Design thinking isn’t only for products such as the Apple watch. It is a methodology used to improve customer experiences not only with products but also with services. Much in the same way that the SOAP note shaped our thinking about diagnosis and treatment, design thinking provides a scaffold to help us better understand the needs and wants of customers, or in our case, patients.

Design thinking uses specific tools and methodologies to understand experiences from others’ perspectives. From its roots in Silicon Valley, design thinking has grown steadily in its influence. Its first high priests were people such as Steve Jobs and David Kelly, who famously designed the computer mouse. The principles learned or applied to increasingly complicated products and services led to the growth of an entire industry in Palo Alto, Calif., with companies such as IDEO and gurus such as IDEO CEO and President Tim Brown of Stanford (Calif.) University has an entire graduate school program on design thinking called d.school while Coursera offers online courses on design thinking.

The principles are simple: The better you understand your customers and their needs, the better you can design your services. There are many toolkits that are available for you to try for free. Empathy Mapping is an easy one you could apply to your practice to enhance your patients’ experience.

The idea behind this technique is to immerse yourself in your patient’s world. Pick a time when your practice is closed. Then take a journey through your office as if you were a patient. It’s important that you keep the experience as close to reality as possible. Start before you even arrive at your office. What is the experience like driving to your office? Do patients have to fight traffic to get to you? Is parking easy to find? How far must they walk from their car to get to your office? What is your check-in process like? Are patients greeted by name? Are they first handed paperwork to complete? Or are they introduced and warmly welcomed to your practice first?

What’s the experience like in the waiting room? Take note of not only what your patients see but also what they hear, smell, touch, and say. What experience does your furniture give patients? What type of magazines are available to them? Do you have Wi-Fi? Is there a television? If so, is it showing simply an advertisement, or is it something that your patients would connect with? Is there music playing?

Using the same process, continue your journey through an entire patient visit. Make note of what the experience is like walking back to your exam rooms. What do your patients see and smell while sitting in an exam room waiting for you? Does it smell of isopropyl alcohol? Is it cold or hot? What’s it like to sit in your room wearing nothing but a patient gown? Are there instruments such as cryo guns that could be intimidating to patients? All of these factors can be modified and thus “designed” to optimize the experience for your patients. Continue this journey including a physical exam and discussion with the doctor and other providers and assistants.

This is a great exercise not only for you but more importantly for your staff. Ask your staff to take notes as they walk through the same empathy mapping journey. It will give them an entirely new and valuable perspective on what it’s like to be a patient in your office. Once you’ve completed your empathy mapping, sit with your team and brainstorm about opportunities to improve the experience for your patients. Ask yourselves what things surprised you. What things do you feel could have the largest impact on your patients’ experience in your office? In what ways can you modify the spaces in your office to optimize your patients’ experience?

Having done this exercise in my own clinic, I found it highly impactful. It gave me a deeper understanding of and appreciation for my patients and caused me to make several minor but important changes in my exam room and to my and my staff’s interactions with patients. I hope you have a similarly informative experience.

If you’re interested in learning more about design thinking, then check out the following books and articles:

• “Change by Design: How Design Thinking Transforms Organization and Inspires Innovation,” by Tim Brown (New York: Harper Business, 2009).

• “The Art of Innovation,” by Tom Kelley (New York: A Currency Book, Doubleday, Random House, 2001).

• Design Thinking Comes of Age, by Jon Kolko (Harv Bus Rev. Sep 2015;pp 66-71).

Dr. Benabio is a partner physician in the department of dermatology of the Southern California Permanente Group in San Diego, and a volunteer clinical assistant professor at the University of California, San Diego. Dr. Benabio is @dermdoc on Twitter.

Design thinking isn’t only for products such as the Apple watch. It is a methodology used to improve customer experiences not only with products but also with services. Much in the same way that the SOAP note shaped our thinking about diagnosis and treatment, design thinking provides a scaffold to help us better understand the needs and wants of customers, or in our case, patients.

Design thinking uses specific tools and methodologies to understand experiences from others’ perspectives. From its roots in Silicon Valley, design thinking has grown steadily in its influence. Its first high priests were people such as Steve Jobs and David Kelly, who famously designed the computer mouse. The principles learned or applied to increasingly complicated products and services led to the growth of an entire industry in Palo Alto, Calif., with companies such as IDEO and gurus such as IDEO CEO and President Tim Brown of Stanford (Calif.) University has an entire graduate school program on design thinking called d.school while Coursera offers online courses on design thinking.

The principles are simple: The better you understand your customers and their needs, the better you can design your services. There are many toolkits that are available for you to try for free. Empathy Mapping is an easy one you could apply to your practice to enhance your patients’ experience.

The idea behind this technique is to immerse yourself in your patient’s world. Pick a time when your practice is closed. Then take a journey through your office as if you were a patient. It’s important that you keep the experience as close to reality as possible. Start before you even arrive at your office. What is the experience like driving to your office? Do patients have to fight traffic to get to you? Is parking easy to find? How far must they walk from their car to get to your office? What is your check-in process like? Are patients greeted by name? Are they first handed paperwork to complete? Or are they introduced and warmly welcomed to your practice first?

What’s the experience like in the waiting room? Take note of not only what your patients see but also what they hear, smell, touch, and say. What experience does your furniture give patients? What type of magazines are available to them? Do you have Wi-Fi? Is there a television? If so, is it showing simply an advertisement, or is it something that your patients would connect with? Is there music playing?

Using the same process, continue your journey through an entire patient visit. Make note of what the experience is like walking back to your exam rooms. What do your patients see and smell while sitting in an exam room waiting for you? Does it smell of isopropyl alcohol? Is it cold or hot? What’s it like to sit in your room wearing nothing but a patient gown? Are there instruments such as cryo guns that could be intimidating to patients? All of these factors can be modified and thus “designed” to optimize the experience for your patients. Continue this journey including a physical exam and discussion with the doctor and other providers and assistants.

This is a great exercise not only for you but more importantly for your staff. Ask your staff to take notes as they walk through the same empathy mapping journey. It will give them an entirely new and valuable perspective on what it’s like to be a patient in your office. Once you’ve completed your empathy mapping, sit with your team and brainstorm about opportunities to improve the experience for your patients. Ask yourselves what things surprised you. What things do you feel could have the largest impact on your patients’ experience in your office? In what ways can you modify the spaces in your office to optimize your patients’ experience?

Having done this exercise in my own clinic, I found it highly impactful. It gave me a deeper understanding of and appreciation for my patients and caused me to make several minor but important changes in my exam room and to my and my staff’s interactions with patients. I hope you have a similarly informative experience.

If you’re interested in learning more about design thinking, then check out the following books and articles:

• “Change by Design: How Design Thinking Transforms Organization and Inspires Innovation,” by Tim Brown (New York: Harper Business, 2009).

• “The Art of Innovation,” by Tom Kelley (New York: A Currency Book, Doubleday, Random House, 2001).

• Design Thinking Comes of Age, by Jon Kolko (Harv Bus Rev. Sep 2015;pp 66-71).

Dr. Benabio is a partner physician in the department of dermatology of the Southern California Permanente Group in San Diego, and a volunteer clinical assistant professor at the University of California, San Diego. Dr. Benabio is @dermdoc on Twitter.

Design thinking isn’t only for products such as the Apple watch. It is a methodology used to improve customer experiences not only with products but also with services. Much in the same way that the SOAP note shaped our thinking about diagnosis and treatment, design thinking provides a scaffold to help us better understand the needs and wants of customers, or in our case, patients.

Design thinking uses specific tools and methodologies to understand experiences from others’ perspectives. From its roots in Silicon Valley, design thinking has grown steadily in its influence. Its first high priests were people such as Steve Jobs and David Kelly, who famously designed the computer mouse. The principles learned or applied to increasingly complicated products and services led to the growth of an entire industry in Palo Alto, Calif., with companies such as IDEO and gurus such as IDEO CEO and President Tim Brown of Stanford (Calif.) University has an entire graduate school program on design thinking called d.school while Coursera offers online courses on design thinking.

The principles are simple: The better you understand your customers and their needs, the better you can design your services. There are many toolkits that are available for you to try for free. Empathy Mapping is an easy one you could apply to your practice to enhance your patients’ experience.

The idea behind this technique is to immerse yourself in your patient’s world. Pick a time when your practice is closed. Then take a journey through your office as if you were a patient. It’s important that you keep the experience as close to reality as possible. Start before you even arrive at your office. What is the experience like driving to your office? Do patients have to fight traffic to get to you? Is parking easy to find? How far must they walk from their car to get to your office? What is your check-in process like? Are patients greeted by name? Are they first handed paperwork to complete? Or are they introduced and warmly welcomed to your practice first?

What’s the experience like in the waiting room? Take note of not only what your patients see but also what they hear, smell, touch, and say. What experience does your furniture give patients? What type of magazines are available to them? Do you have Wi-Fi? Is there a television? If so, is it showing simply an advertisement, or is it something that your patients would connect with? Is there music playing?

Using the same process, continue your journey through an entire patient visit. Make note of what the experience is like walking back to your exam rooms. What do your patients see and smell while sitting in an exam room waiting for you? Does it smell of isopropyl alcohol? Is it cold or hot? What’s it like to sit in your room wearing nothing but a patient gown? Are there instruments such as cryo guns that could be intimidating to patients? All of these factors can be modified and thus “designed” to optimize the experience for your patients. Continue this journey including a physical exam and discussion with the doctor and other providers and assistants.

This is a great exercise not only for you but more importantly for your staff. Ask your staff to take notes as they walk through the same empathy mapping journey. It will give them an entirely new and valuable perspective on what it’s like to be a patient in your office. Once you’ve completed your empathy mapping, sit with your team and brainstorm about opportunities to improve the experience for your patients. Ask yourselves what things surprised you. What things do you feel could have the largest impact on your patients’ experience in your office? In what ways can you modify the spaces in your office to optimize your patients’ experience?

Having done this exercise in my own clinic, I found it highly impactful. It gave me a deeper understanding of and appreciation for my patients and caused me to make several minor but important changes in my exam room and to my and my staff’s interactions with patients. I hope you have a similarly informative experience.

If you’re interested in learning more about design thinking, then check out the following books and articles:

• “Change by Design: How Design Thinking Transforms Organization and Inspires Innovation,” by Tim Brown (New York: Harper Business, 2009).

• “The Art of Innovation,” by Tom Kelley (New York: A Currency Book, Doubleday, Random House, 2001).

• Design Thinking Comes of Age, by Jon Kolko (Harv Bus Rev. Sep 2015;pp 66-71).

Dr. Benabio is a partner physician in the department of dermatology of the Southern California Permanente Group in San Diego, and a volunteer clinical assistant professor at the University of California, San Diego. Dr. Benabio is @dermdoc on Twitter.

Dear Dr. Mossman,

Psychiatrists should not reveal what their patients say except to avert a threat to health or safety or to report abuse. So, how can psy­chiatrists be subpoenaed to provide informa­tion for a trial? If I receive a subpoena, how can I comply without violating patient privacy? If I have to go to court, can I “plead the Fifth”?

Submitted by “Dr. S”

Physicians who are served with a sub­poena feel upset for the reason Dr. S described: Complying with a sub­poena seems to violate the obligation to pro­tect patients’ privacy. But physicians can’t “plead the Fifth” under these circumstances, because the Fifth Amendment to the U.S. Constitution only bars forcing someone to give self-incriminating testimony.¹

If you receive a subpoena for information gleaned during patient care, you should not ignore it. Failing to respond might place you in contempt of court and subject you to a fine or even jail time. Yet simply comply­ing could have legal and professional impli­cations, too.

Often, a psychiatrist who receives a sub­poena should seek an attorney’s advice on how to best respond. But understanding what subpoenas are and how they work might let you feel less anxious as you go through the process of responding. With this goal in mind, this article covers:
   • what a subpoena is and isn’t
   • 2 types of privacy obligations
   • legal options
   • avoiding potential embarrassment (Box).²

What is a subpoena?
All citizens have a legal obligation to fur­nish courts with the information needed to decide legal issues.³ Statutes and legal rules dictate how such material comes to court.

Issuing a subpoena (from the Latin sub poena, “under penalty”) is one way of obtaining information needed for a legal proceeding. A subpoena ad testificandum directs the recipient to appear at a legal pro­ceeding and provide testimony. A subpoena duces tecum (“you shall bring with you”) directs the recipient to produce specific records or to appear at a legal proceeding with the records.

Usually, subpoenas are issued by attor­neys or court clerks, not by judges. As such, they are not court orders. If you receive a subpoena, you should make a timely response of some sort. But, ultimately, you might not have to release the information. Although physicians have to follow the same rules as other citizens, courts recog­nize that doctors also have professional obligations to their patients.

Confidentiality: Your reason to hesitate
Receiving a subpoena doesn’t change your obligation to protect your patient’s con­fidentiality. From the law’s standpoint, patient confidentiality is a function of the rules that govern use of information in legal proceedings.

The Privacy Rule⁴ that arose from the Health Insurance Portability and Accountability Act (HIPAA) of 1996⁵ pro­vides guidance on acceptable responses to subpoenas by “covered entities,” which includes most physicians’ practices. HIPAA permits disclosure of the minimum amount of personal information needed to fulfill the demands of a subpoena. The Table^6,7 explains HIPAA’s rules about specific responses to subpoenas, depending on their source.
 

Many states have patient privacy laws that are stricter than HIPAA rules. If you practice in one of those states, you have to follow the more stringent rule.⁸ For example, Ohio law does not let subpoenaed provid­ers tender medical records for use in a grand jury proceeding without a release signed by the patient, although HIPAA would allow this (Table).^6,7 Out of concern that “giving law enforcement unbridled access to medi­cal records could discourage patients from seeking medical treatment,” Ohio protects patient records more than HIPAA does.⁹ New York State’s privilege rules also are stricter than HIPAA¹⁰ and contain specific provisions about releasing certain types of information (eg, HIV status¹¹). State courts expect physicians to follow their laws about patient privacy and to consult attorneys to make sure that releasing information is done properly.¹²

Releasing information improperly could become grounds for legal action against you, even if you released the information in response to a subpoena. Legal action could take the form of a lawsuit for breach of con­fidentiality, a HIPAA-based complaint, a complaint to the state medical board, or all 3 of these.

Must you turn over information?
Before you testify or turn over documents, you need to verify that the legal and ethi­cal requirements for the disclosure are met—as you would for any release of patient information. You can do this by obtaining your patient’s formal, writ­ten consent for the disclosure. Before you accept the patient’s agreement, however, you might—and in most cases should— consider discussing how the disclosure could affect the patient’s well-being or your treatment relationship.

If the patient will not agree to the disclo­sure, the patient or the patient’s attorney can seek to have the subpoena modified or quashed (declared void). One tactic for doing this is by asserting doctor–patient privilege, a legal doctrine codified in most state’s laws. The privilege recognizes that, because privacy is important in medical care, stopping clinical information from automatically coming in court serves an important social purpose.¹³

The doctor–patient privilege belongs to the litigant—here, your patient—not to you, so your patient has to raise the objection to releasing information.¹⁴ Also, the privilege is not absolute. If having the clinical information is necessary, the judge may issue a court order denying the patient’s motion to quash. Unless the judge later modifies or vacates the order, you risk being found in contempt of court if you still refuse to turn over documents demanded by the subpoena.

Fact witness or expert witness?
If the subpoena demands your testimony, the issuing party might want you to serve as a fact witness or expert witness. Persons with relevant personal knowledge to a legal proceeding can serve as fact witnesses, and testify about things they did or perceived.¹⁵ For example, a psychiatrist serving as a fact witness could recount having heard or seen a patient talking aloud as if arguing with someone when no real interlocutor was present.

A witness whom the court deems an “expert” by virtue of special knowledge, skill, experience, training, or education may offer opinions based on specific sets of facts. Courts hear such testimony when the expert’s specialized knowledge will help the jury understand the evidence or reach a verdict in a case.¹⁶ To return to the example above: a psychiatric expert witness might tell jurors that the patient’s “arguing” was evidence that she was hallucinating and suffered from schizophrenia.

If you receive a subpoena to testify about someone you have treated, you should notify the issuing party that you will pro­vide fact testimony if required to do so. You cannot be compelled to serve as an expert witness, however. In many situations, attempting to provide objective expert testi­mony about one’s own patient could create unresolvable conflicts between the obliga­tion to tell the truth and your obligation to serve your patient’s interests.¹⁷

If the subpoena requests deposition tes­timony about a patient, you probably will be able to schedule the deposition at a time that is convenient for you and the attor­neys involved. Yet you should not agree to be deposed unless (a) you have received the patient’s authorization, (b) a court has ordered you to testify despite the patient’s objection, or (c) your attorney (whom you have consulted about the situation) has advised you that providing testimony is appropriate.

If you are called as a fact witness for a trial, the attorney or court that has subpoe­naed you often will try to schedule things to minimize the time taken away from your other duties. Once in court, you can ask the judge (on the record) whether you must answer if you are asked questions about a patient who has not previously autho­rized you to release treatment information. A judge’s explicit command to respond absolves you of any further ethical obliga­tion to withhold confidential information about the patient’s care.

Bottom Line
If you receive a subpoena for records or testimony, obtaining the patient’s written authorization should allow you to release the information without violating confidentiality obligations. If your patient won’t agree to the release, if turning over information might adversely affect the patient, or if you’re not sure what to do, seek advice from an attorney who knows about medical privacy rules. That way, you can be sure you are meeting all legal and professional standards that apply.

Disclosure  
The author reports no financial relationship with any company whose products are mentioned in this article or with any manufacturers of competing products.

Dear Dr. Mossman,

Psychiatrists should not reveal what their patients say except to avert a threat to health or safety or to report abuse. So, how can psy­chiatrists be subpoenaed to provide informa­tion for a trial? If I receive a subpoena, how can I comply without violating patient privacy? If I have to go to court, can I “plead the Fifth”?

Submitted by “Dr. S”

Physicians who are served with a sub­poena feel upset for the reason Dr. S described: Complying with a sub­poena seems to violate the obligation to pro­tect patients’ privacy. But physicians can’t “plead the Fifth” under these circumstances, because the Fifth Amendment to the U.S. Constitution only bars forcing someone to give self-incriminating testimony.¹

If you receive a subpoena for information gleaned during patient care, you should not ignore it. Failing to respond might place you in contempt of court and subject you to a fine or even jail time. Yet simply comply­ing could have legal and professional impli­cations, too.

Often, a psychiatrist who receives a sub­poena should seek an attorney’s advice on how to best respond. But understanding what subpoenas are and how they work might let you feel less anxious as you go through the process of responding. With this goal in mind, this article covers:
   • what a subpoena is and isn’t
   • 2 types of privacy obligations
   • legal options
   • avoiding potential embarrassment (Box).²

What is a subpoena?
All citizens have a legal obligation to fur­nish courts with the information needed to decide legal issues.³ Statutes and legal rules dictate how such material comes to court.

Issuing a subpoena (from the Latin sub poena, “under penalty”) is one way of obtaining information needed for a legal proceeding. A subpoena ad testificandum directs the recipient to appear at a legal pro­ceeding and provide testimony. A subpoena duces tecum (“you shall bring with you”) directs the recipient to produce specific records or to appear at a legal proceeding with the records.

Usually, subpoenas are issued by attor­neys or court clerks, not by judges. As such, they are not court orders. If you receive a subpoena, you should make a timely response of some sort. But, ultimately, you might not have to release the information. Although physicians have to follow the same rules as other citizens, courts recog­nize that doctors also have professional obligations to their patients.

Confidentiality: Your reason to hesitate
Receiving a subpoena doesn’t change your obligation to protect your patient’s con­fidentiality. From the law’s standpoint, patient confidentiality is a function of the rules that govern use of information in legal proceedings.

The Privacy Rule⁴ that arose from the Health Insurance Portability and Accountability Act (HIPAA) of 1996⁵ pro­vides guidance on acceptable responses to subpoenas by “covered entities,” which includes most physicians’ practices. HIPAA permits disclosure of the minimum amount of personal information needed to fulfill the demands of a subpoena. The Table^6,7 explains HIPAA’s rules about specific responses to subpoenas, depending on their source.
 

Many states have patient privacy laws that are stricter than HIPAA rules. If you practice in one of those states, you have to follow the more stringent rule.⁸ For example, Ohio law does not let subpoenaed provid­ers tender medical records for use in a grand jury proceeding without a release signed by the patient, although HIPAA would allow this (Table).^6,7 Out of concern that “giving law enforcement unbridled access to medi­cal records could discourage patients from seeking medical treatment,” Ohio protects patient records more than HIPAA does.⁹ New York State’s privilege rules also are stricter than HIPAA¹⁰ and contain specific provisions about releasing certain types of information (eg, HIV status¹¹). State courts expect physicians to follow their laws about patient privacy and to consult attorneys to make sure that releasing information is done properly.¹²

Releasing information improperly could become grounds for legal action against you, even if you released the information in response to a subpoena. Legal action could take the form of a lawsuit for breach of con­fidentiality, a HIPAA-based complaint, a complaint to the state medical board, or all 3 of these.

Must you turn over information?
Before you testify or turn over documents, you need to verify that the legal and ethi­cal requirements for the disclosure are met—as you would for any release of patient information. You can do this by obtaining your patient’s formal, writ­ten consent for the disclosure. Before you accept the patient’s agreement, however, you might—and in most cases should— consider discussing how the disclosure could affect the patient’s well-being or your treatment relationship.

If the patient will not agree to the disclo­sure, the patient or the patient’s attorney can seek to have the subpoena modified or quashed (declared void). One tactic for doing this is by asserting doctor–patient privilege, a legal doctrine codified in most state’s laws. The privilege recognizes that, because privacy is important in medical care, stopping clinical information from automatically coming in court serves an important social purpose.¹³

The doctor–patient privilege belongs to the litigant—here, your patient—not to you, so your patient has to raise the objection to releasing information.¹⁴ Also, the privilege is not absolute. If having the clinical information is necessary, the judge may issue a court order denying the patient’s motion to quash. Unless the judge later modifies or vacates the order, you risk being found in contempt of court if you still refuse to turn over documents demanded by the subpoena.

Fact witness or expert witness?
If the subpoena demands your testimony, the issuing party might want you to serve as a fact witness or expert witness. Persons with relevant personal knowledge to a legal proceeding can serve as fact witnesses, and testify about things they did or perceived.¹⁵ For example, a psychiatrist serving as a fact witness could recount having heard or seen a patient talking aloud as if arguing with someone when no real interlocutor was present.

A witness whom the court deems an “expert” by virtue of special knowledge, skill, experience, training, or education may offer opinions based on specific sets of facts. Courts hear such testimony when the expert’s specialized knowledge will help the jury understand the evidence or reach a verdict in a case.¹⁶ To return to the example above: a psychiatric expert witness might tell jurors that the patient’s “arguing” was evidence that she was hallucinating and suffered from schizophrenia.

If you receive a subpoena to testify about someone you have treated, you should notify the issuing party that you will pro­vide fact testimony if required to do so. You cannot be compelled to serve as an expert witness, however. In many situations, attempting to provide objective expert testi­mony about one’s own patient could create unresolvable conflicts between the obliga­tion to tell the truth and your obligation to serve your patient’s interests.¹⁷

If the subpoena requests deposition tes­timony about a patient, you probably will be able to schedule the deposition at a time that is convenient for you and the attor­neys involved. Yet you should not agree to be deposed unless (a) you have received the patient’s authorization, (b) a court has ordered you to testify despite the patient’s objection, or (c) your attorney (whom you have consulted about the situation) has advised you that providing testimony is appropriate.

If you are called as a fact witness for a trial, the attorney or court that has subpoe­naed you often will try to schedule things to minimize the time taken away from your other duties. Once in court, you can ask the judge (on the record) whether you must answer if you are asked questions about a patient who has not previously autho­rized you to release treatment information. A judge’s explicit command to respond absolves you of any further ethical obliga­tion to withhold confidential information about the patient’s care.

Bottom Line
If you receive a subpoena for records or testimony, obtaining the patient’s written authorization should allow you to release the information without violating confidentiality obligations. If your patient won’t agree to the release, if turning over information might adversely affect the patient, or if you’re not sure what to do, seek advice from an attorney who knows about medical privacy rules. That way, you can be sure you are meeting all legal and professional standards that apply.

Disclosure  
The author reports no financial relationship with any company whose products are mentioned in this article or with any manufacturers of competing products.

Dear Dr. Mossman,

Psychiatrists should not reveal what their patients say except to avert a threat to health or safety or to report abuse. So, how can psy­chiatrists be subpoenaed to provide informa­tion for a trial? If I receive a subpoena, how can I comply without violating patient privacy? If I have to go to court, can I “plead the Fifth”?

Submitted by “Dr. S”

Physicians who are served with a sub­poena feel upset for the reason Dr. S described: Complying with a sub­poena seems to violate the obligation to pro­tect patients’ privacy. But physicians can’t “plead the Fifth” under these circumstances, because the Fifth Amendment to the U.S. Constitution only bars forcing someone to give self-incriminating testimony.¹

If you receive a subpoena for information gleaned during patient care, you should not ignore it. Failing to respond might place you in contempt of court and subject you to a fine or even jail time. Yet simply comply­ing could have legal and professional impli­cations, too.

Often, a psychiatrist who receives a sub­poena should seek an attorney’s advice on how to best respond. But understanding what subpoenas are and how they work might let you feel less anxious as you go through the process of responding. With this goal in mind, this article covers:
   • what a subpoena is and isn’t
   • 2 types of privacy obligations
   • legal options
   • avoiding potential embarrassment (Box).²

What is a subpoena?
All citizens have a legal obligation to fur­nish courts with the information needed to decide legal issues.³ Statutes and legal rules dictate how such material comes to court.

Issuing a subpoena (from the Latin sub poena, “under penalty”) is one way of obtaining information needed for a legal proceeding. A subpoena ad testificandum directs the recipient to appear at a legal pro­ceeding and provide testimony. A subpoena duces tecum (“you shall bring with you”) directs the recipient to produce specific records or to appear at a legal proceeding with the records.

Usually, subpoenas are issued by attor­neys or court clerks, not by judges. As such, they are not court orders. If you receive a subpoena, you should make a timely response of some sort. But, ultimately, you might not have to release the information. Although physicians have to follow the same rules as other citizens, courts recog­nize that doctors also have professional obligations to their patients.

Confidentiality: Your reason to hesitate
Receiving a subpoena doesn’t change your obligation to protect your patient’s con­fidentiality. From the law’s standpoint, patient confidentiality is a function of the rules that govern use of information in legal proceedings.

The Privacy Rule⁴ that arose from the Health Insurance Portability and Accountability Act (HIPAA) of 1996⁵ pro­vides guidance on acceptable responses to subpoenas by “covered entities,” which includes most physicians’ practices. HIPAA permits disclosure of the minimum amount of personal information needed to fulfill the demands of a subpoena. The Table^6,7 explains HIPAA’s rules about specific responses to subpoenas, depending on their source.
 

Many states have patient privacy laws that are stricter than HIPAA rules. If you practice in one of those states, you have to follow the more stringent rule.⁸ For example, Ohio law does not let subpoenaed provid­ers tender medical records for use in a grand jury proceeding without a release signed by the patient, although HIPAA would allow this (Table).^6,7 Out of concern that “giving law enforcement unbridled access to medi­cal records could discourage patients from seeking medical treatment,” Ohio protects patient records more than HIPAA does.⁹ New York State’s privilege rules also are stricter than HIPAA¹⁰ and contain specific provisions about releasing certain types of information (eg, HIV status¹¹). State courts expect physicians to follow their laws about patient privacy and to consult attorneys to make sure that releasing information is done properly.¹²

Releasing information improperly could become grounds for legal action against you, even if you released the information in response to a subpoena. Legal action could take the form of a lawsuit for breach of con­fidentiality, a HIPAA-based complaint, a complaint to the state medical board, or all 3 of these.

Must you turn over information?
Before you testify or turn over documents, you need to verify that the legal and ethi­cal requirements for the disclosure are met—as you would for any release of patient information. You can do this by obtaining your patient’s formal, writ­ten consent for the disclosure. Before you accept the patient’s agreement, however, you might—and in most cases should— consider discussing how the disclosure could affect the patient’s well-being or your treatment relationship.

If the patient will not agree to the disclo­sure, the patient or the patient’s attorney can seek to have the subpoena modified or quashed (declared void). One tactic for doing this is by asserting doctor–patient privilege, a legal doctrine codified in most state’s laws. The privilege recognizes that, because privacy is important in medical care, stopping clinical information from automatically coming in court serves an important social purpose.¹³

The doctor–patient privilege belongs to the litigant—here, your patient—not to you, so your patient has to raise the objection to releasing information.¹⁴ Also, the privilege is not absolute. If having the clinical information is necessary, the judge may issue a court order denying the patient’s motion to quash. Unless the judge later modifies or vacates the order, you risk being found in contempt of court if you still refuse to turn over documents demanded by the subpoena.

Fact witness or expert witness?
If the subpoena demands your testimony, the issuing party might want you to serve as a fact witness or expert witness. Persons with relevant personal knowledge to a legal proceeding can serve as fact witnesses, and testify about things they did or perceived.¹⁵ For example, a psychiatrist serving as a fact witness could recount having heard or seen a patient talking aloud as if arguing with someone when no real interlocutor was present.

A witness whom the court deems an “expert” by virtue of special knowledge, skill, experience, training, or education may offer opinions based on specific sets of facts. Courts hear such testimony when the expert’s specialized knowledge will help the jury understand the evidence or reach a verdict in a case.¹⁶ To return to the example above: a psychiatric expert witness might tell jurors that the patient’s “arguing” was evidence that she was hallucinating and suffered from schizophrenia.

If you receive a subpoena to testify about someone you have treated, you should notify the issuing party that you will pro­vide fact testimony if required to do so. You cannot be compelled to serve as an expert witness, however. In many situations, attempting to provide objective expert testi­mony about one’s own patient could create unresolvable conflicts between the obliga­tion to tell the truth and your obligation to serve your patient’s interests.¹⁷

If the subpoena requests deposition tes­timony about a patient, you probably will be able to schedule the deposition at a time that is convenient for you and the attor­neys involved. Yet you should not agree to be deposed unless (a) you have received the patient’s authorization, (b) a court has ordered you to testify despite the patient’s objection, or (c) your attorney (whom you have consulted about the situation) has advised you that providing testimony is appropriate.

If you are called as a fact witness for a trial, the attorney or court that has subpoe­naed you often will try to schedule things to minimize the time taken away from your other duties. Once in court, you can ask the judge (on the record) whether you must answer if you are asked questions about a patient who has not previously autho­rized you to release treatment information. A judge’s explicit command to respond absolves you of any further ethical obliga­tion to withhold confidential information about the patient’s care.

Bottom Line
If you receive a subpoena for records or testimony, obtaining the patient’s written authorization should allow you to release the information without violating confidentiality obligations. If your patient won’t agree to the release, if turning over information might adversely affect the patient, or if you’re not sure what to do, seek advice from an attorney who knows about medical privacy rules. That way, you can be sure you are meeting all legal and professional standards that apply.

Disclosure  
The author reports no financial relationship with any company whose products are mentioned in this article or with any manufacturers of competing products.

The Food and Drug Administration has approved the first nasal spray variant of the opioid-overdose drug naloxone hydrochloride.

Marketed in the United States as Narcan by Adapt Pharma, a partner of Lightlake Therapeutics, the nasal spray is known to stop or, in some cases, reverse the effects of opioid overdosing in patients. Narcan is the first naloxone hydrochloride nasal spray approved by the FDA.

“Combating the opioid abuse epidemic is a top priority for the FDA,” Dr. Stephen Ostroff, FDA acting commissioner, said in a statement released with the Nov. 18 approval announcement. “We cannot stand by while Americans are dying. While naloxone will not solve the underlying problems of the opioid epidemic, we are speeding to review new formulations that will ultimately save lives that might otherwise be lost to drug addiction and overdose.”

The nasal spray itself is available only with a prescription, and is safe for use by both adults and children, according to the FDA.

The spray delivers a dose of 4 mg naloxone in a single 0.1-mL nasal spray, which comes in a ready-to-use, needle-free device, according to Adapt Pharma. Dosage varies for each individual and should be determined by physicians.

Administration of Narcan, which is sprayed into one nostril while the patient is lying on his or her back, does not require special training and can be performed by anyone.

Narcan’s approval comes less than 4 months after the FDA granted the medication a fast-track designation and priority review status, both of which are meant to expedite the review and approval processes for drugs that “demonstrate the potential to address an unmet medical need” and “offer a significant improvement in the safety or effectiveness of the treatment, prevention, or diagnosis of a serious condition,” according to the FDA’s approval statement.

Adverse events associated with opiate withdrawal have been noted in Narcan patients. Specifically, the FDA warned that body aches, diarrhea, tachycardia, fever, piloerection, nausea, nervousness, abdominal cramps, weakness, and increased blood pressure, among other conditions, are all possible side effects of Narcan.

“Opioid overdose is responsible for the deaths of thousands of Americans in communities throughout the country, leaving a trail of devastation for friends and families,” Seamus Mulligan, Adapt Pharma’s chairman and CEO, said in a statement. “This new device makes naloxone readily available for emergency use by a friend, family member, or caregiver, as well as offering an alternative treatment option for first responders and health care providers.”

Narcan’s approval is one step of many that must be taken to adequately address and ultimately end the problem of opioid abuse in the United States, cautioned Dr. Peter Friedmann, chief research officer at Baystate Health in Springfield, Mass.

“[Narcan] is just addressing overdose; we need more and better medications for treating addiction, we need more physicians and clinicians who are skilled in using these medications,” said Dr. Friedmann. “Given the ongoing crisis of deaths from opioid overuse, this expands the options that physicians, pharmacies, and community distribution programs can use to reduce these deaths.”

Dr. Friedmann also voiced his concern regarding the pricing of Narcan. Making the drug affordable is crucial to its success at successfully treating opioid overuse, he said.

“Right now, nasal atomizers with syringes are used off label, and the prices have been going up with increasing demand,” he said. “But [Narcan] is a commercial product based around what is essentially a generic medication, so [I] hope it’s priced at a price point that’s accessible to the great majority of patients and their families who are facing addiction, many of whom don’t have huge means.”

Dr. Friedmann said that he hopes addiction medicine becomes a more attractive field for medical students and residents. It’s important for future physicians to know how to properly treat patients of addiction and administer drugs safely and effectively, he said.

“Addiction medicine is on the cusp of full recognition as a medical specialty, and we need people to go into that field to teach patients, medical students, and residents how to treat people with addiction,” Dr. Friedmann said. At the current rate, “we’re never going to have enough, so we need generalists to take this on.”

[email protected]

The Food and Drug Administration has approved the first nasal spray variant of the opioid-overdose drug naloxone hydrochloride.

Marketed in the United States as Narcan by Adapt Pharma, a partner of Lightlake Therapeutics, the nasal spray is known to stop or, in some cases, reverse the effects of opioid overdosing in patients. Narcan is the first naloxone hydrochloride nasal spray approved by the FDA.

“Combating the opioid abuse epidemic is a top priority for the FDA,” Dr. Stephen Ostroff, FDA acting commissioner, said in a statement released with the Nov. 18 approval announcement. “We cannot stand by while Americans are dying. While naloxone will not solve the underlying problems of the opioid epidemic, we are speeding to review new formulations that will ultimately save lives that might otherwise be lost to drug addiction and overdose.”

The nasal spray itself is available only with a prescription, and is safe for use by both adults and children, according to the FDA.

The spray delivers a dose of 4 mg naloxone in a single 0.1-mL nasal spray, which comes in a ready-to-use, needle-free device, according to Adapt Pharma. Dosage varies for each individual and should be determined by physicians.

Administration of Narcan, which is sprayed into one nostril while the patient is lying on his or her back, does not require special training and can be performed by anyone.

Narcan’s approval comes less than 4 months after the FDA granted the medication a fast-track designation and priority review status, both of which are meant to expedite the review and approval processes for drugs that “demonstrate the potential to address an unmet medical need” and “offer a significant improvement in the safety or effectiveness of the treatment, prevention, or diagnosis of a serious condition,” according to the FDA’s approval statement.

Adverse events associated with opiate withdrawal have been noted in Narcan patients. Specifically, the FDA warned that body aches, diarrhea, tachycardia, fever, piloerection, nausea, nervousness, abdominal cramps, weakness, and increased blood pressure, among other conditions, are all possible side effects of Narcan.

“Opioid overdose is responsible for the deaths of thousands of Americans in communities throughout the country, leaving a trail of devastation for friends and families,” Seamus Mulligan, Adapt Pharma’s chairman and CEO, said in a statement. “This new device makes naloxone readily available for emergency use by a friend, family member, or caregiver, as well as offering an alternative treatment option for first responders and health care providers.”

Narcan’s approval is one step of many that must be taken to adequately address and ultimately end the problem of opioid abuse in the United States, cautioned Dr. Peter Friedmann, chief research officer at Baystate Health in Springfield, Mass.

“[Narcan] is just addressing overdose; we need more and better medications for treating addiction, we need more physicians and clinicians who are skilled in using these medications,” said Dr. Friedmann. “Given the ongoing crisis of deaths from opioid overuse, this expands the options that physicians, pharmacies, and community distribution programs can use to reduce these deaths.”

Dr. Friedmann also voiced his concern regarding the pricing of Narcan. Making the drug affordable is crucial to its success at successfully treating opioid overuse, he said.

“Right now, nasal atomizers with syringes are used off label, and the prices have been going up with increasing demand,” he said. “But [Narcan] is a commercial product based around what is essentially a generic medication, so [I] hope it’s priced at a price point that’s accessible to the great majority of patients and their families who are facing addiction, many of whom don’t have huge means.”

Dr. Friedmann said that he hopes addiction medicine becomes a more attractive field for medical students and residents. It’s important for future physicians to know how to properly treat patients of addiction and administer drugs safely and effectively, he said.

“Addiction medicine is on the cusp of full recognition as a medical specialty, and we need people to go into that field to teach patients, medical students, and residents how to treat people with addiction,” Dr. Friedmann said. At the current rate, “we’re never going to have enough, so we need generalists to take this on.”

[email protected]

The Food and Drug Administration has approved the first nasal spray variant of the opioid-overdose drug naloxone hydrochloride.

Marketed in the United States as Narcan by Adapt Pharma, a partner of Lightlake Therapeutics, the nasal spray is known to stop or, in some cases, reverse the effects of opioid overdosing in patients. Narcan is the first naloxone hydrochloride nasal spray approved by the FDA.

“Combating the opioid abuse epidemic is a top priority for the FDA,” Dr. Stephen Ostroff, FDA acting commissioner, said in a statement released with the Nov. 18 approval announcement. “We cannot stand by while Americans are dying. While naloxone will not solve the underlying problems of the opioid epidemic, we are speeding to review new formulations that will ultimately save lives that might otherwise be lost to drug addiction and overdose.”

The nasal spray itself is available only with a prescription, and is safe for use by both adults and children, according to the FDA.

The spray delivers a dose of 4 mg naloxone in a single 0.1-mL nasal spray, which comes in a ready-to-use, needle-free device, according to Adapt Pharma. Dosage varies for each individual and should be determined by physicians.

Administration of Narcan, which is sprayed into one nostril while the patient is lying on his or her back, does not require special training and can be performed by anyone.

Narcan’s approval comes less than 4 months after the FDA granted the medication a fast-track designation and priority review status, both of which are meant to expedite the review and approval processes for drugs that “demonstrate the potential to address an unmet medical need” and “offer a significant improvement in the safety or effectiveness of the treatment, prevention, or diagnosis of a serious condition,” according to the FDA’s approval statement.

Adverse events associated with opiate withdrawal have been noted in Narcan patients. Specifically, the FDA warned that body aches, diarrhea, tachycardia, fever, piloerection, nausea, nervousness, abdominal cramps, weakness, and increased blood pressure, among other conditions, are all possible side effects of Narcan.

“Opioid overdose is responsible for the deaths of thousands of Americans in communities throughout the country, leaving a trail of devastation for friends and families,” Seamus Mulligan, Adapt Pharma’s chairman and CEO, said in a statement. “This new device makes naloxone readily available for emergency use by a friend, family member, or caregiver, as well as offering an alternative treatment option for first responders and health care providers.”

Narcan’s approval is one step of many that must be taken to adequately address and ultimately end the problem of opioid abuse in the United States, cautioned Dr. Peter Friedmann, chief research officer at Baystate Health in Springfield, Mass.

“[Narcan] is just addressing overdose; we need more and better medications for treating addiction, we need more physicians and clinicians who are skilled in using these medications,” said Dr. Friedmann. “Given the ongoing crisis of deaths from opioid overuse, this expands the options that physicians, pharmacies, and community distribution programs can use to reduce these deaths.”

Dr. Friedmann also voiced his concern regarding the pricing of Narcan. Making the drug affordable is crucial to its success at successfully treating opioid overuse, he said.

“Right now, nasal atomizers with syringes are used off label, and the prices have been going up with increasing demand,” he said. “But [Narcan] is a commercial product based around what is essentially a generic medication, so [I] hope it’s priced at a price point that’s accessible to the great majority of patients and their families who are facing addiction, many of whom don’t have huge means.”

Dr. Friedmann said that he hopes addiction medicine becomes a more attractive field for medical students and residents. It’s important for future physicians to know how to properly treat patients of addiction and administer drugs safely and effectively, he said.

“Addiction medicine is on the cusp of full recognition as a medical specialty, and we need people to go into that field to teach patients, medical students, and residents how to treat people with addiction,” Dr. Friedmann said. At the current rate, “we’re never going to have enough, so we need generalists to take this on.”

[email protected]

SAN FRANCISCO – Valid diagnostic criteria for cryopyrin-associated periodic syndromes are sorely needed, and a new model of CAPS diagnostic criteria enables rapid diagnosis of this rare, heterogeneous, inflammatory disease that can have devastating consequences if left undiagnosed and untreated.

“Our novel, unique approach integrated traditional methods of evidence synthesis with expert consensus, web-based decision tools, and innovative statistical methods. We hope this model can be of benefit in the diagnosis of other rare diseases,” said Dr. Jasmin B. Kümmerle-Deschner of the department of pediatrics at the University of Tübingen (Germany). She noted that the panel wanted to develop diagnostic criteria that could be used prior to genetic testing or in cases where no genetic mutation is identified.

Alice Goodman/Frontline Medical News

Dr. Kümmerle-Deschner, who was on the multinational panel that developed the new diagnostic criteria, reviewed the process and presented the new criteria at the annual meeting of the American College of Rheumatology.

Cryopyrin-associated periodic syndromes (CAPS) comprise a rare, clinically heterogeneous group of devastating inflammatory diseases characterized by variable, severe system and organ inflammation resulting in permanent organ damage. The disease can manifest right after birth or later in life, and it can be associated with a mutation in the NLRP3 gene. Because the pathogenesis involves continually increased IL-1 secretion, early diagnosis and rapid initiation of IL-1 inhibition can control inflammation and prevent organ damage in children and adults with CAPS.

The lengthy process for developing the diagnostic criteria involved building an 18-member team of pediatric and adult subspecialists and experts in methods for rare disease. They generated 32 CAPS-typical items from a systematic literature review of 33 papers that described symptoms of CAPS and then reviewed the items in CAPS registries, weighting them via decision analysis software. Next, the panel refined these to 14 items plus the NLRP3 mutation. 1000Minds decision-making software ranked these 14 variables based on importance for the diagnosis of CAPS, with excellent correlation among experts.

Then a correspondence analysis determined variables consistently associated with the diagnosis of CAPS based on 284 cases and 873 controls; this process removed infrequently observed variables, such as “amyloidosis.” The remaining seven variables were found to be significantly associated with a diagnosis of CAPS (P less than .001 for all).

The final CAPS diagnosis model includes raised inflammatory markers (C-reactive protein/serum amyloid A) as a mandatory criterion, plus at least two of six different typical signs and symptoms of CAPS: urticaria-like rash, cold-stress triggered episodes, sensorineural hearing loss, musculoskeletal symptoms such as arthralgia, arthritis, and myalgia, chronic aseptic meningitis, and skeletal abnormalities such as epiphyseal overgrowth/frontal bossing. This model had a sensitivity of 81% and a specificity of 94%, performing well in all CAPS subtypes as well as in subgroups with or without evidence of germline NLRP3 mutations.

Dr. Kümmerle-Deschner opened her talk with a case description of an 81-year-old man who presented with a baffling disease. It turned out that his granddaughter was diagnosed with CAPS and 16 other family members were affected. She closed the talk by showing how this man could have been rapidly diagnosed by the new CAPS criteria. He presented with urticaria-like rash, arthralgia, arthritis, and cold-triggered episodes in the context of raised inflammatory markers.

“Early diagnosis enabling rapid treatment is possible,” she stated.

Dr. Kümmerle-Deschner disclosed financial ties with Novartis.

SAN FRANCISCO – Valid diagnostic criteria for cryopyrin-associated periodic syndromes are sorely needed, and a new model of CAPS diagnostic criteria enables rapid diagnosis of this rare, heterogeneous, inflammatory disease that can have devastating consequences if left undiagnosed and untreated.

“Our novel, unique approach integrated traditional methods of evidence synthesis with expert consensus, web-based decision tools, and innovative statistical methods. We hope this model can be of benefit in the diagnosis of other rare diseases,” said Dr. Jasmin B. Kümmerle-Deschner of the department of pediatrics at the University of Tübingen (Germany). She noted that the panel wanted to develop diagnostic criteria that could be used prior to genetic testing or in cases where no genetic mutation is identified.

Alice Goodman/Frontline Medical News

Dr. Kümmerle-Deschner, who was on the multinational panel that developed the new diagnostic criteria, reviewed the process and presented the new criteria at the annual meeting of the American College of Rheumatology.

Cryopyrin-associated periodic syndromes (CAPS) comprise a rare, clinically heterogeneous group of devastating inflammatory diseases characterized by variable, severe system and organ inflammation resulting in permanent organ damage. The disease can manifest right after birth or later in life, and it can be associated with a mutation in the NLRP3 gene. Because the pathogenesis involves continually increased IL-1 secretion, early diagnosis and rapid initiation of IL-1 inhibition can control inflammation and prevent organ damage in children and adults with CAPS.

The lengthy process for developing the diagnostic criteria involved building an 18-member team of pediatric and adult subspecialists and experts in methods for rare disease. They generated 32 CAPS-typical items from a systematic literature review of 33 papers that described symptoms of CAPS and then reviewed the items in CAPS registries, weighting them via decision analysis software. Next, the panel refined these to 14 items plus the NLRP3 mutation. 1000Minds decision-making software ranked these 14 variables based on importance for the diagnosis of CAPS, with excellent correlation among experts.

Then a correspondence analysis determined variables consistently associated with the diagnosis of CAPS based on 284 cases and 873 controls; this process removed infrequently observed variables, such as “amyloidosis.” The remaining seven variables were found to be significantly associated with a diagnosis of CAPS (P less than .001 for all).

The final CAPS diagnosis model includes raised inflammatory markers (C-reactive protein/serum amyloid A) as a mandatory criterion, plus at least two of six different typical signs and symptoms of CAPS: urticaria-like rash, cold-stress triggered episodes, sensorineural hearing loss, musculoskeletal symptoms such as arthralgia, arthritis, and myalgia, chronic aseptic meningitis, and skeletal abnormalities such as epiphyseal overgrowth/frontal bossing. This model had a sensitivity of 81% and a specificity of 94%, performing well in all CAPS subtypes as well as in subgroups with or without evidence of germline NLRP3 mutations.

Dr. Kümmerle-Deschner opened her talk with a case description of an 81-year-old man who presented with a baffling disease. It turned out that his granddaughter was diagnosed with CAPS and 16 other family members were affected. She closed the talk by showing how this man could have been rapidly diagnosed by the new CAPS criteria. He presented with urticaria-like rash, arthralgia, arthritis, and cold-triggered episodes in the context of raised inflammatory markers.

“Early diagnosis enabling rapid treatment is possible,” she stated.

Dr. Kümmerle-Deschner disclosed financial ties with Novartis.

SAN FRANCISCO – Valid diagnostic criteria for cryopyrin-associated periodic syndromes are sorely needed, and a new model of CAPS diagnostic criteria enables rapid diagnosis of this rare, heterogeneous, inflammatory disease that can have devastating consequences if left undiagnosed and untreated.

“Our novel, unique approach integrated traditional methods of evidence synthesis with expert consensus, web-based decision tools, and innovative statistical methods. We hope this model can be of benefit in the diagnosis of other rare diseases,” said Dr. Jasmin B. Kümmerle-Deschner of the department of pediatrics at the University of Tübingen (Germany). She noted that the panel wanted to develop diagnostic criteria that could be used prior to genetic testing or in cases where no genetic mutation is identified.

Alice Goodman/Frontline Medical News

Dr. Kümmerle-Deschner, who was on the multinational panel that developed the new diagnostic criteria, reviewed the process and presented the new criteria at the annual meeting of the American College of Rheumatology.

Cryopyrin-associated periodic syndromes (CAPS) comprise a rare, clinically heterogeneous group of devastating inflammatory diseases characterized by variable, severe system and organ inflammation resulting in permanent organ damage. The disease can manifest right after birth or later in life, and it can be associated with a mutation in the NLRP3 gene. Because the pathogenesis involves continually increased IL-1 secretion, early diagnosis and rapid initiation of IL-1 inhibition can control inflammation and prevent organ damage in children and adults with CAPS.

The lengthy process for developing the diagnostic criteria involved building an 18-member team of pediatric and adult subspecialists and experts in methods for rare disease. They generated 32 CAPS-typical items from a systematic literature review of 33 papers that described symptoms of CAPS and then reviewed the items in CAPS registries, weighting them via decision analysis software. Next, the panel refined these to 14 items plus the NLRP3 mutation. 1000Minds decision-making software ranked these 14 variables based on importance for the diagnosis of CAPS, with excellent correlation among experts.

Then a correspondence analysis determined variables consistently associated with the diagnosis of CAPS based on 284 cases and 873 controls; this process removed infrequently observed variables, such as “amyloidosis.” The remaining seven variables were found to be significantly associated with a diagnosis of CAPS (P less than .001 for all).

The final CAPS diagnosis model includes raised inflammatory markers (C-reactive protein/serum amyloid A) as a mandatory criterion, plus at least two of six different typical signs and symptoms of CAPS: urticaria-like rash, cold-stress triggered episodes, sensorineural hearing loss, musculoskeletal symptoms such as arthralgia, arthritis, and myalgia, chronic aseptic meningitis, and skeletal abnormalities such as epiphyseal overgrowth/frontal bossing. This model had a sensitivity of 81% and a specificity of 94%, performing well in all CAPS subtypes as well as in subgroups with or without evidence of germline NLRP3 mutations.

Dr. Kümmerle-Deschner opened her talk with a case description of an 81-year-old man who presented with a baffling disease. It turned out that his granddaughter was diagnosed with CAPS and 16 other family members were affected. She closed the talk by showing how this man could have been rapidly diagnosed by the new CAPS criteria. He presented with urticaria-like rash, arthralgia, arthritis, and cold-triggered episodes in the context of raised inflammatory markers.

“Early diagnosis enabling rapid treatment is possible,” she stated.

Dr. Kümmerle-Deschner disclosed financial ties with Novartis.

NEW YORK - While the new International Classification of Diseases, Tenth Revision, Clinical

Modification (ICD-10-CM) codes offer greater diagnostic precision, their implementation will require training of clinicians, coders, and other staff to minimize payment denials or delays from both public and private payers.

Brian Outland and colleagues from the American College of Physicians in Washington, D.C., outline some of the promises and challenges of ICD-10-CM implementation in a report online Sept. 22 in Annals of Internal Medicine.

Although completed and endorsed by the World Health Assembly in 1990, ICD-10-CM's implementation date has repeatedly been delayed, and was scheduled to take effect on Oct. 1.

The authors suggest that "the newer coding system will produce data that will indicate the clinical trajectory and other factors that will enable the data to be used in meaningful ways to better understand complications, design robust algorithms for clinical decision support, and track outcomes. Having these details built into the codes will decrease the need for health care providers to include supporting documentation with claims."

The new ICD-10-CM alphanumeric codes will contain as many as seven characters that specify categories, subcategories, laterality, severity and other features.

The use of codes that are not specific enough can result in payment denials or delays, so practices will need to keep current on payer reimbursement policies to ensure the reporting of ICD-10-CM codes that support reimbursement, the authors note.

The cost for the training of clinicians and staffs will depend on practice size, specialty, the method of training, current documentation quality, and technology readiness and availability.

Dr. Susan H. Fenton from UTHealth School of Biomedical Informatics in Houston, Texas, said by email, "One of the thoughts I cannot get away from is that the U.S. is trying to manage a 21st-century, rapidly evolving healthcare system with a 1970s technology. I can think of little else in healthcare that has remained as static since the 1970s."

"The diagnostic system added lots of codes, but the basic structure is the same," she said.

"Certainly, with more detail such as laterality, as well as first encounter, subsequent encounter, and sequelae, it will be much easier to track care for specific conditions across providers," Dr. Fenton said. "I think the issue of claims denials will have to play out over time."

Resources and tools from the Centers for Medicare & Medicaid Services (CMS) can be found online at www.roadto10.org.

The American College of Physicians also has helpful information available at www.acponline.org/ICD10.

Outland did not respond to a request for comment.

NEW YORK - While the new International Classification of Diseases, Tenth Revision, Clinical

Modification (ICD-10-CM) codes offer greater diagnostic precision, their implementation will require training of clinicians, coders, and other staff to minimize payment denials or delays from both public and private payers.

Brian Outland and colleagues from the American College of Physicians in Washington, D.C., outline some of the promises and challenges of ICD-10-CM implementation in a report online Sept. 22 in Annals of Internal Medicine.

Although completed and endorsed by the World Health Assembly in 1990, ICD-10-CM's implementation date has repeatedly been delayed, and was scheduled to take effect on Oct. 1.

The authors suggest that "the newer coding system will produce data that will indicate the clinical trajectory and other factors that will enable the data to be used in meaningful ways to better understand complications, design robust algorithms for clinical decision support, and track outcomes. Having these details built into the codes will decrease the need for health care providers to include supporting documentation with claims."

The new ICD-10-CM alphanumeric codes will contain as many as seven characters that specify categories, subcategories, laterality, severity and other features.

The use of codes that are not specific enough can result in payment denials or delays, so practices will need to keep current on payer reimbursement policies to ensure the reporting of ICD-10-CM codes that support reimbursement, the authors note.

The cost for the training of clinicians and staffs will depend on practice size, specialty, the method of training, current documentation quality, and technology readiness and availability.

Dr. Susan H. Fenton from UTHealth School of Biomedical Informatics in Houston, Texas, said by email, "One of the thoughts I cannot get away from is that the U.S. is trying to manage a 21st-century, rapidly evolving healthcare system with a 1970s technology. I can think of little else in healthcare that has remained as static since the 1970s."

"The diagnostic system added lots of codes, but the basic structure is the same," she said.

"Certainly, with more detail such as laterality, as well as first encounter, subsequent encounter, and sequelae, it will be much easier to track care for specific conditions across providers," Dr. Fenton said. "I think the issue of claims denials will have to play out over time."

Resources and tools from the Centers for Medicare & Medicaid Services (CMS) can be found online at www.roadto10.org.

The American College of Physicians also has helpful information available at www.acponline.org/ICD10.

Outland did not respond to a request for comment.

NEW YORK - While the new International Classification of Diseases, Tenth Revision, Clinical

Modification (ICD-10-CM) codes offer greater diagnostic precision, their implementation will require training of clinicians, coders, and other staff to minimize payment denials or delays from both public and private payers.

Brian Outland and colleagues from the American College of Physicians in Washington, D.C., outline some of the promises and challenges of ICD-10-CM implementation in a report online Sept. 22 in Annals of Internal Medicine.

Although completed and endorsed by the World Health Assembly in 1990, ICD-10-CM's implementation date has repeatedly been delayed, and was scheduled to take effect on Oct. 1.

The authors suggest that "the newer coding system will produce data that will indicate the clinical trajectory and other factors that will enable the data to be used in meaningful ways to better understand complications, design robust algorithms for clinical decision support, and track outcomes. Having these details built into the codes will decrease the need for health care providers to include supporting documentation with claims."

The new ICD-10-CM alphanumeric codes will contain as many as seven characters that specify categories, subcategories, laterality, severity and other features.

The use of codes that are not specific enough can result in payment denials or delays, so practices will need to keep current on payer reimbursement policies to ensure the reporting of ICD-10-CM codes that support reimbursement, the authors note.

The cost for the training of clinicians and staffs will depend on practice size, specialty, the method of training, current documentation quality, and technology readiness and availability.

Dr. Susan H. Fenton from UTHealth School of Biomedical Informatics in Houston, Texas, said by email, "One of the thoughts I cannot get away from is that the U.S. is trying to manage a 21st-century, rapidly evolving healthcare system with a 1970s technology. I can think of little else in healthcare that has remained as static since the 1970s."

"The diagnostic system added lots of codes, but the basic structure is the same," she said.

"Certainly, with more detail such as laterality, as well as first encounter, subsequent encounter, and sequelae, it will be much easier to track care for specific conditions across providers," Dr. Fenton said. "I think the issue of claims denials will have to play out over time."

Resources and tools from the Centers for Medicare & Medicaid Services (CMS) can be found online at www.roadto10.org.

The American College of Physicians also has helpful information available at www.acponline.org/ICD10.

Outland did not respond to a request for comment.

The rate of congenital syphilis increased to 11.6 cases per 100,000 live births in 2014 in the United States—the highest rate documented since 2001, according to a new report from the Centers for Disease Control and Prevention (CDC).¹ The increase in the rate of congenital syphilis reflects a rise in the rate of primary and secondary syphilis among US women, from 0.9 to 1.1 cases per 100,000 women, during the same period.¹

The rate of congenital syphilis had declined between 2008 and 2012, from 10.5 cases to 8.4 cases per 100,000 live births.

Congenital syphilis occurs when an infected mother transmits the disease to her fetus during pregnancy. Among the adverse effects of congenital syphilis are deformities, stillbirth, and early infant death. “However, among mothers identified with syphilis who deliver past 20 weeks’ gestation, treatment with penicillin at least 30 days before delivery is 98% effective at preventing [congenital syphilis],” the CDC report notes.¹

For the purposes of the CDC report, congenital syphilis includes “both infants and stillbirths with clinical evidence” of the disease, “as well as those infants and stillbirths born to mothers with untreated or inadequately treated syphilis, regardless of the infant’s manifestation of clinical disease.”¹

CDC recommendations
The CDC notes that most of the increases in the rates of maternal and congenital syphilis likely stem from inadequate prenatal care.

“A large percentage of [congenital syphilis] cases continue to be attributable to a lack of prenatal care; even among those receiving some prenatal care, the detection and treatment of maternal syphilis is often not early enough….At particular risk are those who are uninsured or underinsured and those with substance use issues.”¹

Among the recommendations of the CDC:

• Screen all pregnant women for syphilis at their first prenatal visit.
• Screen women at elevated risk for syphilis, as well as those who live in “high-morbidity geographic areas” at the beginning of the third trimester and again at delivery.
• In cases where prenatal care has been lacking, screen the woman for syphilis using a rapid plasma reagin (RPR) card and treat the patient who tests positive at the time the pregnancy is confirmed.
• Do not discharge an infant from the hospital unless the syphilis serologic status of the mother has been tested at least once during pregnancy and, preferably, again at delivery (in high-risk cases).
• Test any woman who delivers a stillborn infant for syphilis.

The rate of congenital syphilis increased to 11.6 cases per 100,000 live births in 2014 in the United States—the highest rate documented since 2001, according to a new report from the Centers for Disease Control and Prevention (CDC).¹ The increase in the rate of congenital syphilis reflects a rise in the rate of primary and secondary syphilis among US women, from 0.9 to 1.1 cases per 100,000 women, during the same period.¹

The rate of congenital syphilis had declined between 2008 and 2012, from 10.5 cases to 8.4 cases per 100,000 live births.

Congenital syphilis occurs when an infected mother transmits the disease to her fetus during pregnancy. Among the adverse effects of congenital syphilis are deformities, stillbirth, and early infant death. “However, among mothers identified with syphilis who deliver past 20 weeks’ gestation, treatment with penicillin at least 30 days before delivery is 98% effective at preventing [congenital syphilis],” the CDC report notes.¹

For the purposes of the CDC report, congenital syphilis includes “both infants and stillbirths with clinical evidence” of the disease, “as well as those infants and stillbirths born to mothers with untreated or inadequately treated syphilis, regardless of the infant’s manifestation of clinical disease.”¹

CDC recommendations
The CDC notes that most of the increases in the rates of maternal and congenital syphilis likely stem from inadequate prenatal care.

“A large percentage of [congenital syphilis] cases continue to be attributable to a lack of prenatal care; even among those receiving some prenatal care, the detection and treatment of maternal syphilis is often not early enough….At particular risk are those who are uninsured or underinsured and those with substance use issues.”¹

Among the recommendations of the CDC:

• Screen all pregnant women for syphilis at their first prenatal visit.
• Screen women at elevated risk for syphilis, as well as those who live in “high-morbidity geographic areas” at the beginning of the third trimester and again at delivery.
• In cases where prenatal care has been lacking, screen the woman for syphilis using a rapid plasma reagin (RPR) card and treat the patient who tests positive at the time the pregnancy is confirmed.
• Do not discharge an infant from the hospital unless the syphilis serologic status of the mother has been tested at least once during pregnancy and, preferably, again at delivery (in high-risk cases).
• Test any woman who delivers a stillborn infant for syphilis.

The rate of congenital syphilis increased to 11.6 cases per 100,000 live births in 2014 in the United States—the highest rate documented since 2001, according to a new report from the Centers for Disease Control and Prevention (CDC).¹ The increase in the rate of congenital syphilis reflects a rise in the rate of primary and secondary syphilis among US women, from 0.9 to 1.1 cases per 100,000 women, during the same period.¹

The rate of congenital syphilis had declined between 2008 and 2012, from 10.5 cases to 8.4 cases per 100,000 live births.

Congenital syphilis occurs when an infected mother transmits the disease to her fetus during pregnancy. Among the adverse effects of congenital syphilis are deformities, stillbirth, and early infant death. “However, among mothers identified with syphilis who deliver past 20 weeks’ gestation, treatment with penicillin at least 30 days before delivery is 98% effective at preventing [congenital syphilis],” the CDC report notes.¹

For the purposes of the CDC report, congenital syphilis includes “both infants and stillbirths with clinical evidence” of the disease, “as well as those infants and stillbirths born to mothers with untreated or inadequately treated syphilis, regardless of the infant’s manifestation of clinical disease.”¹

CDC recommendations
The CDC notes that most of the increases in the rates of maternal and congenital syphilis likely stem from inadequate prenatal care.

“A large percentage of [congenital syphilis] cases continue to be attributable to a lack of prenatal care; even among those receiving some prenatal care, the detection and treatment of maternal syphilis is often not early enough….At particular risk are those who are uninsured or underinsured and those with substance use issues.”¹

Among the recommendations of the CDC:

• Screen all pregnant women for syphilis at their first prenatal visit.
• Screen women at elevated risk for syphilis, as well as those who live in “high-morbidity geographic areas” at the beginning of the third trimester and again at delivery.
• In cases where prenatal care has been lacking, screen the woman for syphilis using a rapid plasma reagin (RPR) card and treat the patient who tests positive at the time the pregnancy is confirmed.
• Do not discharge an infant from the hospital unless the syphilis serologic status of the mother has been tested at least once during pregnancy and, preferably, again at delivery (in high-risk cases).
• Test any woman who delivers a stillborn infant for syphilis.

Clearance rates for actinic keratoses (AKs) on the extremities were prolonged by adding thermal modulation to photodynamic therapy (PDT), a study has shown.

The single-site study of 17 adults with 10 or more AKs on their arms or legs evaluated thermally modulated PDT: 20% 5-aminolevulinic acid (ALA) applied to skin, occluded with plastic wrap and warmed with an electric heating pad to a median 41.2° C for one hour, then exposed to blue light. Treatment resulted in 90% clearance rates at 3 months and 12 months, reported Dr. Andrea Willey, a dermatologist in Sacramento, Calif., and her associates (Dermatol Surg. 2015 Nov;41[11]:1290-5).

They were inspired to conduct the study as a follow-on to a recently published pilot study of three patients, which found that clearance rates of AKs on the arm treated with thermally modulated 5-ALA blue light PDT persisted up to 14 months after treatment, when compared with the control arm, which was not heated.

In their study, there were 724 grade 1 and 2 AKs at baseline – a median of 15 per extremity; patients were followed up at 3, 6, 9, and 12 months. The total lesion count across the entire cohort was 70 at 3 months, 69 at 6 months, 64 at 9 months, and 72 at 1 year. No new AKs were seen in the treated areas during the 1-year follow-up.

There were 13 grade 3 hypertrophic AK lesions among all study participants. Although these lesions persisted, Dr. Willey and her coauthors noted that they did shrink initially after treatment.

Adverse events associated with the combination therapy were low, and included mild erythema and crusting up to 1 week post treatment, indicating the therapy was well tolerated, and patient satisfaction was high.

The results “suggest that mild skin warming may both improve efficacy and reduce variability of response to PDT in practice,” the authors wrote.

[email protected]

On Twitter @whitneymcknight

Clearance rates for actinic keratoses (AKs) on the extremities were prolonged by adding thermal modulation to photodynamic therapy (PDT), a study has shown.

The single-site study of 17 adults with 10 or more AKs on their arms or legs evaluated thermally modulated PDT: 20% 5-aminolevulinic acid (ALA) applied to skin, occluded with plastic wrap and warmed with an electric heating pad to a median 41.2° C for one hour, then exposed to blue light. Treatment resulted in 90% clearance rates at 3 months and 12 months, reported Dr. Andrea Willey, a dermatologist in Sacramento, Calif., and her associates (Dermatol Surg. 2015 Nov;41[11]:1290-5).

They were inspired to conduct the study as a follow-on to a recently published pilot study of three patients, which found that clearance rates of AKs on the arm treated with thermally modulated 5-ALA blue light PDT persisted up to 14 months after treatment, when compared with the control arm, which was not heated.

In their study, there were 724 grade 1 and 2 AKs at baseline – a median of 15 per extremity; patients were followed up at 3, 6, 9, and 12 months. The total lesion count across the entire cohort was 70 at 3 months, 69 at 6 months, 64 at 9 months, and 72 at 1 year. No new AKs were seen in the treated areas during the 1-year follow-up.

There were 13 grade 3 hypertrophic AK lesions among all study participants. Although these lesions persisted, Dr. Willey and her coauthors noted that they did shrink initially after treatment.

Adverse events associated with the combination therapy were low, and included mild erythema and crusting up to 1 week post treatment, indicating the therapy was well tolerated, and patient satisfaction was high.

The results “suggest that mild skin warming may both improve efficacy and reduce variability of response to PDT in practice,” the authors wrote.

[email protected]

On Twitter @whitneymcknight

Clearance rates for actinic keratoses (AKs) on the extremities were prolonged by adding thermal modulation to photodynamic therapy (PDT), a study has shown.

The single-site study of 17 adults with 10 or more AKs on their arms or legs evaluated thermally modulated PDT: 20% 5-aminolevulinic acid (ALA) applied to skin, occluded with plastic wrap and warmed with an electric heating pad to a median 41.2° C for one hour, then exposed to blue light. Treatment resulted in 90% clearance rates at 3 months and 12 months, reported Dr. Andrea Willey, a dermatologist in Sacramento, Calif., and her associates (Dermatol Surg. 2015 Nov;41[11]:1290-5).

They were inspired to conduct the study as a follow-on to a recently published pilot study of three patients, which found that clearance rates of AKs on the arm treated with thermally modulated 5-ALA blue light PDT persisted up to 14 months after treatment, when compared with the control arm, which was not heated.

In their study, there were 724 grade 1 and 2 AKs at baseline – a median of 15 per extremity; patients were followed up at 3, 6, 9, and 12 months. The total lesion count across the entire cohort was 70 at 3 months, 69 at 6 months, 64 at 9 months, and 72 at 1 year. No new AKs were seen in the treated areas during the 1-year follow-up.

There were 13 grade 3 hypertrophic AK lesions among all study participants. Although these lesions persisted, Dr. Willey and her coauthors noted that they did shrink initially after treatment.

Adverse events associated with the combination therapy were low, and included mild erythema and crusting up to 1 week post treatment, indicating the therapy was well tolerated, and patient satisfaction was high.

The results “suggest that mild skin warming may both improve efficacy and reduce variability of response to PDT in practice,” the authors wrote.

[email protected]

On Twitter @whitneymcknight

Myth: Docusate is a stool softener and helps with constipation.

A 60-year-old man is injured in a fall and breaks four ribs. He is in severe pain and is prescribed oxycodone and naproxen for pain. What treatment would you prescribe to help decrease problems with constipation?

A. Docusate.

B. Docusate and polyethylene glycol.

C. Psyllium.

D. Polyethylene glycol.

Constipation is extremely common, occurring in up to 20%-25% of the elderly population and 90% of patients treated with opioids. The formal definition of constipation is fewer than three bowel movements per week. Patients are concerned with other symptoms as well, including hard stool consistency and the feeling of incomplete evacuation.

An extremely commonly prescribed medication for patients with symptoms of constipation/hard stool passage is docusate (Colace). This medication is often a part of bowel programs for institutionalized/hospitalized patients, as well as being frequently prescribed when patients are treated with opiates.

Does it work?

Docusate is frequently prescribed as a “stool softener,” but does it increase water content in stool? In a randomized, controlled trial of docusate vs. psyllium, 170 adult patients with chronic constipation received either 5.1 g twice a day of psyllium or 100 mg twice a day of docusate (Aliment Pharmacol Ther. 1998 May;12[5]:491-7).

Psyllium was superior in its effect on stool frequency, stool water content, total stool output, and the combination of several objective measures of constipation. Compared with baseline, psyllium increased stool water content by 2.33%, vs .01% for docusate (P =. 007), and stool weight was increased in the group treated with psyllium, compared with docusate-treated patients (359.9 g/week vs. 271.9 g/week, respectively; P = .005). Docusate does not appear to have any effect on stool water content or amount of stool.

In a study of constipation treatment in patients receiving opioids, Dr. Yoko Tarumi and her colleagues studied 74 patients admitted to hospice units (J Pain Symptom Manage. 2013 Jan;45[1]:2-13). A total of 74 patients were randomized to receive docusate 100 mg twice a day plus senna, or placebo plus senna. Once the study was started, inclusion criteria were broadened to include hospice patients with nonmalignant disease and patients who were not on opioids.

Almost all patients in the study did receive opioids (94% of the docusate patients and 100% of placebo-treated patients). There were no significant between the groups in stool volume, frequency, consistency, or in perceived completeness of evacuation.

In a randomized, controlled study of elderly patients on a medicine ward, 34 patients were randomized to docusate or control (no laxatives)(J Chronic Dis. 1976 Jan;29[1]:59-63). There was no difference in frequency or quality of stools between groups.

A systematic review of the usefulness of docusate in chronically ill patients concluded that the widespread use of docusate for the treatment of constipation in palliative-care patients is based on inadequate experimental evidence (J Pain Symptom Manage. 2000 Feb;19[2]:130-6).

The Canadian Agency for Drugs and Technologies in Health concluded “the available evidence suggests that docusate is no more effective than placebo in the prevention or management of constipation” (Dioctyl sulfosuccinate or docusate [calcium or sodium] for the prevention or management of constipation: a review of the clinical effectiveness. Canadian Agency for Drugs and Technologies in Health; 2014 Jun 26).

Dr. Davendra Ramkumar and his colleagues published a systematic review of drug trials for the treatment of constipation in 2005 (Am J Gastroenterol. 2005 Apr;100[4]:936-71). Only polyethylene glycol and tegaserod received grade A evidence for published trials. Psyllium and lactulose received grade B evidence. Docusate received a level 3, grade C for evidence (poor quality evidence, poor evidence to support a recommendation for or against the use of the modality).

I have been surprised at how docusate has been the most commonly prescribed laxative agent. Polyethylene glycol or psyllium are better evidence-based options. Docusate is often prescribed as a stool softener, and it has even less evidence that it softens stool than its poor evidence as a laxative.

Acknowledgments

My thanks to the late Dr. David Saunders for teaching me 30 years ago that docusate was not a helpful option for the management of constipation, and to Sarah Steinkruger for doing much of the research that was used in this column.

Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and he serves as third-year medical student clerkship director at the University of Washington. Contact Dr. Paauw at [email protected].

Myth: Docusate is a stool softener and helps with constipation.

A 60-year-old man is injured in a fall and breaks four ribs. He is in severe pain and is prescribed oxycodone and naproxen for pain. What treatment would you prescribe to help decrease problems with constipation?

A. Docusate.

B. Docusate and polyethylene glycol.

C. Psyllium.

D. Polyethylene glycol.

Constipation is extremely common, occurring in up to 20%-25% of the elderly population and 90% of patients treated with opioids. The formal definition of constipation is fewer than three bowel movements per week. Patients are concerned with other symptoms as well, including hard stool consistency and the feeling of incomplete evacuation.

An extremely commonly prescribed medication for patients with symptoms of constipation/hard stool passage is docusate (Colace). This medication is often a part of bowel programs for institutionalized/hospitalized patients, as well as being frequently prescribed when patients are treated with opiates.

Does it work?

Docusate is frequently prescribed as a “stool softener,” but does it increase water content in stool? In a randomized, controlled trial of docusate vs. psyllium, 170 adult patients with chronic constipation received either 5.1 g twice a day of psyllium or 100 mg twice a day of docusate (Aliment Pharmacol Ther. 1998 May;12[5]:491-7).

Psyllium was superior in its effect on stool frequency, stool water content, total stool output, and the combination of several objective measures of constipation. Compared with baseline, psyllium increased stool water content by 2.33%, vs .01% for docusate (P =. 007), and stool weight was increased in the group treated with psyllium, compared with docusate-treated patients (359.9 g/week vs. 271.9 g/week, respectively; P = .005). Docusate does not appear to have any effect on stool water content or amount of stool.

In a study of constipation treatment in patients receiving opioids, Dr. Yoko Tarumi and her colleagues studied 74 patients admitted to hospice units (J Pain Symptom Manage. 2013 Jan;45[1]:2-13). A total of 74 patients were randomized to receive docusate 100 mg twice a day plus senna, or placebo plus senna. Once the study was started, inclusion criteria were broadened to include hospice patients with nonmalignant disease and patients who were not on opioids.

Almost all patients in the study did receive opioids (94% of the docusate patients and 100% of placebo-treated patients). There were no significant between the groups in stool volume, frequency, consistency, or in perceived completeness of evacuation.

In a randomized, controlled study of elderly patients on a medicine ward, 34 patients were randomized to docusate or control (no laxatives)(J Chronic Dis. 1976 Jan;29[1]:59-63). There was no difference in frequency or quality of stools between groups.

A systematic review of the usefulness of docusate in chronically ill patients concluded that the widespread use of docusate for the treatment of constipation in palliative-care patients is based on inadequate experimental evidence (J Pain Symptom Manage. 2000 Feb;19[2]:130-6).

The Canadian Agency for Drugs and Technologies in Health concluded “the available evidence suggests that docusate is no more effective than placebo in the prevention or management of constipation” (Dioctyl sulfosuccinate or docusate [calcium or sodium] for the prevention or management of constipation: a review of the clinical effectiveness. Canadian Agency for Drugs and Technologies in Health; 2014 Jun 26).

Dr. Davendra Ramkumar and his colleagues published a systematic review of drug trials for the treatment of constipation in 2005 (Am J Gastroenterol. 2005 Apr;100[4]:936-71). Only polyethylene glycol and tegaserod received grade A evidence for published trials. Psyllium and lactulose received grade B evidence. Docusate received a level 3, grade C for evidence (poor quality evidence, poor evidence to support a recommendation for or against the use of the modality).

I have been surprised at how docusate has been the most commonly prescribed laxative agent. Polyethylene glycol or psyllium are better evidence-based options. Docusate is often prescribed as a stool softener, and it has even less evidence that it softens stool than its poor evidence as a laxative.

Acknowledgments

My thanks to the late Dr. David Saunders for teaching me 30 years ago that docusate was not a helpful option for the management of constipation, and to Sarah Steinkruger for doing much of the research that was used in this column.

Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and he serves as third-year medical student clerkship director at the University of Washington. Contact Dr. Paauw at [email protected].

Myth: Docusate is a stool softener and helps with constipation.

A 60-year-old man is injured in a fall and breaks four ribs. He is in severe pain and is prescribed oxycodone and naproxen for pain. What treatment would you prescribe to help decrease problems with constipation?

A. Docusate.

B. Docusate and polyethylene glycol.

C. Psyllium.

D. Polyethylene glycol.

Constipation is extremely common, occurring in up to 20%-25% of the elderly population and 90% of patients treated with opioids. The formal definition of constipation is fewer than three bowel movements per week. Patients are concerned with other symptoms as well, including hard stool consistency and the feeling of incomplete evacuation.

An extremely commonly prescribed medication for patients with symptoms of constipation/hard stool passage is docusate (Colace). This medication is often a part of bowel programs for institutionalized/hospitalized patients, as well as being frequently prescribed when patients are treated with opiates.

Does it work?

Docusate is frequently prescribed as a “stool softener,” but does it increase water content in stool? In a randomized, controlled trial of docusate vs. psyllium, 170 adult patients with chronic constipation received either 5.1 g twice a day of psyllium or 100 mg twice a day of docusate (Aliment Pharmacol Ther. 1998 May;12[5]:491-7).

Psyllium was superior in its effect on stool frequency, stool water content, total stool output, and the combination of several objective measures of constipation. Compared with baseline, psyllium increased stool water content by 2.33%, vs .01% for docusate (P =. 007), and stool weight was increased in the group treated with psyllium, compared with docusate-treated patients (359.9 g/week vs. 271.9 g/week, respectively; P = .005). Docusate does not appear to have any effect on stool water content or amount of stool.

In a study of constipation treatment in patients receiving opioids, Dr. Yoko Tarumi and her colleagues studied 74 patients admitted to hospice units (J Pain Symptom Manage. 2013 Jan;45[1]:2-13). A total of 74 patients were randomized to receive docusate 100 mg twice a day plus senna, or placebo plus senna. Once the study was started, inclusion criteria were broadened to include hospice patients with nonmalignant disease and patients who were not on opioids.

Almost all patients in the study did receive opioids (94% of the docusate patients and 100% of placebo-treated patients). There were no significant between the groups in stool volume, frequency, consistency, or in perceived completeness of evacuation.

In a randomized, controlled study of elderly patients on a medicine ward, 34 patients were randomized to docusate or control (no laxatives)(J Chronic Dis. 1976 Jan;29[1]:59-63). There was no difference in frequency or quality of stools between groups.

A systematic review of the usefulness of docusate in chronically ill patients concluded that the widespread use of docusate for the treatment of constipation in palliative-care patients is based on inadequate experimental evidence (J Pain Symptom Manage. 2000 Feb;19[2]:130-6).

The Canadian Agency for Drugs and Technologies in Health concluded “the available evidence suggests that docusate is no more effective than placebo in the prevention or management of constipation” (Dioctyl sulfosuccinate or docusate [calcium or sodium] for the prevention or management of constipation: a review of the clinical effectiveness. Canadian Agency for Drugs and Technologies in Health; 2014 Jun 26).

Dr. Davendra Ramkumar and his colleagues published a systematic review of drug trials for the treatment of constipation in 2005 (Am J Gastroenterol. 2005 Apr;100[4]:936-71). Only polyethylene glycol and tegaserod received grade A evidence for published trials. Psyllium and lactulose received grade B evidence. Docusate received a level 3, grade C for evidence (poor quality evidence, poor evidence to support a recommendation for or against the use of the modality).

I have been surprised at how docusate has been the most commonly prescribed laxative agent. Polyethylene glycol or psyllium are better evidence-based options. Docusate is often prescribed as a stool softener, and it has even less evidence that it softens stool than its poor evidence as a laxative.

Acknowledgments

My thanks to the late Dr. David Saunders for teaching me 30 years ago that docusate was not a helpful option for the management of constipation, and to Sarah Steinkruger for doing much of the research that was used in this column.

Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and he serves as third-year medical student clerkship director at the University of Washington. Contact Dr. Paauw at [email protected].

Blood drop

Finger-prick blood tests can deliver inaccurate results, according to a study published in the American Journal of Clinical Pathology.

Investigators found that results varied greatly when they performed multiple finger-prick tests on a single subject.

However, averaging the results of multiple droplet tests allowed the investigators to achieve results on par with venous blood tests.

They required 6 to 9 drops of blood to achieve consistent results.

“We began looking at this after we got some surprising results from our controls in an earlier study,” explained lead investigator Rebecca Richards-Kortum, PhD, of Rice University in Houston, Texas.

“Students in my lab are developing novel, low-cost platforms for anemia, platelet, and white blood cell testing in low-resource settings, and one of my students, Meaghan Bond, noticed there was wide variation in some of the benchmark tests that she was performing on hospital-grade blood analyzers.”

The benchmark controls are used to gauge the accuracy of test results from the new technology under study, so the variation among the control data was a sign that something was amiss.

What wasn’t immediately clear was whether the readings resulted from a problem with the current experiments or actual variations in the amount of hemoglobin, platelets, and white blood cells in the different drops of blood.

So Dr Richards-Kortum and Bond designed a simple protocol to test whether there was actual variation and, if so, how much.

They drew 6 successive 20 µL droplets of blood from 11 donors. As an additional test to determine whether minimum droplet size might also affect the results, the pair drew 10 successive 10 µL droplets from 7 additional donors.

All droplets were drawn from the same finger prick, and the investigators followed best practices in obtaining the droplets. The first drop was wiped away to remove contamination from disinfectants, and the finger was not squeezed or “milked,” which can lead to inaccurate results.

For experimental controls, the investigators used venipuncture to draw tubes of blood from an arm vein.

Each 20 µL droplet was analyzed with a hospital-grade blood analyzer for hemoglobin concentration, total white blood cell count, platelet count, and 3-part white blood cell differential. Each 10 µL droplet was tested for hemoglobin concentration with a popular point-of-care blood analyzer.

“A growing number of clinically important tests are performed using finger-prick blood, and this is especially true in low-resource settings,” Bond noted.

“It is important to understand how variations in finger-prick blood collection protocols can affect point-of-care test accuracy as well as how results might vary between different kinds of point-of-care tests that use finger-prick blood from the same patient.”

She and Dr Richards-Kortum found that hemoglobin content, platelet count, and white blood cell count each varied significantly from blood drop to blood drop.

“Some of the differences were surprising,” Bond said. “For example, in some donors, the hemoglobin concentration changed by more than 2 g/dL in the span of 2 successive drops of blood.”

Fortunately, the investigators found that averaging the results of the droplet tests could produce results that were on par with venous blood tests, but tests on 6 to 9 drops of blood were needed to achieve consistent results.

“Finger-prick blood tests can be accurate, and they are an important tool for healthcare providers, particularly in point-of-care and low-resource settings,” Bond said.

“Our results show that people need to take care to administer finger-prick tests in a way that produces accurate results because accuracy in these tests is increasingly important for diagnosing conditions like anemia, infections, and sickle cell anemia, malaria, HIV, and other diseases.”

Blood drop

Finger-prick blood tests can deliver inaccurate results, according to a study published in the American Journal of Clinical Pathology.

Investigators found that results varied greatly when they performed multiple finger-prick tests on a single subject.

However, averaging the results of multiple droplet tests allowed the investigators to achieve results on par with venous blood tests.

They required 6 to 9 drops of blood to achieve consistent results.

“We began looking at this after we got some surprising results from our controls in an earlier study,” explained lead investigator Rebecca Richards-Kortum, PhD, of Rice University in Houston, Texas.

“Students in my lab are developing novel, low-cost platforms for anemia, platelet, and white blood cell testing in low-resource settings, and one of my students, Meaghan Bond, noticed there was wide variation in some of the benchmark tests that she was performing on hospital-grade blood analyzers.”

The benchmark controls are used to gauge the accuracy of test results from the new technology under study, so the variation among the control data was a sign that something was amiss.

What wasn’t immediately clear was whether the readings resulted from a problem with the current experiments or actual variations in the amount of hemoglobin, platelets, and white blood cells in the different drops of blood.

So Dr Richards-Kortum and Bond designed a simple protocol to test whether there was actual variation and, if so, how much.

They drew 6 successive 20 µL droplets of blood from 11 donors. As an additional test to determine whether minimum droplet size might also affect the results, the pair drew 10 successive 10 µL droplets from 7 additional donors.

All droplets were drawn from the same finger prick, and the investigators followed best practices in obtaining the droplets. The first drop was wiped away to remove contamination from disinfectants, and the finger was not squeezed or “milked,” which can lead to inaccurate results.

For experimental controls, the investigators used venipuncture to draw tubes of blood from an arm vein.

Each 20 µL droplet was analyzed with a hospital-grade blood analyzer for hemoglobin concentration, total white blood cell count, platelet count, and 3-part white blood cell differential. Each 10 µL droplet was tested for hemoglobin concentration with a popular point-of-care blood analyzer.

“A growing number of clinically important tests are performed using finger-prick blood, and this is especially true in low-resource settings,” Bond noted.

“It is important to understand how variations in finger-prick blood collection protocols can affect point-of-care test accuracy as well as how results might vary between different kinds of point-of-care tests that use finger-prick blood from the same patient.”

She and Dr Richards-Kortum found that hemoglobin content, platelet count, and white blood cell count each varied significantly from blood drop to blood drop.

“Some of the differences were surprising,” Bond said. “For example, in some donors, the hemoglobin concentration changed by more than 2 g/dL in the span of 2 successive drops of blood.”

Fortunately, the investigators found that averaging the results of the droplet tests could produce results that were on par with venous blood tests, but tests on 6 to 9 drops of blood were needed to achieve consistent results.

“Finger-prick blood tests can be accurate, and they are an important tool for healthcare providers, particularly in point-of-care and low-resource settings,” Bond said.

“Our results show that people need to take care to administer finger-prick tests in a way that produces accurate results because accuracy in these tests is increasingly important for diagnosing conditions like anemia, infections, and sickle cell anemia, malaria, HIV, and other diseases.”

Blood drop

Finger-prick blood tests can deliver inaccurate results, according to a study published in the American Journal of Clinical Pathology.

Investigators found that results varied greatly when they performed multiple finger-prick tests on a single subject.

However, averaging the results of multiple droplet tests allowed the investigators to achieve results on par with venous blood tests.

They required 6 to 9 drops of blood to achieve consistent results.

“We began looking at this after we got some surprising results from our controls in an earlier study,” explained lead investigator Rebecca Richards-Kortum, PhD, of Rice University in Houston, Texas.

“Students in my lab are developing novel, low-cost platforms for anemia, platelet, and white blood cell testing in low-resource settings, and one of my students, Meaghan Bond, noticed there was wide variation in some of the benchmark tests that she was performing on hospital-grade blood analyzers.”

The benchmark controls are used to gauge the accuracy of test results from the new technology under study, so the variation among the control data was a sign that something was amiss.

What wasn’t immediately clear was whether the readings resulted from a problem with the current experiments or actual variations in the amount of hemoglobin, platelets, and white blood cells in the different drops of blood.

So Dr Richards-Kortum and Bond designed a simple protocol to test whether there was actual variation and, if so, how much.

They drew 6 successive 20 µL droplets of blood from 11 donors. As an additional test to determine whether minimum droplet size might also affect the results, the pair drew 10 successive 10 µL droplets from 7 additional donors.

All droplets were drawn from the same finger prick, and the investigators followed best practices in obtaining the droplets. The first drop was wiped away to remove contamination from disinfectants, and the finger was not squeezed or “milked,” which can lead to inaccurate results.

For experimental controls, the investigators used venipuncture to draw tubes of blood from an arm vein.

Each 20 µL droplet was analyzed with a hospital-grade blood analyzer for hemoglobin concentration, total white blood cell count, platelet count, and 3-part white blood cell differential. Each 10 µL droplet was tested for hemoglobin concentration with a popular point-of-care blood analyzer.

“A growing number of clinically important tests are performed using finger-prick blood, and this is especially true in low-resource settings,” Bond noted.

“It is important to understand how variations in finger-prick blood collection protocols can affect point-of-care test accuracy as well as how results might vary between different kinds of point-of-care tests that use finger-prick blood from the same patient.”

She and Dr Richards-Kortum found that hemoglobin content, platelet count, and white blood cell count each varied significantly from blood drop to blood drop.

“Some of the differences were surprising,” Bond said. “For example, in some donors, the hemoglobin concentration changed by more than 2 g/dL in the span of 2 successive drops of blood.”

Fortunately, the investigators found that averaging the results of the droplet tests could produce results that were on par with venous blood tests, but tests on 6 to 9 drops of blood were needed to achieve consistent results.

“Finger-prick blood tests can be accurate, and they are an important tool for healthcare providers, particularly in point-of-care and low-resource settings,” Bond said.

“Our results show that people need to take care to administer finger-prick tests in a way that produces accurate results because accuracy in these tests is increasingly important for diagnosing conditions like anemia, infections, and sickle cell anemia, malaria, HIV, and other diseases.”

Blood donation

A device used to measure hemoglobin can deliver inaccurate results and may have prompted an increase in anemia among blood donors in Ireland, according to the Irish Blood Transfusion Service (IBTS).

The IBTS began using the device—called haemospect—in July 2014 but recently discovered that it cannot detect anemia accurately in all cases.

This may have resulted in anemic individuals donating blood or caused individuals to become anemic by donating.

The IBTS said this issue likely affected female donors more than males, so the organization has decided to temporarily stop taking blood donations from women who have donated in the last 18 months.

The IBTS also said it will perform a full blood count on all male and female donors going forward, until this issue has been resolved.

“Until we have a resolution to the problem that has arisen, we are asking male donors to attend our clinics and give blood,” said IBTS Medical and Scientific Director William Murphy, MD.

“We need male donors to make an extra effort to donate and maintain the blood supply. We will be double-checking all hemoglobin results on these donors.”

Discovering the problem

Haemospect is a noninvasive device that uses white light to detect hemoglobin levels. The device is made by the German company MBR Optical Systems.

IBTS learned of the potential for inaccuracies with haemospect after a blood donor contacted the organization. She had been diagnosed as severely anemic by her doctor but had given blood the week before.

“We have now discovered that the device gives inaccurate results in some individuals with anemia down to, and probably below, 8.4 g/dL,” Dr Murphy said. “As a result of the issue . . . , some women, and probably a much smaller number of men, could have been rendered iron-deficient and anemic from blood donation in the past 18 months.”

Steps to resolution

Since the issue was discovered, more than 30 women with anemia have been identified and contacted. The IBTS said it will contact all donors who are found to be anemic.

“Over the next few weeks, we will introduce new software to reanalyze all the electronic results from all donors who have been tested and accepted for donation since we introduced this device,” Dr Murphy said. “Any discrepant results will be notified to the donors involved.”

Dr Murphy also said donors who think they might be anemic or iron-deficient should visit their doctors for testing, and the IBTS will foot the bill. Concerned donors can contact the IBTS at 1850 731137.

The IBTS plans to replace haemospect with an alternative device as soon as possible. The organization has contacted the Health Products Regularity Authority about the issue with haemospect, which is used in Austria and Germany as well.

“We are determined to have this matter resolved as soon as possible,” Dr Murphy said. “We are confident that this issue . . . has not had any impact on blood received by patients.”

Blood donation

A device used to measure hemoglobin can deliver inaccurate results and may have prompted an increase in anemia among blood donors in Ireland, according to the Irish Blood Transfusion Service (IBTS).

The IBTS began using the device—called haemospect—in July 2014 but recently discovered that it cannot detect anemia accurately in all cases.

This may have resulted in anemic individuals donating blood or caused individuals to become anemic by donating.

The IBTS said this issue likely affected female donors more than males, so the organization has decided to temporarily stop taking blood donations from women who have donated in the last 18 months.

The IBTS also said it will perform a full blood count on all male and female donors going forward, until this issue has been resolved.

“Until we have a resolution to the problem that has arisen, we are asking male donors to attend our clinics and give blood,” said IBTS Medical and Scientific Director William Murphy, MD.

“We need male donors to make an extra effort to donate and maintain the blood supply. We will be double-checking all hemoglobin results on these donors.”

Discovering the problem

Haemospect is a noninvasive device that uses white light to detect hemoglobin levels. The device is made by the German company MBR Optical Systems.

IBTS learned of the potential for inaccuracies with haemospect after a blood donor contacted the organization. She had been diagnosed as severely anemic by her doctor but had given blood the week before.

“We have now discovered that the device gives inaccurate results in some individuals with anemia down to, and probably below, 8.4 g/dL,” Dr Murphy said. “As a result of the issue . . . , some women, and probably a much smaller number of men, could have been rendered iron-deficient and anemic from blood donation in the past 18 months.”

Steps to resolution

Since the issue was discovered, more than 30 women with anemia have been identified and contacted. The IBTS said it will contact all donors who are found to be anemic.

“Over the next few weeks, we will introduce new software to reanalyze all the electronic results from all donors who have been tested and accepted for donation since we introduced this device,” Dr Murphy said. “Any discrepant results will be notified to the donors involved.”

Dr Murphy also said donors who think they might be anemic or iron-deficient should visit their doctors for testing, and the IBTS will foot the bill. Concerned donors can contact the IBTS at 1850 731137.

The IBTS plans to replace haemospect with an alternative device as soon as possible. The organization has contacted the Health Products Regularity Authority about the issue with haemospect, which is used in Austria and Germany as well.

“We are determined to have this matter resolved as soon as possible,” Dr Murphy said. “We are confident that this issue . . . has not had any impact on blood received by patients.”

Blood donation

A device used to measure hemoglobin can deliver inaccurate results and may have prompted an increase in anemia among blood donors in Ireland, according to the Irish Blood Transfusion Service (IBTS).

The IBTS began using the device—called haemospect—in July 2014 but recently discovered that it cannot detect anemia accurately in all cases.

This may have resulted in anemic individuals donating blood or caused individuals to become anemic by donating.

The IBTS said this issue likely affected female donors more than males, so the organization has decided to temporarily stop taking blood donations from women who have donated in the last 18 months.

The IBTS also said it will perform a full blood count on all male and female donors going forward, until this issue has been resolved.

“Until we have a resolution to the problem that has arisen, we are asking male donors to attend our clinics and give blood,” said IBTS Medical and Scientific Director William Murphy, MD.

“We need male donors to make an extra effort to donate and maintain the blood supply. We will be double-checking all hemoglobin results on these donors.”

Discovering the problem

Haemospect is a noninvasive device that uses white light to detect hemoglobin levels. The device is made by the German company MBR Optical Systems.

IBTS learned of the potential for inaccuracies with haemospect after a blood donor contacted the organization. She had been diagnosed as severely anemic by her doctor but had given blood the week before.

“We have now discovered that the device gives inaccurate results in some individuals with anemia down to, and probably below, 8.4 g/dL,” Dr Murphy said. “As a result of the issue . . . , some women, and probably a much smaller number of men, could have been rendered iron-deficient and anemic from blood donation in the past 18 months.”

Steps to resolution

Since the issue was discovered, more than 30 women with anemia have been identified and contacted. The IBTS said it will contact all donors who are found to be anemic.

“Over the next few weeks, we will introduce new software to reanalyze all the electronic results from all donors who have been tested and accepted for donation since we introduced this device,” Dr Murphy said. “Any discrepant results will be notified to the donors involved.”

Dr Murphy also said donors who think they might be anemic or iron-deficient should visit their doctors for testing, and the IBTS will foot the bill. Concerned donors can contact the IBTS at 1850 731137.

The IBTS plans to replace haemospect with an alternative device as soon as possible. The organization has contacted the Health Products Regularity Authority about the issue with haemospect, which is used in Austria and Germany as well.

“We are determined to have this matter resolved as soon as possible,” Dr Murphy said. “We are confident that this issue . . . has not had any impact on blood received by patients.”