On May 17, the Accreditation Council for Graduate Medical Education (ACGME) announced that it “has issued a multicenter research trial waiver, along with seed funding, to the Flexibility in Duty Hour Requirements for Surgical Trainees (FIRST) Trial for the 2016−2017 academic year, based on the recommendation of the ACGME Review Committee for Surgery.” The ACGME Task Force reviewing Common Program Requirements for residency training in the U.S. determined that, in order to comprehensively evaluate the clinical education and experience environment, “it is premature to issue any proposed modifications to requirements for the upcoming academic year.”

Working together in the best interests of surgical patient safety, the American College of Surgeons and the American Board of Surgery will continue to collect high-quality data during this one-year expansion of the FIRST Trial. In this time, new programs that meet the requirements as of July 1, 2016, will be allowed to enroll in the trial, and those programs already enrolled will be able to add ongoing data to support future reviews of residency program standards. The one-year expansion will conclude in June 2017.

FIRST Trial results were released online February 2 in the New England Journal of Medicine and presented concurrently at the 2016 Academic Surgical Congress in Jacksonville, FL, by the trial’s principal investigator, Karl Y. Bilimoria, MD, MS, FACS. The findings indicated that surgical residents can work more flexible hours than currently allowed by the ACGME without compromising surgical patient safety.

In addition to the patient safety findings, FIRST Trial results indicated that flexibility allowed for greater continuity of patient care, fewer handoffs to other care providers, and increased resident satisfaction. Read the announcement on the ACGME website at www.acgme.org/Portals/0/PDFs/Nasca-Community/NascaLettertotheCommunity-5-17-16.pdf.

On May 17, the Accreditation Council for Graduate Medical Education (ACGME) announced that it “has issued a multicenter research trial waiver, along with seed funding, to the Flexibility in Duty Hour Requirements for Surgical Trainees (FIRST) Trial for the 2016−2017 academic year, based on the recommendation of the ACGME Review Committee for Surgery.” The ACGME Task Force reviewing Common Program Requirements for residency training in the U.S. determined that, in order to comprehensively evaluate the clinical education and experience environment, “it is premature to issue any proposed modifications to requirements for the upcoming academic year.”

Working together in the best interests of surgical patient safety, the American College of Surgeons and the American Board of Surgery will continue to collect high-quality data during this one-year expansion of the FIRST Trial. In this time, new programs that meet the requirements as of July 1, 2016, will be allowed to enroll in the trial, and those programs already enrolled will be able to add ongoing data to support future reviews of residency program standards. The one-year expansion will conclude in June 2017.

FIRST Trial results were released online February 2 in the New England Journal of Medicine and presented concurrently at the 2016 Academic Surgical Congress in Jacksonville, FL, by the trial’s principal investigator, Karl Y. Bilimoria, MD, MS, FACS. The findings indicated that surgical residents can work more flexible hours than currently allowed by the ACGME without compromising surgical patient safety.

In addition to the patient safety findings, FIRST Trial results indicated that flexibility allowed for greater continuity of patient care, fewer handoffs to other care providers, and increased resident satisfaction. Read the announcement on the ACGME website at www.acgme.org/Portals/0/PDFs/Nasca-Community/NascaLettertotheCommunity-5-17-16.pdf.

On May 17, the Accreditation Council for Graduate Medical Education (ACGME) announced that it “has issued a multicenter research trial waiver, along with seed funding, to the Flexibility in Duty Hour Requirements for Surgical Trainees (FIRST) Trial for the 2016−2017 academic year, based on the recommendation of the ACGME Review Committee for Surgery.” The ACGME Task Force reviewing Common Program Requirements for residency training in the U.S. determined that, in order to comprehensively evaluate the clinical education and experience environment, “it is premature to issue any proposed modifications to requirements for the upcoming academic year.”

Working together in the best interests of surgical patient safety, the American College of Surgeons and the American Board of Surgery will continue to collect high-quality data during this one-year expansion of the FIRST Trial. In this time, new programs that meet the requirements as of July 1, 2016, will be allowed to enroll in the trial, and those programs already enrolled will be able to add ongoing data to support future reviews of residency program standards. The one-year expansion will conclude in June 2017.

FIRST Trial results were released online February 2 in the New England Journal of Medicine and presented concurrently at the 2016 Academic Surgical Congress in Jacksonville, FL, by the trial’s principal investigator, Karl Y. Bilimoria, MD, MS, FACS. The findings indicated that surgical residents can work more flexible hours than currently allowed by the ACGME without compromising surgical patient safety.

In addition to the patient safety findings, FIRST Trial results indicated that flexibility allowed for greater continuity of patient care, fewer handoffs to other care providers, and increased resident satisfaction. Read the announcement on the ACGME website at www.acgme.org/Portals/0/PDFs/Nasca-Community/NascaLettertotheCommunity-5-17-16.pdf.

This month I write about one of the College’s current advocacy efforts directed at ensuring an adequate surgical workforce in underserved and rural areas. Evidence indicates a current and growing shortage of surgeons available to serve the needs of populations in certain parts of the country. A shortage of general surgeons is a clear component to the crisis in health care workforce. Accordingly, the American College of Surgeons (ACS) is urging policy makers to recognize that only surgeons are uniquely qualified to provide certain necessary, lifesaving procedures, which other health professionals are neither trained nor competent to provide.

To determine where these areas of shortage are located and where access to surgical care is thus potentially a challenge, the ACS is strongly supporting the efforts of Representatives Larry Bucshon, MD, FACS (R-Ind.) and Ami Bera, MD (D-Calif.) who recently introduced H.R. 4959, the Ensuring Access to General Surgery Act of 2016. This legislation serves to direct the Secretary of the Department of Health and Human Services (HHS) to conduct a study on the designation of surgical Health Professional Shortage Areas (HPSA).

A variety of federal programs use the HPSA designation to improve access to health care by focusing aid and assistance on specific geographic areas and populations with the greatest unmet needs. The division of HHS known as the Health Resources and Services Administration (HRSA) has developed criteria used to determine whether certain geographic areas, population groups, or facilities may be designated as a HPSA. HPSA designation may be applied to urban or rural geographic areas, specific population groups, medical provider groups, or other public health care facilities. Currently, HRSA limits HPSA designations to shortages in primary care services, dental services, or mental health services.

HRSA has never designated an entity as a HPSA purely based upon a shortage of surgical services. In light of the available evidence relative to the shortage of surgical providers in certain parts of the country, ACS believes that research is necessary to determine exactly what constitutes a surgical shortage area, e.g., establish definitional criteria, with subsequent application of those criteria to determine where areas so defined are located. Such would provide HRSA with a valuable tool to utilize in efforts directed at increasing patient access to surgical care. Ultimately, offering incentives to surgeons to locate or remain in HPSA communities could become critical in guaranteeing all Medicare beneficiaries, regardless of geographic location, have access to quality surgical care. Determining what constitutes a surgical shortage area will serve to help HRSA to appropriately focus its resources.

Accordingly, we need your help and urge you to take action today.

Using the information below, please call your representatives today and urge them to join their colleagues and cosponsor H.R. 4959, the Ensuring Access to General Surgery Act of 2016.

Instructions

Call toll-free: 1-877-996-4464

You will be connected to your representative‘s office. Once you are connected, provide your name and indicate that you are a constituent. You should also be prepared to provide additional contact information for follow-up purposes.

Next, we suggest you use the following message:

• As a surgeon and as your constituent, I urge you to join your colleagues and cosponsor H.R. 4959, the Ensuring Access to General Surgery Act of 2016, which would direct the Secretary of Department of Health and Human Services (HHS) to conduct a study to designate General Surgery Health Professional Shortage Areas (HPSA).

• The division of HHS known as the Health Resources and Services Administration (HRSA) has developed designation criteria in order to determine whether certain geographic areas, population groups, or facilities may be designated as a HPSA.

• HRSA has never designated an entity as a HPSA purely based upon a shortage of surgical services.

• In light of evidence relative to a shortage of surgeons, ACS believes that research is necessary to determine exactly what constitutes a surgical shortage area and subsequently where these areas exist.

Alternatively, for those who were seeking a topic on which to initiate a personal in-district meeting with representatives and their staff as was discussed in last month’s edition of this column, H.R. 4959 presents a prime subject for such in order to have a focused meeting with a specific ask on a “white hat” issue that will surely resonate with members of Congress. Currently, in-district work periods are scheduled for the last week of June, the last two weeks of July, and the entire month of August.

As always, those with questions or concerns, or those who need assistance in setting up an in-district meeting may contact staff of the Division of Advocacy and Health Policy by phone at 202-337-2701 or via e-mail at [email protected].

Thank you for taking the time to engage and take action on this critical issue.

Please encourage your colleagues to do likewise.

Until next month ...

Dr. Patrick V. Bailey is an ACS Fellow, a pediatric surgeon, and Medical Director, Advocacy, for the Division of Advocacy and Health Policy, in the ACS offices in Washington, DC.

This month I write about one of the College’s current advocacy efforts directed at ensuring an adequate surgical workforce in underserved and rural areas. Evidence indicates a current and growing shortage of surgeons available to serve the needs of populations in certain parts of the country. A shortage of general surgeons is a clear component to the crisis in health care workforce. Accordingly, the American College of Surgeons (ACS) is urging policy makers to recognize that only surgeons are uniquely qualified to provide certain necessary, lifesaving procedures, which other health professionals are neither trained nor competent to provide.

To determine where these areas of shortage are located and where access to surgical care is thus potentially a challenge, the ACS is strongly supporting the efforts of Representatives Larry Bucshon, MD, FACS (R-Ind.) and Ami Bera, MD (D-Calif.) who recently introduced H.R. 4959, the Ensuring Access to General Surgery Act of 2016. This legislation serves to direct the Secretary of the Department of Health and Human Services (HHS) to conduct a study on the designation of surgical Health Professional Shortage Areas (HPSA).

A variety of federal programs use the HPSA designation to improve access to health care by focusing aid and assistance on specific geographic areas and populations with the greatest unmet needs. The division of HHS known as the Health Resources and Services Administration (HRSA) has developed criteria used to determine whether certain geographic areas, population groups, or facilities may be designated as a HPSA. HPSA designation may be applied to urban or rural geographic areas, specific population groups, medical provider groups, or other public health care facilities. Currently, HRSA limits HPSA designations to shortages in primary care services, dental services, or mental health services.

HRSA has never designated an entity as a HPSA purely based upon a shortage of surgical services. In light of the available evidence relative to the shortage of surgical providers in certain parts of the country, ACS believes that research is necessary to determine exactly what constitutes a surgical shortage area, e.g., establish definitional criteria, with subsequent application of those criteria to determine where areas so defined are located. Such would provide HRSA with a valuable tool to utilize in efforts directed at increasing patient access to surgical care. Ultimately, offering incentives to surgeons to locate or remain in HPSA communities could become critical in guaranteeing all Medicare beneficiaries, regardless of geographic location, have access to quality surgical care. Determining what constitutes a surgical shortage area will serve to help HRSA to appropriately focus its resources.

Accordingly, we need your help and urge you to take action today.

Using the information below, please call your representatives today and urge them to join their colleagues and cosponsor H.R. 4959, the Ensuring Access to General Surgery Act of 2016.

Instructions

Call toll-free: 1-877-996-4464

You will be connected to your representative‘s office. Once you are connected, provide your name and indicate that you are a constituent. You should also be prepared to provide additional contact information for follow-up purposes.

Next, we suggest you use the following message:

• As a surgeon and as your constituent, I urge you to join your colleagues and cosponsor H.R. 4959, the Ensuring Access to General Surgery Act of 2016, which would direct the Secretary of Department of Health and Human Services (HHS) to conduct a study to designate General Surgery Health Professional Shortage Areas (HPSA).

• The division of HHS known as the Health Resources and Services Administration (HRSA) has developed designation criteria in order to determine whether certain geographic areas, population groups, or facilities may be designated as a HPSA.

• HRSA has never designated an entity as a HPSA purely based upon a shortage of surgical services.

• In light of evidence relative to a shortage of surgeons, ACS believes that research is necessary to determine exactly what constitutes a surgical shortage area and subsequently where these areas exist.

Alternatively, for those who were seeking a topic on which to initiate a personal in-district meeting with representatives and their staff as was discussed in last month’s edition of this column, H.R. 4959 presents a prime subject for such in order to have a focused meeting with a specific ask on a “white hat” issue that will surely resonate with members of Congress. Currently, in-district work periods are scheduled for the last week of June, the last two weeks of July, and the entire month of August.

As always, those with questions or concerns, or those who need assistance in setting up an in-district meeting may contact staff of the Division of Advocacy and Health Policy by phone at 202-337-2701 or via e-mail at [email protected].

Thank you for taking the time to engage and take action on this critical issue.

Please encourage your colleagues to do likewise.

Until next month ...

Dr. Patrick V. Bailey is an ACS Fellow, a pediatric surgeon, and Medical Director, Advocacy, for the Division of Advocacy and Health Policy, in the ACS offices in Washington, DC.

This month I write about one of the College’s current advocacy efforts directed at ensuring an adequate surgical workforce in underserved and rural areas. Evidence indicates a current and growing shortage of surgeons available to serve the needs of populations in certain parts of the country. A shortage of general surgeons is a clear component to the crisis in health care workforce. Accordingly, the American College of Surgeons (ACS) is urging policy makers to recognize that only surgeons are uniquely qualified to provide certain necessary, lifesaving procedures, which other health professionals are neither trained nor competent to provide.

To determine where these areas of shortage are located and where access to surgical care is thus potentially a challenge, the ACS is strongly supporting the efforts of Representatives Larry Bucshon, MD, FACS (R-Ind.) and Ami Bera, MD (D-Calif.) who recently introduced H.R. 4959, the Ensuring Access to General Surgery Act of 2016. This legislation serves to direct the Secretary of the Department of Health and Human Services (HHS) to conduct a study on the designation of surgical Health Professional Shortage Areas (HPSA).

A variety of federal programs use the HPSA designation to improve access to health care by focusing aid and assistance on specific geographic areas and populations with the greatest unmet needs. The division of HHS known as the Health Resources and Services Administration (HRSA) has developed criteria used to determine whether certain geographic areas, population groups, or facilities may be designated as a HPSA. HPSA designation may be applied to urban or rural geographic areas, specific population groups, medical provider groups, or other public health care facilities. Currently, HRSA limits HPSA designations to shortages in primary care services, dental services, or mental health services.

HRSA has never designated an entity as a HPSA purely based upon a shortage of surgical services. In light of the available evidence relative to the shortage of surgical providers in certain parts of the country, ACS believes that research is necessary to determine exactly what constitutes a surgical shortage area, e.g., establish definitional criteria, with subsequent application of those criteria to determine where areas so defined are located. Such would provide HRSA with a valuable tool to utilize in efforts directed at increasing patient access to surgical care. Ultimately, offering incentives to surgeons to locate or remain in HPSA communities could become critical in guaranteeing all Medicare beneficiaries, regardless of geographic location, have access to quality surgical care. Determining what constitutes a surgical shortage area will serve to help HRSA to appropriately focus its resources.

Accordingly, we need your help and urge you to take action today.

Using the information below, please call your representatives today and urge them to join their colleagues and cosponsor H.R. 4959, the Ensuring Access to General Surgery Act of 2016.

Instructions

Call toll-free: 1-877-996-4464

You will be connected to your representative‘s office. Once you are connected, provide your name and indicate that you are a constituent. You should also be prepared to provide additional contact information for follow-up purposes.

Next, we suggest you use the following message:

• As a surgeon and as your constituent, I urge you to join your colleagues and cosponsor H.R. 4959, the Ensuring Access to General Surgery Act of 2016, which would direct the Secretary of Department of Health and Human Services (HHS) to conduct a study to designate General Surgery Health Professional Shortage Areas (HPSA).

• The division of HHS known as the Health Resources and Services Administration (HRSA) has developed designation criteria in order to determine whether certain geographic areas, population groups, or facilities may be designated as a HPSA.

• HRSA has never designated an entity as a HPSA purely based upon a shortage of surgical services.

• In light of evidence relative to a shortage of surgeons, ACS believes that research is necessary to determine exactly what constitutes a surgical shortage area and subsequently where these areas exist.

Alternatively, for those who were seeking a topic on which to initiate a personal in-district meeting with representatives and their staff as was discussed in last month’s edition of this column, H.R. 4959 presents a prime subject for such in order to have a focused meeting with a specific ask on a “white hat” issue that will surely resonate with members of Congress. Currently, in-district work periods are scheduled for the last week of June, the last two weeks of July, and the entire month of August.

As always, those with questions or concerns, or those who need assistance in setting up an in-district meeting may contact staff of the Division of Advocacy and Health Policy by phone at 202-337-2701 or via e-mail at [email protected].

Thank you for taking the time to engage and take action on this critical issue.

Please encourage your colleagues to do likewise.

Until next month ...

Dr. Patrick V. Bailey is an ACS Fellow, a pediatric surgeon, and Medical Director, Advocacy, for the Division of Advocacy and Health Policy, in the ACS offices in Washington, DC.

Last month, I discussed RSS news feeds as a useful tool for keeping abreast of frequently updated information, such as blog entries, news headlines, audio, and video, without having to visit a multitude of different Web pages each day.

This month, I’ll explain how to set up your own feed, which is useful if you want to increase the readership on your website, or publicize a podcast, or keep your patients abreast of your practice’s latest treatments and procedures. It will also alert you immediately if your name pops up in news or gossip sites.

There are several options, depending on your budget, and how involved you personally want to be in the process: Many Web hosting services will automatically create and update your feed for a monthly fee; so if you already have a professionally hosted website, check to see if your host offers that service. If not, Web services such as Feedity and Rapidfeeds allow you to manage multiple feeds, with automatic updates, so that you will not need to manually update your feed each time you update your website content. Feedity’s software can even generate an RSS file without your having to input each item. Other popular hosting options include Web Hosting Hub, Arvixe, and MyHosting, among many others. (As always, I have no financial interest in any service I mention here.)

Another option, used by many organizations that publish their own articles and news stories, is a content management system (CMS), an application designed to organize, store, and publish content, including tools for adding RSS feeds. Examples include Drupal and Plone – both free, open-source programs.

Alternatively, you can download a stand-alone RSS creation program, then create and update your feed manually. Again, there are many options to choose from. One popular example is RSS Builder, a free, open source RSS creation program that allows you to create RSS files, upload them to your website, and automatically manage them to some extent. Disadvantages of free systems include advertisements (sometimes removable for a monthly fee), scarce or nonexistent technical support, and in many cases, no option to create more than one feed. You may also have to manually add new headlines, links, and descriptive text yourself. Your “free” feed can become quite expensive if you or staffers are forced to spend an inordinate amount of time maintaining it. Paid programs such as FeedForAll allow easier creation and maintenance, and less time commitment.

Once you have chosen your service, create your first feed. The process will differ from program to program, but the general idea is the same for almost all of them. All feeds will need some basic data: A title (which should be the same as your website or podcast); the URL for your website, to help viewers link back to your home page; and a description – a sentence or two describing the general content on the feed.

Once you’ve entered this information, you can start populating the feed with content. Enter in the title of each article, blog post, podcast episode, etc., the URL that links directly to that content, and the publishing date. Each entry should have its own short but sweet description; this is what your readers will see before they choose to click your entry in their RSS readers. You can add author information and further comments if needed. Add a new entry for each piece of content that you want to broadcast.

Most RSS apps suggest that you assign each item in your feed a global unique identifier (GUID), which RSS readers use to determine if an item has been changed or updated. Each feed item should have its own GUID, particularly if multiple items are located at the same URL.

Once you’re done entering in all of your content to your feed, you need to export it to an XML file, which will allow visitors to subscribe to your feed. Then upload the XML file to your website, place it on your homepage, and click the Publish Feed button.

Once your feed is live, consider submitting it to some of the many RSS feed directories (also called aggregate sites) that collect articles from similar interests and can significantly increase your viewership. Search for medically oriented directories, and others that match the interests that your feed addresses, and submit each directory’s URL to your feed’s XML file.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a long-time monthly columnist for Dermatology News. Write to him at [email protected].

Last month, I discussed RSS news feeds as a useful tool for keeping abreast of frequently updated information, such as blog entries, news headlines, audio, and video, without having to visit a multitude of different Web pages each day.

This month, I’ll explain how to set up your own feed, which is useful if you want to increase the readership on your website, or publicize a podcast, or keep your patients abreast of your practice’s latest treatments and procedures. It will also alert you immediately if your name pops up in news or gossip sites.

There are several options, depending on your budget, and how involved you personally want to be in the process: Many Web hosting services will automatically create and update your feed for a monthly fee; so if you already have a professionally hosted website, check to see if your host offers that service. If not, Web services such as Feedity and Rapidfeeds allow you to manage multiple feeds, with automatic updates, so that you will not need to manually update your feed each time you update your website content. Feedity’s software can even generate an RSS file without your having to input each item. Other popular hosting options include Web Hosting Hub, Arvixe, and MyHosting, among many others. (As always, I have no financial interest in any service I mention here.)

Another option, used by many organizations that publish their own articles and news stories, is a content management system (CMS), an application designed to organize, store, and publish content, including tools for adding RSS feeds. Examples include Drupal and Plone – both free, open-source programs.

Alternatively, you can download a stand-alone RSS creation program, then create and update your feed manually. Again, there are many options to choose from. One popular example is RSS Builder, a free, open source RSS creation program that allows you to create RSS files, upload them to your website, and automatically manage them to some extent. Disadvantages of free systems include advertisements (sometimes removable for a monthly fee), scarce or nonexistent technical support, and in many cases, no option to create more than one feed. You may also have to manually add new headlines, links, and descriptive text yourself. Your “free” feed can become quite expensive if you or staffers are forced to spend an inordinate amount of time maintaining it. Paid programs such as FeedForAll allow easier creation and maintenance, and less time commitment.

Once you have chosen your service, create your first feed. The process will differ from program to program, but the general idea is the same for almost all of them. All feeds will need some basic data: A title (which should be the same as your website or podcast); the URL for your website, to help viewers link back to your home page; and a description – a sentence or two describing the general content on the feed.

Once you’ve entered this information, you can start populating the feed with content. Enter in the title of each article, blog post, podcast episode, etc., the URL that links directly to that content, and the publishing date. Each entry should have its own short but sweet description; this is what your readers will see before they choose to click your entry in their RSS readers. You can add author information and further comments if needed. Add a new entry for each piece of content that you want to broadcast.

Most RSS apps suggest that you assign each item in your feed a global unique identifier (GUID), which RSS readers use to determine if an item has been changed or updated. Each feed item should have its own GUID, particularly if multiple items are located at the same URL.

Once you’re done entering in all of your content to your feed, you need to export it to an XML file, which will allow visitors to subscribe to your feed. Then upload the XML file to your website, place it on your homepage, and click the Publish Feed button.

Once your feed is live, consider submitting it to some of the many RSS feed directories (also called aggregate sites) that collect articles from similar interests and can significantly increase your viewership. Search for medically oriented directories, and others that match the interests that your feed addresses, and submit each directory’s URL to your feed’s XML file.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a long-time monthly columnist for Dermatology News. Write to him at [email protected].

Last month, I discussed RSS news feeds as a useful tool for keeping abreast of frequently updated information, such as blog entries, news headlines, audio, and video, without having to visit a multitude of different Web pages each day.

This month, I’ll explain how to set up your own feed, which is useful if you want to increase the readership on your website, or publicize a podcast, or keep your patients abreast of your practice’s latest treatments and procedures. It will also alert you immediately if your name pops up in news or gossip sites.

There are several options, depending on your budget, and how involved you personally want to be in the process: Many Web hosting services will automatically create and update your feed for a monthly fee; so if you already have a professionally hosted website, check to see if your host offers that service. If not, Web services such as Feedity and Rapidfeeds allow you to manage multiple feeds, with automatic updates, so that you will not need to manually update your feed each time you update your website content. Feedity’s software can even generate an RSS file without your having to input each item. Other popular hosting options include Web Hosting Hub, Arvixe, and MyHosting, among many others. (As always, I have no financial interest in any service I mention here.)

Another option, used by many organizations that publish their own articles and news stories, is a content management system (CMS), an application designed to organize, store, and publish content, including tools for adding RSS feeds. Examples include Drupal and Plone – both free, open-source programs.

Alternatively, you can download a stand-alone RSS creation program, then create and update your feed manually. Again, there are many options to choose from. One popular example is RSS Builder, a free, open source RSS creation program that allows you to create RSS files, upload them to your website, and automatically manage them to some extent. Disadvantages of free systems include advertisements (sometimes removable for a monthly fee), scarce or nonexistent technical support, and in many cases, no option to create more than one feed. You may also have to manually add new headlines, links, and descriptive text yourself. Your “free” feed can become quite expensive if you or staffers are forced to spend an inordinate amount of time maintaining it. Paid programs such as FeedForAll allow easier creation and maintenance, and less time commitment.

Once you have chosen your service, create your first feed. The process will differ from program to program, but the general idea is the same for almost all of them. All feeds will need some basic data: A title (which should be the same as your website or podcast); the URL for your website, to help viewers link back to your home page; and a description – a sentence or two describing the general content on the feed.

Once you’ve entered this information, you can start populating the feed with content. Enter in the title of each article, blog post, podcast episode, etc., the URL that links directly to that content, and the publishing date. Each entry should have its own short but sweet description; this is what your readers will see before they choose to click your entry in their RSS readers. You can add author information and further comments if needed. Add a new entry for each piece of content that you want to broadcast.

Most RSS apps suggest that you assign each item in your feed a global unique identifier (GUID), which RSS readers use to determine if an item has been changed or updated. Each feed item should have its own GUID, particularly if multiple items are located at the same URL.

Once you’re done entering in all of your content to your feed, you need to export it to an XML file, which will allow visitors to subscribe to your feed. Then upload the XML file to your website, place it on your homepage, and click the Publish Feed button.

Once your feed is live, consider submitting it to some of the many RSS feed directories (also called aggregate sites) that collect articles from similar interests and can significantly increase your viewership. Search for medically oriented directories, and others that match the interests that your feed addresses, and submit each directory’s URL to your feed’s XML file.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a long-time monthly columnist for Dermatology News. Write to him at [email protected].

NEW ORLEANs – Between 2001 and 2013, a cohort of persons with newly diagnosed diabetes spent $3,489 more on average on medical costs in the first year after their diagnosis than they had in the year preceding it. Comparied with their diabetes-free counterparts, patients spent $6,424 more on average in the first year following diagnosis, results from a large data analysis found. In addition, during the period of 9 years before and 9 years after the diagnosis of diabetes, per capita total medical expenditures for the diabetes cohort increased annually by $382, compared with an increase of $177 for the cohort who did not have the condition.

“We know that people with diagnosed diabetes spend more on medical care than those without diagnosed diabetes because of the additional costs associated with managing diabetes and diabetes complications,” lead study author Sundar S. Shrestha, Ph.D., said in an interview in advance of the annual scientific sessions of the American Diabetes Association. “However, little information is available on how much more those with diagnosed diabetes spend after diagnosis than before diagnosis. Also, little information is available on how much more those with diagnosed diabetes spend on medical care, compared with those without diagnosed diabetes.”

Dr. Shrestha, a health economist at the Centers for Disease Control and Prevention, and his associates, analyzed the MarketScan Commercial Claims and Encounters database for the period 2001-2013 to compare the trajectory of medical expenditures (in 2013 U.S. dollars) among a diabetes cohort 9 years before and 9 years after diagnosis with a matched cohort of individuals without diabetes for U.S. adults aged 25-64 years. They defined diabetes incidence as having two or more outpatient claims 30 days apart or at least one inpatient claim with diabetes codes during the case identification period that spanned up to 2 calendar years after the first diabetes claim with at least 2 previous years without any diabetes claim.

Dr. Shrestha reported on 415,728 patient-years of data. The diabetes cohort spent an additional $51,000 on average during the 9 years before and after diagnosis, compared with their counterparts who had no diabetes diagnosis. Overall medical expenditures after diagnosis were also 2.3 times higher than before diagnosis.

“Although the additional expenditure after diagnosis was much higher for people with diagnosed diabetes, after the first year of diagnosis, it did not increase with the duration of diabetes during the study period,” Dr. Shrestha said. “However, the composition of expenditures differed, increasing for prescription drugs and decreasing for inpatient care.” He noted that the estimated excess medical expenditures described in the study indicate that “identifying those at high risk of diabetes, delaying/preventing development of diabetes through a lifestyle change program or other intervention, and managing diabetes effectively could reduce health care costs substantially.”

He acknowledged certain limitations of the study, including the fact that the data were drawn from a privately insured adult population and therefore may not be generalizable to the entire population of the United States. “Additionally, the data do not allow us to distinguish between type 1 and type 2 diabetes,” Dr. Shrestha said. He reported having no financial disclosures.

[email protected]

NEW ORLEANs – Between 2001 and 2013, a cohort of persons with newly diagnosed diabetes spent $3,489 more on average on medical costs in the first year after their diagnosis than they had in the year preceding it. Comparied with their diabetes-free counterparts, patients spent $6,424 more on average in the first year following diagnosis, results from a large data analysis found. In addition, during the period of 9 years before and 9 years after the diagnosis of diabetes, per capita total medical expenditures for the diabetes cohort increased annually by $382, compared with an increase of $177 for the cohort who did not have the condition.

“We know that people with diagnosed diabetes spend more on medical care than those without diagnosed diabetes because of the additional costs associated with managing diabetes and diabetes complications,” lead study author Sundar S. Shrestha, Ph.D., said in an interview in advance of the annual scientific sessions of the American Diabetes Association. “However, little information is available on how much more those with diagnosed diabetes spend after diagnosis than before diagnosis. Also, little information is available on how much more those with diagnosed diabetes spend on medical care, compared with those without diagnosed diabetes.”

Dr. Shrestha, a health economist at the Centers for Disease Control and Prevention, and his associates, analyzed the MarketScan Commercial Claims and Encounters database for the period 2001-2013 to compare the trajectory of medical expenditures (in 2013 U.S. dollars) among a diabetes cohort 9 years before and 9 years after diagnosis with a matched cohort of individuals without diabetes for U.S. adults aged 25-64 years. They defined diabetes incidence as having two or more outpatient claims 30 days apart or at least one inpatient claim with diabetes codes during the case identification period that spanned up to 2 calendar years after the first diabetes claim with at least 2 previous years without any diabetes claim.

Dr. Shrestha reported on 415,728 patient-years of data. The diabetes cohort spent an additional $51,000 on average during the 9 years before and after diagnosis, compared with their counterparts who had no diabetes diagnosis. Overall medical expenditures after diagnosis were also 2.3 times higher than before diagnosis.

“Although the additional expenditure after diagnosis was much higher for people with diagnosed diabetes, after the first year of diagnosis, it did not increase with the duration of diabetes during the study period,” Dr. Shrestha said. “However, the composition of expenditures differed, increasing for prescription drugs and decreasing for inpatient care.” He noted that the estimated excess medical expenditures described in the study indicate that “identifying those at high risk of diabetes, delaying/preventing development of diabetes through a lifestyle change program or other intervention, and managing diabetes effectively could reduce health care costs substantially.”

He acknowledged certain limitations of the study, including the fact that the data were drawn from a privately insured adult population and therefore may not be generalizable to the entire population of the United States. “Additionally, the data do not allow us to distinguish between type 1 and type 2 diabetes,” Dr. Shrestha said. He reported having no financial disclosures.

[email protected]

NEW ORLEANs – Between 2001 and 2013, a cohort of persons with newly diagnosed diabetes spent $3,489 more on average on medical costs in the first year after their diagnosis than they had in the year preceding it. Comparied with their diabetes-free counterparts, patients spent $6,424 more on average in the first year following diagnosis, results from a large data analysis found. In addition, during the period of 9 years before and 9 years after the diagnosis of diabetes, per capita total medical expenditures for the diabetes cohort increased annually by $382, compared with an increase of $177 for the cohort who did not have the condition.

“We know that people with diagnosed diabetes spend more on medical care than those without diagnosed diabetes because of the additional costs associated with managing diabetes and diabetes complications,” lead study author Sundar S. Shrestha, Ph.D., said in an interview in advance of the annual scientific sessions of the American Diabetes Association. “However, little information is available on how much more those with diagnosed diabetes spend after diagnosis than before diagnosis. Also, little information is available on how much more those with diagnosed diabetes spend on medical care, compared with those without diagnosed diabetes.”

Dr. Shrestha, a health economist at the Centers for Disease Control and Prevention, and his associates, analyzed the MarketScan Commercial Claims and Encounters database for the period 2001-2013 to compare the trajectory of medical expenditures (in 2013 U.S. dollars) among a diabetes cohort 9 years before and 9 years after diagnosis with a matched cohort of individuals without diabetes for U.S. adults aged 25-64 years. They defined diabetes incidence as having two or more outpatient claims 30 days apart or at least one inpatient claim with diabetes codes during the case identification period that spanned up to 2 calendar years after the first diabetes claim with at least 2 previous years without any diabetes claim.

Dr. Shrestha reported on 415,728 patient-years of data. The diabetes cohort spent an additional $51,000 on average during the 9 years before and after diagnosis, compared with their counterparts who had no diabetes diagnosis. Overall medical expenditures after diagnosis were also 2.3 times higher than before diagnosis.

“Although the additional expenditure after diagnosis was much higher for people with diagnosed diabetes, after the first year of diagnosis, it did not increase with the duration of diabetes during the study period,” Dr. Shrestha said. “However, the composition of expenditures differed, increasing for prescription drugs and decreasing for inpatient care.” He noted that the estimated excess medical expenditures described in the study indicate that “identifying those at high risk of diabetes, delaying/preventing development of diabetes through a lifestyle change program or other intervention, and managing diabetes effectively could reduce health care costs substantially.”

He acknowledged certain limitations of the study, including the fact that the data were drawn from a privately insured adult population and therefore may not be generalizable to the entire population of the United States. “Additionally, the data do not allow us to distinguish between type 1 and type 2 diabetes,” Dr. Shrestha said. He reported having no financial disclosures.

[email protected]

Use of systemic glucocorticoids significantly increased risk for community-acquired Staphylococcus aureus bacteremia (CA-SAB) in a dose-dependent fashion, based on data from a large Danish registry.

On average, current users of systemic glucocorticoids had an adjusted 2.5-fold increased risk of CA-SAB, compared with nonusers. The risk was most pronounced in long-term users of glucocorticoids, including patients with connective tissue disease and patients with chronic pulmonary disease. Among new users of glucocorticoids, the risk of CA-SAB was highest for patients with cancer, in the retrospective, case-control study published by Mayo Clinic Proceedings.

CDC/Janice Haney Carr

Dr. Jesper Smit of Aalborg (Denmark) University and his colleagues, looked at all 2,638 patients admitted with first-time CA-SAB and 26,379 matched population controls in Northern Denmark medical databases between January 1, 2000, and December 31, 2011.

New glucocorticoid users had an odds ratio for CA-SAB of 2.7, slightly higher than the OR of 2.3 for long-term users. Former glucocorticoid users had a considerably lower OR for CA-SAB of 1.3.

Risk of CA-SAB rose in a dose-dependent fashion as 90-day cumulative doses increased. For subjects taking a cumulative dose of 150 mg or less, the adjusted OR for CA-SAB was 1.3. At a cumulative dose of 500-1000 mg, OR rose to 2.4. At a cumulative dose greater than 1000 mg, OR was 6.2.

Risk did not differ based on individuals’ sex, age group, or the severity of any comorbidity.

“This is the first study to specifically investigate whether the use of glucocorticoids is associated with increased risk of CA-SAB,” the authors concluded, adding that “these results extend the current knowledge of risk factors for CA-SAB and may serve as a reminder for clinicians to carefully weigh the elevated risk against the potential beneficial effect of glucocorticoid therapy, particularly in patients with concomitant CA-SAB risk factors.”

This study was supported by grants from Heinrich Kopp, Hertha Christensen, and North Denmark Health Sciences Research foundation. The authors did not report any relevant financial disclosures.

[email protected]

Use of systemic glucocorticoids significantly increased risk for community-acquired Staphylococcus aureus bacteremia (CA-SAB) in a dose-dependent fashion, based on data from a large Danish registry.

On average, current users of systemic glucocorticoids had an adjusted 2.5-fold increased risk of CA-SAB, compared with nonusers. The risk was most pronounced in long-term users of glucocorticoids, including patients with connective tissue disease and patients with chronic pulmonary disease. Among new users of glucocorticoids, the risk of CA-SAB was highest for patients with cancer, in the retrospective, case-control study published by Mayo Clinic Proceedings.

CDC/Janice Haney Carr

Dr. Jesper Smit of Aalborg (Denmark) University and his colleagues, looked at all 2,638 patients admitted with first-time CA-SAB and 26,379 matched population controls in Northern Denmark medical databases between January 1, 2000, and December 31, 2011.

New glucocorticoid users had an odds ratio for CA-SAB of 2.7, slightly higher than the OR of 2.3 for long-term users. Former glucocorticoid users had a considerably lower OR for CA-SAB of 1.3.

Risk of CA-SAB rose in a dose-dependent fashion as 90-day cumulative doses increased. For subjects taking a cumulative dose of 150 mg or less, the adjusted OR for CA-SAB was 1.3. At a cumulative dose of 500-1000 mg, OR rose to 2.4. At a cumulative dose greater than 1000 mg, OR was 6.2.

Risk did not differ based on individuals’ sex, age group, or the severity of any comorbidity.

“This is the first study to specifically investigate whether the use of glucocorticoids is associated with increased risk of CA-SAB,” the authors concluded, adding that “these results extend the current knowledge of risk factors for CA-SAB and may serve as a reminder for clinicians to carefully weigh the elevated risk against the potential beneficial effect of glucocorticoid therapy, particularly in patients with concomitant CA-SAB risk factors.”

This study was supported by grants from Heinrich Kopp, Hertha Christensen, and North Denmark Health Sciences Research foundation. The authors did not report any relevant financial disclosures.

[email protected]

Use of systemic glucocorticoids significantly increased risk for community-acquired Staphylococcus aureus bacteremia (CA-SAB) in a dose-dependent fashion, based on data from a large Danish registry.

On average, current users of systemic glucocorticoids had an adjusted 2.5-fold increased risk of CA-SAB, compared with nonusers. The risk was most pronounced in long-term users of glucocorticoids, including patients with connective tissue disease and patients with chronic pulmonary disease. Among new users of glucocorticoids, the risk of CA-SAB was highest for patients with cancer, in the retrospective, case-control study published by Mayo Clinic Proceedings.

CDC/Janice Haney Carr

Dr. Jesper Smit of Aalborg (Denmark) University and his colleagues, looked at all 2,638 patients admitted with first-time CA-SAB and 26,379 matched population controls in Northern Denmark medical databases between January 1, 2000, and December 31, 2011.

New glucocorticoid users had an odds ratio for CA-SAB of 2.7, slightly higher than the OR of 2.3 for long-term users. Former glucocorticoid users had a considerably lower OR for CA-SAB of 1.3.

Risk of CA-SAB rose in a dose-dependent fashion as 90-day cumulative doses increased. For subjects taking a cumulative dose of 150 mg or less, the adjusted OR for CA-SAB was 1.3. At a cumulative dose of 500-1000 mg, OR rose to 2.4. At a cumulative dose greater than 1000 mg, OR was 6.2.

Risk did not differ based on individuals’ sex, age group, or the severity of any comorbidity.

“This is the first study to specifically investigate whether the use of glucocorticoids is associated with increased risk of CA-SAB,” the authors concluded, adding that “these results extend the current knowledge of risk factors for CA-SAB and may serve as a reminder for clinicians to carefully weigh the elevated risk against the potential beneficial effect of glucocorticoid therapy, particularly in patients with concomitant CA-SAB risk factors.”

This study was supported by grants from Heinrich Kopp, Hertha Christensen, and North Denmark Health Sciences Research foundation. The authors did not report any relevant financial disclosures.

[email protected]

SCOTTSDALE, ARIZ. – A small proof-of-concept study of low-field magnetic stimulation to augment medical treatment for 85 individuals with treatment-resistant major depressive disorder failed to meet its primary endpoint of significant improvement in core depression symptoms at 48 hours after treatment, though some nonsignificant improvement in mood was seen, compared with sham treatment.

The study’s design did succeed, however, in reducing the substantial placebo response that plagues many clinical trials of treatments for psychiatric illness.

During a meeting of the American Society of Clinical Psychopharmacology, formerly known as the New Clinical Drug Evaluation Unit meeting, Dr. Maurizio Fava shared the results of a double-blind, proof-of-concept trial of low-field magnetic stimulation (LFMS) augmentation of antidepressant therapy for patients with treatment-resistant depression.

Overall, patients receiving LFMS saw no significant improvement on an abbreviated 6-item Hamilton Rating Scale for Depression (HAMD-6), compared with those receiving sham treatment (P = .61). Since the study looked at changes in depression scores just 24 hours after treatment, Dr. Fava said, “We used the HAMD-6, because it’s a more sensitive measure for rapid changes than the HAMD-17.

“Unfortunately, the LFMS did not separate out after 48 hours,” he said.

Nonsignificant differences also were seen for two other rating scales, the Montgomery-Åsberg Depression Scale (MADRS) and the Strengths and Difficulties Questionnaire (SDQ). The use of a visual analog scale to detect mood changes 120 minutes after treatment did not yield significant differences between those receiving LFMS and those receiving sham.

Many avenues in addition to medication are being explored to provide rapid relief for individuals with treatment-resistant depression (TRD), said Dr. Fava, the study’s lead investigator, associate dean for clinical and translational research, and Slater Family Professor of Psychiatry at Harvard Medical School, Boston.

The six-site Rapidly-Acting Treatments for Treatment-Resistant Depression trial was sham controlled and used a prerandomized sequential parallel comparison design (SPCD). The intervention of LFMS or sham was delivered for 20 minutes daily on 2 consecutive days, and then again for 2 more days after an interim assessment.

“In the second stage of the study, only the patients who had not responded to sham are included,” Dr. Fava said. This is the aspect of an SPCD study that can help to reduce the negative effect on results that can be seen with high placebo response rates, a common phenomenon in psychiatric clinical trials.

“This was a complicated study, involving all kind of methodologic approaches,” said Dr. Fava, noting that each enrollee had the diagnosis of moderate to severe depression (MADRS score equal to or greater than 20) confirmed by two interviewers, including one remote interviewer who was not involved in the study.

Patients who were on a stable dose of antidepressant were included “if they failed to achieve a treatment response after no more than one, but not more than three, treatment courses of antidepressant therapy of at least 8 weeks’ duration,” Dr. Fava said. “We wanted to avoid ‘super-resistance,’ which can reduce the ability to detect a signal” for efficacy, he said.

Dr. Fava also made the point that this study was of very short design, compared with other SPCD trials. “People were skeptical that you would see a reduction in placebo with only 4 days of treatment in two stages,” he said. However, “The design worked,” he said, since the reduction in depression scores was the equivalent of just 1.6 points on the HAMD-17 in the second stage of the study after the placebo responders had been eliminated. “That’s a very low placebo rate,” Dr. Fava said.

Many experimental building blocks support the use of LFMS to treat depression. Investigations began after a serendipitous 2004 discovery that patients with bipolar disorder who underwent diagnostic echo-planar magnetic resonance spectroscopic imaging (EP-MRSI) experienced relief from depressive symptoms after the scan (Am J Psychiatry. 2004 Jan;161[1]:93-8). Since then, LFMS has been shown to reduce helpless behavior in mice during a forced swim test.

In humans, FDG-PET imaging studies also have shown perceptible physiological changes when individuals with depression receive LFMS, consistent with those seen in reduced depression. Patients in two earlier proof-of-concept studies who had either bipolar or unipolar depression and who received LFMS experienced significantly greater symptom relief than did those receiving sham treatment.

Study design limitations included the relatively small sample size and potential recruitment biases for those seeking this form of augmentation for depression treatment. The study included only patients with unipolar depression, although “two previous positive studies included 81 bipolar patients and 22 unipolar patients,” Dr. Fava said.

Potential technical limitations included the low dosing of LFMS, with just 20 minutes of exposure two times; however, Dr. Fava said, the duration was chosen to parallel the previous studies done in patients with bipolar disorder. Also, seeing a detectable change in depression scoring at 48-72 hours after LFMS might not be an entirely realistic expectation.

The National Institutes of Health and the Department of Health and Human Services funded the study. Dr. Fava reported having a patent for Sequential Parallel Comparison Design (SPCD), which is licensed by Massachusetts General Hospital to RCT Logic, LLC. He also reported multiple financial relationships with pharmaceutical and medical device companies.

[email protected]

On Twitter @karioakes

SCOTTSDALE, ARIZ. – A small proof-of-concept study of low-field magnetic stimulation to augment medical treatment for 85 individuals with treatment-resistant major depressive disorder failed to meet its primary endpoint of significant improvement in core depression symptoms at 48 hours after treatment, though some nonsignificant improvement in mood was seen, compared with sham treatment.

The study’s design did succeed, however, in reducing the substantial placebo response that plagues many clinical trials of treatments for psychiatric illness.

During a meeting of the American Society of Clinical Psychopharmacology, formerly known as the New Clinical Drug Evaluation Unit meeting, Dr. Maurizio Fava shared the results of a double-blind, proof-of-concept trial of low-field magnetic stimulation (LFMS) augmentation of antidepressant therapy for patients with treatment-resistant depression.

Overall, patients receiving LFMS saw no significant improvement on an abbreviated 6-item Hamilton Rating Scale for Depression (HAMD-6), compared with those receiving sham treatment (P = .61). Since the study looked at changes in depression scores just 24 hours after treatment, Dr. Fava said, “We used the HAMD-6, because it’s a more sensitive measure for rapid changes than the HAMD-17.

“Unfortunately, the LFMS did not separate out after 48 hours,” he said.

Nonsignificant differences also were seen for two other rating scales, the Montgomery-Åsberg Depression Scale (MADRS) and the Strengths and Difficulties Questionnaire (SDQ). The use of a visual analog scale to detect mood changes 120 minutes after treatment did not yield significant differences between those receiving LFMS and those receiving sham.

Many avenues in addition to medication are being explored to provide rapid relief for individuals with treatment-resistant depression (TRD), said Dr. Fava, the study’s lead investigator, associate dean for clinical and translational research, and Slater Family Professor of Psychiatry at Harvard Medical School, Boston.

The six-site Rapidly-Acting Treatments for Treatment-Resistant Depression trial was sham controlled and used a prerandomized sequential parallel comparison design (SPCD). The intervention of LFMS or sham was delivered for 20 minutes daily on 2 consecutive days, and then again for 2 more days after an interim assessment.

“In the second stage of the study, only the patients who had not responded to sham are included,” Dr. Fava said. This is the aspect of an SPCD study that can help to reduce the negative effect on results that can be seen with high placebo response rates, a common phenomenon in psychiatric clinical trials.

“This was a complicated study, involving all kind of methodologic approaches,” said Dr. Fava, noting that each enrollee had the diagnosis of moderate to severe depression (MADRS score equal to or greater than 20) confirmed by two interviewers, including one remote interviewer who was not involved in the study.

Patients who were on a stable dose of antidepressant were included “if they failed to achieve a treatment response after no more than one, but not more than three, treatment courses of antidepressant therapy of at least 8 weeks’ duration,” Dr. Fava said. “We wanted to avoid ‘super-resistance,’ which can reduce the ability to detect a signal” for efficacy, he said.

Dr. Fava also made the point that this study was of very short design, compared with other SPCD trials. “People were skeptical that you would see a reduction in placebo with only 4 days of treatment in two stages,” he said. However, “The design worked,” he said, since the reduction in depression scores was the equivalent of just 1.6 points on the HAMD-17 in the second stage of the study after the placebo responders had been eliminated. “That’s a very low placebo rate,” Dr. Fava said.

Many experimental building blocks support the use of LFMS to treat depression. Investigations began after a serendipitous 2004 discovery that patients with bipolar disorder who underwent diagnostic echo-planar magnetic resonance spectroscopic imaging (EP-MRSI) experienced relief from depressive symptoms after the scan (Am J Psychiatry. 2004 Jan;161[1]:93-8). Since then, LFMS has been shown to reduce helpless behavior in mice during a forced swim test.

In humans, FDG-PET imaging studies also have shown perceptible physiological changes when individuals with depression receive LFMS, consistent with those seen in reduced depression. Patients in two earlier proof-of-concept studies who had either bipolar or unipolar depression and who received LFMS experienced significantly greater symptom relief than did those receiving sham treatment.

Study design limitations included the relatively small sample size and potential recruitment biases for those seeking this form of augmentation for depression treatment. The study included only patients with unipolar depression, although “two previous positive studies included 81 bipolar patients and 22 unipolar patients,” Dr. Fava said.

Potential technical limitations included the low dosing of LFMS, with just 20 minutes of exposure two times; however, Dr. Fava said, the duration was chosen to parallel the previous studies done in patients with bipolar disorder. Also, seeing a detectable change in depression scoring at 48-72 hours after LFMS might not be an entirely realistic expectation.

The National Institutes of Health and the Department of Health and Human Services funded the study. Dr. Fava reported having a patent for Sequential Parallel Comparison Design (SPCD), which is licensed by Massachusetts General Hospital to RCT Logic, LLC. He also reported multiple financial relationships with pharmaceutical and medical device companies.

[email protected]

On Twitter @karioakes

SCOTTSDALE, ARIZ. – A small proof-of-concept study of low-field magnetic stimulation to augment medical treatment for 85 individuals with treatment-resistant major depressive disorder failed to meet its primary endpoint of significant improvement in core depression symptoms at 48 hours after treatment, though some nonsignificant improvement in mood was seen, compared with sham treatment.

The study’s design did succeed, however, in reducing the substantial placebo response that plagues many clinical trials of treatments for psychiatric illness.

During a meeting of the American Society of Clinical Psychopharmacology, formerly known as the New Clinical Drug Evaluation Unit meeting, Dr. Maurizio Fava shared the results of a double-blind, proof-of-concept trial of low-field magnetic stimulation (LFMS) augmentation of antidepressant therapy for patients with treatment-resistant depression.

Overall, patients receiving LFMS saw no significant improvement on an abbreviated 6-item Hamilton Rating Scale for Depression (HAMD-6), compared with those receiving sham treatment (P = .61). Since the study looked at changes in depression scores just 24 hours after treatment, Dr. Fava said, “We used the HAMD-6, because it’s a more sensitive measure for rapid changes than the HAMD-17.

“Unfortunately, the LFMS did not separate out after 48 hours,” he said.

Nonsignificant differences also were seen for two other rating scales, the Montgomery-Åsberg Depression Scale (MADRS) and the Strengths and Difficulties Questionnaire (SDQ). The use of a visual analog scale to detect mood changes 120 minutes after treatment did not yield significant differences between those receiving LFMS and those receiving sham.

Many avenues in addition to medication are being explored to provide rapid relief for individuals with treatment-resistant depression (TRD), said Dr. Fava, the study’s lead investigator, associate dean for clinical and translational research, and Slater Family Professor of Psychiatry at Harvard Medical School, Boston.

The six-site Rapidly-Acting Treatments for Treatment-Resistant Depression trial was sham controlled and used a prerandomized sequential parallel comparison design (SPCD). The intervention of LFMS or sham was delivered for 20 minutes daily on 2 consecutive days, and then again for 2 more days after an interim assessment.

“In the second stage of the study, only the patients who had not responded to sham are included,” Dr. Fava said. This is the aspect of an SPCD study that can help to reduce the negative effect on results that can be seen with high placebo response rates, a common phenomenon in psychiatric clinical trials.

“This was a complicated study, involving all kind of methodologic approaches,” said Dr. Fava, noting that each enrollee had the diagnosis of moderate to severe depression (MADRS score equal to or greater than 20) confirmed by two interviewers, including one remote interviewer who was not involved in the study.

Patients who were on a stable dose of antidepressant were included “if they failed to achieve a treatment response after no more than one, but not more than three, treatment courses of antidepressant therapy of at least 8 weeks’ duration,” Dr. Fava said. “We wanted to avoid ‘super-resistance,’ which can reduce the ability to detect a signal” for efficacy, he said.

Dr. Fava also made the point that this study was of very short design, compared with other SPCD trials. “People were skeptical that you would see a reduction in placebo with only 4 days of treatment in two stages,” he said. However, “The design worked,” he said, since the reduction in depression scores was the equivalent of just 1.6 points on the HAMD-17 in the second stage of the study after the placebo responders had been eliminated. “That’s a very low placebo rate,” Dr. Fava said.

Many experimental building blocks support the use of LFMS to treat depression. Investigations began after a serendipitous 2004 discovery that patients with bipolar disorder who underwent diagnostic echo-planar magnetic resonance spectroscopic imaging (EP-MRSI) experienced relief from depressive symptoms after the scan (Am J Psychiatry. 2004 Jan;161[1]:93-8). Since then, LFMS has been shown to reduce helpless behavior in mice during a forced swim test.

In humans, FDG-PET imaging studies also have shown perceptible physiological changes when individuals with depression receive LFMS, consistent with those seen in reduced depression. Patients in two earlier proof-of-concept studies who had either bipolar or unipolar depression and who received LFMS experienced significantly greater symptom relief than did those receiving sham treatment.

Study design limitations included the relatively small sample size and potential recruitment biases for those seeking this form of augmentation for depression treatment. The study included only patients with unipolar depression, although “two previous positive studies included 81 bipolar patients and 22 unipolar patients,” Dr. Fava said.

Potential technical limitations included the low dosing of LFMS, with just 20 minutes of exposure two times; however, Dr. Fava said, the duration was chosen to parallel the previous studies done in patients with bipolar disorder. Also, seeing a detectable change in depression scoring at 48-72 hours after LFMS might not be an entirely realistic expectation.

The National Institutes of Health and the Department of Health and Human Services funded the study. Dr. Fava reported having a patent for Sequential Parallel Comparison Design (SPCD), which is licensed by Massachusetts General Hospital to RCT Logic, LLC. He also reported multiple financial relationships with pharmaceutical and medical device companies.

[email protected]

On Twitter @karioakes

Family meetings are never easy.

They’re difficult, and often held to discuss the case of a demented patient. In these situations, the family doesn’t want the patient to hear their concerns or is afraid they’ll be embarrassed or angry. Sometimes getting the patient to the appointment is simply too difficult.

Of course, most discussions of this type can be done by phone ... in theory. In practice, it doesn’t work that way.

It’s the subject matter that makes the impersonal nature of the phone difficult. Families have hard questions and want real answers at these times. A face-to-face meeting, with the human interaction, is often the best way to get things across clearly and still with compassion. It avoids the problem of the phone being passed around, having to repeat yourself to each person, and wondering who just asked what. Very few families, in my experience, want to do this on the phone.

These meetings are never quick, either. Depending on family and circumstances, they can take 30-60 minutes. Getting an insurance company to pay for that time is near impossible. Most plans only want to pay for visits where the patient is actually present, when in these cases the family is trying to avoid that. While there is a Medicare payment code for “advance care planning,” it doesn’t cover treatment discussions or other neurological issues they may bring up, and many patients are on non-Medicare plans.

I bill people for these times and have found that most families are willing to pay. I’m not fond of doing so, and certainly not trying to get rich off of them. But it’s still time that I’m in my office and have to pay my rent, staff, and utilities.

Part of this job – a big part – is helping patients and their loved ones understand and deal with difficult situations. Realistically, this is the best way to do it. Families understand that as well as I do.

Why won’t insurance companies cover them? I suppose their excuse is that they cover the patient, not the questions or emotional needs of their caregivers. Of course, those things are as important to the care of the patient as any treatment, but the bean counters don’t want to pay for them.

That is unfortunate, because someone has to. Good medical care depends on good communication with all involved.

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

Family meetings are never easy.

They’re difficult, and often held to discuss the case of a demented patient. In these situations, the family doesn’t want the patient to hear their concerns or is afraid they’ll be embarrassed or angry. Sometimes getting the patient to the appointment is simply too difficult.

Of course, most discussions of this type can be done by phone ... in theory. In practice, it doesn’t work that way.

It’s the subject matter that makes the impersonal nature of the phone difficult. Families have hard questions and want real answers at these times. A face-to-face meeting, with the human interaction, is often the best way to get things across clearly and still with compassion. It avoids the problem of the phone being passed around, having to repeat yourself to each person, and wondering who just asked what. Very few families, in my experience, want to do this on the phone.

These meetings are never quick, either. Depending on family and circumstances, they can take 30-60 minutes. Getting an insurance company to pay for that time is near impossible. Most plans only want to pay for visits where the patient is actually present, when in these cases the family is trying to avoid that. While there is a Medicare payment code for “advance care planning,” it doesn’t cover treatment discussions or other neurological issues they may bring up, and many patients are on non-Medicare plans.

I bill people for these times and have found that most families are willing to pay. I’m not fond of doing so, and certainly not trying to get rich off of them. But it’s still time that I’m in my office and have to pay my rent, staff, and utilities.

Part of this job – a big part – is helping patients and their loved ones understand and deal with difficult situations. Realistically, this is the best way to do it. Families understand that as well as I do.

Why won’t insurance companies cover them? I suppose their excuse is that they cover the patient, not the questions or emotional needs of their caregivers. Of course, those things are as important to the care of the patient as any treatment, but the bean counters don’t want to pay for them.

That is unfortunate, because someone has to. Good medical care depends on good communication with all involved.

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

Family meetings are never easy.

They’re difficult, and often held to discuss the case of a demented patient. In these situations, the family doesn’t want the patient to hear their concerns or is afraid they’ll be embarrassed or angry. Sometimes getting the patient to the appointment is simply too difficult.

Of course, most discussions of this type can be done by phone ... in theory. In practice, it doesn’t work that way.

It’s the subject matter that makes the impersonal nature of the phone difficult. Families have hard questions and want real answers at these times. A face-to-face meeting, with the human interaction, is often the best way to get things across clearly and still with compassion. It avoids the problem of the phone being passed around, having to repeat yourself to each person, and wondering who just asked what. Very few families, in my experience, want to do this on the phone.

These meetings are never quick, either. Depending on family and circumstances, they can take 30-60 minutes. Getting an insurance company to pay for that time is near impossible. Most plans only want to pay for visits where the patient is actually present, when in these cases the family is trying to avoid that. While there is a Medicare payment code for “advance care planning,” it doesn’t cover treatment discussions or other neurological issues they may bring up, and many patients are on non-Medicare plans.

I bill people for these times and have found that most families are willing to pay. I’m not fond of doing so, and certainly not trying to get rich off of them. But it’s still time that I’m in my office and have to pay my rent, staff, and utilities.

Part of this job – a big part – is helping patients and their loved ones understand and deal with difficult situations. Realistically, this is the best way to do it. Families understand that as well as I do.

Why won’t insurance companies cover them? I suppose their excuse is that they cover the patient, not the questions or emotional needs of their caregivers. Of course, those things are as important to the care of the patient as any treatment, but the bean counters don’t want to pay for them.

That is unfortunate, because someone has to. Good medical care depends on good communication with all involved.

Dr. Block has a solo neurology practice in Scottsdale, Ariz.