wrote.
Participating clinicians received training in using these cards to prompt discussion during a regular office consultation. Use of the decision aid did not add to the duration of office visits, which is key to routine implementation, the investigators said.
At 3- and 6-month follow-up, patients in the intervention group reported significantly greater comfort with the choice of antidepressant, with a mean difference between the two study groups of 5.3 out of a possible 100 points on a “comfort” scale. Patients in the intervention group also were more knowledgeable about antidepressants (OR, 9.5) and satisfied with their health care (RR, 1.25-2.40), compared with the control group.
Clinicians also were more comfortable with treatment decisions, with a mean difference between the two study groups of 11.4 out of 100 possible points. And clinicians who used the DMC tool reported being more satisfied with the decision-making process (RR, 1.64).
However, there were no significant differences between patients in the two groups regarding control of depression symptoms, remission rate, or rate of response to treatment, as measured by mean PHQ-9 scores. There also was no significant difference in medication adherence. Since most of the clinicians in this study used the DMC tool with very few patients, “it is possible that our trial underestimates the efficacy of the decision aid when used repeatedly and expertly,” Dr. LeBlanc and her associates noted (JAMA Intern Med. 2015 Sep 28. doi:10.10001/jamainternmed.2015.5214).
“Policy makers will have to decide whether the value of decision aids as promoters of patient-centered care and informed patient engagement, as demonstrated in this trial, argue on their own merit for priority,” they noted.
A new tool, the Depression Medication Choice decision aid, helped adults with moderate to severe depression and their primary care physicians choose appropriate medications together, according to a report published online Sept. 28 in JAMA Internal Medicine.
Researchers developed the Depression Medication Choice (DMC) tool to enhance patient involvement in the decision-making process, in the hope that taking their preferences and circumstances into account would improve adherence and stave off premature discontinuation of antidepressants. The investigators then performed a cluster-randomized trial to assess the usefulness of the decision aid in real-world practice, said Annie LeBlanc, Ph.D., of the Knowledge and Evaluation Research Unit, Mayo Clinic, Rochester ,Minn.
The study involved 297 adults treated during a 2-year period by 117 clinicians in 10 rural, urban, and suburban private practices across Minnesota and Wisconsin. These demographically diverse patients had moderate to severe depression as measured by scores of 10 or higher on the Patent Health Questionnaire–9 and were considering antidepressant therapy. They were randomly assigned to clinicians who chose antidepressant therapy in the usual manner (139 patients in the control group) or to clinicians who used the DMC to choose antidepressant therapy together (158 patients in the intervention group).
The DMC tool comprised several laminated 10-by-25-cm cards that presented general information about antidepressant efficacy and adverse effects “in terms that matter to patients: weight change, sleep, libido, discontinuation, and cost,” as well as a leaflet for patients to take home, Dr. LeBlanc and her associates wrote.
Participating clinicians received training in using these cards to prompt discussion during a regular office consultation. Use of the decision aid did not add to the duration of office visits, which is key to routine implementation, the investigators said.
At 3- and 6-month follow-up, patients in the intervention group reported significantly greater comfort with the choice of antidepressant, with a mean difference between the two study groups of 5.3 out of a possible 100 points on a “comfort” scale. Patients in the intervention group also were more knowledgeable about antidepressants (OR, 9.5) and satisfied with their health care (RR, 1.25-2.40), compared with the control group.
Clinicians also were more comfortable with treatment decisions, with a mean difference between the two study groups of 11.4 out of 100 possible points. And clinicians who used the DMC tool reported being more satisfied with the decision-making process (RR, 1.64).
However, there were no significant differences between patients in the two groups regarding control of depression symptoms, remission rate, or rate of response to treatment, as measured by mean PHQ-9 scores. There also was no significant difference in medication adherence. Since most of the clinicians in this study used the DMC tool with very few patients, “it is possible that our trial underestimates the efficacy of the decision aid when used repeatedly and expertly,” Dr. LeBlanc and her associates noted (JAMA Intern Med. 2015 Sep 28. doi:10.10001/jamainternmed.2015.5214).
“Policy makers will have to decide whether the value of decision aids as promoters of patient-centered care and informed patient engagement, as demonstrated in this trial, argue on their own merit for priority,” they noted.
A new tool, the Depression Medication Choice decision aid, helped adults with moderate to severe depression and their primary care physicians choose appropriate medications together, according to a report published online Sept. 28 in JAMA Internal Medicine.
Researchers developed the Depression Medication Choice (DMC) tool to enhance patient involvement in the decision-making process, in the hope that taking their preferences and circumstances into account would improve adherence and stave off premature discontinuation of antidepressants. The investigators then performed a cluster-randomized trial to assess the usefulness of the decision aid in real-world practice, said Annie LeBlanc, Ph.D., of the Knowledge and Evaluation Research Unit, Mayo Clinic, Rochester ,Minn.
The study involved 297 adults treated during a 2-year period by 117 clinicians in 10 rural, urban, and suburban private practices across Minnesota and Wisconsin. These demographically diverse patients had moderate to severe depression as measured by scores of 10 or higher on the Patent Health Questionnaire–9 and were considering antidepressant therapy. They were randomly assigned to clinicians who chose antidepressant therapy in the usual manner (139 patients in the control group) or to clinicians who used the DMC to choose antidepressant therapy together (158 patients in the intervention group).
The DMC tool comprised several laminated 10-by-25-cm cards that presented general information about antidepressant efficacy and adverse effects “in terms that matter to patients: weight change, sleep, libido, discontinuation, and cost,” as well as a leaflet for patients to take home, Dr. LeBlanc and her associates wrote.
Participating clinicians received training in using these cards to prompt discussion during a regular office consultation. Use of the decision aid did not add to the duration of office visits, which is key to routine implementation, the investigators said.
At 3- and 6-month follow-up, patients in the intervention group reported significantly greater comfort with the choice of antidepressant, with a mean difference between the two study groups of 5.3 out of a possible 100 points on a “comfort” scale. Patients in the intervention group also were more knowledgeable about antidepressants (OR, 9.5) and satisfied with their health care (RR, 1.25-2.40), compared with the control group.
Clinicians also were more comfortable with treatment decisions, with a mean difference between the two study groups of 11.4 out of 100 possible points. And clinicians who used the DMC tool reported being more satisfied with the decision-making process (RR, 1.64).
However, there were no significant differences between patients in the two groups regarding control of depression symptoms, remission rate, or rate of response to treatment, as measured by mean PHQ-9 scores. There also was no significant difference in medication adherence. Since most of the clinicians in this study used the DMC tool with very few patients, “it is possible that our trial underestimates the efficacy of the decision aid when used repeatedly and expertly,” Dr. LeBlanc and her associates noted (JAMA Intern Med. 2015 Sep 28. doi:10.10001/jamainternmed.2015.5214).
“Policy makers will have to decide whether the value of decision aids as promoters of patient-centered care and informed patient engagement, as demonstrated in this trial, argue on their own merit for priority,” they noted.
FROM JAMA INTERNAL MEDICINE
Key clinical point: The Depression Medication Choice decision aid helps primary care physicians choose appropriate medication together with patients who have moderate to severe depression.
Major finding: Patients in the intervention group reported significantly greater comfort with the choice of antidepressant, were more knowledgeable about antidepressants (OR, 9.5), and satisfied with their health care (RR, 1.25-2.40), compared with the control group.
Data source: A cluster-randomized trial involving 117 primary care clinicians in 10 private practices who chose antidepressant therapy for and with 297 adult patients.
Disclosures: The Agency for Healthcare and Quality Research funded the study. Dr. LeBlanc and her associates reported having no relevant disclosures.