Writing should be fun! While some may view writing as painful (i.e., something you rather put off until all your household work, taxes, and even changing the litter boxes are done), writing can and will become more enjoyable the more you do it. Over the years that I have been writing with students, residents, and faculty, I have found that writing the discussion section of a manuscript remains the most daunting aspect of writing a paper and the No. 1 reason people put off writing. Thus, I have developed a strategy that distills this process into a very simple task. When followed, manuscript writing won’t seem so intimidating.

I like to consider the writing process in three phases: preparing to write, writing, and then revising. Let’s address each one of these.

Preparing to write

In preparing to write, it is important to know what audience you want to reach when selecting a journal. I recommend that you peruse the table of contents of the journals you have in mind to determine if that journal is publishing papers similar to yours. You also may want to consider the impact factor of the journal, as the journals you publish in can have an effect on your promotion and tenure process. Once you have decided upon a journal, retrieve the Instructions for Authors (IFA). This section will contain very important information about how the journal would like for you to format the manuscript. Follow these instructions!

If you do not follow these instructions, the journal may reject your manuscript without ever sending it out for review (that is, the managing editor will reject it). Think of it this way, if an editor takes the time to develop the IFA, you’d better believe that the requirements are important to that editor.

Once you have decided upon the journal and read the IFA, it is time to make an OUTLINE. Yes – I said it – an outline. So often we skip this simple task that we were taught in grade school. For a manuscript, the outline I start with includes the figures and/or tables. Your figures and/or tables should tell the story. If they don’t tell a cohesive story, something is wrong. I like to draw out story board on 8.5” x 11” plain paper. Each sheet of paper represents one figure (or table), and I literally draw out each panel. Then I spread the pieces of paper out on a desk to see if they tell the story I want. Once the story is determined, the writing begins.
 

Writing

The main structure of a manuscript is simple: introduction, methods, results, and discussion. The introduction section should tell the reader why you did the study. The methods section should tell the reader how you did the study. The results section should tell the reader what you found when you did the study. The discussion section should tell the reader what it all means. The introduction should spark the readers interest and provide them with enough information to understand why you conducted the study. It should consist of two to three paragraphs. The first paragraph should state the problem. The second paragraph should state what is known and unknown about the problem. The third paragraph should logically follow with your aim and hypothesis. All manuscripts can and should have a hypothesis.

The methods section should be presented in a straightforward and logical manner and include enough information for others to reproduce the experiments. The information should be presented with subheadings for each different section. For example, a clinical manuscript may have the follow subheadings: study design, study population, primary outcome, secondary outcomes, and statistical analysis.

The results section should also be presented in a logical manner, with subheadings that make sense. Be sure to refer to the IFA on the type of subheadings to use (descriptive versus simple, etc.) and remember to tell a story. The story can be told with data of most to least important, in chronological order, in vitro to in vivo, etc. The main point is to tell a good story that the reader will want to read! Be sure to cite your figures and table, but don’t duplicate the information in the figures and tables.

A nice trick is to present the data in each paragraph, and end with a sentence summarizing the results. Remember, data are the facts obtained from the experiments while results are statements that interpret the data.

The discussion section should be seen as a straightforward section to write instead of an intimidating discourse. The discussion section is where you tell the reader what the data might mean, how else the data could be interpreted, if other studies had similar or dissimilar results, the limitations of the study, and what should be done next. I propose that all discussion sections can be written in five paragraphs.

Paragraph 1 should summarize the findings with respect to the hypothesis. Paragraphs 2 and 3 should compare and contrast your data with published literature. Paragraph 4 should address limitations of the study. Paragraph 5 should conclude what it all means and what should happen next. If you start by outlining these five paragraphs, the discussion section becomes simple to write.
 

Revising

The most important aspect of writing a manuscript is revising. The importance of this is often overlooked. We all make mistakes in writing. The more you reread and revise your own work, the better it gets. Aim for writing simple sentences that are easy for your reader to read. Choose words carefully and precisely. Write well-designed sentences and structured paragraphs. The Internet has many short online tutorials to remind one how to do this. Use abbreviations sparingly and avoid wordiness. Avoid writing flaws, especially with the subject and verb. For example, “Controls were performed” should read “Control experiments were performed.”

In summary, writing should be an enjoyable process in which one can communicate exciting ideas to others. In this short article, I have presented a few tips and tricks on how to write and revise a manuscript. For a more in-depth resource, I refer the reader to “How to write a paper,” published in 2013 (ANZ J Surg. Jan;83[1-2]:90-2).

Dr. Kibbe is the Zack D. Owens Professor and Chair, department of surgery, the University of North Carolina at Chapel Hill.
 

Writing should be fun! While some may view writing as painful (i.e., something you rather put off until all your household work, taxes, and even changing the litter boxes are done), writing can and will become more enjoyable the more you do it. Over the years that I have been writing with students, residents, and faculty, I have found that writing the discussion section of a manuscript remains the most daunting aspect of writing a paper and the No. 1 reason people put off writing. Thus, I have developed a strategy that distills this process into a very simple task. When followed, manuscript writing won’t seem so intimidating.

I like to consider the writing process in three phases: preparing to write, writing, and then revising. Let’s address each one of these.

Preparing to write

In preparing to write, it is important to know what audience you want to reach when selecting a journal. I recommend that you peruse the table of contents of the journals you have in mind to determine if that journal is publishing papers similar to yours. You also may want to consider the impact factor of the journal, as the journals you publish in can have an effect on your promotion and tenure process. Once you have decided upon a journal, retrieve the Instructions for Authors (IFA). This section will contain very important information about how the journal would like for you to format the manuscript. Follow these instructions!

If you do not follow these instructions, the journal may reject your manuscript without ever sending it out for review (that is, the managing editor will reject it). Think of it this way, if an editor takes the time to develop the IFA, you’d better believe that the requirements are important to that editor.

Once you have decided upon the journal and read the IFA, it is time to make an OUTLINE. Yes – I said it – an outline. So often we skip this simple task that we were taught in grade school. For a manuscript, the outline I start with includes the figures and/or tables. Your figures and/or tables should tell the story. If they don’t tell a cohesive story, something is wrong. I like to draw out story board on 8.5” x 11” plain paper. Each sheet of paper represents one figure (or table), and I literally draw out each panel. Then I spread the pieces of paper out on a desk to see if they tell the story I want. Once the story is determined, the writing begins.
 

Writing

The main structure of a manuscript is simple: introduction, methods, results, and discussion. The introduction section should tell the reader why you did the study. The methods section should tell the reader how you did the study. The results section should tell the reader what you found when you did the study. The discussion section should tell the reader what it all means. The introduction should spark the readers interest and provide them with enough information to understand why you conducted the study. It should consist of two to three paragraphs. The first paragraph should state the problem. The second paragraph should state what is known and unknown about the problem. The third paragraph should logically follow with your aim and hypothesis. All manuscripts can and should have a hypothesis.

The methods section should be presented in a straightforward and logical manner and include enough information for others to reproduce the experiments. The information should be presented with subheadings for each different section. For example, a clinical manuscript may have the follow subheadings: study design, study population, primary outcome, secondary outcomes, and statistical analysis.

The results section should also be presented in a logical manner, with subheadings that make sense. Be sure to refer to the IFA on the type of subheadings to use (descriptive versus simple, etc.) and remember to tell a story. The story can be told with data of most to least important, in chronological order, in vitro to in vivo, etc. The main point is to tell a good story that the reader will want to read! Be sure to cite your figures and table, but don’t duplicate the information in the figures and tables.

A nice trick is to present the data in each paragraph, and end with a sentence summarizing the results. Remember, data are the facts obtained from the experiments while results are statements that interpret the data.

The discussion section should be seen as a straightforward section to write instead of an intimidating discourse. The discussion section is where you tell the reader what the data might mean, how else the data could be interpreted, if other studies had similar or dissimilar results, the limitations of the study, and what should be done next. I propose that all discussion sections can be written in five paragraphs.

Paragraph 1 should summarize the findings with respect to the hypothesis. Paragraphs 2 and 3 should compare and contrast your data with published literature. Paragraph 4 should address limitations of the study. Paragraph 5 should conclude what it all means and what should happen next. If you start by outlining these five paragraphs, the discussion section becomes simple to write.
 

Revising

The most important aspect of writing a manuscript is revising. The importance of this is often overlooked. We all make mistakes in writing. The more you reread and revise your own work, the better it gets. Aim for writing simple sentences that are easy for your reader to read. Choose words carefully and precisely. Write well-designed sentences and structured paragraphs. The Internet has many short online tutorials to remind one how to do this. Use abbreviations sparingly and avoid wordiness. Avoid writing flaws, especially with the subject and verb. For example, “Controls were performed” should read “Control experiments were performed.”

In summary, writing should be an enjoyable process in which one can communicate exciting ideas to others. In this short article, I have presented a few tips and tricks on how to write and revise a manuscript. For a more in-depth resource, I refer the reader to “How to write a paper,” published in 2013 (ANZ J Surg. Jan;83[1-2]:90-2).

Dr. Kibbe is the Zack D. Owens Professor and Chair, department of surgery, the University of North Carolina at Chapel Hill.
 

Writing should be fun! While some may view writing as painful (i.e., something you rather put off until all your household work, taxes, and even changing the litter boxes are done), writing can and will become more enjoyable the more you do it. Over the years that I have been writing with students, residents, and faculty, I have found that writing the discussion section of a manuscript remains the most daunting aspect of writing a paper and the No. 1 reason people put off writing. Thus, I have developed a strategy that distills this process into a very simple task. When followed, manuscript writing won’t seem so intimidating.

I like to consider the writing process in three phases: preparing to write, writing, and then revising. Let’s address each one of these.

Preparing to write

In preparing to write, it is important to know what audience you want to reach when selecting a journal. I recommend that you peruse the table of contents of the journals you have in mind to determine if that journal is publishing papers similar to yours. You also may want to consider the impact factor of the journal, as the journals you publish in can have an effect on your promotion and tenure process. Once you have decided upon a journal, retrieve the Instructions for Authors (IFA). This section will contain very important information about how the journal would like for you to format the manuscript. Follow these instructions!

If you do not follow these instructions, the journal may reject your manuscript without ever sending it out for review (that is, the managing editor will reject it). Think of it this way, if an editor takes the time to develop the IFA, you’d better believe that the requirements are important to that editor.

Once you have decided upon the journal and read the IFA, it is time to make an OUTLINE. Yes – I said it – an outline. So often we skip this simple task that we were taught in grade school. For a manuscript, the outline I start with includes the figures and/or tables. Your figures and/or tables should tell the story. If they don’t tell a cohesive story, something is wrong. I like to draw out story board on 8.5” x 11” plain paper. Each sheet of paper represents one figure (or table), and I literally draw out each panel. Then I spread the pieces of paper out on a desk to see if they tell the story I want. Once the story is determined, the writing begins.
 

Writing

The main structure of a manuscript is simple: introduction, methods, results, and discussion. The introduction section should tell the reader why you did the study. The methods section should tell the reader how you did the study. The results section should tell the reader what you found when you did the study. The discussion section should tell the reader what it all means. The introduction should spark the readers interest and provide them with enough information to understand why you conducted the study. It should consist of two to three paragraphs. The first paragraph should state the problem. The second paragraph should state what is known and unknown about the problem. The third paragraph should logically follow with your aim and hypothesis. All manuscripts can and should have a hypothesis.

The methods section should be presented in a straightforward and logical manner and include enough information for others to reproduce the experiments. The information should be presented with subheadings for each different section. For example, a clinical manuscript may have the follow subheadings: study design, study population, primary outcome, secondary outcomes, and statistical analysis.

The results section should also be presented in a logical manner, with subheadings that make sense. Be sure to refer to the IFA on the type of subheadings to use (descriptive versus simple, etc.) and remember to tell a story. The story can be told with data of most to least important, in chronological order, in vitro to in vivo, etc. The main point is to tell a good story that the reader will want to read! Be sure to cite your figures and table, but don’t duplicate the information in the figures and tables.

A nice trick is to present the data in each paragraph, and end with a sentence summarizing the results. Remember, data are the facts obtained from the experiments while results are statements that interpret the data.

The discussion section should be seen as a straightforward section to write instead of an intimidating discourse. The discussion section is where you tell the reader what the data might mean, how else the data could be interpreted, if other studies had similar or dissimilar results, the limitations of the study, and what should be done next. I propose that all discussion sections can be written in five paragraphs.

Paragraph 1 should summarize the findings with respect to the hypothesis. Paragraphs 2 and 3 should compare and contrast your data with published literature. Paragraph 4 should address limitations of the study. Paragraph 5 should conclude what it all means and what should happen next. If you start by outlining these five paragraphs, the discussion section becomes simple to write.
 

Revising

The most important aspect of writing a manuscript is revising. The importance of this is often overlooked. We all make mistakes in writing. The more you reread and revise your own work, the better it gets. Aim for writing simple sentences that are easy for your reader to read. Choose words carefully and precisely. Write well-designed sentences and structured paragraphs. The Internet has many short online tutorials to remind one how to do this. Use abbreviations sparingly and avoid wordiness. Avoid writing flaws, especially with the subject and verb. For example, “Controls were performed” should read “Control experiments were performed.”

In summary, writing should be an enjoyable process in which one can communicate exciting ideas to others. In this short article, I have presented a few tips and tricks on how to write and revise a manuscript. For a more in-depth resource, I refer the reader to “How to write a paper,” published in 2013 (ANZ J Surg. Jan;83[1-2]:90-2).

Dr. Kibbe is the Zack D. Owens Professor and Chair, department of surgery, the University of North Carolina at Chapel Hill.
 

In-hospital mortality did not vary for patients who received transfusions of blood that had been stored for 2 weeks and for patients who got blood that had been stored for 4 weeks, based on results from 20,858 hospitalized patients in the randomized, controlled INFORM (Informing Fresh versus Old Red Cell Management) trial conducted at six hospitals in four countries.

While previous trials have concluded that the storage time of blood did not affect patient mortality, those studies largely included high-risk patients and were not statistically powered to detect small mortality differences, Nancy M. Heddle, professor of medicine and director of the McMaster (University) transfusion research program, Hamilton, Ont., and colleagues reported in an article published online in the New England Journal of Medicine (doi: 10.1056/NEJMoa1609014). Standard practice is to transfuse with the oldest available blood, which can be stored up to 42 days.

Their study included general hospitalized patients who required a red cell transfusion. From April 2012 through October 2015, patients were randomly assigned in a 1:2 ratio patients to receive blood that had been stored for the shortest duration (mean duration 13 days, 6,936 patients) or the longest duration (mean duration 23.6 days, 13,922 patients).

Only patients with type A or O blood were included in the study’s primary analysis, because of the difficulty of achieving a difference of at least 10 days in the mean duration of blood storage with other blood types.

There were 634 deaths (9.1% mortality) among patients in the short-term blood storage group and 1,213 deaths (8.7% mortality) in the long-term blood storage group. The difference was not statistically significant. Similar results were seen when the analysis was expanded to include all 24,736 patients with any blood type; the mortality rates were 9.1% and 8.8%, respectively.

An additional analysis found similar results in three prespecified high-risk subgroups – patients undergoing cardiovascular surgery, those admitted to intensive care, and those with cancer.

INFORM, Current Controlled Trials number ISRCTN08118744, was funded by the Canadian Institutes of Health Research, Canadian Blood Services, and Health Canada. Ms. Heddle had no relevant financial disclosures.

[email protected]

On Twitter @maryjodales

In-hospital mortality did not vary for patients who received transfusions of blood that had been stored for 2 weeks and for patients who got blood that had been stored for 4 weeks, based on results from 20,858 hospitalized patients in the randomized, controlled INFORM (Informing Fresh versus Old Red Cell Management) trial conducted at six hospitals in four countries.

While previous trials have concluded that the storage time of blood did not affect patient mortality, those studies largely included high-risk patients and were not statistically powered to detect small mortality differences, Nancy M. Heddle, professor of medicine and director of the McMaster (University) transfusion research program, Hamilton, Ont., and colleagues reported in an article published online in the New England Journal of Medicine (doi: 10.1056/NEJMoa1609014). Standard practice is to transfuse with the oldest available blood, which can be stored up to 42 days.

Their study included general hospitalized patients who required a red cell transfusion. From April 2012 through October 2015, patients were randomly assigned in a 1:2 ratio patients to receive blood that had been stored for the shortest duration (mean duration 13 days, 6,936 patients) or the longest duration (mean duration 23.6 days, 13,922 patients).

Only patients with type A or O blood were included in the study’s primary analysis, because of the difficulty of achieving a difference of at least 10 days in the mean duration of blood storage with other blood types.

There were 634 deaths (9.1% mortality) among patients in the short-term blood storage group and 1,213 deaths (8.7% mortality) in the long-term blood storage group. The difference was not statistically significant. Similar results were seen when the analysis was expanded to include all 24,736 patients with any blood type; the mortality rates were 9.1% and 8.8%, respectively.

An additional analysis found similar results in three prespecified high-risk subgroups – patients undergoing cardiovascular surgery, those admitted to intensive care, and those with cancer.

INFORM, Current Controlled Trials number ISRCTN08118744, was funded by the Canadian Institutes of Health Research, Canadian Blood Services, and Health Canada. Ms. Heddle had no relevant financial disclosures.

[email protected]

On Twitter @maryjodales

In-hospital mortality did not vary for patients who received transfusions of blood that had been stored for 2 weeks and for patients who got blood that had been stored for 4 weeks, based on results from 20,858 hospitalized patients in the randomized, controlled INFORM (Informing Fresh versus Old Red Cell Management) trial conducted at six hospitals in four countries.

While previous trials have concluded that the storage time of blood did not affect patient mortality, those studies largely included high-risk patients and were not statistically powered to detect small mortality differences, Nancy M. Heddle, professor of medicine and director of the McMaster (University) transfusion research program, Hamilton, Ont., and colleagues reported in an article published online in the New England Journal of Medicine (doi: 10.1056/NEJMoa1609014). Standard practice is to transfuse with the oldest available blood, which can be stored up to 42 days.

Their study included general hospitalized patients who required a red cell transfusion. From April 2012 through October 2015, patients were randomly assigned in a 1:2 ratio patients to receive blood that had been stored for the shortest duration (mean duration 13 days, 6,936 patients) or the longest duration (mean duration 23.6 days, 13,922 patients).

Only patients with type A or O blood were included in the study’s primary analysis, because of the difficulty of achieving a difference of at least 10 days in the mean duration of blood storage with other blood types.

There were 634 deaths (9.1% mortality) among patients in the short-term blood storage group and 1,213 deaths (8.7% mortality) in the long-term blood storage group. The difference was not statistically significant. Similar results were seen when the analysis was expanded to include all 24,736 patients with any blood type; the mortality rates were 9.1% and 8.8%, respectively.

An additional analysis found similar results in three prespecified high-risk subgroups – patients undergoing cardiovascular surgery, those admitted to intensive care, and those with cancer.

INFORM, Current Controlled Trials number ISRCTN08118744, was funded by the Canadian Institutes of Health Research, Canadian Blood Services, and Health Canada. Ms. Heddle had no relevant financial disclosures.

[email protected]

On Twitter @maryjodales

LOS ANGELES – Compared with other parts of the United States, survival rates for sepsis were highest in the Northeast and in metropolitan areas in the Western regions of the United States, which mirrors the concentration of critical care fellowship programs, results from a descriptive analysis found.

“There must be consideration to redistribute the critical care work force based on the spread of the malady that they are trained to deal with,” lead study author Aditya Shah, MD, said in an interview in advance of the annual meeting of the American College of Chest Physicians. “This could be linked to better reimbursements in the underserved areas.”

[email protected]

LOS ANGELES – Compared with other parts of the United States, survival rates for sepsis were highest in the Northeast and in metropolitan areas in the Western regions of the United States, which mirrors the concentration of critical care fellowship programs, results from a descriptive analysis found.

“There must be consideration to redistribute the critical care work force based on the spread of the malady that they are trained to deal with,” lead study author Aditya Shah, MD, said in an interview in advance of the annual meeting of the American College of Chest Physicians. “This could be linked to better reimbursements in the underserved areas.”

[email protected]

LOS ANGELES – Compared with other parts of the United States, survival rates for sepsis were highest in the Northeast and in metropolitan areas in the Western regions of the United States, which mirrors the concentration of critical care fellowship programs, results from a descriptive analysis found.

“There must be consideration to redistribute the critical care work force based on the spread of the malady that they are trained to deal with,” lead study author Aditya Shah, MD, said in an interview in advance of the annual meeting of the American College of Chest Physicians. “This could be linked to better reimbursements in the underserved areas.”

[email protected]

The naturally occurring polyphenol resveratrol may have beneficial hormonal effects in women with polycystic ovary syndrome (PCOS), according to the results of a new study.

Previous in vitro research by the lead author, Beata Banaszewska, MD, from the division of infertility and reproductive endocrinology, in the department of gynecology, obstetrics, and gynecological oncology, Poznan University of Medical Sciences, Poznan, Poland, and her colleagues, suggested that resveratrol may inhibit cell growth and reduce androgen production in rat theca-interstitial cells, which are implicated in excessive androgen production in PCOS in humans.

Fuse/Thinkstock.com

At three months, serum total testosterone, the primary outcome, had declined significantly by 23.1% in the resveratrol group (P = .01), but increased by a non-significant 2.9% in the placebo group. The reduction in serum testosterone was even greater among individuals with a lower body mass index (J Clin Endocrinol Metab. 101: 3575–81, 2016. October 18. doi: 10.1210/jc.2016-1858).

Similarly, levels of dehydroepiandrosterone sulfate declined by a significant 22.2% in the resveratrol group (P = .01), but increased by a non-significant 10.5% in the placebo group, suggesting an effect on ovarian as well as adrenal androgen production.

“The magnitude of improvement of hyperandrogenemia observed in response to resveratrol is comparable to or greater than that found in response to OC [oral contraceptive] pills or metformin, with the exception of preparations containing cypretorone acetate, which are not available in the United States,” the authors wrote. They cited another study showing a 19% reduction in testosterone either with 12 months of treatment with the oral contraceptive pill or with metformin.

They also noted that while reductions in testosterone with metformin occur gradually over 3 to 6 months, their study showed a marked reduction in just three months.

Researchers also saw a significant 31.8% decline in fasting insulin (P = .007) and a 66.3% increase (P =.04) in the Insulin Sensitivity Index among patients treated with resveratrol.

Resveratrol was not associated with significant effects on BMI, ovarian volume, gonadotropins, lipid profile, or markers of inflammation and endothelial function. The women on placebo did show a significant reduction in ovarian volume, and increases in total and high-density lipoprotein cholesterol levels, prompting the authors to suggest that resveratrol may have prevented an increase in cholesterol that would otherwise have occurred.

Other than two patients on resveratrol reporting transient numbness, no other adverse events were noted.

While resveratrol, which is found in grapes, nuts and berries, is known to have anti-inflammatory, antioxidant, and cardioprotective properties, the authors said this was the first clinical study examining its effects in PCOS.

“Although identification of the mechanisms of action of resveratrol is not possible in this clinical trial, several possible mechanisms may be considered,” including a reduction of growth of theca cells, “and the improvement of insulin sensitivity with consequent reduction of insulin levels,” they wrote.

“Furthermore, given that insulin is known to stimulate androgen production in both ovarian and adrenal tissues, it is likely that the resveratrol-induced reduction of insulin observed in the present study may have contributed to a decrease of androgen levels,” they added.

RevGenetics provided the resveratrol for the study. The study was supported by the authors’ own institutions, and no conflicts of interest were declared.

The naturally occurring polyphenol resveratrol may have beneficial hormonal effects in women with polycystic ovary syndrome (PCOS), according to the results of a new study.

Previous in vitro research by the lead author, Beata Banaszewska, MD, from the division of infertility and reproductive endocrinology, in the department of gynecology, obstetrics, and gynecological oncology, Poznan University of Medical Sciences, Poznan, Poland, and her colleagues, suggested that resveratrol may inhibit cell growth and reduce androgen production in rat theca-interstitial cells, which are implicated in excessive androgen production in PCOS in humans.

Fuse/Thinkstock.com

At three months, serum total testosterone, the primary outcome, had declined significantly by 23.1% in the resveratrol group (P = .01), but increased by a non-significant 2.9% in the placebo group. The reduction in serum testosterone was even greater among individuals with a lower body mass index (J Clin Endocrinol Metab. 101: 3575–81, 2016. October 18. doi: 10.1210/jc.2016-1858).

Similarly, levels of dehydroepiandrosterone sulfate declined by a significant 22.2% in the resveratrol group (P = .01), but increased by a non-significant 10.5% in the placebo group, suggesting an effect on ovarian as well as adrenal androgen production.

“The magnitude of improvement of hyperandrogenemia observed in response to resveratrol is comparable to or greater than that found in response to OC [oral contraceptive] pills or metformin, with the exception of preparations containing cypretorone acetate, which are not available in the United States,” the authors wrote. They cited another study showing a 19% reduction in testosterone either with 12 months of treatment with the oral contraceptive pill or with metformin.

They also noted that while reductions in testosterone with metformin occur gradually over 3 to 6 months, their study showed a marked reduction in just three months.

Researchers also saw a significant 31.8% decline in fasting insulin (P = .007) and a 66.3% increase (P =.04) in the Insulin Sensitivity Index among patients treated with resveratrol.

Resveratrol was not associated with significant effects on BMI, ovarian volume, gonadotropins, lipid profile, or markers of inflammation and endothelial function. The women on placebo did show a significant reduction in ovarian volume, and increases in total and high-density lipoprotein cholesterol levels, prompting the authors to suggest that resveratrol may have prevented an increase in cholesterol that would otherwise have occurred.

Other than two patients on resveratrol reporting transient numbness, no other adverse events were noted.

While resveratrol, which is found in grapes, nuts and berries, is known to have anti-inflammatory, antioxidant, and cardioprotective properties, the authors said this was the first clinical study examining its effects in PCOS.

“Although identification of the mechanisms of action of resveratrol is not possible in this clinical trial, several possible mechanisms may be considered,” including a reduction of growth of theca cells, “and the improvement of insulin sensitivity with consequent reduction of insulin levels,” they wrote.

“Furthermore, given that insulin is known to stimulate androgen production in both ovarian and adrenal tissues, it is likely that the resveratrol-induced reduction of insulin observed in the present study may have contributed to a decrease of androgen levels,” they added.

RevGenetics provided the resveratrol for the study. The study was supported by the authors’ own institutions, and no conflicts of interest were declared.

The naturally occurring polyphenol resveratrol may have beneficial hormonal effects in women with polycystic ovary syndrome (PCOS), according to the results of a new study.

Previous in vitro research by the lead author, Beata Banaszewska, MD, from the division of infertility and reproductive endocrinology, in the department of gynecology, obstetrics, and gynecological oncology, Poznan University of Medical Sciences, Poznan, Poland, and her colleagues, suggested that resveratrol may inhibit cell growth and reduce androgen production in rat theca-interstitial cells, which are implicated in excessive androgen production in PCOS in humans.

Fuse/Thinkstock.com

At three months, serum total testosterone, the primary outcome, had declined significantly by 23.1% in the resveratrol group (P = .01), but increased by a non-significant 2.9% in the placebo group. The reduction in serum testosterone was even greater among individuals with a lower body mass index (J Clin Endocrinol Metab. 101: 3575–81, 2016. October 18. doi: 10.1210/jc.2016-1858).

Similarly, levels of dehydroepiandrosterone sulfate declined by a significant 22.2% in the resveratrol group (P = .01), but increased by a non-significant 10.5% in the placebo group, suggesting an effect on ovarian as well as adrenal androgen production.

“The magnitude of improvement of hyperandrogenemia observed in response to resveratrol is comparable to or greater than that found in response to OC [oral contraceptive] pills or metformin, with the exception of preparations containing cypretorone acetate, which are not available in the United States,” the authors wrote. They cited another study showing a 19% reduction in testosterone either with 12 months of treatment with the oral contraceptive pill or with metformin.

They also noted that while reductions in testosterone with metformin occur gradually over 3 to 6 months, their study showed a marked reduction in just three months.

Researchers also saw a significant 31.8% decline in fasting insulin (P = .007) and a 66.3% increase (P =.04) in the Insulin Sensitivity Index among patients treated with resveratrol.

Resveratrol was not associated with significant effects on BMI, ovarian volume, gonadotropins, lipid profile, or markers of inflammation and endothelial function. The women on placebo did show a significant reduction in ovarian volume, and increases in total and high-density lipoprotein cholesterol levels, prompting the authors to suggest that resveratrol may have prevented an increase in cholesterol that would otherwise have occurred.

Other than two patients on resveratrol reporting transient numbness, no other adverse events were noted.

While resveratrol, which is found in grapes, nuts and berries, is known to have anti-inflammatory, antioxidant, and cardioprotective properties, the authors said this was the first clinical study examining its effects in PCOS.

“Although identification of the mechanisms of action of resveratrol is not possible in this clinical trial, several possible mechanisms may be considered,” including a reduction of growth of theca cells, “and the improvement of insulin sensitivity with consequent reduction of insulin levels,” they wrote.

“Furthermore, given that insulin is known to stimulate androgen production in both ovarian and adrenal tissues, it is likely that the resveratrol-induced reduction of insulin observed in the present study may have contributed to a decrease of androgen levels,” they added.

RevGenetics provided the resveratrol for the study. The study was supported by the authors’ own institutions, and no conflicts of interest were declared.

One in 5 Americans are taking at least 1 psychotropic medication.¹ Elderly dementia patients in extended care facilities are the most likely population to be prescribed psychotropic medication: 87% of these patients are on at least 1 psychotropic medication, 66% on at least 2, 36% on at least 3, and 11% on 4 or more.² Psychotropic medications alleviate the symptoms of mental illness, such as depression, anxiety, and psychosis. Unfortunately, these medications often have adverse effects (AEs), including, but not limited to, excessive sedation, cardiac abnormalities, and tardive dyskinesia.

In 1987, Congress passed the Nursing Home Reform Act (NHRA) as part of the Omnibus Budget Reconciliation Act. The NHRA mandated that residents must remain free of “physical or chemical restraints imposed for the purpose of discipline or convenience.”³

In 1991, in order to meet the NHRA requirements, the Centers for Medicare and Medicaid Services (CMS) issued a guideline that nursing homes should use antipsychotic drug therapy only to treat a specific condition as diagnosed and documented in the clinical record. In 2006, CMS published guidance on the reduction of psychotropic medication usage. These CMS guidelines are the community-accepted standards for prescribing psychotropic medications, and accrediting bodies expect compliance with the guidelines. The guidelines also recommend that antipsychotics should be prescribed at the lowest possible dose, used for the shortest period, and continually undergo gradual dose reduction (GDR).⁴ To ensure these standards are met, a review of the use of psychotropic medications should be performed regularly.

The purpose of this project was to improve documentation of GDR and review of psychotropic medication based on CMS guidelines in the community living centers (CLCs) at the Carl Vinson Veterans Affairs Medical Center (CVVAMC) in Dublin, Georgia.

Background

The CVVAMC provides long-term care to veterans living in CLCs in a comfortable, homelike environment with a person-centered, nursing-home level of care. During a patient’s stay, clinical pharmacy services reviews patient medication use regularly. Additionally, an interdisciplinary team (IDT) of physicians, pharmacists, nurses, recreation therapists, dieticians, and chaplains meet to discuss the medical, psychosocial, and spiritual needs of the residents at the time of admission and quarterly thereafter. Family and caregivers are invited to attend as well.

During the meeting, the IDT care plan is updated and reviewed with the veteran. Currently at the CVVAMC, care plans include discussion of pain management; however, the plan does not address psychotropic medication use. To be compliant with CMS guidelines, during IDT meetings discussion of psychotropic medication use would be advantageous, because physicians could receive input and feedback from other health care team members in determining whether psychotropic medication changes are needed.

Methods

All documentation and chart notes are recorded and stored in the Computerized Patient Record System (CPRS). The purpose of an electronic template within CPRS is to provide standardized, guided documentation in an easy-to-use format that can be integrated smoothly into the existing system. Template utilization has been shown to improve documentation of medication reconciliation, health records, and coding in the VA health system.^5-7 A review of CPRS showed that no template existed for documenting psychotropic medication initiation and GDR.

Objectives

The authors’ primary objective was to improve patient record documentation in CPRS through implementation of staff education and an electronic template for physicians to document the management of psychotropic medications and patients’ GDRs. The secondary objective was to implement a discussion involving the physician and other members of the team during IDT meetings about patient safety and effectiveness of psychotropic medications.

Template

To improve the suboptimal compliance with the CMS guidelines, an electronic template was created to evaluate GDR attempts and facilitate review of prescribed psychotropic medications. The pharmacy and therapeutics committee approved the template, and the clinical applications coordinator implemented the electronic template. The template was then revised as necessary for ease of use, based on health care provider (HCP) and pharmacist feedback.

The use of the electronic template was phased in over a 1-month period. Complete implementation was achieved in January 2014. An in-service was provided for nurses, HCPs, and directors on the importance of psychotropic medication review and GDRs. A second in-service was conducted for the HCPs to learn how to properly complete the electronic template. Providers were instructed to use the template during IDT meetings when completing monthly chart reviews and changing psychotropic medications.

Additionally, resident assessment coordinators who attend all IDT meetings were requested to remind the team to discuss psychotropic medication use if appropriate in an effort to add a psychotropic medication review to the IDT care plan.

To determine whether the electronic template improved documentation, a retrospective chart review of CPRS was conducted February 2014. The study included veterans in the CLC who were prescribed psychotropic medications since January 2014. The subjects who screened positive for psychotropic medication use were further evaluated by chart review. Before and after implementation, information was collected on the number and percentage of patients who had documentation in their CPRS records of a psychotropic medication review and on whether a GDR evaluation was recorded in CPRS. Additionally, a clinical pharmacist specialist attending the IDT meeting monitored the incidence of psychotropic medication review or discussion that took place if the veteran was on an included agent.

Results

A total of 67 patients on psychotropic medication on the CLC wards since January 2014 were included in the program. Before implementation of the program, 35 patients had documentation of psychotropic medication review. Following implementation, this increased to 54 patients. Hence, 80% of the patients had appropriate documentation.

Before implementation, no patients had documentation regarding evaluation of a GDR in CPRS. After the program implementation, 54 patients had documentation of GDR. Of the 54 patients, 50 had documentation that a GDR could not be completed, and 4 patients had undergone a trial of GDR with appropriate documentation in CPRS (Figure).

The secondary objective evaluated how often a review of patient’s psychotropic medication occurred during IDT meetings. During March 2014, 21 patients with scheduled IDT meetings were prescribed psychotropic medications. For 14 of the 21 patients (67%) appropriateness of psychotropic medications was reviewed with the team and the resident’s families.

Discussion

Documentation is fundamental to improving quality of care, patient outcomes, and reimbursement for the facility. Effective since July 1, 2014, the Joint Commission standards for Nursing Care Center accreditation require the physician and consulting pharmacist to review the patients’ or residents’ medication list. The review should verify the following:

• Clinical indication for the antipsychotic medication;
• Necessity for ongoing use of the antipsychotic medication;
• Consideration of GDR of the antipsychotic medication;
• Consideration of an alternative to antipsychotic medication use.⁸

When used correctly, the psychotropic medication review and GDR template ensures veterans’ psychotropic medications are continually reviewed. Furthermore, better psychotropic medication management allows veterans to be adequately treated while minimizing the risk for potential AEs.

At CVVAMC, the electronic template helped improve documentation and evaluation of GDR. The CVVAMC success can be attributed partly to physicians who were willing to use the template.

New standards from the Joint Commission provided an additional incentive to use the template. The Joint Commission also required that patients and their family be involved in decisions about placing the resident on antipsychotic medication. The optimal time for this discussion is during IDT meetings. At CVVAMC, discussion of psychotropic medications took place in IDT meetings for 67% of the patients prescribed psychotropic medication.

It is important to note that tools, such as this template, are successful only if they are used by HCPs. The CPRS does not have any clinical reminders to prompt physicians to complete the task. Instead, HCPs had to develop a routine of entering information into the template. Additionally, if the resident assessment coordinator was not at the IDT meeting, discussion of psychotropic medication was not always completed. After completion of this project, psychotropic medication review has become a permanent component of the IDT care plan.

Conclusion

This project demonstrated that template development and use have the potential to improve documentation, patient care, and survey scores. The electronic template could potentially benefit any long-term care facility that uses an electronic recording system. Further research should focus on ease of use and on ensuring that a psychotropic medication review is added to all CLC IDT care plans.

Acknowledgments

The authors acknowledge Brooke Butler, clinical pharmacy specialist and project mentor for her assistance and guidance; and Deborah Hobbs, residency director, both at the Carl Vinson VA Medical Center for her input and leadership, and Freddie Miles, for her work on development of the electronic order set.

One in 5 Americans are taking at least 1 psychotropic medication.¹ Elderly dementia patients in extended care facilities are the most likely population to be prescribed psychotropic medication: 87% of these patients are on at least 1 psychotropic medication, 66% on at least 2, 36% on at least 3, and 11% on 4 or more.² Psychotropic medications alleviate the symptoms of mental illness, such as depression, anxiety, and psychosis. Unfortunately, these medications often have adverse effects (AEs), including, but not limited to, excessive sedation, cardiac abnormalities, and tardive dyskinesia.

In 1987, Congress passed the Nursing Home Reform Act (NHRA) as part of the Omnibus Budget Reconciliation Act. The NHRA mandated that residents must remain free of “physical or chemical restraints imposed for the purpose of discipline or convenience.”³

In 1991, in order to meet the NHRA requirements, the Centers for Medicare and Medicaid Services (CMS) issued a guideline that nursing homes should use antipsychotic drug therapy only to treat a specific condition as diagnosed and documented in the clinical record. In 2006, CMS published guidance on the reduction of psychotropic medication usage. These CMS guidelines are the community-accepted standards for prescribing psychotropic medications, and accrediting bodies expect compliance with the guidelines. The guidelines also recommend that antipsychotics should be prescribed at the lowest possible dose, used for the shortest period, and continually undergo gradual dose reduction (GDR).⁴ To ensure these standards are met, a review of the use of psychotropic medications should be performed regularly.

The purpose of this project was to improve documentation of GDR and review of psychotropic medication based on CMS guidelines in the community living centers (CLCs) at the Carl Vinson Veterans Affairs Medical Center (CVVAMC) in Dublin, Georgia.

Background

The CVVAMC provides long-term care to veterans living in CLCs in a comfortable, homelike environment with a person-centered, nursing-home level of care. During a patient’s stay, clinical pharmacy services reviews patient medication use regularly. Additionally, an interdisciplinary team (IDT) of physicians, pharmacists, nurses, recreation therapists, dieticians, and chaplains meet to discuss the medical, psychosocial, and spiritual needs of the residents at the time of admission and quarterly thereafter. Family and caregivers are invited to attend as well.

During the meeting, the IDT care plan is updated and reviewed with the veteran. Currently at the CVVAMC, care plans include discussion of pain management; however, the plan does not address psychotropic medication use. To be compliant with CMS guidelines, during IDT meetings discussion of psychotropic medication use would be advantageous, because physicians could receive input and feedback from other health care team members in determining whether psychotropic medication changes are needed.

Methods

All documentation and chart notes are recorded and stored in the Computerized Patient Record System (CPRS). The purpose of an electronic template within CPRS is to provide standardized, guided documentation in an easy-to-use format that can be integrated smoothly into the existing system. Template utilization has been shown to improve documentation of medication reconciliation, health records, and coding in the VA health system.^5-7 A review of CPRS showed that no template existed for documenting psychotropic medication initiation and GDR.

Objectives

The authors’ primary objective was to improve patient record documentation in CPRS through implementation of staff education and an electronic template for physicians to document the management of psychotropic medications and patients’ GDRs. The secondary objective was to implement a discussion involving the physician and other members of the team during IDT meetings about patient safety and effectiveness of psychotropic medications.

Template

To improve the suboptimal compliance with the CMS guidelines, an electronic template was created to evaluate GDR attempts and facilitate review of prescribed psychotropic medications. The pharmacy and therapeutics committee approved the template, and the clinical applications coordinator implemented the electronic template. The template was then revised as necessary for ease of use, based on health care provider (HCP) and pharmacist feedback.

The use of the electronic template was phased in over a 1-month period. Complete implementation was achieved in January 2014. An in-service was provided for nurses, HCPs, and directors on the importance of psychotropic medication review and GDRs. A second in-service was conducted for the HCPs to learn how to properly complete the electronic template. Providers were instructed to use the template during IDT meetings when completing monthly chart reviews and changing psychotropic medications.

Additionally, resident assessment coordinators who attend all IDT meetings were requested to remind the team to discuss psychotropic medication use if appropriate in an effort to add a psychotropic medication review to the IDT care plan.

To determine whether the electronic template improved documentation, a retrospective chart review of CPRS was conducted February 2014. The study included veterans in the CLC who were prescribed psychotropic medications since January 2014. The subjects who screened positive for psychotropic medication use were further evaluated by chart review. Before and after implementation, information was collected on the number and percentage of patients who had documentation in their CPRS records of a psychotropic medication review and on whether a GDR evaluation was recorded in CPRS. Additionally, a clinical pharmacist specialist attending the IDT meeting monitored the incidence of psychotropic medication review or discussion that took place if the veteran was on an included agent.

Results

A total of 67 patients on psychotropic medication on the CLC wards since January 2014 were included in the program. Before implementation of the program, 35 patients had documentation of psychotropic medication review. Following implementation, this increased to 54 patients. Hence, 80% of the patients had appropriate documentation.

Before implementation, no patients had documentation regarding evaluation of a GDR in CPRS. After the program implementation, 54 patients had documentation of GDR. Of the 54 patients, 50 had documentation that a GDR could not be completed, and 4 patients had undergone a trial of GDR with appropriate documentation in CPRS (Figure).

The secondary objective evaluated how often a review of patient’s psychotropic medication occurred during IDT meetings. During March 2014, 21 patients with scheduled IDT meetings were prescribed psychotropic medications. For 14 of the 21 patients (67%) appropriateness of psychotropic medications was reviewed with the team and the resident’s families.

Discussion

Documentation is fundamental to improving quality of care, patient outcomes, and reimbursement for the facility. Effective since July 1, 2014, the Joint Commission standards for Nursing Care Center accreditation require the physician and consulting pharmacist to review the patients’ or residents’ medication list. The review should verify the following:

• Clinical indication for the antipsychotic medication;
• Necessity for ongoing use of the antipsychotic medication;
• Consideration of GDR of the antipsychotic medication;
• Consideration of an alternative to antipsychotic medication use.⁸

When used correctly, the psychotropic medication review and GDR template ensures veterans’ psychotropic medications are continually reviewed. Furthermore, better psychotropic medication management allows veterans to be adequately treated while minimizing the risk for potential AEs.

At CVVAMC, the electronic template helped improve documentation and evaluation of GDR. The CVVAMC success can be attributed partly to physicians who were willing to use the template.

New standards from the Joint Commission provided an additional incentive to use the template. The Joint Commission also required that patients and their family be involved in decisions about placing the resident on antipsychotic medication. The optimal time for this discussion is during IDT meetings. At CVVAMC, discussion of psychotropic medications took place in IDT meetings for 67% of the patients prescribed psychotropic medication.

It is important to note that tools, such as this template, are successful only if they are used by HCPs. The CPRS does not have any clinical reminders to prompt physicians to complete the task. Instead, HCPs had to develop a routine of entering information into the template. Additionally, if the resident assessment coordinator was not at the IDT meeting, discussion of psychotropic medication was not always completed. After completion of this project, psychotropic medication review has become a permanent component of the IDT care plan.

Conclusion

This project demonstrated that template development and use have the potential to improve documentation, patient care, and survey scores. The electronic template could potentially benefit any long-term care facility that uses an electronic recording system. Further research should focus on ease of use and on ensuring that a psychotropic medication review is added to all CLC IDT care plans.

Acknowledgments

The authors acknowledge Brooke Butler, clinical pharmacy specialist and project mentor for her assistance and guidance; and Deborah Hobbs, residency director, both at the Carl Vinson VA Medical Center for her input and leadership, and Freddie Miles, for her work on development of the electronic order set.

One in 5 Americans are taking at least 1 psychotropic medication.¹ Elderly dementia patients in extended care facilities are the most likely population to be prescribed psychotropic medication: 87% of these patients are on at least 1 psychotropic medication, 66% on at least 2, 36% on at least 3, and 11% on 4 or more.² Psychotropic medications alleviate the symptoms of mental illness, such as depression, anxiety, and psychosis. Unfortunately, these medications often have adverse effects (AEs), including, but not limited to, excessive sedation, cardiac abnormalities, and tardive dyskinesia.

In 1987, Congress passed the Nursing Home Reform Act (NHRA) as part of the Omnibus Budget Reconciliation Act. The NHRA mandated that residents must remain free of “physical or chemical restraints imposed for the purpose of discipline or convenience.”³

In 1991, in order to meet the NHRA requirements, the Centers for Medicare and Medicaid Services (CMS) issued a guideline that nursing homes should use antipsychotic drug therapy only to treat a specific condition as diagnosed and documented in the clinical record. In 2006, CMS published guidance on the reduction of psychotropic medication usage. These CMS guidelines are the community-accepted standards for prescribing psychotropic medications, and accrediting bodies expect compliance with the guidelines. The guidelines also recommend that antipsychotics should be prescribed at the lowest possible dose, used for the shortest period, and continually undergo gradual dose reduction (GDR).⁴ To ensure these standards are met, a review of the use of psychotropic medications should be performed regularly.

The purpose of this project was to improve documentation of GDR and review of psychotropic medication based on CMS guidelines in the community living centers (CLCs) at the Carl Vinson Veterans Affairs Medical Center (CVVAMC) in Dublin, Georgia.

Background

The CVVAMC provides long-term care to veterans living in CLCs in a comfortable, homelike environment with a person-centered, nursing-home level of care. During a patient’s stay, clinical pharmacy services reviews patient medication use regularly. Additionally, an interdisciplinary team (IDT) of physicians, pharmacists, nurses, recreation therapists, dieticians, and chaplains meet to discuss the medical, psychosocial, and spiritual needs of the residents at the time of admission and quarterly thereafter. Family and caregivers are invited to attend as well.

During the meeting, the IDT care plan is updated and reviewed with the veteran. Currently at the CVVAMC, care plans include discussion of pain management; however, the plan does not address psychotropic medication use. To be compliant with CMS guidelines, during IDT meetings discussion of psychotropic medication use would be advantageous, because physicians could receive input and feedback from other health care team members in determining whether psychotropic medication changes are needed.

Methods

All documentation and chart notes are recorded and stored in the Computerized Patient Record System (CPRS). The purpose of an electronic template within CPRS is to provide standardized, guided documentation in an easy-to-use format that can be integrated smoothly into the existing system. Template utilization has been shown to improve documentation of medication reconciliation, health records, and coding in the VA health system.^5-7 A review of CPRS showed that no template existed for documenting psychotropic medication initiation and GDR.

Objectives

The authors’ primary objective was to improve patient record documentation in CPRS through implementation of staff education and an electronic template for physicians to document the management of psychotropic medications and patients’ GDRs. The secondary objective was to implement a discussion involving the physician and other members of the team during IDT meetings about patient safety and effectiveness of psychotropic medications.

Template

To improve the suboptimal compliance with the CMS guidelines, an electronic template was created to evaluate GDR attempts and facilitate review of prescribed psychotropic medications. The pharmacy and therapeutics committee approved the template, and the clinical applications coordinator implemented the electronic template. The template was then revised as necessary for ease of use, based on health care provider (HCP) and pharmacist feedback.

The use of the electronic template was phased in over a 1-month period. Complete implementation was achieved in January 2014. An in-service was provided for nurses, HCPs, and directors on the importance of psychotropic medication review and GDRs. A second in-service was conducted for the HCPs to learn how to properly complete the electronic template. Providers were instructed to use the template during IDT meetings when completing monthly chart reviews and changing psychotropic medications.

Additionally, resident assessment coordinators who attend all IDT meetings were requested to remind the team to discuss psychotropic medication use if appropriate in an effort to add a psychotropic medication review to the IDT care plan.

To determine whether the electronic template improved documentation, a retrospective chart review of CPRS was conducted February 2014. The study included veterans in the CLC who were prescribed psychotropic medications since January 2014. The subjects who screened positive for psychotropic medication use were further evaluated by chart review. Before and after implementation, information was collected on the number and percentage of patients who had documentation in their CPRS records of a psychotropic medication review and on whether a GDR evaluation was recorded in CPRS. Additionally, a clinical pharmacist specialist attending the IDT meeting monitored the incidence of psychotropic medication review or discussion that took place if the veteran was on an included agent.

Results

A total of 67 patients on psychotropic medication on the CLC wards since January 2014 were included in the program. Before implementation of the program, 35 patients had documentation of psychotropic medication review. Following implementation, this increased to 54 patients. Hence, 80% of the patients had appropriate documentation.

Before implementation, no patients had documentation regarding evaluation of a GDR in CPRS. After the program implementation, 54 patients had documentation of GDR. Of the 54 patients, 50 had documentation that a GDR could not be completed, and 4 patients had undergone a trial of GDR with appropriate documentation in CPRS (Figure).

The secondary objective evaluated how often a review of patient’s psychotropic medication occurred during IDT meetings. During March 2014, 21 patients with scheduled IDT meetings were prescribed psychotropic medications. For 14 of the 21 patients (67%) appropriateness of psychotropic medications was reviewed with the team and the resident’s families.

Discussion

Documentation is fundamental to improving quality of care, patient outcomes, and reimbursement for the facility. Effective since July 1, 2014, the Joint Commission standards for Nursing Care Center accreditation require the physician and consulting pharmacist to review the patients’ or residents’ medication list. The review should verify the following:

• Clinical indication for the antipsychotic medication;
• Necessity for ongoing use of the antipsychotic medication;
• Consideration of GDR of the antipsychotic medication;
• Consideration of an alternative to antipsychotic medication use.⁸

When used correctly, the psychotropic medication review and GDR template ensures veterans’ psychotropic medications are continually reviewed. Furthermore, better psychotropic medication management allows veterans to be adequately treated while minimizing the risk for potential AEs.

At CVVAMC, the electronic template helped improve documentation and evaluation of GDR. The CVVAMC success can be attributed partly to physicians who were willing to use the template.

New standards from the Joint Commission provided an additional incentive to use the template. The Joint Commission also required that patients and their family be involved in decisions about placing the resident on antipsychotic medication. The optimal time for this discussion is during IDT meetings. At CVVAMC, discussion of psychotropic medications took place in IDT meetings for 67% of the patients prescribed psychotropic medication.

It is important to note that tools, such as this template, are successful only if they are used by HCPs. The CPRS does not have any clinical reminders to prompt physicians to complete the task. Instead, HCPs had to develop a routine of entering information into the template. Additionally, if the resident assessment coordinator was not at the IDT meeting, discussion of psychotropic medication was not always completed. After completion of this project, psychotropic medication review has become a permanent component of the IDT care plan.

Conclusion

This project demonstrated that template development and use have the potential to improve documentation, patient care, and survey scores. The electronic template could potentially benefit any long-term care facility that uses an electronic recording system. Further research should focus on ease of use and on ensuring that a psychotropic medication review is added to all CLC IDT care plans.

Acknowledgments

The authors acknowledge Brooke Butler, clinical pharmacy specialist and project mentor for her assistance and guidance; and Deborah Hobbs, residency director, both at the Carl Vinson VA Medical Center for her input and leadership, and Freddie Miles, for her work on development of the electronic order set.

NIH Director Francis Collins

Photo by Bill Branson

Investigators conducting a phase 1 trial failed to follow requirements for reporting serious adverse events (AEs), including deaths, according to officials from the National Cancer Institute (NCI) and the National Institutes of Health (NIH).

The trial was an NCI-sponsored study of ibrutinib in combination with dose-adjusted temozolomide, etoposide, liposomal doxorubicin, dexamethasone, and rituximab (DA-TEDDi-R) in patients with primary CNS lymphoma.

Four patients in this trial developed invasive aspergillosis, 3 others had unconfirmed Aspergillus infections, and 2 patients died of aspergillosis in 2015.

Trial investigators did not report these events to the NCI or the institutional review board (IRB) as quickly as required by the study protocol.

In addition, the suspected relationship between Aspergillus infections and the study treatment wasn’t reported to the US Food and Drug Administration (FDA) until May 2016, several months after the second patient died of aspergillosis.

Francis S. Collins, MD, PhD, director of the NIH, and Douglas R. Lowy, MD, acting director of the NCI, discussed this delay in reporting during a meeting of the Clinical Center Hospital Board last Friday.

About the trial

The trial (NCT02203526) enrolled 18 patients with primary CNS lymphoma—13 relapsed/refractory and 5 previously untreated—between August 2014 and March 2016.

Patients received 14 days of ibrutinib (with corticosteroids to prevent cerebral edema), followed by six 21-day cycles of DA-TEDDi-R.

Twelve patients achieved a complete response following treatment, 5 had a partial response, and 1 patient progressed without responding. Eight patients remain in complete response, 2 have progressed, and 8 have died.

Four patients developed invasive aspergillosis, and 3 had possible Aspergillus infections. Two deaths, which occurred in May and December of 2015, were attributed to aspergillosis.

Some patients developed aspergillosis while they were receiving only steroids and ibrutinib, which led the investigators to believe there was a causative relationship between Aspergillus infections and treatment with ibrutinib/steroids.

The investigators stopped trial accrual in April 2016 due to the Aspergillus infections. The suspected relationship between the infections and ibrutinib/steroids was reported to the FDA in late May 2016.

Delayed reporting

On October 3, 2016, the FDA issued a 483 report to the trial’s principal investigator, Kieron Dunleavy, MD, of the NCI. The report cited “delays and deficient reporting” of serious AEs/unanticipated problems to the trial’s sponsor and IRB.

The trial’s protocol required that grade 3-5 AEs be reported to the NCI within 24 hours of occurrence and unanticipated problems be reported to the IRB within 7 days.

The median time of delayed reporting to the NCI was 40 days (range, 4 to 456), and the median time of delayed reporting to the IRB was 18 days (range, 8 to 56).

As a result of the delayed reporting, Dr Dunleavy has been suspended from conducting clinical research in the NIH Clinical Center, and holds have been placed on trials conducted by the NCI lymphoma team.

The accrual of current studies and the opening of planned studies by the lymphoma team have been stopped. The team will be allowed to resume/begin studies after they undergo training and once the NCI and an outside contractor complete an audit of all NCI lymphoma trials that have been open over the last 3 years.

Patients involved in the trial of DA-TEDDi-R (and their families) have been informed of the delayed AE reporting.

Various parties involved in NIH/NCI trials have been reminded about the importance of timely reporting of safety and regulatory information.

The NCI and NIH are taking steps to ensure that AEs are reported promptly in the future. And the Office of Research Support and Compliance has been tasked with investigating past reporting of AEs in NIH trials, particularly those conducted at the Clinical Center.

NIH Director Francis Collins

Photo by Bill Branson

Investigators conducting a phase 1 trial failed to follow requirements for reporting serious adverse events (AEs), including deaths, according to officials from the National Cancer Institute (NCI) and the National Institutes of Health (NIH).

The trial was an NCI-sponsored study of ibrutinib in combination with dose-adjusted temozolomide, etoposide, liposomal doxorubicin, dexamethasone, and rituximab (DA-TEDDi-R) in patients with primary CNS lymphoma.

Four patients in this trial developed invasive aspergillosis, 3 others had unconfirmed Aspergillus infections, and 2 patients died of aspergillosis in 2015.

Trial investigators did not report these events to the NCI or the institutional review board (IRB) as quickly as required by the study protocol.

In addition, the suspected relationship between Aspergillus infections and the study treatment wasn’t reported to the US Food and Drug Administration (FDA) until May 2016, several months after the second patient died of aspergillosis.

Francis S. Collins, MD, PhD, director of the NIH, and Douglas R. Lowy, MD, acting director of the NCI, discussed this delay in reporting during a meeting of the Clinical Center Hospital Board last Friday.

About the trial

The trial (NCT02203526) enrolled 18 patients with primary CNS lymphoma—13 relapsed/refractory and 5 previously untreated—between August 2014 and March 2016.

Patients received 14 days of ibrutinib (with corticosteroids to prevent cerebral edema), followed by six 21-day cycles of DA-TEDDi-R.

Twelve patients achieved a complete response following treatment, 5 had a partial response, and 1 patient progressed without responding. Eight patients remain in complete response, 2 have progressed, and 8 have died.

Four patients developed invasive aspergillosis, and 3 had possible Aspergillus infections. Two deaths, which occurred in May and December of 2015, were attributed to aspergillosis.

Some patients developed aspergillosis while they were receiving only steroids and ibrutinib, which led the investigators to believe there was a causative relationship between Aspergillus infections and treatment with ibrutinib/steroids.

The investigators stopped trial accrual in April 2016 due to the Aspergillus infections. The suspected relationship between the infections and ibrutinib/steroids was reported to the FDA in late May 2016.

Delayed reporting

On October 3, 2016, the FDA issued a 483 report to the trial’s principal investigator, Kieron Dunleavy, MD, of the NCI. The report cited “delays and deficient reporting” of serious AEs/unanticipated problems to the trial’s sponsor and IRB.

The trial’s protocol required that grade 3-5 AEs be reported to the NCI within 24 hours of occurrence and unanticipated problems be reported to the IRB within 7 days.

The median time of delayed reporting to the NCI was 40 days (range, 4 to 456), and the median time of delayed reporting to the IRB was 18 days (range, 8 to 56).

As a result of the delayed reporting, Dr Dunleavy has been suspended from conducting clinical research in the NIH Clinical Center, and holds have been placed on trials conducted by the NCI lymphoma team.

The accrual of current studies and the opening of planned studies by the lymphoma team have been stopped. The team will be allowed to resume/begin studies after they undergo training and once the NCI and an outside contractor complete an audit of all NCI lymphoma trials that have been open over the last 3 years.

Patients involved in the trial of DA-TEDDi-R (and their families) have been informed of the delayed AE reporting.

Various parties involved in NIH/NCI trials have been reminded about the importance of timely reporting of safety and regulatory information.

The NCI and NIH are taking steps to ensure that AEs are reported promptly in the future. And the Office of Research Support and Compliance has been tasked with investigating past reporting of AEs in NIH trials, particularly those conducted at the Clinical Center.

NIH Director Francis Collins

Photo by Bill Branson

Investigators conducting a phase 1 trial failed to follow requirements for reporting serious adverse events (AEs), including deaths, according to officials from the National Cancer Institute (NCI) and the National Institutes of Health (NIH).

The trial was an NCI-sponsored study of ibrutinib in combination with dose-adjusted temozolomide, etoposide, liposomal doxorubicin, dexamethasone, and rituximab (DA-TEDDi-R) in patients with primary CNS lymphoma.

Four patients in this trial developed invasive aspergillosis, 3 others had unconfirmed Aspergillus infections, and 2 patients died of aspergillosis in 2015.

Trial investigators did not report these events to the NCI or the institutional review board (IRB) as quickly as required by the study protocol.

In addition, the suspected relationship between Aspergillus infections and the study treatment wasn’t reported to the US Food and Drug Administration (FDA) until May 2016, several months after the second patient died of aspergillosis.

Francis S. Collins, MD, PhD, director of the NIH, and Douglas R. Lowy, MD, acting director of the NCI, discussed this delay in reporting during a meeting of the Clinical Center Hospital Board last Friday.

About the trial

The trial (NCT02203526) enrolled 18 patients with primary CNS lymphoma—13 relapsed/refractory and 5 previously untreated—between August 2014 and March 2016.

Patients received 14 days of ibrutinib (with corticosteroids to prevent cerebral edema), followed by six 21-day cycles of DA-TEDDi-R.

Twelve patients achieved a complete response following treatment, 5 had a partial response, and 1 patient progressed without responding. Eight patients remain in complete response, 2 have progressed, and 8 have died.

Four patients developed invasive aspergillosis, and 3 had possible Aspergillus infections. Two deaths, which occurred in May and December of 2015, were attributed to aspergillosis.

Some patients developed aspergillosis while they were receiving only steroids and ibrutinib, which led the investigators to believe there was a causative relationship between Aspergillus infections and treatment with ibrutinib/steroids.

The investigators stopped trial accrual in April 2016 due to the Aspergillus infections. The suspected relationship between the infections and ibrutinib/steroids was reported to the FDA in late May 2016.

Delayed reporting

On October 3, 2016, the FDA issued a 483 report to the trial’s principal investigator, Kieron Dunleavy, MD, of the NCI. The report cited “delays and deficient reporting” of serious AEs/unanticipated problems to the trial’s sponsor and IRB.

The trial’s protocol required that grade 3-5 AEs be reported to the NCI within 24 hours of occurrence and unanticipated problems be reported to the IRB within 7 days.

The median time of delayed reporting to the NCI was 40 days (range, 4 to 456), and the median time of delayed reporting to the IRB was 18 days (range, 8 to 56).

As a result of the delayed reporting, Dr Dunleavy has been suspended from conducting clinical research in the NIH Clinical Center, and holds have been placed on trials conducted by the NCI lymphoma team.

The accrual of current studies and the opening of planned studies by the lymphoma team have been stopped. The team will be allowed to resume/begin studies after they undergo training and once the NCI and an outside contractor complete an audit of all NCI lymphoma trials that have been open over the last 3 years.

Patients involved in the trial of DA-TEDDi-R (and their families) have been informed of the delayed AE reporting.

Various parties involved in NIH/NCI trials have been reminded about the importance of timely reporting of safety and regulatory information.

The NCI and NIH are taking steps to ensure that AEs are reported promptly in the future. And the Office of Research Support and Compliance has been tasked with investigating past reporting of AEs in NIH trials, particularly those conducted at the Clinical Center.

Iclusig (ponatinib)

Photo from Business Wire

A pair of US legislators are questioning why ARIAD Pharmaceuticals, Inc. has increased the price of its leukemia drug Iclusig (ponatinib) by more than $80,000 over the last several years.

ARIAD raised the price of Iclusig 4 times in 2016. The drug now costs nearly $199,000 a year.

Senator Bernie Sanders (Vermont) and Congressman Elijah Cummings (Maryland) sent a letter to ARIAD last week requesting information about these price increases.

Cummings and Sanders are also investigating whether ARIAD took additional steps to boost profits by discontinuing sales of certain dosages and quantities of Iclusig in order to charge patients and insurers more in exchange for less medicine.

“These outrageous sales tactics indicate that ARIAD is more concerned with its profit than with its patients,” Sanders and Cummings wrote in the letter.

The US Food and Drug Administration (FDA) approved Iclusig in December 2012 to treat chronic myeloid leukemia (CML) and Philadelphia chromosome-positive acute lymphoblastic leukemia (ALL).

In late 2013, the FDA suspended sales and clinical trials of the drug due to reports of serious adverse events.

The FDA allowed ARIAD to resume selling Iclusig in December 2013, but only to CML/ALL patients who cannot tolerate, or whose disease is resistant to, other tyrosine kinase inhibitors.

“Despite this new evidence showing the drug posed a far greater safety risk to patients than was known when the drug came on the market, ARIAD nonetheless raised the price of Iclusig several times over the subsequent 4 years,” Sanders and Cummings wrote.

“In the interest of patients and taxpayers, we are interested in learning more about the impact that the escalating price and restrictions on product availability have had.”

ARIAD has released a statement acknowledging Cummings’ and Sanders’ letter and defending its decisions to increase the price of Iclusig.

The company said it “makes significant investments in research and development (R&D) to advance breakthrough treatments” for patients with rare cancers.

In fact, ARIAD has invested more than $1.3 billion in R&D and accumulated losses of approximately $1.4 billion, which have not been recovered. In 2015, ARIAD generated $119 million in total revenue and invested $171 million in R&D.

The company said it intends to respond to Cummings’ and Sanders’ request for information.

Iclusig (ponatinib)

Photo from Business Wire

A pair of US legislators are questioning why ARIAD Pharmaceuticals, Inc. has increased the price of its leukemia drug Iclusig (ponatinib) by more than $80,000 over the last several years.

ARIAD raised the price of Iclusig 4 times in 2016. The drug now costs nearly $199,000 a year.

Senator Bernie Sanders (Vermont) and Congressman Elijah Cummings (Maryland) sent a letter to ARIAD last week requesting information about these price increases.

Cummings and Sanders are also investigating whether ARIAD took additional steps to boost profits by discontinuing sales of certain dosages and quantities of Iclusig in order to charge patients and insurers more in exchange for less medicine.

“These outrageous sales tactics indicate that ARIAD is more concerned with its profit than with its patients,” Sanders and Cummings wrote in the letter.

The US Food and Drug Administration (FDA) approved Iclusig in December 2012 to treat chronic myeloid leukemia (CML) and Philadelphia chromosome-positive acute lymphoblastic leukemia (ALL).

In late 2013, the FDA suspended sales and clinical trials of the drug due to reports of serious adverse events.

The FDA allowed ARIAD to resume selling Iclusig in December 2013, but only to CML/ALL patients who cannot tolerate, or whose disease is resistant to, other tyrosine kinase inhibitors.

“Despite this new evidence showing the drug posed a far greater safety risk to patients than was known when the drug came on the market, ARIAD nonetheless raised the price of Iclusig several times over the subsequent 4 years,” Sanders and Cummings wrote.

“In the interest of patients and taxpayers, we are interested in learning more about the impact that the escalating price and restrictions on product availability have had.”

ARIAD has released a statement acknowledging Cummings’ and Sanders’ letter and defending its decisions to increase the price of Iclusig.

The company said it “makes significant investments in research and development (R&D) to advance breakthrough treatments” for patients with rare cancers.

In fact, ARIAD has invested more than $1.3 billion in R&D and accumulated losses of approximately $1.4 billion, which have not been recovered. In 2015, ARIAD generated $119 million in total revenue and invested $171 million in R&D.

The company said it intends to respond to Cummings’ and Sanders’ request for information.

Iclusig (ponatinib)

Photo from Business Wire

A pair of US legislators are questioning why ARIAD Pharmaceuticals, Inc. has increased the price of its leukemia drug Iclusig (ponatinib) by more than $80,000 over the last several years.

ARIAD raised the price of Iclusig 4 times in 2016. The drug now costs nearly $199,000 a year.

Senator Bernie Sanders (Vermont) and Congressman Elijah Cummings (Maryland) sent a letter to ARIAD last week requesting information about these price increases.

Cummings and Sanders are also investigating whether ARIAD took additional steps to boost profits by discontinuing sales of certain dosages and quantities of Iclusig in order to charge patients and insurers more in exchange for less medicine.

“These outrageous sales tactics indicate that ARIAD is more concerned with its profit than with its patients,” Sanders and Cummings wrote in the letter.

The US Food and Drug Administration (FDA) approved Iclusig in December 2012 to treat chronic myeloid leukemia (CML) and Philadelphia chromosome-positive acute lymphoblastic leukemia (ALL).

In late 2013, the FDA suspended sales and clinical trials of the drug due to reports of serious adverse events.

The FDA allowed ARIAD to resume selling Iclusig in December 2013, but only to CML/ALL patients who cannot tolerate, or whose disease is resistant to, other tyrosine kinase inhibitors.

“Despite this new evidence showing the drug posed a far greater safety risk to patients than was known when the drug came on the market, ARIAD nonetheless raised the price of Iclusig several times over the subsequent 4 years,” Sanders and Cummings wrote.

“In the interest of patients and taxpayers, we are interested in learning more about the impact that the escalating price and restrictions on product availability have had.”

ARIAD has released a statement acknowledging Cummings’ and Sanders’ letter and defending its decisions to increase the price of Iclusig.

The company said it “makes significant investments in research and development (R&D) to advance breakthrough treatments” for patients with rare cancers.

In fact, ARIAD has invested more than $1.3 billion in R&D and accumulated losses of approximately $1.4 billion, which have not been recovered. In 2015, ARIAD generated $119 million in total revenue and invested $171 million in R&D.

The company said it intends to respond to Cummings’ and Sanders’ request for information.

LOS ANGELES – Hand grip strength is independently predictive of risk for respiratory events in smokers who have or are at risk for chronic obstructive pulmonary disease, results from a single-center study showed.

“Measures of lung function, including spirometry, are used as the main descriptors of COPD severity and prognosis,” Carlos H. Martinez, MD, MPH, said in an interview in advance of the annual meeting of the American College of Chest Physicians. “These measurements, as important as they are, need to be improved, in order to develop better risk and prognostic models of the disease, to identify subgroups at higher risk of poor outcomes ... With our work, we have proved that simple physical tests could be part of future prognostic models.”

[email protected]

LOS ANGELES – Hand grip strength is independently predictive of risk for respiratory events in smokers who have or are at risk for chronic obstructive pulmonary disease, results from a single-center study showed.

“Measures of lung function, including spirometry, are used as the main descriptors of COPD severity and prognosis,” Carlos H. Martinez, MD, MPH, said in an interview in advance of the annual meeting of the American College of Chest Physicians. “These measurements, as important as they are, need to be improved, in order to develop better risk and prognostic models of the disease, to identify subgroups at higher risk of poor outcomes ... With our work, we have proved that simple physical tests could be part of future prognostic models.”

[email protected]

LOS ANGELES – Hand grip strength is independently predictive of risk for respiratory events in smokers who have or are at risk for chronic obstructive pulmonary disease, results from a single-center study showed.

“Measures of lung function, including spirometry, are used as the main descriptors of COPD severity and prognosis,” Carlos H. Martinez, MD, MPH, said in an interview in advance of the annual meeting of the American College of Chest Physicians. “These measurements, as important as they are, need to be improved, in order to develop better risk and prognostic models of the disease, to identify subgroups at higher risk of poor outcomes ... With our work, we have proved that simple physical tests could be part of future prognostic models.”

[email protected]

WAIKOLOA, HAWAII – Venous thromboembolism prophylaxis with low molecular weight heparin (LMWH), instead of unfractionated heparin (UH), is associated with lower risk of pulmonary embolism (PE) in patients with major trauma, results from a large study have shown.

The results of the study, based on data from the American College of Surgeons (ACS) Trauma Quality Improvement Program, suggest that LMWH-based strategies for thromboprophylaxis should be preferred after major trauma.

[email protected]

WAIKOLOA, HAWAII – Venous thromboembolism prophylaxis with low molecular weight heparin (LMWH), instead of unfractionated heparin (UH), is associated with lower risk of pulmonary embolism (PE) in patients with major trauma, results from a large study have shown.

The results of the study, based on data from the American College of Surgeons (ACS) Trauma Quality Improvement Program, suggest that LMWH-based strategies for thromboprophylaxis should be preferred after major trauma.

[email protected]

WAIKOLOA, HAWAII – Venous thromboembolism prophylaxis with low molecular weight heparin (LMWH), instead of unfractionated heparin (UH), is associated with lower risk of pulmonary embolism (PE) in patients with major trauma, results from a large study have shown.

The results of the study, based on data from the American College of Surgeons (ACS) Trauma Quality Improvement Program, suggest that LMWH-based strategies for thromboprophylaxis should be preferred after major trauma.

[email protected]