“Keep an eye on that one, and call me if it changes,” is as much a stock phrase for dermatologists as “Wear your sunscreen.” Yet, how do patients know if a mole changes? I’m quite sure many of my patients wouldn’t notice if I shaved my head and grew a beard, let alone notice if 1 of 30 moles on their back changed color.

Mole Mapper is an iPhone app developed by the department of dermatology at Oregon Health and Science University (OHSU) to solve this problem. The app provides a framework for patients to photo, measure, and track their moles. With clear instructions, an anatomical map, and sophisticated markers, it is a significant aid for motivated patients who want medical-grade photos suitable for tracking.

To standardize the photos, the app prompts you to include a nickel, dime, or quarter in photos with nevi of interest. The user then calibrates the app by pinching onscreen circles overlying the photo such that they correspond exactly to the circumference of the coin and to the mole. Using a coin as a standard, the app then calculates the precise size of the mole regardless of the size of the photo. For example, photos taken 2 feet and 4 feet away both give the same diameter because both photos are calibrated by the dime in each.

The app was developed by a cancer biologist, Dan Webster, Ph.D., to help his wife monitor her moles between dermatology appointments. Interestingly, it was largely developed by a single person, a sign that creating apps is nearly entering into a DIY era. This increases the possibility for useful health care tools to be developed while also increasing the already crushing crowd of apps, few of which are truly useful.

The app’s functionality would not have been possible without the inclusion of Apple’s ResearchKit and Sage Bionetworks’ Bridge Server. ResearchKit provided open-source tools to facilitate informed consent over the phone and the ability to conduct participant surveys, among other activities. Bridge Server enabled the app to encrypt and securely transfer participant data from the phone to firewalled storage. The combination of these two software frameworks is paving the way for an exciting future of integrated technology and biomedical research.

According to Dan Webster, “ResearchKit is a game-changer because it provides an open-source platform for elegant informed consent, measurement tools, and participant data protection. The ability for participants to have so few barriers to contribute to a research study is the truly transformative aspect of ResearchKit, and we have seen unprecedented numbers of research study enrollees as a result.”

But that’s not all. The app is more than just a consumer tool for tracking – ResearchKit allows OHSU researchers to gather data on nevi, track them over time, and learn characteristics associated with melanoma from user-generated outcomes. This could significantly increase our understanding of melanoma and perhaps spawn an artificially intelligent app that learns to diagnose melanoma without human assistance.

Because of the institutional review board’s requirements for their research, users must be 18 years old to participate in the study. The app gracefully walks users through the consent process and even has a knowledge check at the end to ensure that they understood the risks and benefits of participating. The consent process is so streamlined that it ought to be a model for us to consent any patient for any reason.

To be clear, the app does not make diagnoses. It only provides a framework for patients to photograph their moles and track them. It also politely prompts users to rephotograph moles every 30 days so changes can be recorded.

There are apps with similar names, so be sure you have Mole Mapper from Sage Bionetworks. I tried it out to offer my experience here. Taking photos was as simple as any photo on an iPhone. Like any selfie, however, there are azimuth limits to the human arm – you can’t get shots in remote bodily corners easily. Also, placing a coin on yourself is easier said than done, unless you want to use your bubble gum to hold it in place while you take the shot. (I asked for assistance from my wife instead.)

The photos I took were accurate when compared with the measured diameter in real life, but there are still user-dependent adjustments that could lead to large artifacts. Making the measurement circles even slightly smaller or larger around the coin or the mole can lead to more than a millimeter of margins of error. If detecting melanoma requires less than 1-mm error in mole changes, then this could limit its usefulness.

Whether or not it leads to an app that automatically diagnoses melanoma from patient mole selfies, Mole Mapper has value. Any tool that empowers patients to be actively involved in their care and to meticulously monitor their moles will surely help us in keeping them safe.

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. He has no conflicts relating to the topic of this column.

“Keep an eye on that one, and call me if it changes,” is as much a stock phrase for dermatologists as “Wear your sunscreen.” Yet, how do patients know if a mole changes? I’m quite sure many of my patients wouldn’t notice if I shaved my head and grew a beard, let alone notice if 1 of 30 moles on their back changed color.

Mole Mapper is an iPhone app developed by the department of dermatology at Oregon Health and Science University (OHSU) to solve this problem. The app provides a framework for patients to photo, measure, and track their moles. With clear instructions, an anatomical map, and sophisticated markers, it is a significant aid for motivated patients who want medical-grade photos suitable for tracking.

To standardize the photos, the app prompts you to include a nickel, dime, or quarter in photos with nevi of interest. The user then calibrates the app by pinching onscreen circles overlying the photo such that they correspond exactly to the circumference of the coin and to the mole. Using a coin as a standard, the app then calculates the precise size of the mole regardless of the size of the photo. For example, photos taken 2 feet and 4 feet away both give the same diameter because both photos are calibrated by the dime in each.

The app was developed by a cancer biologist, Dan Webster, Ph.D., to help his wife monitor her moles between dermatology appointments. Interestingly, it was largely developed by a single person, a sign that creating apps is nearly entering into a DIY era. This increases the possibility for useful health care tools to be developed while also increasing the already crushing crowd of apps, few of which are truly useful.

The app’s functionality would not have been possible without the inclusion of Apple’s ResearchKit and Sage Bionetworks’ Bridge Server. ResearchKit provided open-source tools to facilitate informed consent over the phone and the ability to conduct participant surveys, among other activities. Bridge Server enabled the app to encrypt and securely transfer participant data from the phone to firewalled storage. The combination of these two software frameworks is paving the way for an exciting future of integrated technology and biomedical research.

According to Dan Webster, “ResearchKit is a game-changer because it provides an open-source platform for elegant informed consent, measurement tools, and participant data protection. The ability for participants to have so few barriers to contribute to a research study is the truly transformative aspect of ResearchKit, and we have seen unprecedented numbers of research study enrollees as a result.”

But that’s not all. The app is more than just a consumer tool for tracking – ResearchKit allows OHSU researchers to gather data on nevi, track them over time, and learn characteristics associated with melanoma from user-generated outcomes. This could significantly increase our understanding of melanoma and perhaps spawn an artificially intelligent app that learns to diagnose melanoma without human assistance.

Because of the institutional review board’s requirements for their research, users must be 18 years old to participate in the study. The app gracefully walks users through the consent process and even has a knowledge check at the end to ensure that they understood the risks and benefits of participating. The consent process is so streamlined that it ought to be a model for us to consent any patient for any reason.

To be clear, the app does not make diagnoses. It only provides a framework for patients to photograph their moles and track them. It also politely prompts users to rephotograph moles every 30 days so changes can be recorded.

There are apps with similar names, so be sure you have Mole Mapper from Sage Bionetworks. I tried it out to offer my experience here. Taking photos was as simple as any photo on an iPhone. Like any selfie, however, there are azimuth limits to the human arm – you can’t get shots in remote bodily corners easily. Also, placing a coin on yourself is easier said than done, unless you want to use your bubble gum to hold it in place while you take the shot. (I asked for assistance from my wife instead.)

The photos I took were accurate when compared with the measured diameter in real life, but there are still user-dependent adjustments that could lead to large artifacts. Making the measurement circles even slightly smaller or larger around the coin or the mole can lead to more than a millimeter of margins of error. If detecting melanoma requires less than 1-mm error in mole changes, then this could limit its usefulness.

Whether or not it leads to an app that automatically diagnoses melanoma from patient mole selfies, Mole Mapper has value. Any tool that empowers patients to be actively involved in their care and to meticulously monitor their moles will surely help us in keeping them safe.

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. He has no conflicts relating to the topic of this column.

“Keep an eye on that one, and call me if it changes,” is as much a stock phrase for dermatologists as “Wear your sunscreen.” Yet, how do patients know if a mole changes? I’m quite sure many of my patients wouldn’t notice if I shaved my head and grew a beard, let alone notice if 1 of 30 moles on their back changed color.

Mole Mapper is an iPhone app developed by the department of dermatology at Oregon Health and Science University (OHSU) to solve this problem. The app provides a framework for patients to photo, measure, and track their moles. With clear instructions, an anatomical map, and sophisticated markers, it is a significant aid for motivated patients who want medical-grade photos suitable for tracking.

To standardize the photos, the app prompts you to include a nickel, dime, or quarter in photos with nevi of interest. The user then calibrates the app by pinching onscreen circles overlying the photo such that they correspond exactly to the circumference of the coin and to the mole. Using a coin as a standard, the app then calculates the precise size of the mole regardless of the size of the photo. For example, photos taken 2 feet and 4 feet away both give the same diameter because both photos are calibrated by the dime in each.

The app was developed by a cancer biologist, Dan Webster, Ph.D., to help his wife monitor her moles between dermatology appointments. Interestingly, it was largely developed by a single person, a sign that creating apps is nearly entering into a DIY era. This increases the possibility for useful health care tools to be developed while also increasing the already crushing crowd of apps, few of which are truly useful.

The app’s functionality would not have been possible without the inclusion of Apple’s ResearchKit and Sage Bionetworks’ Bridge Server. ResearchKit provided open-source tools to facilitate informed consent over the phone and the ability to conduct participant surveys, among other activities. Bridge Server enabled the app to encrypt and securely transfer participant data from the phone to firewalled storage. The combination of these two software frameworks is paving the way for an exciting future of integrated technology and biomedical research.

According to Dan Webster, “ResearchKit is a game-changer because it provides an open-source platform for elegant informed consent, measurement tools, and participant data protection. The ability for participants to have so few barriers to contribute to a research study is the truly transformative aspect of ResearchKit, and we have seen unprecedented numbers of research study enrollees as a result.”

But that’s not all. The app is more than just a consumer tool for tracking – ResearchKit allows OHSU researchers to gather data on nevi, track them over time, and learn characteristics associated with melanoma from user-generated outcomes. This could significantly increase our understanding of melanoma and perhaps spawn an artificially intelligent app that learns to diagnose melanoma without human assistance.

Because of the institutional review board’s requirements for their research, users must be 18 years old to participate in the study. The app gracefully walks users through the consent process and even has a knowledge check at the end to ensure that they understood the risks and benefits of participating. The consent process is so streamlined that it ought to be a model for us to consent any patient for any reason.

To be clear, the app does not make diagnoses. It only provides a framework for patients to photograph their moles and track them. It also politely prompts users to rephotograph moles every 30 days so changes can be recorded.

There are apps with similar names, so be sure you have Mole Mapper from Sage Bionetworks. I tried it out to offer my experience here. Taking photos was as simple as any photo on an iPhone. Like any selfie, however, there are azimuth limits to the human arm – you can’t get shots in remote bodily corners easily. Also, placing a coin on yourself is easier said than done, unless you want to use your bubble gum to hold it in place while you take the shot. (I asked for assistance from my wife instead.)

The photos I took were accurate when compared with the measured diameter in real life, but there are still user-dependent adjustments that could lead to large artifacts. Making the measurement circles even slightly smaller or larger around the coin or the mole can lead to more than a millimeter of margins of error. If detecting melanoma requires less than 1-mm error in mole changes, then this could limit its usefulness.

Whether or not it leads to an app that automatically diagnoses melanoma from patient mole selfies, Mole Mapper has value. Any tool that empowers patients to be actively involved in their care and to meticulously monitor their moles will surely help us in keeping them safe.

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. He has no conflicts relating to the topic of this column.

ORLANDO – When it comes to preventing alopecia, it may be best to advise patients against certain trendy hairstyles that can cause early hair loss.

At the Orlando Dermatology Aesthetic and Clinical Conference, Dr. Wendy Roberts, a dermatologist practicing in Rancho Mirage, Calif., spoke about the risks of traction alopecia associated with some hairstyles and why it’s in patients’ best interest to avoid them if they don’t want to experience premature hair loss.

Dr. Roberts brings up the topic of hair loss with patients during the full-body exam. Full-body skin exams are “opportunities for us, as the skin and hair experts, to speak to our patients about hair loss, [but] it’s rarely asked about,” she said. “Typically, what I do is start my full-body skin exam from the head and I always ask the question right away ‘How’s your hair? Are you having any problems with your hair? How’s your scalp?’ And about 50% of the time, there’s a positive answer or an interest in learning more about it.”

To avoid traction alopecia, caused frequently by intense pulling or pressure on the hair follicles, patients should be advised against braiding their hair or, for male patients, styling their hair in a “man bun.” For braids, the tightness of the braid and pulling along the hairlines will cause intense pressure on follicles over time that can lead to hair loss. For the man bun, Dr. Roberts noted that dermatologists will likely see an uptick in male patients with traction alopecia as this hairstyle becomes more popular.

In the evaluation and treatment of traction alopecia – as with any form of alopecia – clinical presentation, ethnicity, and the age of the patient should be considered, Dr. Roberts said. Additionally, collection of evidence – hair pulls, biopsy, dermoscopy, and lab work should be obtained.

Labs will check for iron levels and anemia, thyroid disease, vitamin D deficiency, and perhaps signs of a connective tissue disorder, she noted. “It’s staggering the amount of African-American women who are deficient in vitamin D, [and] there is some soft evidence that perhaps vitamin D deficiency may be a culprit in some of the clinical signs of discoid lupus erythematosus, [so] check the vitamin D and zinc levels.”

After making a diagnosis, it is important to quickly begin rigorous treatment of the alopecia. Aggressive treatment is “the bottom line,” Dr. Roberts emphasized, “because people are losing their hair and when they come to you, they’ve really had enough.”

She did not report any relevant financial disclosures.

[email protected]

ORLANDO – When it comes to preventing alopecia, it may be best to advise patients against certain trendy hairstyles that can cause early hair loss.

At the Orlando Dermatology Aesthetic and Clinical Conference, Dr. Wendy Roberts, a dermatologist practicing in Rancho Mirage, Calif., spoke about the risks of traction alopecia associated with some hairstyles and why it’s in patients’ best interest to avoid them if they don’t want to experience premature hair loss.

Dr. Roberts brings up the topic of hair loss with patients during the full-body exam. Full-body skin exams are “opportunities for us, as the skin and hair experts, to speak to our patients about hair loss, [but] it’s rarely asked about,” she said. “Typically, what I do is start my full-body skin exam from the head and I always ask the question right away ‘How’s your hair? Are you having any problems with your hair? How’s your scalp?’ And about 50% of the time, there’s a positive answer or an interest in learning more about it.”

To avoid traction alopecia, caused frequently by intense pulling or pressure on the hair follicles, patients should be advised against braiding their hair or, for male patients, styling their hair in a “man bun.” For braids, the tightness of the braid and pulling along the hairlines will cause intense pressure on follicles over time that can lead to hair loss. For the man bun, Dr. Roberts noted that dermatologists will likely see an uptick in male patients with traction alopecia as this hairstyle becomes more popular.

In the evaluation and treatment of traction alopecia – as with any form of alopecia – clinical presentation, ethnicity, and the age of the patient should be considered, Dr. Roberts said. Additionally, collection of evidence – hair pulls, biopsy, dermoscopy, and lab work should be obtained.

Labs will check for iron levels and anemia, thyroid disease, vitamin D deficiency, and perhaps signs of a connective tissue disorder, she noted. “It’s staggering the amount of African-American women who are deficient in vitamin D, [and] there is some soft evidence that perhaps vitamin D deficiency may be a culprit in some of the clinical signs of discoid lupus erythematosus, [so] check the vitamin D and zinc levels.”

After making a diagnosis, it is important to quickly begin rigorous treatment of the alopecia. Aggressive treatment is “the bottom line,” Dr. Roberts emphasized, “because people are losing their hair and when they come to you, they’ve really had enough.”

She did not report any relevant financial disclosures.

[email protected]

ORLANDO – When it comes to preventing alopecia, it may be best to advise patients against certain trendy hairstyles that can cause early hair loss.

At the Orlando Dermatology Aesthetic and Clinical Conference, Dr. Wendy Roberts, a dermatologist practicing in Rancho Mirage, Calif., spoke about the risks of traction alopecia associated with some hairstyles and why it’s in patients’ best interest to avoid them if they don’t want to experience premature hair loss.

Dr. Roberts brings up the topic of hair loss with patients during the full-body exam. Full-body skin exams are “opportunities for us, as the skin and hair experts, to speak to our patients about hair loss, [but] it’s rarely asked about,” she said. “Typically, what I do is start my full-body skin exam from the head and I always ask the question right away ‘How’s your hair? Are you having any problems with your hair? How’s your scalp?’ And about 50% of the time, there’s a positive answer or an interest in learning more about it.”

To avoid traction alopecia, caused frequently by intense pulling or pressure on the hair follicles, patients should be advised against braiding their hair or, for male patients, styling their hair in a “man bun.” For braids, the tightness of the braid and pulling along the hairlines will cause intense pressure on follicles over time that can lead to hair loss. For the man bun, Dr. Roberts noted that dermatologists will likely see an uptick in male patients with traction alopecia as this hairstyle becomes more popular.

In the evaluation and treatment of traction alopecia – as with any form of alopecia – clinical presentation, ethnicity, and the age of the patient should be considered, Dr. Roberts said. Additionally, collection of evidence – hair pulls, biopsy, dermoscopy, and lab work should be obtained.

Labs will check for iron levels and anemia, thyroid disease, vitamin D deficiency, and perhaps signs of a connective tissue disorder, she noted. “It’s staggering the amount of African-American women who are deficient in vitamin D, [and] there is some soft evidence that perhaps vitamin D deficiency may be a culprit in some of the clinical signs of discoid lupus erythematosus, [so] check the vitamin D and zinc levels.”

After making a diagnosis, it is important to quickly begin rigorous treatment of the alopecia. Aggressive treatment is “the bottom line,” Dr. Roberts emphasized, “because people are losing their hair and when they come to you, they’ve really had enough.”

She did not report any relevant financial disclosures.

[email protected]

From the Department of Anesthesiology, University of Michigan, Ann Arbor, MI.

Abstract

• Objective: To provide an overview of the critical treatment domains for patients with chronic pain and describe nonpharmacologic strategies by which these domains can be addressed.
• Methods: A literature review was conducted to evaluate the evidence underlying commonly used nonpharmacologic strategies for the treatment of chronic pain, with a focus on interventions that require patient engagement.
• Results: Nonpharmacologic interventions that actively engage the patient in pain management, such as exercise, behavioral activation, sleep hygiene, and stress management, are relatively easy to implement and do not necessarily require the expertise of mental health professionals. Nonpharmacologic strategies can directly address pain and also address secondary complications, and thus serve to enhance treatment outcomes.
• Conclusion: The critical domains approach can be used to organize a comprehensive nonpharmacologic approach to treating widespread chronic pain.

 According to the Institute of Medicine (IOM), chronic pain affects more Americans than coronary heart disease, diabetes, and cancer combined at an estimated cost of $635 billion per year [1]. While it has been demonstrated that we have reasonably good ability to reduce acute pain, providing pharmacologic treatment with even modest effects when addressing chronic pain remains challenging [1]. The ability to treat one form of pain successfully but not the other stems from the fact that chronic pain is not a simple extension of acute pain [2,3]; rather, the mechanisms differ and so must the treatments. The IOM report called for a cultural transformation in how pain is understood, assessed, and treated. In response, the National Pain Strategy [4] was developed. It was recommended that efficacious self-management strategies be used for individuals with chronic pain; such strategies are largely nonpharmacologic [4].

This article presents an approach to addressing chronic pain using nonpharmacologic strategies. While a number of nonpharmacologic treatments involve patients as passive recipients (eg, massage, acupuncture, balneotherapy or spa treatments), most require the patient to be engaged, eg, to exert physical energy, learn a new skill, and/or change a behavior. The approach presented here is organized around addressing critical domains, including the need to increase activity, deal with psychiatric comorbidities, address sleep problems, and tackle stress. The strategies suggested will be those that have the best evidence base and are predominantly ones that can be deployed by physicians and other health care professionals who do not necessarily have specialized training in behavioral health. A case is presented to illustrate this approach.

Case Presentation

Lisa is a 42-year-old Caucasian woman with a 2-year history of chronic low back pain presenting to a primary care clinic. She reported that the back pain began when she was working as an office manager in a busy dental clinic. The onset was sudden, occurring when she lifted a heavy box of copier paper using a “leaning and twisting motion.” The pain is described as constant (rated as 5 out of 10) and she experiences periods of more intense pain or “flares” (rated as 9 out of 10); Lisa noted that “10 is reserved for childbirth.” The flares seem to coincide with periods of stress and can result in up to 2 days of immobility, causing her to miss work at the dental office.

The pain is described as deep, aching, and throbbing but does not radiate to her legs. It is made worse by sitting still for longer than an hour and gets better if she keeps moving and gets a good night of sleep. Her sleep is generally disturbed as she has trouble falling asleep and when she does sleep, she usually wakes up feeling unrefreshed and extremely irritable. Moreover, while she knows that activity makes her pain better, Lisa can rarely find the energy or motivation to exercise.

Various evaluations by specialists have been obtained and studies conducted, including a recent MRI. All were found to be negative for a clear-cut pathology. A visit to a rheumatologist 5 years ago resulted in a diagnosis of fibromyalgia that Lisa does not accept. Upon probing, she detailed what turns out to be an almost 20-year history of chronic pain. The back pain is only the latest diagnosis in an extensive list of painful conditions including premenstrual syndrome (PMS), headache, temporomandibular joint disorder (TMJ), and fibromyalgia. There are no aspects of her history or presentation that suggest a diagnosis other than chronic musculoskeletal pain.

Lisa is a divorced mother of 2 adolescent children who are generally well-adjusted if not age-appropriately defiant. She is overweight (body mass index = 29) and admits to overeating when under stress. She says that the back pain has disrupted every aspect of her life and work is the only thing that gets adequate attention. Her salary is critical to her family’s financial stability, thus it is a priority. Lisa noted that she saves all of her energy for her job and has “nothing left in the tank” for her children or herself. She notes that, “I have zero joy in my life—I rarely go anywhere fun with my kids anymore, putter in my garden, and forget about going on dates. I can’t remember the last enjoyable thing I did!”

• What are aspects to consider in addressing this patient’s symptoms?

Lisa’s case is likely recognizable—she presents with a long history of pain in multiple areas of her body (eg, low back pain, PMS, headache, TMJ) without clear-cut pathology. She has multiple physical and social problems and limited resources. The diagnosis of fibromyalgia is likely correct. The low back pain is probably another manifestation of a broader “centralized pain” condition [5,6]. The term centralized pain refers to the amplification of pain via changes in the central nervous system [7,8]. This does not mean that peripheral nociceptive input (ie, tissue damage or inflammation) plays no role in the pain; however, it implies that any painful stimulus is experienced with greater intensity than would be expected [5,6]. Further, psychological, behavioral, and social elements tend to be key factors in centralized pain states due in part to the exhausting challenge of living with chronic pain, as well as genetic factors that predispose to both pain and mood disturbances [9].

Due to the often complex nature of chronic pain, successful treatment usually requires addressing multiple areas of concern, including addressing behavioral, cognitive, and affective processes. It is suggested that a plan for nonpharmacologic pain management could be built around 6 domains represented by the acronym ExPRESS [10], namely Exercise, Psychological distress, Regaining function, Emotional well-being, Sleep hygiene, and Stress management. This article provides a review of the literature that focuses on systematic reviews and meta-analyses to summarize a massive literature largely supporting the use of nonpharmacologic strategies such as exercise, cognitive-behavioral therapy, mindfulness-based treatments, behavioral self-management, resilience-based interventions, and education to address the ExPRESS [10] domains using Lisa’s case as an example.

• How effective is exercise for treating chronic pain and how should it be integrated into treatment?

Exercise

Over the last 5 years, a number of meta-analyses have been conducted to evaluate a robust literature regarding exercise interventions for the treatment of chronic pain [11–14]. The evidence is strong that patients with chronic pain benefit from increased physical activity and in many cases the effect size is quite substantial [14]. Meta-analytic data suggest that aerobic exercise results in significantly less pain and disability [13], improved physical fitness [14], less fatigue and better mood [14]. Exercise can be land-based or water-based [14], be conducted at a slight to moderate intensity and/or even involve only a program of walking [12]. Most established guidelines highlight the benefits of including exercise as part of the nonpharmacologic management of patients with chronic pain [15–18].

Data suggest that chronic pain patients should begin exercise training slowly starting at levels below capacity and increase duration and intensity over time until patients are exercising at low to moderate intensity (ie, 50% to 70% of age-adjusted maximum heart rate) for 20 to 30 minutes per session 2 to 3 times per week [19].

Obesity and deconditioning are common and are thought to contribute to pain sensitivity, poor sleep, and depressed mood [20]. Lisa is overweight and inactive. She injured her back and reports generally avoiding any form of exercise. Getting her moving will be imperative as an increase in physical activity could not only help her to lose weight, but could have the added benefits of decreasing her pain and stiffness, helping her sleep better and improving her mood and self-esteem. Yet, she reports not having the time or motivation.

A reasonable approach would be to not prescribe formal exercise at first but rather encourage small and immediate changes in how she already goes about her day. One concrete step would be to encourage her to stand up and stretch every 20 minutes or so while working at her computer. This is something that she cites as directly contributing to her pain. Next, an increase in physical activity such as adding a few steps every day and doing regular activities with more vigor would be a great initial step.

One of the most formidable barriers to getting patients to exercise is the perception that they must go to the gym and begin a formal program in order to achieve any benefit. As an employed single mother with two children Lisa likely lacks the time and resources for a formal exercise program. She could instead, begin a walking program that starts with reasonable goals (eg, 6000 steps per day) and builds at a slow and steady pace (eg, add 100 steps per day). Activity trackers range in price, but a simple pedometer can be found for under $10. By initiating such a walking program, the things she does already such as chores around the house all count as physical activity. She could do these with more energy and mindfulness and incrementally add activity over time.

Once a new habit of increased physical activity has been established, the strategy of branching out into new physical activities (or even more formal exercise) is usually more successful especially if they are enjoyable and feasible (ie, affordable, not too time consuming). The need to engage in more physical activity could be the impetus to encourage Lisa to do more activities with her children—walking to the park, flying a kite, and exploring the science museum are all activities that can provide physical, emotional and social benefits simultaneously.

• What interventions are helpful in addressing psychiatric comorbidity?

Psychological Distress

Comorbidity with mood and anxiety disorders is often observed and complicates treatment in patients with chronic pain states [21–23]. Patients with centralized pain conditions like fibromyalgia tend to have even higher rates of psychiatric comorbidity than those with other pain conditions like arthritis alone [24–26]. While estimates vary widely, we have recently reported that 36.2% of patients evaluated in our tertiary care setting meet case criteria for depression [27]. Such psychiatric comorbidity has been shown to be associated with increased pain, worse functioning, higher costs and increased use of opioids [27–30]. Further, suicidal ideation is common in chronic pain populations, especially those with depression and anxiety, and should be carefully evaluated if suspected [31]. The presence of psychiatric comorbidity takes a toll on the individual and society. One study found that pain patients with comorbid depression utilized twice the resources that other patients without depression utilized [32]. Perhaps the most troubling element is that psychiatric comorbidity is too often not adequately addressed in medical settings [33].

Assessing for depression using a standardized measure like the PHQ-9 [34] or anxiety using the GAD-7 [35] can provide a sense of the severity of the psychiatric symptoms. More severe forms of depression and anxiety may require referral, but more mild depressive and/or anxiety symptoms may be treated by the medical personnel the patient already knows and trusts. Nonpharmacologic strategies that can be used to address depression, anxiety, and even pain in chronic pain populations include cognitive-behavioral therapy, exercise/physical activity, regulating sleep and behavioral activation (ie, getting patients engaged with valued activities, social support).

Perhaps the most effective strategy to address depression, anxiety, and pain in chronic pain populations is cognitive-behavioral therapy (CBT) [36–38]. CBT for pain consists of both cognitive and behavioral therapy interventions. Cognitive therapy proposes that modifying maladaptive thoughts will result in changes in emotions and behavior [39]. Thus, errors in thinking like catastrophizing, overgeneralizing, and minimizing positives are confronted and changed to more realistic and helpful thoughts. This results in less emotional distress and fewer self-defeating behaviors. In cognitive therapy for chronic pain, catastrophic thoughts such as “My pain is terrible and nothing I do helps” are replaced by more adaptive thoughts like “Although my pain is severe, there still are a few things I can do to make it a little better.” Several behavioral techniques are also employed such as behavioral activation (getting patients moving again), activity pacing (not overdoing it on days patients feel good and remaining active on days they feel bad), sleep hygiene (identifying then changing behaviors know to disrupt sleep), and relaxation skills (eg, breathing, imagery, progressive muscle relaxation). Meta-analyses have shown that CBT has empirical support for its effectiveness in treating patients with chronic pain [40,41].

During the visit, Lisa reported a loss of joy in her life and then began crying. Such a report should prompt a more formal exploration of the potential for depression. She would likely benefit from antidepressant medication and behavioral intervention. The physical activity prescribed above will also pertain to treating her depressive symptoms as will strategies to improve her emotional well-being, sleep and stress noted below. Perhaps the most beneficial strategy would be to refer her to CBT for pain and depressive symptoms. CBT for pain would help Lisa acquire the skills required to address many ExPRESS [10] domains including increasing physical activity, improving mood, decreasing stress, and improving sleep.

• What strategy can be recommended to help patients regain function?

Regaining Function

Pain is disruptive. Patients with pain may avoid activity due to fear of re-injury or making the pain worse. Pain may keep them awake at night and lead to daytime fatigue. Pain can be so bad that a patient cannot even do simple tasks, One of the most important goals in successfully managing pain is to move away from trying to cure the pain and instead focus on regaining function—helping the patient do some of the things he/she really wants to do despite the pain. The patient may not be able to all the things he/she used to do, but new ways to do many of these activities can be found. Patients can also identify new rewarding activities to do now that things have changed.

To regain function, an evidence-based strategy comes from behavior therapy and is known as graded activation [42–46]. Here the patient is assigned one very small, manageable and incremental step towards achieving a goal. As these small goals are met, the patient feels motivated to engage in more and larger goals.

Lisa specifically mentioned giving up valued activities in light of her chronic pain. To help her re-engage a graded task assignment approach can be taken. For example, Lisa would be encouraged to first identify an activity she would like to get back to doing again. If she were to say “gardening,” then she is to next identify one small, specific, and easily achievable goal for the short term, such as “garden for 20 minutes at least once in the next week.” Help her identify the roadblocks to completing this small goal and brainstorm solutions such as “My kids have soccer and basketball practices 5 days next week so I will ask my ex-husband take them to practice at least one day next week so I can spend time in my garden.” Lisa will be told to schedule time to garden as if it were an appointment with a doctor.

Another important issue to consider is the tendency for inconsistent levels of activities across days that are predicated on how one feels that particular day. On “good days” often patients inadvertently engage in more activity than personal limitations allow and as a consequence experience several “bad days” of pain and other symptom flare up which can result in lost productivity and worse self-esteem. The goal is to have patients engage in a moderate amount of activity every day and avoid activity “binges” or days with little of no activity. Graded activation is a method of pacing that can improve physical functioning while minimizing the likelihood of pain flare-ups.

• What simple strategies can be used to improve patients’ emotional well-being?

Emotional Well-Being

Psychological distress and emotional well-being occur along a continuum. Eliminating psychological distress only returns one to a state of being without distress. That is not the same as experiencing emotional well-being or happiness. People with chronic pain who also have higher levels of emotional well-being (or happiness) have decreased pain severity, fewer symptoms, better levels of functioning, and greater life satisfaction [47–49].

Recent studies provide preliminary evidence suggesting that resilience-based interventions such as keeping a gratitude journal or scheduling time to engage in pleasant activities boast equivalence or even superiority to CBT for the treatment of mood with effects that persist over time [50,51]. Two recent meta-analyses have shown that resilience-based interventions have been used to treat healthy individuals and a range of clinical conditions with a mean effect size for improving well-being ranging between 0.34 to 0.61 (ie, moderate-large effects [Cohen’s d]) [52,53]. Positive activities interventions are thought to function by increasing positive affect, which in turn, enables creativity, problem-solving, perspective-taking, and other beneficial states [54]. Such states are conducive to better mood [55,56], behavioral activation/increased physical activity [57–60], better sleep [61–63], increased social support [54,64] and physiological changes (eg, improved vagal tone, lower blood pressure, more adaptive immune responses) [57,65–69]. Recent studies have successfully adapted resilience-based interventions and shown them to be effective for individuals with pain [70–72]. Resilience-based interventions may be particularly helpful for chronic pain patients given that depression and sleep disturbances are frequent comorbidities [5,21–26,28,73,74].

Lisa stated, “I have zero joy in my life…” and later burst into tears. It is easy to surmise that her emotional well-being is quite poor. She also noted that she saves all of her energy for her job and has “nothing left in the tank” for her children or herself. This is a common picture for individuals with chronic pain. Valued life activities like spending quality time with loved ones, going to sporting events or doing a hobby are put aside in favor of obligatory (eg, activities of daily living) and committed (eg, work, school) activities. While this strategy might help one survive, it certainly is not conducive to thriving. To help Lisa improve her emotional well-being, there are good data supporting pleasant activity scheduling amongst other strategies. For pleasant activity scheduling Lisa would be directed to set aside time a few days a week (at least an hour) to do things that she enjoys. This time should be placed on her calendar and treated with the same level of commitment as going to work or to an appointment with her physician.

• What nonpharmacologic options are available to help improve patients’ sleep?

Sleep

Lisa indicated that she has trouble falling asleep and then when she does sleep, she usually wakes up feeling unrefreshed and irritable. This is a common complaint amongst individuals with chronic pain who often report difficulty falling asleep, being awakened by pain or discomfort and awakening feeling unrefreshed and unrestored [75]. Sleep, pain and mood form a symptomatic triad such that when one aspect is affected the others are impacted. For example, when Lisa does not sleep well, her pain and mood worsen, as well. Conversely, when her pain is better, she likely sleeps better and wakes up feeling less irritable and experiences less pain.

Behavioral strategies for improving sleep, if used on a regular basis, can help individuals get needed restorative sleep with the additional benefits of improving mood, pain, fatigue, and mental clarity [76]. Some of these behavioral strategies focus on maintaining regular sleep routines (go to bed at the same time every night even on weekends), engaging in sleep conducive behaviors (eg, attempting to sleep only when in feeling sleepy), and avoiding stimulating activities (eg, watching action movies, or consuming nicotine or caffeine). Studies have shown that behavioral strategies targeting sleep appear to have a direct impact on pain symptoms and on functional interference resulting from nonrestorative sleep [77,78].

• What stress reduction strategies can be recommended to the patient?

Stress

Stress management has long been a target of treatment in patients with chronic pain. Progressive muscle relaxation (PRM) [79] and autogenic training have typically served as an important foundation of behavioral intervention for chronic pain [80] although there are no randomized controlled trials for PRM as a stand-alone intervention and two separate trials of autogenic training failed to find superiority for this intervention [81,82]. Despite the lack of direct evidence, clinical experience and the knowledge that both relaxation techniques are commonly part of CBT for chronic pain, their efficacy is generally accepted.

An emerging area of nonpharmacologic treatment is mindfulness-based interventions [83], which can include mindfulness-based stress reduction (MBSR) and Acceptance and Commitment Therapy [84], which can be considered a hybrid between mindfulness meditation and CBT. These interventions are still relatively new and larger, better controlled studies are needed. In MBSR, the patient is directed to focus on one thing such as a sound, a pleasant scene or their own breathing. The practitioner is encouraged to keep thoughts present oriented and analytical concerns are to be gently dismissed in favor of focusing on the sounds, scene, or breath. A recent meta-analysis evaluating 15 studies in clinical populations reported that there were small to medium effect sizes for patients with chronic pain [85]. In another new meta-analysis evaluating only studies in chronic pain the authors reported that sleep quality and pain acceptance were the 2 variables with the largest effect sizes based on the 11 studies they evaluated [83]. Similarly, a meta-analysis that included both MBSR and ACT found that 22 studies of varying quality suggest significant but small effect sizes for pain (ES = 0.37) and depression (ES = 0.32) [86]. They concluded the mindfulness-based treatments were not superior to CBT but could be a viable alternative.

For Lisa and many other chronic pain patients, the symptom flares seem to coincide with periods of stress. These flare ups are not inconsequential and have cost her days of lost productivity and potentially put her employment at risk. Moreover, she has identified stress as a trigger for over-eating which certainly contributes to her weight problems and low self-esteem. MBSR can be learned in a structured class or online--many of the principles can be taught by lay instructors.

Summary

While it is likely that health care professionals will continue to rely on pharmacological therapies in treating chronic pain, it is important to be aware that reliance on medications and procedural interventions alone is unlikely to bring adequate relief to individuals living with chronic pain [1]. Optimal pain management appears to be achieved by using a combination of both pharmacologic and nonpharmacologic approaches. Nonpharmacologic interventions that actively engage the patient in pain management such as exercise, behavioral activation, sleep hygiene and stress management are relatively easy to implement and do not necessarily require the expertise of mental health professionals. The challenge is considering pain in its biopsychosocial contexts and defining an approach that is both comprehensive and feasible. Using the ExPRESS domains to help guide care can provide a road map.

Corresponding author: Afton L. Hassett, PsyD, 24 Frank Lloyd Wright Drive, Lobby M, CPFRC, Ann Arbor, MI 48106, [email protected].

From the Department of Anesthesiology, University of Michigan, Ann Arbor, MI.

Abstract

• Objective: To provide an overview of the critical treatment domains for patients with chronic pain and describe nonpharmacologic strategies by which these domains can be addressed.
• Methods: A literature review was conducted to evaluate the evidence underlying commonly used nonpharmacologic strategies for the treatment of chronic pain, with a focus on interventions that require patient engagement.
• Results: Nonpharmacologic interventions that actively engage the patient in pain management, such as exercise, behavioral activation, sleep hygiene, and stress management, are relatively easy to implement and do not necessarily require the expertise of mental health professionals. Nonpharmacologic strategies can directly address pain and also address secondary complications, and thus serve to enhance treatment outcomes.
• Conclusion: The critical domains approach can be used to organize a comprehensive nonpharmacologic approach to treating widespread chronic pain.

 According to the Institute of Medicine (IOM), chronic pain affects more Americans than coronary heart disease, diabetes, and cancer combined at an estimated cost of $635 billion per year [1]. While it has been demonstrated that we have reasonably good ability to reduce acute pain, providing pharmacologic treatment with even modest effects when addressing chronic pain remains challenging [1]. The ability to treat one form of pain successfully but not the other stems from the fact that chronic pain is not a simple extension of acute pain [2,3]; rather, the mechanisms differ and so must the treatments. The IOM report called for a cultural transformation in how pain is understood, assessed, and treated. In response, the National Pain Strategy [4] was developed. It was recommended that efficacious self-management strategies be used for individuals with chronic pain; such strategies are largely nonpharmacologic [4].

This article presents an approach to addressing chronic pain using nonpharmacologic strategies. While a number of nonpharmacologic treatments involve patients as passive recipients (eg, massage, acupuncture, balneotherapy or spa treatments), most require the patient to be engaged, eg, to exert physical energy, learn a new skill, and/or change a behavior. The approach presented here is organized around addressing critical domains, including the need to increase activity, deal with psychiatric comorbidities, address sleep problems, and tackle stress. The strategies suggested will be those that have the best evidence base and are predominantly ones that can be deployed by physicians and other health care professionals who do not necessarily have specialized training in behavioral health. A case is presented to illustrate this approach.

Case Presentation

Lisa is a 42-year-old Caucasian woman with a 2-year history of chronic low back pain presenting to a primary care clinic. She reported that the back pain began when she was working as an office manager in a busy dental clinic. The onset was sudden, occurring when she lifted a heavy box of copier paper using a “leaning and twisting motion.” The pain is described as constant (rated as 5 out of 10) and she experiences periods of more intense pain or “flares” (rated as 9 out of 10); Lisa noted that “10 is reserved for childbirth.” The flares seem to coincide with periods of stress and can result in up to 2 days of immobility, causing her to miss work at the dental office.

The pain is described as deep, aching, and throbbing but does not radiate to her legs. It is made worse by sitting still for longer than an hour and gets better if she keeps moving and gets a good night of sleep. Her sleep is generally disturbed as she has trouble falling asleep and when she does sleep, she usually wakes up feeling unrefreshed and extremely irritable. Moreover, while she knows that activity makes her pain better, Lisa can rarely find the energy or motivation to exercise.

Various evaluations by specialists have been obtained and studies conducted, including a recent MRI. All were found to be negative for a clear-cut pathology. A visit to a rheumatologist 5 years ago resulted in a diagnosis of fibromyalgia that Lisa does not accept. Upon probing, she detailed what turns out to be an almost 20-year history of chronic pain. The back pain is only the latest diagnosis in an extensive list of painful conditions including premenstrual syndrome (PMS), headache, temporomandibular joint disorder (TMJ), and fibromyalgia. There are no aspects of her history or presentation that suggest a diagnosis other than chronic musculoskeletal pain.

Lisa is a divorced mother of 2 adolescent children who are generally well-adjusted if not age-appropriately defiant. She is overweight (body mass index = 29) and admits to overeating when under stress. She says that the back pain has disrupted every aspect of her life and work is the only thing that gets adequate attention. Her salary is critical to her family’s financial stability, thus it is a priority. Lisa noted that she saves all of her energy for her job and has “nothing left in the tank” for her children or herself. She notes that, “I have zero joy in my life—I rarely go anywhere fun with my kids anymore, putter in my garden, and forget about going on dates. I can’t remember the last enjoyable thing I did!”

• What are aspects to consider in addressing this patient’s symptoms?

Lisa’s case is likely recognizable—she presents with a long history of pain in multiple areas of her body (eg, low back pain, PMS, headache, TMJ) without clear-cut pathology. She has multiple physical and social problems and limited resources. The diagnosis of fibromyalgia is likely correct. The low back pain is probably another manifestation of a broader “centralized pain” condition [5,6]. The term centralized pain refers to the amplification of pain via changes in the central nervous system [7,8]. This does not mean that peripheral nociceptive input (ie, tissue damage or inflammation) plays no role in the pain; however, it implies that any painful stimulus is experienced with greater intensity than would be expected [5,6]. Further, psychological, behavioral, and social elements tend to be key factors in centralized pain states due in part to the exhausting challenge of living with chronic pain, as well as genetic factors that predispose to both pain and mood disturbances [9].

Due to the often complex nature of chronic pain, successful treatment usually requires addressing multiple areas of concern, including addressing behavioral, cognitive, and affective processes. It is suggested that a plan for nonpharmacologic pain management could be built around 6 domains represented by the acronym ExPRESS [10], namely Exercise, Psychological distress, Regaining function, Emotional well-being, Sleep hygiene, and Stress management. This article provides a review of the literature that focuses on systematic reviews and meta-analyses to summarize a massive literature largely supporting the use of nonpharmacologic strategies such as exercise, cognitive-behavioral therapy, mindfulness-based treatments, behavioral self-management, resilience-based interventions, and education to address the ExPRESS [10] domains using Lisa’s case as an example.

• How effective is exercise for treating chronic pain and how should it be integrated into treatment?

Exercise

Over the last 5 years, a number of meta-analyses have been conducted to evaluate a robust literature regarding exercise interventions for the treatment of chronic pain [11–14]. The evidence is strong that patients with chronic pain benefit from increased physical activity and in many cases the effect size is quite substantial [14]. Meta-analytic data suggest that aerobic exercise results in significantly less pain and disability [13], improved physical fitness [14], less fatigue and better mood [14]. Exercise can be land-based or water-based [14], be conducted at a slight to moderate intensity and/or even involve only a program of walking [12]. Most established guidelines highlight the benefits of including exercise as part of the nonpharmacologic management of patients with chronic pain [15–18].

Data suggest that chronic pain patients should begin exercise training slowly starting at levels below capacity and increase duration and intensity over time until patients are exercising at low to moderate intensity (ie, 50% to 70% of age-adjusted maximum heart rate) for 20 to 30 minutes per session 2 to 3 times per week [19].

Obesity and deconditioning are common and are thought to contribute to pain sensitivity, poor sleep, and depressed mood [20]. Lisa is overweight and inactive. She injured her back and reports generally avoiding any form of exercise. Getting her moving will be imperative as an increase in physical activity could not only help her to lose weight, but could have the added benefits of decreasing her pain and stiffness, helping her sleep better and improving her mood and self-esteem. Yet, she reports not having the time or motivation.

A reasonable approach would be to not prescribe formal exercise at first but rather encourage small and immediate changes in how she already goes about her day. One concrete step would be to encourage her to stand up and stretch every 20 minutes or so while working at her computer. This is something that she cites as directly contributing to her pain. Next, an increase in physical activity such as adding a few steps every day and doing regular activities with more vigor would be a great initial step.

One of the most formidable barriers to getting patients to exercise is the perception that they must go to the gym and begin a formal program in order to achieve any benefit. As an employed single mother with two children Lisa likely lacks the time and resources for a formal exercise program. She could instead, begin a walking program that starts with reasonable goals (eg, 6000 steps per day) and builds at a slow and steady pace (eg, add 100 steps per day). Activity trackers range in price, but a simple pedometer can be found for under $10. By initiating such a walking program, the things she does already such as chores around the house all count as physical activity. She could do these with more energy and mindfulness and incrementally add activity over time.

Once a new habit of increased physical activity has been established, the strategy of branching out into new physical activities (or even more formal exercise) is usually more successful especially if they are enjoyable and feasible (ie, affordable, not too time consuming). The need to engage in more physical activity could be the impetus to encourage Lisa to do more activities with her children—walking to the park, flying a kite, and exploring the science museum are all activities that can provide physical, emotional and social benefits simultaneously.

• What interventions are helpful in addressing psychiatric comorbidity?

Psychological Distress

Comorbidity with mood and anxiety disorders is often observed and complicates treatment in patients with chronic pain states [21–23]. Patients with centralized pain conditions like fibromyalgia tend to have even higher rates of psychiatric comorbidity than those with other pain conditions like arthritis alone [24–26]. While estimates vary widely, we have recently reported that 36.2% of patients evaluated in our tertiary care setting meet case criteria for depression [27]. Such psychiatric comorbidity has been shown to be associated with increased pain, worse functioning, higher costs and increased use of opioids [27–30]. Further, suicidal ideation is common in chronic pain populations, especially those with depression and anxiety, and should be carefully evaluated if suspected [31]. The presence of psychiatric comorbidity takes a toll on the individual and society. One study found that pain patients with comorbid depression utilized twice the resources that other patients without depression utilized [32]. Perhaps the most troubling element is that psychiatric comorbidity is too often not adequately addressed in medical settings [33].

Assessing for depression using a standardized measure like the PHQ-9 [34] or anxiety using the GAD-7 [35] can provide a sense of the severity of the psychiatric symptoms. More severe forms of depression and anxiety may require referral, but more mild depressive and/or anxiety symptoms may be treated by the medical personnel the patient already knows and trusts. Nonpharmacologic strategies that can be used to address depression, anxiety, and even pain in chronic pain populations include cognitive-behavioral therapy, exercise/physical activity, regulating sleep and behavioral activation (ie, getting patients engaged with valued activities, social support).

Perhaps the most effective strategy to address depression, anxiety, and pain in chronic pain populations is cognitive-behavioral therapy (CBT) [36–38]. CBT for pain consists of both cognitive and behavioral therapy interventions. Cognitive therapy proposes that modifying maladaptive thoughts will result in changes in emotions and behavior [39]. Thus, errors in thinking like catastrophizing, overgeneralizing, and minimizing positives are confronted and changed to more realistic and helpful thoughts. This results in less emotional distress and fewer self-defeating behaviors. In cognitive therapy for chronic pain, catastrophic thoughts such as “My pain is terrible and nothing I do helps” are replaced by more adaptive thoughts like “Although my pain is severe, there still are a few things I can do to make it a little better.” Several behavioral techniques are also employed such as behavioral activation (getting patients moving again), activity pacing (not overdoing it on days patients feel good and remaining active on days they feel bad), sleep hygiene (identifying then changing behaviors know to disrupt sleep), and relaxation skills (eg, breathing, imagery, progressive muscle relaxation). Meta-analyses have shown that CBT has empirical support for its effectiveness in treating patients with chronic pain [40,41].

During the visit, Lisa reported a loss of joy in her life and then began crying. Such a report should prompt a more formal exploration of the potential for depression. She would likely benefit from antidepressant medication and behavioral intervention. The physical activity prescribed above will also pertain to treating her depressive symptoms as will strategies to improve her emotional well-being, sleep and stress noted below. Perhaps the most beneficial strategy would be to refer her to CBT for pain and depressive symptoms. CBT for pain would help Lisa acquire the skills required to address many ExPRESS [10] domains including increasing physical activity, improving mood, decreasing stress, and improving sleep.

• What strategy can be recommended to help patients regain function?

Regaining Function

Pain is disruptive. Patients with pain may avoid activity due to fear of re-injury or making the pain worse. Pain may keep them awake at night and lead to daytime fatigue. Pain can be so bad that a patient cannot even do simple tasks, One of the most important goals in successfully managing pain is to move away from trying to cure the pain and instead focus on regaining function—helping the patient do some of the things he/she really wants to do despite the pain. The patient may not be able to all the things he/she used to do, but new ways to do many of these activities can be found. Patients can also identify new rewarding activities to do now that things have changed.

To regain function, an evidence-based strategy comes from behavior therapy and is known as graded activation [42–46]. Here the patient is assigned one very small, manageable and incremental step towards achieving a goal. As these small goals are met, the patient feels motivated to engage in more and larger goals.

Lisa specifically mentioned giving up valued activities in light of her chronic pain. To help her re-engage a graded task assignment approach can be taken. For example, Lisa would be encouraged to first identify an activity she would like to get back to doing again. If she were to say “gardening,” then she is to next identify one small, specific, and easily achievable goal for the short term, such as “garden for 20 minutes at least once in the next week.” Help her identify the roadblocks to completing this small goal and brainstorm solutions such as “My kids have soccer and basketball practices 5 days next week so I will ask my ex-husband take them to practice at least one day next week so I can spend time in my garden.” Lisa will be told to schedule time to garden as if it were an appointment with a doctor.

Another important issue to consider is the tendency for inconsistent levels of activities across days that are predicated on how one feels that particular day. On “good days” often patients inadvertently engage in more activity than personal limitations allow and as a consequence experience several “bad days” of pain and other symptom flare up which can result in lost productivity and worse self-esteem. The goal is to have patients engage in a moderate amount of activity every day and avoid activity “binges” or days with little of no activity. Graded activation is a method of pacing that can improve physical functioning while minimizing the likelihood of pain flare-ups.

• What simple strategies can be used to improve patients’ emotional well-being?

Emotional Well-Being

Psychological distress and emotional well-being occur along a continuum. Eliminating psychological distress only returns one to a state of being without distress. That is not the same as experiencing emotional well-being or happiness. People with chronic pain who also have higher levels of emotional well-being (or happiness) have decreased pain severity, fewer symptoms, better levels of functioning, and greater life satisfaction [47–49].

Recent studies provide preliminary evidence suggesting that resilience-based interventions such as keeping a gratitude journal or scheduling time to engage in pleasant activities boast equivalence or even superiority to CBT for the treatment of mood with effects that persist over time [50,51]. Two recent meta-analyses have shown that resilience-based interventions have been used to treat healthy individuals and a range of clinical conditions with a mean effect size for improving well-being ranging between 0.34 to 0.61 (ie, moderate-large effects [Cohen’s d]) [52,53]. Positive activities interventions are thought to function by increasing positive affect, which in turn, enables creativity, problem-solving, perspective-taking, and other beneficial states [54]. Such states are conducive to better mood [55,56], behavioral activation/increased physical activity [57–60], better sleep [61–63], increased social support [54,64] and physiological changes (eg, improved vagal tone, lower blood pressure, more adaptive immune responses) [57,65–69]. Recent studies have successfully adapted resilience-based interventions and shown them to be effective for individuals with pain [70–72]. Resilience-based interventions may be particularly helpful for chronic pain patients given that depression and sleep disturbances are frequent comorbidities [5,21–26,28,73,74].

Lisa stated, “I have zero joy in my life…” and later burst into tears. It is easy to surmise that her emotional well-being is quite poor. She also noted that she saves all of her energy for her job and has “nothing left in the tank” for her children or herself. This is a common picture for individuals with chronic pain. Valued life activities like spending quality time with loved ones, going to sporting events or doing a hobby are put aside in favor of obligatory (eg, activities of daily living) and committed (eg, work, school) activities. While this strategy might help one survive, it certainly is not conducive to thriving. To help Lisa improve her emotional well-being, there are good data supporting pleasant activity scheduling amongst other strategies. For pleasant activity scheduling Lisa would be directed to set aside time a few days a week (at least an hour) to do things that she enjoys. This time should be placed on her calendar and treated with the same level of commitment as going to work or to an appointment with her physician.

• What nonpharmacologic options are available to help improve patients’ sleep?

Sleep

Lisa indicated that she has trouble falling asleep and then when she does sleep, she usually wakes up feeling unrefreshed and irritable. This is a common complaint amongst individuals with chronic pain who often report difficulty falling asleep, being awakened by pain or discomfort and awakening feeling unrefreshed and unrestored [75]. Sleep, pain and mood form a symptomatic triad such that when one aspect is affected the others are impacted. For example, when Lisa does not sleep well, her pain and mood worsen, as well. Conversely, when her pain is better, she likely sleeps better and wakes up feeling less irritable and experiences less pain.

Behavioral strategies for improving sleep, if used on a regular basis, can help individuals get needed restorative sleep with the additional benefits of improving mood, pain, fatigue, and mental clarity [76]. Some of these behavioral strategies focus on maintaining regular sleep routines (go to bed at the same time every night even on weekends), engaging in sleep conducive behaviors (eg, attempting to sleep only when in feeling sleepy), and avoiding stimulating activities (eg, watching action movies, or consuming nicotine or caffeine). Studies have shown that behavioral strategies targeting sleep appear to have a direct impact on pain symptoms and on functional interference resulting from nonrestorative sleep [77,78].

• What stress reduction strategies can be recommended to the patient?

Stress

Stress management has long been a target of treatment in patients with chronic pain. Progressive muscle relaxation (PRM) [79] and autogenic training have typically served as an important foundation of behavioral intervention for chronic pain [80] although there are no randomized controlled trials for PRM as a stand-alone intervention and two separate trials of autogenic training failed to find superiority for this intervention [81,82]. Despite the lack of direct evidence, clinical experience and the knowledge that both relaxation techniques are commonly part of CBT for chronic pain, their efficacy is generally accepted.

An emerging area of nonpharmacologic treatment is mindfulness-based interventions [83], which can include mindfulness-based stress reduction (MBSR) and Acceptance and Commitment Therapy [84], which can be considered a hybrid between mindfulness meditation and CBT. These interventions are still relatively new and larger, better controlled studies are needed. In MBSR, the patient is directed to focus on one thing such as a sound, a pleasant scene or their own breathing. The practitioner is encouraged to keep thoughts present oriented and analytical concerns are to be gently dismissed in favor of focusing on the sounds, scene, or breath. A recent meta-analysis evaluating 15 studies in clinical populations reported that there were small to medium effect sizes for patients with chronic pain [85]. In another new meta-analysis evaluating only studies in chronic pain the authors reported that sleep quality and pain acceptance were the 2 variables with the largest effect sizes based on the 11 studies they evaluated [83]. Similarly, a meta-analysis that included both MBSR and ACT found that 22 studies of varying quality suggest significant but small effect sizes for pain (ES = 0.37) and depression (ES = 0.32) [86]. They concluded the mindfulness-based treatments were not superior to CBT but could be a viable alternative.

For Lisa and many other chronic pain patients, the symptom flares seem to coincide with periods of stress. These flare ups are not inconsequential and have cost her days of lost productivity and potentially put her employment at risk. Moreover, she has identified stress as a trigger for over-eating which certainly contributes to her weight problems and low self-esteem. MBSR can be learned in a structured class or online--many of the principles can be taught by lay instructors.

Summary

While it is likely that health care professionals will continue to rely on pharmacological therapies in treating chronic pain, it is important to be aware that reliance on medications and procedural interventions alone is unlikely to bring adequate relief to individuals living with chronic pain [1]. Optimal pain management appears to be achieved by using a combination of both pharmacologic and nonpharmacologic approaches. Nonpharmacologic interventions that actively engage the patient in pain management such as exercise, behavioral activation, sleep hygiene and stress management are relatively easy to implement and do not necessarily require the expertise of mental health professionals. The challenge is considering pain in its biopsychosocial contexts and defining an approach that is both comprehensive and feasible. Using the ExPRESS domains to help guide care can provide a road map.

Corresponding author: Afton L. Hassett, PsyD, 24 Frank Lloyd Wright Drive, Lobby M, CPFRC, Ann Arbor, MI 48106, [email protected].

From the Department of Anesthesiology, University of Michigan, Ann Arbor, MI.

Abstract

• Objective: To provide an overview of the critical treatment domains for patients with chronic pain and describe nonpharmacologic strategies by which these domains can be addressed.
• Methods: A literature review was conducted to evaluate the evidence underlying commonly used nonpharmacologic strategies for the treatment of chronic pain, with a focus on interventions that require patient engagement.
• Results: Nonpharmacologic interventions that actively engage the patient in pain management, such as exercise, behavioral activation, sleep hygiene, and stress management, are relatively easy to implement and do not necessarily require the expertise of mental health professionals. Nonpharmacologic strategies can directly address pain and also address secondary complications, and thus serve to enhance treatment outcomes.
• Conclusion: The critical domains approach can be used to organize a comprehensive nonpharmacologic approach to treating widespread chronic pain.

 According to the Institute of Medicine (IOM), chronic pain affects more Americans than coronary heart disease, diabetes, and cancer combined at an estimated cost of $635 billion per year [1]. While it has been demonstrated that we have reasonably good ability to reduce acute pain, providing pharmacologic treatment with even modest effects when addressing chronic pain remains challenging [1]. The ability to treat one form of pain successfully but not the other stems from the fact that chronic pain is not a simple extension of acute pain [2,3]; rather, the mechanisms differ and so must the treatments. The IOM report called for a cultural transformation in how pain is understood, assessed, and treated. In response, the National Pain Strategy [4] was developed. It was recommended that efficacious self-management strategies be used for individuals with chronic pain; such strategies are largely nonpharmacologic [4].

This article presents an approach to addressing chronic pain using nonpharmacologic strategies. While a number of nonpharmacologic treatments involve patients as passive recipients (eg, massage, acupuncture, balneotherapy or spa treatments), most require the patient to be engaged, eg, to exert physical energy, learn a new skill, and/or change a behavior. The approach presented here is organized around addressing critical domains, including the need to increase activity, deal with psychiatric comorbidities, address sleep problems, and tackle stress. The strategies suggested will be those that have the best evidence base and are predominantly ones that can be deployed by physicians and other health care professionals who do not necessarily have specialized training in behavioral health. A case is presented to illustrate this approach.

Case Presentation

Lisa is a 42-year-old Caucasian woman with a 2-year history of chronic low back pain presenting to a primary care clinic. She reported that the back pain began when she was working as an office manager in a busy dental clinic. The onset was sudden, occurring when she lifted a heavy box of copier paper using a “leaning and twisting motion.” The pain is described as constant (rated as 5 out of 10) and she experiences periods of more intense pain or “flares” (rated as 9 out of 10); Lisa noted that “10 is reserved for childbirth.” The flares seem to coincide with periods of stress and can result in up to 2 days of immobility, causing her to miss work at the dental office.

The pain is described as deep, aching, and throbbing but does not radiate to her legs. It is made worse by sitting still for longer than an hour and gets better if she keeps moving and gets a good night of sleep. Her sleep is generally disturbed as she has trouble falling asleep and when she does sleep, she usually wakes up feeling unrefreshed and extremely irritable. Moreover, while she knows that activity makes her pain better, Lisa can rarely find the energy or motivation to exercise.

Various evaluations by specialists have been obtained and studies conducted, including a recent MRI. All were found to be negative for a clear-cut pathology. A visit to a rheumatologist 5 years ago resulted in a diagnosis of fibromyalgia that Lisa does not accept. Upon probing, she detailed what turns out to be an almost 20-year history of chronic pain. The back pain is only the latest diagnosis in an extensive list of painful conditions including premenstrual syndrome (PMS), headache, temporomandibular joint disorder (TMJ), and fibromyalgia. There are no aspects of her history or presentation that suggest a diagnosis other than chronic musculoskeletal pain.

Lisa is a divorced mother of 2 adolescent children who are generally well-adjusted if not age-appropriately defiant. She is overweight (body mass index = 29) and admits to overeating when under stress. She says that the back pain has disrupted every aspect of her life and work is the only thing that gets adequate attention. Her salary is critical to her family’s financial stability, thus it is a priority. Lisa noted that she saves all of her energy for her job and has “nothing left in the tank” for her children or herself. She notes that, “I have zero joy in my life—I rarely go anywhere fun with my kids anymore, putter in my garden, and forget about going on dates. I can’t remember the last enjoyable thing I did!”

• What are aspects to consider in addressing this patient’s symptoms?

Lisa’s case is likely recognizable—she presents with a long history of pain in multiple areas of her body (eg, low back pain, PMS, headache, TMJ) without clear-cut pathology. She has multiple physical and social problems and limited resources. The diagnosis of fibromyalgia is likely correct. The low back pain is probably another manifestation of a broader “centralized pain” condition [5,6]. The term centralized pain refers to the amplification of pain via changes in the central nervous system [7,8]. This does not mean that peripheral nociceptive input (ie, tissue damage or inflammation) plays no role in the pain; however, it implies that any painful stimulus is experienced with greater intensity than would be expected [5,6]. Further, psychological, behavioral, and social elements tend to be key factors in centralized pain states due in part to the exhausting challenge of living with chronic pain, as well as genetic factors that predispose to both pain and mood disturbances [9].

Due to the often complex nature of chronic pain, successful treatment usually requires addressing multiple areas of concern, including addressing behavioral, cognitive, and affective processes. It is suggested that a plan for nonpharmacologic pain management could be built around 6 domains represented by the acronym ExPRESS [10], namely Exercise, Psychological distress, Regaining function, Emotional well-being, Sleep hygiene, and Stress management. This article provides a review of the literature that focuses on systematic reviews and meta-analyses to summarize a massive literature largely supporting the use of nonpharmacologic strategies such as exercise, cognitive-behavioral therapy, mindfulness-based treatments, behavioral self-management, resilience-based interventions, and education to address the ExPRESS [10] domains using Lisa’s case as an example.

• How effective is exercise for treating chronic pain and how should it be integrated into treatment?

Exercise

Over the last 5 years, a number of meta-analyses have been conducted to evaluate a robust literature regarding exercise interventions for the treatment of chronic pain [11–14]. The evidence is strong that patients with chronic pain benefit from increased physical activity and in many cases the effect size is quite substantial [14]. Meta-analytic data suggest that aerobic exercise results in significantly less pain and disability [13], improved physical fitness [14], less fatigue and better mood [14]. Exercise can be land-based or water-based [14], be conducted at a slight to moderate intensity and/or even involve only a program of walking [12]. Most established guidelines highlight the benefits of including exercise as part of the nonpharmacologic management of patients with chronic pain [15–18].

Data suggest that chronic pain patients should begin exercise training slowly starting at levels below capacity and increase duration and intensity over time until patients are exercising at low to moderate intensity (ie, 50% to 70% of age-adjusted maximum heart rate) for 20 to 30 minutes per session 2 to 3 times per week [19].

Obesity and deconditioning are common and are thought to contribute to pain sensitivity, poor sleep, and depressed mood [20]. Lisa is overweight and inactive. She injured her back and reports generally avoiding any form of exercise. Getting her moving will be imperative as an increase in physical activity could not only help her to lose weight, but could have the added benefits of decreasing her pain and stiffness, helping her sleep better and improving her mood and self-esteem. Yet, she reports not having the time or motivation.

A reasonable approach would be to not prescribe formal exercise at first but rather encourage small and immediate changes in how she already goes about her day. One concrete step would be to encourage her to stand up and stretch every 20 minutes or so while working at her computer. This is something that she cites as directly contributing to her pain. Next, an increase in physical activity such as adding a few steps every day and doing regular activities with more vigor would be a great initial step.

One of the most formidable barriers to getting patients to exercise is the perception that they must go to the gym and begin a formal program in order to achieve any benefit. As an employed single mother with two children Lisa likely lacks the time and resources for a formal exercise program. She could instead, begin a walking program that starts with reasonable goals (eg, 6000 steps per day) and builds at a slow and steady pace (eg, add 100 steps per day). Activity trackers range in price, but a simple pedometer can be found for under $10. By initiating such a walking program, the things she does already such as chores around the house all count as physical activity. She could do these with more energy and mindfulness and incrementally add activity over time.

Once a new habit of increased physical activity has been established, the strategy of branching out into new physical activities (or even more formal exercise) is usually more successful especially if they are enjoyable and feasible (ie, affordable, not too time consuming). The need to engage in more physical activity could be the impetus to encourage Lisa to do more activities with her children—walking to the park, flying a kite, and exploring the science museum are all activities that can provide physical, emotional and social benefits simultaneously.

• What interventions are helpful in addressing psychiatric comorbidity?

Psychological Distress

Comorbidity with mood and anxiety disorders is often observed and complicates treatment in patients with chronic pain states [21–23]. Patients with centralized pain conditions like fibromyalgia tend to have even higher rates of psychiatric comorbidity than those with other pain conditions like arthritis alone [24–26]. While estimates vary widely, we have recently reported that 36.2% of patients evaluated in our tertiary care setting meet case criteria for depression [27]. Such psychiatric comorbidity has been shown to be associated with increased pain, worse functioning, higher costs and increased use of opioids [27–30]. Further, suicidal ideation is common in chronic pain populations, especially those with depression and anxiety, and should be carefully evaluated if suspected [31]. The presence of psychiatric comorbidity takes a toll on the individual and society. One study found that pain patients with comorbid depression utilized twice the resources that other patients without depression utilized [32]. Perhaps the most troubling element is that psychiatric comorbidity is too often not adequately addressed in medical settings [33].

Assessing for depression using a standardized measure like the PHQ-9 [34] or anxiety using the GAD-7 [35] can provide a sense of the severity of the psychiatric symptoms. More severe forms of depression and anxiety may require referral, but more mild depressive and/or anxiety symptoms may be treated by the medical personnel the patient already knows and trusts. Nonpharmacologic strategies that can be used to address depression, anxiety, and even pain in chronic pain populations include cognitive-behavioral therapy, exercise/physical activity, regulating sleep and behavioral activation (ie, getting patients engaged with valued activities, social support).

Perhaps the most effective strategy to address depression, anxiety, and pain in chronic pain populations is cognitive-behavioral therapy (CBT) [36–38]. CBT for pain consists of both cognitive and behavioral therapy interventions. Cognitive therapy proposes that modifying maladaptive thoughts will result in changes in emotions and behavior [39]. Thus, errors in thinking like catastrophizing, overgeneralizing, and minimizing positives are confronted and changed to more realistic and helpful thoughts. This results in less emotional distress and fewer self-defeating behaviors. In cognitive therapy for chronic pain, catastrophic thoughts such as “My pain is terrible and nothing I do helps” are replaced by more adaptive thoughts like “Although my pain is severe, there still are a few things I can do to make it a little better.” Several behavioral techniques are also employed such as behavioral activation (getting patients moving again), activity pacing (not overdoing it on days patients feel good and remaining active on days they feel bad), sleep hygiene (identifying then changing behaviors know to disrupt sleep), and relaxation skills (eg, breathing, imagery, progressive muscle relaxation). Meta-analyses have shown that CBT has empirical support for its effectiveness in treating patients with chronic pain [40,41].

During the visit, Lisa reported a loss of joy in her life and then began crying. Such a report should prompt a more formal exploration of the potential for depression. She would likely benefit from antidepressant medication and behavioral intervention. The physical activity prescribed above will also pertain to treating her depressive symptoms as will strategies to improve her emotional well-being, sleep and stress noted below. Perhaps the most beneficial strategy would be to refer her to CBT for pain and depressive symptoms. CBT for pain would help Lisa acquire the skills required to address many ExPRESS [10] domains including increasing physical activity, improving mood, decreasing stress, and improving sleep.

• What strategy can be recommended to help patients regain function?

Regaining Function

Pain is disruptive. Patients with pain may avoid activity due to fear of re-injury or making the pain worse. Pain may keep them awake at night and lead to daytime fatigue. Pain can be so bad that a patient cannot even do simple tasks, One of the most important goals in successfully managing pain is to move away from trying to cure the pain and instead focus on regaining function—helping the patient do some of the things he/she really wants to do despite the pain. The patient may not be able to all the things he/she used to do, but new ways to do many of these activities can be found. Patients can also identify new rewarding activities to do now that things have changed.

To regain function, an evidence-based strategy comes from behavior therapy and is known as graded activation [42–46]. Here the patient is assigned one very small, manageable and incremental step towards achieving a goal. As these small goals are met, the patient feels motivated to engage in more and larger goals.

Lisa specifically mentioned giving up valued activities in light of her chronic pain. To help her re-engage a graded task assignment approach can be taken. For example, Lisa would be encouraged to first identify an activity she would like to get back to doing again. If she were to say “gardening,” then she is to next identify one small, specific, and easily achievable goal for the short term, such as “garden for 20 minutes at least once in the next week.” Help her identify the roadblocks to completing this small goal and brainstorm solutions such as “My kids have soccer and basketball practices 5 days next week so I will ask my ex-husband take them to practice at least one day next week so I can spend time in my garden.” Lisa will be told to schedule time to garden as if it were an appointment with a doctor.

Another important issue to consider is the tendency for inconsistent levels of activities across days that are predicated on how one feels that particular day. On “good days” often patients inadvertently engage in more activity than personal limitations allow and as a consequence experience several “bad days” of pain and other symptom flare up which can result in lost productivity and worse self-esteem. The goal is to have patients engage in a moderate amount of activity every day and avoid activity “binges” or days with little of no activity. Graded activation is a method of pacing that can improve physical functioning while minimizing the likelihood of pain flare-ups.

• What simple strategies can be used to improve patients’ emotional well-being?

Emotional Well-Being

Psychological distress and emotional well-being occur along a continuum. Eliminating psychological distress only returns one to a state of being without distress. That is not the same as experiencing emotional well-being or happiness. People with chronic pain who also have higher levels of emotional well-being (or happiness) have decreased pain severity, fewer symptoms, better levels of functioning, and greater life satisfaction [47–49].

Recent studies provide preliminary evidence suggesting that resilience-based interventions such as keeping a gratitude journal or scheduling time to engage in pleasant activities boast equivalence or even superiority to CBT for the treatment of mood with effects that persist over time [50,51]. Two recent meta-analyses have shown that resilience-based interventions have been used to treat healthy individuals and a range of clinical conditions with a mean effect size for improving well-being ranging between 0.34 to 0.61 (ie, moderate-large effects [Cohen’s d]) [52,53]. Positive activities interventions are thought to function by increasing positive affect, which in turn, enables creativity, problem-solving, perspective-taking, and other beneficial states [54]. Such states are conducive to better mood [55,56], behavioral activation/increased physical activity [57–60], better sleep [61–63], increased social support [54,64] and physiological changes (eg, improved vagal tone, lower blood pressure, more adaptive immune responses) [57,65–69]. Recent studies have successfully adapted resilience-based interventions and shown them to be effective for individuals with pain [70–72]. Resilience-based interventions may be particularly helpful for chronic pain patients given that depression and sleep disturbances are frequent comorbidities [5,21–26,28,73,74].

Lisa stated, “I have zero joy in my life…” and later burst into tears. It is easy to surmise that her emotional well-being is quite poor. She also noted that she saves all of her energy for her job and has “nothing left in the tank” for her children or herself. This is a common picture for individuals with chronic pain. Valued life activities like spending quality time with loved ones, going to sporting events or doing a hobby are put aside in favor of obligatory (eg, activities of daily living) and committed (eg, work, school) activities. While this strategy might help one survive, it certainly is not conducive to thriving. To help Lisa improve her emotional well-being, there are good data supporting pleasant activity scheduling amongst other strategies. For pleasant activity scheduling Lisa would be directed to set aside time a few days a week (at least an hour) to do things that she enjoys. This time should be placed on her calendar and treated with the same level of commitment as going to work or to an appointment with her physician.

• What nonpharmacologic options are available to help improve patients’ sleep?

Sleep

Lisa indicated that she has trouble falling asleep and then when she does sleep, she usually wakes up feeling unrefreshed and irritable. This is a common complaint amongst individuals with chronic pain who often report difficulty falling asleep, being awakened by pain or discomfort and awakening feeling unrefreshed and unrestored [75]. Sleep, pain and mood form a symptomatic triad such that when one aspect is affected the others are impacted. For example, when Lisa does not sleep well, her pain and mood worsen, as well. Conversely, when her pain is better, she likely sleeps better and wakes up feeling less irritable and experiences less pain.

Behavioral strategies for improving sleep, if used on a regular basis, can help individuals get needed restorative sleep with the additional benefits of improving mood, pain, fatigue, and mental clarity [76]. Some of these behavioral strategies focus on maintaining regular sleep routines (go to bed at the same time every night even on weekends), engaging in sleep conducive behaviors (eg, attempting to sleep only when in feeling sleepy), and avoiding stimulating activities (eg, watching action movies, or consuming nicotine or caffeine). Studies have shown that behavioral strategies targeting sleep appear to have a direct impact on pain symptoms and on functional interference resulting from nonrestorative sleep [77,78].

• What stress reduction strategies can be recommended to the patient?

Stress

Stress management has long been a target of treatment in patients with chronic pain. Progressive muscle relaxation (PRM) [79] and autogenic training have typically served as an important foundation of behavioral intervention for chronic pain [80] although there are no randomized controlled trials for PRM as a stand-alone intervention and two separate trials of autogenic training failed to find superiority for this intervention [81,82]. Despite the lack of direct evidence, clinical experience and the knowledge that both relaxation techniques are commonly part of CBT for chronic pain, their efficacy is generally accepted.

An emerging area of nonpharmacologic treatment is mindfulness-based interventions [83], which can include mindfulness-based stress reduction (MBSR) and Acceptance and Commitment Therapy [84], which can be considered a hybrid between mindfulness meditation and CBT. These interventions are still relatively new and larger, better controlled studies are needed. In MBSR, the patient is directed to focus on one thing such as a sound, a pleasant scene or their own breathing. The practitioner is encouraged to keep thoughts present oriented and analytical concerns are to be gently dismissed in favor of focusing on the sounds, scene, or breath. A recent meta-analysis evaluating 15 studies in clinical populations reported that there were small to medium effect sizes for patients with chronic pain [85]. In another new meta-analysis evaluating only studies in chronic pain the authors reported that sleep quality and pain acceptance were the 2 variables with the largest effect sizes based on the 11 studies they evaluated [83]. Similarly, a meta-analysis that included both MBSR and ACT found that 22 studies of varying quality suggest significant but small effect sizes for pain (ES = 0.37) and depression (ES = 0.32) [86]. They concluded the mindfulness-based treatments were not superior to CBT but could be a viable alternative.

For Lisa and many other chronic pain patients, the symptom flares seem to coincide with periods of stress. These flare ups are not inconsequential and have cost her days of lost productivity and potentially put her employment at risk. Moreover, she has identified stress as a trigger for over-eating which certainly contributes to her weight problems and low self-esteem. MBSR can be learned in a structured class or online--many of the principles can be taught by lay instructors.

Summary

While it is likely that health care professionals will continue to rely on pharmacological therapies in treating chronic pain, it is important to be aware that reliance on medications and procedural interventions alone is unlikely to bring adequate relief to individuals living with chronic pain [1]. Optimal pain management appears to be achieved by using a combination of both pharmacologic and nonpharmacologic approaches. Nonpharmacologic interventions that actively engage the patient in pain management such as exercise, behavioral activation, sleep hygiene and stress management are relatively easy to implement and do not necessarily require the expertise of mental health professionals. The challenge is considering pain in its biopsychosocial contexts and defining an approach that is both comprehensive and feasible. Using the ExPRESS domains to help guide care can provide a road map.

Corresponding author: Afton L. Hassett, PsyD, 24 Frank Lloyd Wright Drive, Lobby M, CPFRC, Ann Arbor, MI 48106, [email protected].

From the Massachusetts General Hospital for Children, Boston, MA (Walters, Drehmer, Nabi-Burza, Winickoff), the University of Rochester School of Medicine, Rochester, NY (Ossip), and the American Academy of Pediatrics Julius B. Richmond Center of Excellence, Elk Grove Village, IL (Whitmore, Gorzkowski). ^†Deceased 31 December 2015.

Abstract

• Background: Family tobacco use and exposure are significant threats to the health of children and their families. However, few pediatric clinicians address family tobacco use and exposure in a routine and effective manner. The Clinical Effort Against Secondhand Smoke Exposure (CEASE) intervention was developed to tackle this gap between clinical need and clinical practice.
• Objective: To review the main considerations and questions that clinicians and office staff expressed during telephone training to participate in CEASE.
• Methods: This study was conducted in pediatric practices in 5 US states. Practices were recruited by the American Academy of Pediatrics (10 intervention, 10 control). Ten training calls were recorded and transcribed. The data was then coded inductively based on themes found in the transcripts.
• Results: The data revealed that clinicians and staff were concerned about prescribing, dosing, and insurance coverage of nicotine replacement therapy; motivation for and methods to help families become tobacco-free; and the impact of the intervention on practice operations.
• Conclusion: While the majority of clinicians and office staff were interested and enthusiastic about helping families become tobacco-free, they expressed concerns that could threaten implementation of family tobacco control strategies.

The devastating health consequences of smoking and exposure to tobacco smoke have been well demonstrated. As declared in the 2006 Surgeon General’s Report, there is no safe level of exposure to tobacco [1]. Children are especially at risk for exposure to toxins and toxicants in tobacco smoke [1,2]. Exposure to tobacco smoke is associated with higher levels of asthma, increased risk of sudden infant death syndrome, increased rates of upper respiratory infections, and behavioral issues [3–5]. Recent research shows that over 70% of children in the United States have some level of exposure to tobacco smoke [6]; parents and other family members are commonly the cause of this exposure, especially in young children. Children and parents benefit when parents stop smoking; parent life expectancy increases by an average of 7 years [7], the risk of tobacco-related poor pregnancy outcomes is reduced, and future children are spared from exposure to tobacco smoke [8].

There is a growing movement to address tobacco use and exposure in the pediatric office setting; the 2015 American Academy of Pediatrics tobacco policy statement Clinical Practice Policy to Protect Children From Tobacco, Nicotine, and Tobacco Smoke recommends that pediatricians ask about children’s exposure to tobacco and address parental tobacco use by implementing office-wide systems to deliver advice, counseling, referral to cessation resources, and smoking cessation medication to smokers [9].

Despite significant risks of tobacco smoke exposure to children, we found in a previous paper that only 3.5% of parents in control practices received any tobacco control assistance [10]. Through a systematic and ongoing line of research, the Clinical Effort Against Secondhand Smoke Exposure (CEASE) intervention was developed to tackle this gap between clinical need and clinical practice. The CEASE intervention has been successfully shown to train and equip pediatric officesfrom a distance to address family tobacco use within existing office systems [10–14]. An enhanced CEASE intervention is undergoing testing in pediatric practices in 5 US states.

One of the more innovative aspects of CEASE has been the use of training calls. In studies of CEASE, the peer-to-peer call was conducted by the principal investigator with the project leader at the practice using a train-the-trainer model. After the project leader was trained through the peer-to-peer call, the project leader then led the whole office training call, with the support of CEASE staff by phone. The training calls worked in conjunction with the other aspects of the training, as shown in the Table. The training calls for the practices provided a valuable research opportunity. We examined the concerns and issues that clinicians and office staff had about implementing an office-wide tobacco control program through a qualitative analysis of the call transcripts. This paper outlines the main considerations and questions that clinicians and office staff expressed during the training calls. Understanding the points of view of clinicians and staff will help researchers and clinical educators strengthen the design of tobacco control interventions.

Methods

Study Aims

The data for this paper were collected as part of a larger mixed-methods controlled trial. The overarching aims of the trial were to study implementation and sustainability of tobacco-control services delivered at the clinic level, to facilitate behavior change among parents and evaluate cost-per-quit among parents who smoke, and to study systems changes and the processes that affect them at the practice level. The study was conducted in 5 intervention and 5 control pediatric primary care practices in 5 states; this paper reports on data collected in intervention practices and focuses on understanding the systems changes and processes that are instituted when implementing a tobacco control program at the clinician and practice level.

Practice Recruitment and Eligibility

Practices were recruited through the American Academy of Pediatrics using direct emails, newsletter/listserv articles, phone calls to members, and in-person recruitment at national meetings. Eligible practices were located in a non–hospital-based setting, had an average patient flow of at least 50 patients per day, used an electronic medical record (EMR) system, and were matched in each state based on practice size and smoking rate. Interested practices also had to be willing to host a research assistant to collect exit interview data from parents. Practices were excluded if they took part in previous CEASE studies or were actively enrolling participants into other tobacco control research studies. Based on these criteria, 18 eligible practices from Indiana, North Carolina, Ohio, Tennessee, Michigan, and Virginia agreed to participate in the study. Of the 6 states, one state was chosen as a replacement state. Five practices from the remaining states were assigned to the intervention group, 5 to the control group, and 5 were assigned to the replacement group in case an intervention or control practice in their state withdrew from the study. Each intervention practice participated in a peer-to-peer training call and a whole office training call. Data analyzed in this paper was collected from all 10 intervention practice training calls.

Training Calls Data Collection

The peer-to-peer and whole office training calls were recorded and transcribed. Permission to record the calls was requested by the trainer (the principal investigator of the study) and given verbally by each person being trained. The training call recordings were then transcribed verbatim by a commercial service; the transcriptions were spot-checked for accuracy.

The transcripts were first read closely by the first author (BHW), then coded inductively into relevant themes that emerged from the calls. The inductive coding was guided by the questions and concerns that the clinicians raised during the training, as well as the ways in which the trainer addressed these concerns and tailored the training to the needs and interests of the pediatric clinicians [26]. The coding was reviewed and confirmed by the other study team members.

After the data were coded into themes, the coded data were analyzed by the first author using qualitative description. Qualitative description is a method of analyzing coded qualitative data by looking at the words and meanings expressed by respondents [27]. Through this method of analysis, we were able to understand what concerns the clinicians and staff voiced about aspects of the CEASE intervention.

Ethics

The study was approved institutional review boards at Massachusetts General Hospital, the AAP, and the health care practices that required local IRB approval. The quotes used in this paper have been anonymized and cleaned to remove any identifying information, such as location and names.

Peer-to-Peer Training Calls

The peer-to-peer training calls were conducted after training and study materials arrived. The project leader (a pediatrician in the practice who was interested in spearheading the CEASE intervention) was asked to watch the training video. Using an evidence-based, previously developed call script [28], the principal investigator trained the project leader in key aspects of addressing family tobacco use and exposure, such as using an electronic tablet screener survey to identify family members who smoke, exploring techniques for prescribing or recommending NRT, and identifying ways to connect family members to free tobacco cessation counseling and support services. On occasion, other staff from the pediatric office (eg, a nurse or office manager) joined the call.

The principal investigator presented information, clarified points in the video, explained the materials, and asked questions and elicited relevant experiences from the project leader. In addition to teaching the project leader about the tobacco control strategies used in CEASE, the peer-to-peer calls prepared the project leader to train the rest of their own practice clinicians and staff in the CEASE intervention.

Whole Office Training Calls

Each practice’s local project leader led the whole office training calls, but CEASE study staff were on the call to introduce themselves to office staff, answer any questions that staff may have raised that the project leader could not answer, give information about data collection, and to generally support the implementation of the CEASE intervention and research program. During this call, the project leader watched the video with the group and tailored the training for his or her practice, focusing on issues of relevance for patients and staff.

Training Calls as Research Data

As many practices struggle with research burden [29], finding innovative and unobtrusive methods of collecting data is especially useful for research teams and participating practices. During both calls, clinicians and staff were asked open-ended questions to learn about their concerns regarding intervention implementation, share their own experiences with tobacco and tobacco control, and explore practice-specific methods to address family smoking. CEASE staff used this opportunity to help practices tailor the intervention to the local setting, such as by offering quitline enrollment sheets in another language. Clinician and staff answers to open-ended questions provided qualitative data for this manuscript.

Results and Discussion

The research team used training call data to explore clinician and staff concerns and desires related to family-centered tobacco control. The most common themes were: (1) prescribing, dosing, and insurance coverage of NRT, (2) motivation for and methods to help families become tobacco-free, and (3) the impact of the CEASE intervention on the day-to-day operations of the practice.

Nicotine Replacement Therapy

Prescribing or recommending NRT is one of the best ways to help families become tobacco-free and is a crucial component of the CEASE intervention [30–32]. Through the telephone trainings, clinicians and staff were trained to prescribe NRT using pre-printed prescription sheets, presented information about the effectiveness of NRT for smoking cessation, and referred to an information sheet on NRT to answer other questions as needed.

During the calls, it became clear that the pediatric clinicians were interested in prescribing NRT to help smokers quit, but lacked the skills and knowledge to do so:

I’m writing all this down [about NRT], because I don’t know any of this. (IN peer-to-peer)

Is 4 mg the strongest the gum comes in? (NC whole office)

This lack of knowledge may be a barrier to prescribing NRT in the pediatric setting. A national survey revealed that while smoking parents would accept prescriptions for NRT from their child’s doctor, very few received a prescription [33]. The calls provided an opportunity to have clinicians’ questions about NRT be answered by a pediatric tobacco control expert.

Clinicians were interested in helping parents stop smoking with medication, but were worried about access to medication; one of the most common questions voiced was not about how or why to prescribe NRT but how to help low-income parents get NRT for free or low-cost.

Some people—they don’t have insurance, so, how much it costs, they need to know that. (TN peer-to-peer)

I just know I’ve got a bunch ... Obamacare doesn’t work down here, so—I’ve still got families who don’t have any insurance, and you’re like, “Oh, I was hoping you could get something,” and they’re like, “Well, we can’t.” I have a fair number of kids who—are on some type of insurance, but the parents don’t have any coverage for NRT. (VA peer-to-peer)

While NRT is covered under the Affordable Care Act, many states have not expanded their Medicaid coverage [34]; this leaves many low-income families without access to health insurance or to free or low-cost NRT. While NRT remains one of the best and most common smoking cessation tools [35] there was no way to reassure practices that parents would be able to obtain the prescribed NRT without guaranteed coverage. In a previous study, the cost of NRT was seen by smokers as a barrier to using NRT to quit smoking [32]. Clinicians’ concerns about the cost of NRT reveal an understanding of the needs and issues relevant to their patient population.

Motivation for and Methods to Help Families Become Tobacco-Free

Clinicians and office staff were motivated to help families become tobacco-free and were interested in various ways to do so. The motivation and interest were personal, clinical, and organizational, relating to the ways in which care in the pediatric office could be altered to address tobacco in a more systematic way.

Motivation

The interest in smoking cessation stems from the desire to protect children from the harmful effects tobacco smoke and to prevent children themselves from taking up smoking:

We’d always talked about the smoking, and the parents finally quit. Probably not like I helped them—I just had been harping on them—but by that point the boy was smoking. When he was little he was like, “Oh, that’s nasty. I can’t believe my parents smoke.” Then by the time he was 14-15 and the parents actually did manage to quit, he was smoking, and I was like, “Ugh, really?” (VA peer-to-peer)

I totally understand the dire need for this project, in both the tobacco in the households, as well as the teenagers smoking. I heard one stat[istic], that one of our high schools had 80% of children using tobacco products… And that’s on my watch… I understand and I share the same passion that you do, for personal reasons, as well as reasons to help the whole community. (NC peer-to-peer)

Pediatricians saw themselves as responsible for protecting children’s health through reducing their tobacco smoke exposure, for working to prevent teen smoking, and for the overall health of their communities. Helping prevent childhood exposure to tobacco smoke and teen smoking initiation are crucial tasks for pediatricians; the 2015 AAP tobacco policy statement strongly recommends that pediatric offices include tobacco use prevention messages when talking to children and teens to help prevent smoking initiation, as well as helping families establish smoking bans for homes and cars [36]. By participating in the CEASE telephone trainings, clinicians and office staff were learning skills and tools to help them act on their motivation to protect families from the harms of tobacco.

Strategies

Pediatricians and office staff were interested in learning specific strategies and tools to help parents stop smoking. Practices wanted to know how and when to set a quit date with families, how to use services to help families become smoke-free, and how to tailor assistance to specific populations.

Yeah, we’re wondering about other languages, because we do have a large Hispanic patient population and a sizable group of folks that come from Saudi Arabia, and I know that some of them do smoke. (TN peer-to-peer)

Set[ting] a quit date for the patient —so how long we want to set the date? 6 months, 3 months, 1 year, 2 years, what? (TN peer-to-peer)

If you have a mom who lives with grandma and grandpa, the mom may not smoke but grandma and grandpa smoke, but they still live in that home… But anyone who comes in, we’re going to help. Does that sound right? (VA peer-to-peer)

By participating in the study, the clinicians and office staff were actively seeking to improve their knowledge of tobacco-related issues; past research has shown that pediatric residents saw lack of training in tobacco control as a key reason for inconsistent tobacco control outreach and intervention [37]. The training calls were an opportunity to gain information more specifically related to the pediatric practice’s population and office setting, building upon the other CEASE training materials. The training calls were also a chance for the CEASE research team to adapt strategies and tools to the practices, for example by providing materials that met the practices’ needs.

Impact of Intervention on Day-To-Day Operations

The training calls revealed that integrating CEASE into office workflows was a major concern. Integrating preventive services into routine office practice is a frequent concern of primary care providers [38–41]. These concerns about office flow reflect worries about financing [42] and benchmarking [43–45].

I think they’re going to have some of the same questions [that I initially had] in terms of how this might work with workflow. But as we’ve talked through all of this, I think we can make it work, and make it just sort of incorporated as part of our everyday questions that we ask. And it shouldn’t really slow things down. And I think that’ll be the main thing the providers would be focusing on is, how’s this going to impact me and all the other things I have to do in the course of a visit? This [phone call] answers a lot of questions I had in terms of that. (IN peer-to-peer)

As wait time was a performance measure for many of the practices, the clinicians and staff were hesitant to add any activities to check-in that might increase wait time.

I know, so especially, we’re trying to do a care team right now... don’t want them to spend too much time in the waiting room. (OH whole office)

During the calls, clinicians and office staff were asked to reflect on their practices and discuss ways that their practice would implement the CEASE intervention. This moment of reflection is a benefit of research participation, as it allows practices to improve the care they provide [46]. The calls allowed for on-the-spot tailoring of the intervention to meet the specific needs of the practice, an opportunity for the research staff and practice to work together to make the intervention fit their particular office situation and flow. Data collected from the training calls were also reviewed during the CEASE implementation process to support practices with specific concerns.

Strengths and Limitations

As these data were collected during training calls and subject to social desirability bias, the concerns raised may not be an exhaustive list of all concerns that clinicians and office staff had. However, the concerns that were raised by clinicians became a natural and essential part of the training process. As the practices’ initial concerns were identified early in the study, it was possible to address these concerns throughout the early implementation phases of CEASE. Transcribing calls and analyzing training call data as quickly as possible during the training phases of an intervention could prove beneficial for strengthening the implementation.

Dedicating the extra time and effort to record the training calls as a source of data formalized and strengthened the implementation process. By recording training calls, the study team was able to document the practices’ concerns and share them among the research team, including those who were not on training calls. This effort was a significant source of quality improvement data for the research team and helped ensure that we were responsive to the articulated needs of clinicians and practices.

Conclusion

The training call data revealed both the concerns as well as the interests of child health care clinicians in regard to addressing family tobacco use. While the majority of clinicians and office staff were interested and enthusiastic about helping families become tobacco free, they expressed concerns that could threaten full implementation of family tobacco control strategies. These concerns and interests related to the coverage and affordability of NRT, integrating tobacco control strategies into the practice flow, and learning strategies to address family-wide tobacco use, such as helping grandparents quit smoking or addressing tobacco use with those who were not native English speakers. The concerns and interests of clinicians and office staff revealed that they were genuinely interested in learning ways to tailor strategies to address tobacco use for their practices and patient populations. By recording the training calls, the study team was better able to help them tailor the intervention to their practice, both during the calls and during subsequent implementation by providing new materials and additional information on subjects of concern to the practice. Carefully documenting training calls with health care practices are an ideal opportunity to collect information on issues that may impact full implementation of future interventions.

Corresponding author: Jonathan P. Winickoff, [email protected]

From the Massachusetts General Hospital for Children, Boston, MA (Walters, Drehmer, Nabi-Burza, Winickoff), the University of Rochester School of Medicine, Rochester, NY (Ossip), and the American Academy of Pediatrics Julius B. Richmond Center of Excellence, Elk Grove Village, IL (Whitmore, Gorzkowski). ^†Deceased 31 December 2015.

Abstract

• Background: Family tobacco use and exposure are significant threats to the health of children and their families. However, few pediatric clinicians address family tobacco use and exposure in a routine and effective manner. The Clinical Effort Against Secondhand Smoke Exposure (CEASE) intervention was developed to tackle this gap between clinical need and clinical practice.
• Objective: To review the main considerations and questions that clinicians and office staff expressed during telephone training to participate in CEASE.
• Methods: This study was conducted in pediatric practices in 5 US states. Practices were recruited by the American Academy of Pediatrics (10 intervention, 10 control). Ten training calls were recorded and transcribed. The data was then coded inductively based on themes found in the transcripts.
• Results: The data revealed that clinicians and staff were concerned about prescribing, dosing, and insurance coverage of nicotine replacement therapy; motivation for and methods to help families become tobacco-free; and the impact of the intervention on practice operations.
• Conclusion: While the majority of clinicians and office staff were interested and enthusiastic about helping families become tobacco-free, they expressed concerns that could threaten implementation of family tobacco control strategies.

The devastating health consequences of smoking and exposure to tobacco smoke have been well demonstrated. As declared in the 2006 Surgeon General’s Report, there is no safe level of exposure to tobacco [1]. Children are especially at risk for exposure to toxins and toxicants in tobacco smoke [1,2]. Exposure to tobacco smoke is associated with higher levels of asthma, increased risk of sudden infant death syndrome, increased rates of upper respiratory infections, and behavioral issues [3–5]. Recent research shows that over 70% of children in the United States have some level of exposure to tobacco smoke [6]; parents and other family members are commonly the cause of this exposure, especially in young children. Children and parents benefit when parents stop smoking; parent life expectancy increases by an average of 7 years [7], the risk of tobacco-related poor pregnancy outcomes is reduced, and future children are spared from exposure to tobacco smoke [8].

There is a growing movement to address tobacco use and exposure in the pediatric office setting; the 2015 American Academy of Pediatrics tobacco policy statement Clinical Practice Policy to Protect Children From Tobacco, Nicotine, and Tobacco Smoke recommends that pediatricians ask about children’s exposure to tobacco and address parental tobacco use by implementing office-wide systems to deliver advice, counseling, referral to cessation resources, and smoking cessation medication to smokers [9].

Despite significant risks of tobacco smoke exposure to children, we found in a previous paper that only 3.5% of parents in control practices received any tobacco control assistance [10]. Through a systematic and ongoing line of research, the Clinical Effort Against Secondhand Smoke Exposure (CEASE) intervention was developed to tackle this gap between clinical need and clinical practice. The CEASE intervention has been successfully shown to train and equip pediatric officesfrom a distance to address family tobacco use within existing office systems [10–14]. An enhanced CEASE intervention is undergoing testing in pediatric practices in 5 US states.

One of the more innovative aspects of CEASE has been the use of training calls. In studies of CEASE, the peer-to-peer call was conducted by the principal investigator with the project leader at the practice using a train-the-trainer model. After the project leader was trained through the peer-to-peer call, the project leader then led the whole office training call, with the support of CEASE staff by phone. The training calls worked in conjunction with the other aspects of the training, as shown in the Table. The training calls for the practices provided a valuable research opportunity. We examined the concerns and issues that clinicians and office staff had about implementing an office-wide tobacco control program through a qualitative analysis of the call transcripts. This paper outlines the main considerations and questions that clinicians and office staff expressed during the training calls. Understanding the points of view of clinicians and staff will help researchers and clinical educators strengthen the design of tobacco control interventions.

Methods

Study Aims

The data for this paper were collected as part of a larger mixed-methods controlled trial. The overarching aims of the trial were to study implementation and sustainability of tobacco-control services delivered at the clinic level, to facilitate behavior change among parents and evaluate cost-per-quit among parents who smoke, and to study systems changes and the processes that affect them at the practice level. The study was conducted in 5 intervention and 5 control pediatric primary care practices in 5 states; this paper reports on data collected in intervention practices and focuses on understanding the systems changes and processes that are instituted when implementing a tobacco control program at the clinician and practice level.

Practice Recruitment and Eligibility

Practices were recruited through the American Academy of Pediatrics using direct emails, newsletter/listserv articles, phone calls to members, and in-person recruitment at national meetings. Eligible practices were located in a non–hospital-based setting, had an average patient flow of at least 50 patients per day, used an electronic medical record (EMR) system, and were matched in each state based on practice size and smoking rate. Interested practices also had to be willing to host a research assistant to collect exit interview data from parents. Practices were excluded if they took part in previous CEASE studies or were actively enrolling participants into other tobacco control research studies. Based on these criteria, 18 eligible practices from Indiana, North Carolina, Ohio, Tennessee, Michigan, and Virginia agreed to participate in the study. Of the 6 states, one state was chosen as a replacement state. Five practices from the remaining states were assigned to the intervention group, 5 to the control group, and 5 were assigned to the replacement group in case an intervention or control practice in their state withdrew from the study. Each intervention practice participated in a peer-to-peer training call and a whole office training call. Data analyzed in this paper was collected from all 10 intervention practice training calls.

Training Calls Data Collection

The peer-to-peer and whole office training calls were recorded and transcribed. Permission to record the calls was requested by the trainer (the principal investigator of the study) and given verbally by each person being trained. The training call recordings were then transcribed verbatim by a commercial service; the transcriptions were spot-checked for accuracy.

The transcripts were first read closely by the first author (BHW), then coded inductively into relevant themes that emerged from the calls. The inductive coding was guided by the questions and concerns that the clinicians raised during the training, as well as the ways in which the trainer addressed these concerns and tailored the training to the needs and interests of the pediatric clinicians [26]. The coding was reviewed and confirmed by the other study team members.

After the data were coded into themes, the coded data were analyzed by the first author using qualitative description. Qualitative description is a method of analyzing coded qualitative data by looking at the words and meanings expressed by respondents [27]. Through this method of analysis, we were able to understand what concerns the clinicians and staff voiced about aspects of the CEASE intervention.

Ethics

The study was approved institutional review boards at Massachusetts General Hospital, the AAP, and the health care practices that required local IRB approval. The quotes used in this paper have been anonymized and cleaned to remove any identifying information, such as location and names.

Peer-to-Peer Training Calls

The peer-to-peer training calls were conducted after training and study materials arrived. The project leader (a pediatrician in the practice who was interested in spearheading the CEASE intervention) was asked to watch the training video. Using an evidence-based, previously developed call script [28], the principal investigator trained the project leader in key aspects of addressing family tobacco use and exposure, such as using an electronic tablet screener survey to identify family members who smoke, exploring techniques for prescribing or recommending NRT, and identifying ways to connect family members to free tobacco cessation counseling and support services. On occasion, other staff from the pediatric office (eg, a nurse or office manager) joined the call.

The principal investigator presented information, clarified points in the video, explained the materials, and asked questions and elicited relevant experiences from the project leader. In addition to teaching the project leader about the tobacco control strategies used in CEASE, the peer-to-peer calls prepared the project leader to train the rest of their own practice clinicians and staff in the CEASE intervention.

Whole Office Training Calls

Each practice’s local project leader led the whole office training calls, but CEASE study staff were on the call to introduce themselves to office staff, answer any questions that staff may have raised that the project leader could not answer, give information about data collection, and to generally support the implementation of the CEASE intervention and research program. During this call, the project leader watched the video with the group and tailored the training for his or her practice, focusing on issues of relevance for patients and staff.

Training Calls as Research Data

As many practices struggle with research burden [29], finding innovative and unobtrusive methods of collecting data is especially useful for research teams and participating practices. During both calls, clinicians and staff were asked open-ended questions to learn about their concerns regarding intervention implementation, share their own experiences with tobacco and tobacco control, and explore practice-specific methods to address family smoking. CEASE staff used this opportunity to help practices tailor the intervention to the local setting, such as by offering quitline enrollment sheets in another language. Clinician and staff answers to open-ended questions provided qualitative data for this manuscript.

Results and Discussion

The research team used training call data to explore clinician and staff concerns and desires related to family-centered tobacco control. The most common themes were: (1) prescribing, dosing, and insurance coverage of NRT, (2) motivation for and methods to help families become tobacco-free, and (3) the impact of the CEASE intervention on the day-to-day operations of the practice.

Nicotine Replacement Therapy

Prescribing or recommending NRT is one of the best ways to help families become tobacco-free and is a crucial component of the CEASE intervention [30–32]. Through the telephone trainings, clinicians and staff were trained to prescribe NRT using pre-printed prescription sheets, presented information about the effectiveness of NRT for smoking cessation, and referred to an information sheet on NRT to answer other questions as needed.

During the calls, it became clear that the pediatric clinicians were interested in prescribing NRT to help smokers quit, but lacked the skills and knowledge to do so:

I’m writing all this down [about NRT], because I don’t know any of this. (IN peer-to-peer)

Is 4 mg the strongest the gum comes in? (NC whole office)

This lack of knowledge may be a barrier to prescribing NRT in the pediatric setting. A national survey revealed that while smoking parents would accept prescriptions for NRT from their child’s doctor, very few received a prescription [33]. The calls provided an opportunity to have clinicians’ questions about NRT be answered by a pediatric tobacco control expert.

Clinicians were interested in helping parents stop smoking with medication, but were worried about access to medication; one of the most common questions voiced was not about how or why to prescribe NRT but how to help low-income parents get NRT for free or low-cost.

Some people—they don’t have insurance, so, how much it costs, they need to know that. (TN peer-to-peer)

I just know I’ve got a bunch ... Obamacare doesn’t work down here, so—I’ve still got families who don’t have any insurance, and you’re like, “Oh, I was hoping you could get something,” and they’re like, “Well, we can’t.” I have a fair number of kids who—are on some type of insurance, but the parents don’t have any coverage for NRT. (VA peer-to-peer)

While NRT is covered under the Affordable Care Act, many states have not expanded their Medicaid coverage [34]; this leaves many low-income families without access to health insurance or to free or low-cost NRT. While NRT remains one of the best and most common smoking cessation tools [35] there was no way to reassure practices that parents would be able to obtain the prescribed NRT without guaranteed coverage. In a previous study, the cost of NRT was seen by smokers as a barrier to using NRT to quit smoking [32]. Clinicians’ concerns about the cost of NRT reveal an understanding of the needs and issues relevant to their patient population.

Motivation for and Methods to Help Families Become Tobacco-Free

Clinicians and office staff were motivated to help families become tobacco-free and were interested in various ways to do so. The motivation and interest were personal, clinical, and organizational, relating to the ways in which care in the pediatric office could be altered to address tobacco in a more systematic way.

Motivation

The interest in smoking cessation stems from the desire to protect children from the harmful effects tobacco smoke and to prevent children themselves from taking up smoking:

We’d always talked about the smoking, and the parents finally quit. Probably not like I helped them—I just had been harping on them—but by that point the boy was smoking. When he was little he was like, “Oh, that’s nasty. I can’t believe my parents smoke.” Then by the time he was 14-15 and the parents actually did manage to quit, he was smoking, and I was like, “Ugh, really?” (VA peer-to-peer)

I totally understand the dire need for this project, in both the tobacco in the households, as well as the teenagers smoking. I heard one stat[istic], that one of our high schools had 80% of children using tobacco products… And that’s on my watch… I understand and I share the same passion that you do, for personal reasons, as well as reasons to help the whole community. (NC peer-to-peer)

Pediatricians saw themselves as responsible for protecting children’s health through reducing their tobacco smoke exposure, for working to prevent teen smoking, and for the overall health of their communities. Helping prevent childhood exposure to tobacco smoke and teen smoking initiation are crucial tasks for pediatricians; the 2015 AAP tobacco policy statement strongly recommends that pediatric offices include tobacco use prevention messages when talking to children and teens to help prevent smoking initiation, as well as helping families establish smoking bans for homes and cars [36]. By participating in the CEASE telephone trainings, clinicians and office staff were learning skills and tools to help them act on their motivation to protect families from the harms of tobacco.

Strategies

Pediatricians and office staff were interested in learning specific strategies and tools to help parents stop smoking. Practices wanted to know how and when to set a quit date with families, how to use services to help families become smoke-free, and how to tailor assistance to specific populations.

Yeah, we’re wondering about other languages, because we do have a large Hispanic patient population and a sizable group of folks that come from Saudi Arabia, and I know that some of them do smoke. (TN peer-to-peer)

Set[ting] a quit date for the patient —so how long we want to set the date? 6 months, 3 months, 1 year, 2 years, what? (TN peer-to-peer)

If you have a mom who lives with grandma and grandpa, the mom may not smoke but grandma and grandpa smoke, but they still live in that home… But anyone who comes in, we’re going to help. Does that sound right? (VA peer-to-peer)

By participating in the study, the clinicians and office staff were actively seeking to improve their knowledge of tobacco-related issues; past research has shown that pediatric residents saw lack of training in tobacco control as a key reason for inconsistent tobacco control outreach and intervention [37]. The training calls were an opportunity to gain information more specifically related to the pediatric practice’s population and office setting, building upon the other CEASE training materials. The training calls were also a chance for the CEASE research team to adapt strategies and tools to the practices, for example by providing materials that met the practices’ needs.

Impact of Intervention on Day-To-Day Operations

The training calls revealed that integrating CEASE into office workflows was a major concern. Integrating preventive services into routine office practice is a frequent concern of primary care providers [38–41]. These concerns about office flow reflect worries about financing [42] and benchmarking [43–45].

I think they’re going to have some of the same questions [that I initially had] in terms of how this might work with workflow. But as we’ve talked through all of this, I think we can make it work, and make it just sort of incorporated as part of our everyday questions that we ask. And it shouldn’t really slow things down. And I think that’ll be the main thing the providers would be focusing on is, how’s this going to impact me and all the other things I have to do in the course of a visit? This [phone call] answers a lot of questions I had in terms of that. (IN peer-to-peer)

As wait time was a performance measure for many of the practices, the clinicians and staff were hesitant to add any activities to check-in that might increase wait time.

I know, so especially, we’re trying to do a care team right now... don’t want them to spend too much time in the waiting room. (OH whole office)

During the calls, clinicians and office staff were asked to reflect on their practices and discuss ways that their practice would implement the CEASE intervention. This moment of reflection is a benefit of research participation, as it allows practices to improve the care they provide [46]. The calls allowed for on-the-spot tailoring of the intervention to meet the specific needs of the practice, an opportunity for the research staff and practice to work together to make the intervention fit their particular office situation and flow. Data collected from the training calls were also reviewed during the CEASE implementation process to support practices with specific concerns.

Strengths and Limitations

As these data were collected during training calls and subject to social desirability bias, the concerns raised may not be an exhaustive list of all concerns that clinicians and office staff had. However, the concerns that were raised by clinicians became a natural and essential part of the training process. As the practices’ initial concerns were identified early in the study, it was possible to address these concerns throughout the early implementation phases of CEASE. Transcribing calls and analyzing training call data as quickly as possible during the training phases of an intervention could prove beneficial for strengthening the implementation.

Dedicating the extra time and effort to record the training calls as a source of data formalized and strengthened the implementation process. By recording training calls, the study team was able to document the practices’ concerns and share them among the research team, including those who were not on training calls. This effort was a significant source of quality improvement data for the research team and helped ensure that we were responsive to the articulated needs of clinicians and practices.

Conclusion

The training call data revealed both the concerns as well as the interests of child health care clinicians in regard to addressing family tobacco use. While the majority of clinicians and office staff were interested and enthusiastic about helping families become tobacco free, they expressed concerns that could threaten full implementation of family tobacco control strategies. These concerns and interests related to the coverage and affordability of NRT, integrating tobacco control strategies into the practice flow, and learning strategies to address family-wide tobacco use, such as helping grandparents quit smoking or addressing tobacco use with those who were not native English speakers. The concerns and interests of clinicians and office staff revealed that they were genuinely interested in learning ways to tailor strategies to address tobacco use for their practices and patient populations. By recording the training calls, the study team was better able to help them tailor the intervention to their practice, both during the calls and during subsequent implementation by providing new materials and additional information on subjects of concern to the practice. Carefully documenting training calls with health care practices are an ideal opportunity to collect information on issues that may impact full implementation of future interventions.

Corresponding author: Jonathan P. Winickoff, [email protected]

From the Massachusetts General Hospital for Children, Boston, MA (Walters, Drehmer, Nabi-Burza, Winickoff), the University of Rochester School of Medicine, Rochester, NY (Ossip), and the American Academy of Pediatrics Julius B. Richmond Center of Excellence, Elk Grove Village, IL (Whitmore, Gorzkowski). ^†Deceased 31 December 2015.

Abstract

• Background: Family tobacco use and exposure are significant threats to the health of children and their families. However, few pediatric clinicians address family tobacco use and exposure in a routine and effective manner. The Clinical Effort Against Secondhand Smoke Exposure (CEASE) intervention was developed to tackle this gap between clinical need and clinical practice.
• Objective: To review the main considerations and questions that clinicians and office staff expressed during telephone training to participate in CEASE.
• Methods: This study was conducted in pediatric practices in 5 US states. Practices were recruited by the American Academy of Pediatrics (10 intervention, 10 control). Ten training calls were recorded and transcribed. The data was then coded inductively based on themes found in the transcripts.
• Results: The data revealed that clinicians and staff were concerned about prescribing, dosing, and insurance coverage of nicotine replacement therapy; motivation for and methods to help families become tobacco-free; and the impact of the intervention on practice operations.
• Conclusion: While the majority of clinicians and office staff were interested and enthusiastic about helping families become tobacco-free, they expressed concerns that could threaten implementation of family tobacco control strategies.

The devastating health consequences of smoking and exposure to tobacco smoke have been well demonstrated. As declared in the 2006 Surgeon General’s Report, there is no safe level of exposure to tobacco [1]. Children are especially at risk for exposure to toxins and toxicants in tobacco smoke [1,2]. Exposure to tobacco smoke is associated with higher levels of asthma, increased risk of sudden infant death syndrome, increased rates of upper respiratory infections, and behavioral issues [3–5]. Recent research shows that over 70% of children in the United States have some level of exposure to tobacco smoke [6]; parents and other family members are commonly the cause of this exposure, especially in young children. Children and parents benefit when parents stop smoking; parent life expectancy increases by an average of 7 years [7], the risk of tobacco-related poor pregnancy outcomes is reduced, and future children are spared from exposure to tobacco smoke [8].

There is a growing movement to address tobacco use and exposure in the pediatric office setting; the 2015 American Academy of Pediatrics tobacco policy statement Clinical Practice Policy to Protect Children From Tobacco, Nicotine, and Tobacco Smoke recommends that pediatricians ask about children’s exposure to tobacco and address parental tobacco use by implementing office-wide systems to deliver advice, counseling, referral to cessation resources, and smoking cessation medication to smokers [9].

Despite significant risks of tobacco smoke exposure to children, we found in a previous paper that only 3.5% of parents in control practices received any tobacco control assistance [10]. Through a systematic and ongoing line of research, the Clinical Effort Against Secondhand Smoke Exposure (CEASE) intervention was developed to tackle this gap between clinical need and clinical practice. The CEASE intervention has been successfully shown to train and equip pediatric officesfrom a distance to address family tobacco use within existing office systems [10–14]. An enhanced CEASE intervention is undergoing testing in pediatric practices in 5 US states.

One of the more innovative aspects of CEASE has been the use of training calls. In studies of CEASE, the peer-to-peer call was conducted by the principal investigator with the project leader at the practice using a train-the-trainer model. After the project leader was trained through the peer-to-peer call, the project leader then led the whole office training call, with the support of CEASE staff by phone. The training calls worked in conjunction with the other aspects of the training, as shown in the Table. The training calls for the practices provided a valuable research opportunity. We examined the concerns and issues that clinicians and office staff had about implementing an office-wide tobacco control program through a qualitative analysis of the call transcripts. This paper outlines the main considerations and questions that clinicians and office staff expressed during the training calls. Understanding the points of view of clinicians and staff will help researchers and clinical educators strengthen the design of tobacco control interventions.

Methods

Study Aims

The data for this paper were collected as part of a larger mixed-methods controlled trial. The overarching aims of the trial were to study implementation and sustainability of tobacco-control services delivered at the clinic level, to facilitate behavior change among parents and evaluate cost-per-quit among parents who smoke, and to study systems changes and the processes that affect them at the practice level. The study was conducted in 5 intervention and 5 control pediatric primary care practices in 5 states; this paper reports on data collected in intervention practices and focuses on understanding the systems changes and processes that are instituted when implementing a tobacco control program at the clinician and practice level.

Practice Recruitment and Eligibility

Practices were recruited through the American Academy of Pediatrics using direct emails, newsletter/listserv articles, phone calls to members, and in-person recruitment at national meetings. Eligible practices were located in a non–hospital-based setting, had an average patient flow of at least 50 patients per day, used an electronic medical record (EMR) system, and were matched in each state based on practice size and smoking rate. Interested practices also had to be willing to host a research assistant to collect exit interview data from parents. Practices were excluded if they took part in previous CEASE studies or were actively enrolling participants into other tobacco control research studies. Based on these criteria, 18 eligible practices from Indiana, North Carolina, Ohio, Tennessee, Michigan, and Virginia agreed to participate in the study. Of the 6 states, one state was chosen as a replacement state. Five practices from the remaining states were assigned to the intervention group, 5 to the control group, and 5 were assigned to the replacement group in case an intervention or control practice in their state withdrew from the study. Each intervention practice participated in a peer-to-peer training call and a whole office training call. Data analyzed in this paper was collected from all 10 intervention practice training calls.

Training Calls Data Collection

The peer-to-peer and whole office training calls were recorded and transcribed. Permission to record the calls was requested by the trainer (the principal investigator of the study) and given verbally by each person being trained. The training call recordings were then transcribed verbatim by a commercial service; the transcriptions were spot-checked for accuracy.

The transcripts were first read closely by the first author (BHW), then coded inductively into relevant themes that emerged from the calls. The inductive coding was guided by the questions and concerns that the clinicians raised during the training, as well as the ways in which the trainer addressed these concerns and tailored the training to the needs and interests of the pediatric clinicians [26]. The coding was reviewed and confirmed by the other study team members.

After the data were coded into themes, the coded data were analyzed by the first author using qualitative description. Qualitative description is a method of analyzing coded qualitative data by looking at the words and meanings expressed by respondents [27]. Through this method of analysis, we were able to understand what concerns the clinicians and staff voiced about aspects of the CEASE intervention.

Ethics

The study was approved institutional review boards at Massachusetts General Hospital, the AAP, and the health care practices that required local IRB approval. The quotes used in this paper have been anonymized and cleaned to remove any identifying information, such as location and names.

Peer-to-Peer Training Calls

The peer-to-peer training calls were conducted after training and study materials arrived. The project leader (a pediatrician in the practice who was interested in spearheading the CEASE intervention) was asked to watch the training video. Using an evidence-based, previously developed call script [28], the principal investigator trained the project leader in key aspects of addressing family tobacco use and exposure, such as using an electronic tablet screener survey to identify family members who smoke, exploring techniques for prescribing or recommending NRT, and identifying ways to connect family members to free tobacco cessation counseling and support services. On occasion, other staff from the pediatric office (eg, a nurse or office manager) joined the call.

The principal investigator presented information, clarified points in the video, explained the materials, and asked questions and elicited relevant experiences from the project leader. In addition to teaching the project leader about the tobacco control strategies used in CEASE, the peer-to-peer calls prepared the project leader to train the rest of their own practice clinicians and staff in the CEASE intervention.

Whole Office Training Calls

Each practice’s local project leader led the whole office training calls, but CEASE study staff were on the call to introduce themselves to office staff, answer any questions that staff may have raised that the project leader could not answer, give information about data collection, and to generally support the implementation of the CEASE intervention and research program. During this call, the project leader watched the video with the group and tailored the training for his or her practice, focusing on issues of relevance for patients and staff.

Training Calls as Research Data

As many practices struggle with research burden [29], finding innovative and unobtrusive methods of collecting data is especially useful for research teams and participating practices. During both calls, clinicians and staff were asked open-ended questions to learn about their concerns regarding intervention implementation, share their own experiences with tobacco and tobacco control, and explore practice-specific methods to address family smoking. CEASE staff used this opportunity to help practices tailor the intervention to the local setting, such as by offering quitline enrollment sheets in another language. Clinician and staff answers to open-ended questions provided qualitative data for this manuscript.

Results and Discussion

The research team used training call data to explore clinician and staff concerns and desires related to family-centered tobacco control. The most common themes were: (1) prescribing, dosing, and insurance coverage of NRT, (2) motivation for and methods to help families become tobacco-free, and (3) the impact of the CEASE intervention on the day-to-day operations of the practice.

Nicotine Replacement Therapy

Prescribing or recommending NRT is one of the best ways to help families become tobacco-free and is a crucial component of the CEASE intervention [30–32]. Through the telephone trainings, clinicians and staff were trained to prescribe NRT using pre-printed prescription sheets, presented information about the effectiveness of NRT for smoking cessation, and referred to an information sheet on NRT to answer other questions as needed.

During the calls, it became clear that the pediatric clinicians were interested in prescribing NRT to help smokers quit, but lacked the skills and knowledge to do so:

I’m writing all this down [about NRT], because I don’t know any of this. (IN peer-to-peer)

Is 4 mg the strongest the gum comes in? (NC whole office)

This lack of knowledge may be a barrier to prescribing NRT in the pediatric setting. A national survey revealed that while smoking parents would accept prescriptions for NRT from their child’s doctor, very few received a prescription [33]. The calls provided an opportunity to have clinicians’ questions about NRT be answered by a pediatric tobacco control expert.

Clinicians were interested in helping parents stop smoking with medication, but were worried about access to medication; one of the most common questions voiced was not about how or why to prescribe NRT but how to help low-income parents get NRT for free or low-cost.

Some people—they don’t have insurance, so, how much it costs, they need to know that. (TN peer-to-peer)

I just know I’ve got a bunch ... Obamacare doesn’t work down here, so—I’ve still got families who don’t have any insurance, and you’re like, “Oh, I was hoping you could get something,” and they’re like, “Well, we can’t.” I have a fair number of kids who—are on some type of insurance, but the parents don’t have any coverage for NRT. (VA peer-to-peer)

While NRT is covered under the Affordable Care Act, many states have not expanded their Medicaid coverage [34]; this leaves many low-income families without access to health insurance or to free or low-cost NRT. While NRT remains one of the best and most common smoking cessation tools [35] there was no way to reassure practices that parents would be able to obtain the prescribed NRT without guaranteed coverage. In a previous study, the cost of NRT was seen by smokers as a barrier to using NRT to quit smoking [32]. Clinicians’ concerns about the cost of NRT reveal an understanding of the needs and issues relevant to their patient population.

Motivation for and Methods to Help Families Become Tobacco-Free

Clinicians and office staff were motivated to help families become tobacco-free and were interested in various ways to do so. The motivation and interest were personal, clinical, and organizational, relating to the ways in which care in the pediatric office could be altered to address tobacco in a more systematic way.

Motivation

The interest in smoking cessation stems from the desire to protect children from the harmful effects tobacco smoke and to prevent children themselves from taking up smoking:

We’d always talked about the smoking, and the parents finally quit. Probably not like I helped them—I just had been harping on them—but by that point the boy was smoking. When he was little he was like, “Oh, that’s nasty. I can’t believe my parents smoke.” Then by the time he was 14-15 and the parents actually did manage to quit, he was smoking, and I was like, “Ugh, really?” (VA peer-to-peer)

I totally understand the dire need for this project, in both the tobacco in the households, as well as the teenagers smoking. I heard one stat[istic], that one of our high schools had 80% of children using tobacco products… And that’s on my watch… I understand and I share the same passion that you do, for personal reasons, as well as reasons to help the whole community. (NC peer-to-peer)

Pediatricians saw themselves as responsible for protecting children’s health through reducing their tobacco smoke exposure, for working to prevent teen smoking, and for the overall health of their communities. Helping prevent childhood exposure to tobacco smoke and teen smoking initiation are crucial tasks for pediatricians; the 2015 AAP tobacco policy statement strongly recommends that pediatric offices include tobacco use prevention messages when talking to children and teens to help prevent smoking initiation, as well as helping families establish smoking bans for homes and cars [36]. By participating in the CEASE telephone trainings, clinicians and office staff were learning skills and tools to help them act on their motivation to protect families from the harms of tobacco.

Strategies

Pediatricians and office staff were interested in learning specific strategies and tools to help parents stop smoking. Practices wanted to know how and when to set a quit date with families, how to use services to help families become smoke-free, and how to tailor assistance to specific populations.

Yeah, we’re wondering about other languages, because we do have a large Hispanic patient population and a sizable group of folks that come from Saudi Arabia, and I know that some of them do smoke. (TN peer-to-peer)

Set[ting] a quit date for the patient —so how long we want to set the date? 6 months, 3 months, 1 year, 2 years, what? (TN peer-to-peer)

If you have a mom who lives with grandma and grandpa, the mom may not smoke but grandma and grandpa smoke, but they still live in that home… But anyone who comes in, we’re going to help. Does that sound right? (VA peer-to-peer)

By participating in the study, the clinicians and office staff were actively seeking to improve their knowledge of tobacco-related issues; past research has shown that pediatric residents saw lack of training in tobacco control as a key reason for inconsistent tobacco control outreach and intervention [37]. The training calls were an opportunity to gain information more specifically related to the pediatric practice’s population and office setting, building upon the other CEASE training materials. The training calls were also a chance for the CEASE research team to adapt strategies and tools to the practices, for example by providing materials that met the practices’ needs.

Impact of Intervention on Day-To-Day Operations

The training calls revealed that integrating CEASE into office workflows was a major concern. Integrating preventive services into routine office practice is a frequent concern of primary care providers [38–41]. These concerns about office flow reflect worries about financing [42] and benchmarking [43–45].

I think they’re going to have some of the same questions [that I initially had] in terms of how this might work with workflow. But as we’ve talked through all of this, I think we can make it work, and make it just sort of incorporated as part of our everyday questions that we ask. And it shouldn’t really slow things down. And I think that’ll be the main thing the providers would be focusing on is, how’s this going to impact me and all the other things I have to do in the course of a visit? This [phone call] answers a lot of questions I had in terms of that. (IN peer-to-peer)

As wait time was a performance measure for many of the practices, the clinicians and staff were hesitant to add any activities to check-in that might increase wait time.

I know, so especially, we’re trying to do a care team right now... don’t want them to spend too much time in the waiting room. (OH whole office)

During the calls, clinicians and office staff were asked to reflect on their practices and discuss ways that their practice would implement the CEASE intervention. This moment of reflection is a benefit of research participation, as it allows practices to improve the care they provide [46]. The calls allowed for on-the-spot tailoring of the intervention to meet the specific needs of the practice, an opportunity for the research staff and practice to work together to make the intervention fit their particular office situation and flow. Data collected from the training calls were also reviewed during the CEASE implementation process to support practices with specific concerns.

Strengths and Limitations

As these data were collected during training calls and subject to social desirability bias, the concerns raised may not be an exhaustive list of all concerns that clinicians and office staff had. However, the concerns that were raised by clinicians became a natural and essential part of the training process. As the practices’ initial concerns were identified early in the study, it was possible to address these concerns throughout the early implementation phases of CEASE. Transcribing calls and analyzing training call data as quickly as possible during the training phases of an intervention could prove beneficial for strengthening the implementation.

Dedicating the extra time and effort to record the training calls as a source of data formalized and strengthened the implementation process. By recording training calls, the study team was able to document the practices’ concerns and share them among the research team, including those who were not on training calls. This effort was a significant source of quality improvement data for the research team and helped ensure that we were responsive to the articulated needs of clinicians and practices.

Conclusion

The training call data revealed both the concerns as well as the interests of child health care clinicians in regard to addressing family tobacco use. While the majority of clinicians and office staff were interested and enthusiastic about helping families become tobacco free, they expressed concerns that could threaten full implementation of family tobacco control strategies. These concerns and interests related to the coverage and affordability of NRT, integrating tobacco control strategies into the practice flow, and learning strategies to address family-wide tobacco use, such as helping grandparents quit smoking or addressing tobacco use with those who were not native English speakers. The concerns and interests of clinicians and office staff revealed that they were genuinely interested in learning ways to tailor strategies to address tobacco use for their practices and patient populations. By recording the training calls, the study team was better able to help them tailor the intervention to their practice, both during the calls and during subsequent implementation by providing new materials and additional information on subjects of concern to the practice. Carefully documenting training calls with health care practices are an ideal opportunity to collect information on issues that may impact full implementation of future interventions.

Corresponding author: Jonathan P. Winickoff, [email protected]

From the MetroHealth Medical Center, Cleveland, OH.

Abstract

• Objective: To describe the process for the creation and development of the Daily Safety Brief (DSB) in our safety net hospital.
• Methods: We developed the DSB, a daily interdepartmental briefing intended to increase the safety of patients, employees, and visitors by improving communication and situational awareness. Situational awareness involves gathering the right information, analyzing it, and making predictions and projections based on the analysis. Reporting issues while they are small oftentimes makes them easier to manage. The average call length with 25 departments reporting is just 9.5 minutes.
• Results: Survey results reveal an overall average improvement in awareness among DSB participants about hospital safety issues. Average days to issue resolution is currently 2.3 days, with open issues tracked and reported on daily.
• Conclusion: The DSB has improved real-time communication and awareness about safety issues in our organization.

As health care organizations strive to ensure a culture of safety for patients and staff, they must also be able to demonstrate reliability in that culture. The concept of highly reliable organizations originated in aviation and military fields due to the high-stakes environment and need for rapid and effective communication across departments. High reliability in health care organizations is described by the Joint Commission as consistent excellence in quality and safety for every patient, every time [1].

Highly reliable organizations put systems in place that makes them resilient with methods that lead to consistent accomplishment of goals and strategies to avoid potentially catastrophic errors [2]. An integral component to success in all high reliability organizations is a method of “Plan-of-the-Day” meetings to keep staff apprised of critical updates throughout the health system impacting care delivery [3]. Leaders at MetroHealth Medical Center believed that a daily safety briefing would help support the hospital’s journey to high reliability. We developed the Daily Safety Brief (DSB), a daily interdepartmental briefing intended to increase the safety of patients, employees, and visitors by improving communication and situational awareness. Situational awareness involves gathering the right information, analyzing it, and making predictions and projections based on the analysis [4]. Reporting issues while they are small oftentimes makes them easier to manage. This article will describe the development and implementation of the DSB in our hospital.

Setting

MetroHealth Medical Center is an academic medical center in Cleveland, OH, affiliated with Case Western Reserve University. Metrohealth is a public safety net hospital with 731 licensed beds and a total of 1,160,773 patient visits in 2014, with 27,933 inpatient stays and 106,000 emergency department (ED) visits. The staff includes 507 physicians, 374 resident physicians, and 1222 nurses.

Program Development

As Metrohealth was contemplating the DSB, a group of senior leaders, including the chief medical officer, visited the Cincinnati Children’s Hospital, which had a DSB process in place. Following that visit, a larger group of physicians and administrators from intake points, procedural areas, and ancillary departments were invited to listen in live to Cincinnati’s DSB. This turned out to be a pivotal step in gaining buy-in. The initial concerns from participants were that this would be another scheduled meeting in an already busy day. What we learned from listening in was that the DSB was conducted in a manner that was succinct and professional. Issues were identified without accusations or unrelated agendas. Following the call, participants discussed how impressed they were and clearly saw the value of the information that was shared. They began to brainstorm about what they could report that would be relevant to the audience.

It was determined that a leader and 2 facilitators would be assigned to each call. The role of the DSB leader is to trigger individual department report outs and to ensure follow-up on unresolved safety issues from the previous DSB. Leaders are recruited by senior leadership and need to be familiar with the effects that issues can have across the health care system. Leaders need to be able to ask pertinent questions, have the credibility to raise concerns, and have access to senior administration when they need to bypass usual administrative channels.

The role of the facilitators, who are all members of the Center for Quality, is to connect to the conference bridge line, to keep the DSB leader on task, and to record all departmental data and pertinent details of the DSB. The facilitators maintain the daily DSB document, which outlines the order in which departments are called to report and identifies for the leader any open items identified in the previous day’s DSB.

The Daily Safety Brief

Rollout

The DSB began 3 days per week on Monday, Wednesday and Friday at 0830. The time was moved to 0800 since participants found the later time difficult as it fell in the middle of an hour, potentially conflicting with other meetings and preparation for the daily bed huddle. We recognized that many meetings began right at the start of the DSB. The CEO requested that all 0800 meetings begin with a call in to listen to the DSB. After 2 months, the frequency was increased to 5 days per week, Monday through Friday. The hospital trialed a weekend DSB, however, feedback from participants found this extremely difficult to attend due to leaner weekend staffing models and found that information shared was not impactful. In particular, items were identified on the weekend daily safety briefs but the staff needed to resolve those items were generally not available until Monday.

Refinements

Coaching occurred to help people be more succinct in sharing information that would impact other areas. Information that was relevant only internally to their department was streamlined. The participants were counseled to identify items that had potential impact on other departments or where other departments had resources that might improve operations.

After a year, participating departments requested the addition of the logistics and construction departments to the DSB. The addition of the logistics department offered the opportunity for clinical departments to communicate what equipment was needed to start the day and created the opportunity for logistics to close the feedback loop by giving an estimate on expected time of arrival of equipment. The addition of the construction department helped communicate issues that may impact the organization, and helps to coordinate care to minimally impact patients and operations.

Examples of Safety Improvements

The DSB keeps the departmental leadership aware of problems developing in all areas of the hospital. Upcoming safety risks are identified early so that plans can be put in place to ameliorate them. The expectation of the DSB leader is that a problem that isn’t readily solved during the DSB must be taken to senior administration for resolution. As an example, an issue involving delays in the purchase of a required neonatal ventilator was taken directly to the CEO by the DSB leader, resulting in completion of the purchase within days. Importantly, the requirement to report at the DSB leads to a preoccupation with risk and reporting and leads to transparency among interdependent departments.

Another issue effectively addressed by the DSB was when we received notification of a required mandatory power shutdown for an extended period of time. The local power company informed our facilities management department director that they discovered issues requiring urgent replacement of the transformer within 2 weeks. Facilities management reported this in the morning DSB. The DSB leader requested all stakeholders to stay on the call following completion of the DSB, and plans were set in motion to plan for the shutdown of power. The team agreed to conference call again at noon the same day to continue planning, and the affected building was prepared for the shutdown by the following day.

Another benefit of the DSB is illustrated by our inpatient psychiatry unit, which reports an acuity measure each day on a scale of 1 to 10. The MetroHealth Police Department utilizes the report to adjust their rounding schedule, with increased presence on days with high acuity, which has led to an improvement in morale among psychiatry unit staff.

Challenges and Solutions

Since these reports are available to a wide audience in the organization, it is important to assure the reporters that no repercussions will ensue from any information that they provide. Senior leadership was enlisted to communicate with their departments that no repercussions would occur from reporting. As an example, some managers reported to the DSB development team privately that their supervisors were concerned about reporting of staff shortages on the DSB. As the shortages had patient care implications and affected other clinical departments, the DSB development team met with the involved supervisors to address the need for open reporting. In fact, repeated reporting of shortages in one support department on the DSB resulted in that issue being taken to high levels of administration leading to an increase in their staffing levels.

Scheduling can be a challenge for DSB participants. Holding the DSB at 0800 has led some departments to delegate the reporting or information gathering. For the individual reporting departments, creating a reporting workflow was a challenge. The departments needed to ensure that their DSB report was ready to go by 0800. This timeline forced departments to improve their own interdepartmental communication structure. An unexpected benefit of this requirement is that some departments have created a morning huddle to share information, which has reportedly improved communication and morale. The ambulatory network created a separate shared database for clinics to post concerns meeting DSB reporting criteria. One designated staff member would access this collective information when preparing for the DSB report. While most departments have a senior manager providing their report, this is not a requirement. In many departments, that reporter varies from day to day, although consistently it is someone with some administrative or leadership role in the department.

Conference call technology presented the solution to the problem of acquiring a meeting space for a large group. The DSB is broadcast from one physical location, where the facilitators and leader convene. While this conference room is open to anyone who wants to attend in person, most departments choose to participate through the conference line. The DSB conference call is open to anyone in the organization to access. Typically 35 to 40 phones are accessing the line each DSB. Challenges included callers not muting their phones, creating distracting background noise, and callers placing their phones on hold, which prompted the hospital hold message to play continuously. Multiple repeated reminders via email and at the start of the DSB has rectified this issue for the most part, with occasional reminders made when the issue recurs.

Data Management

Initially, an Excel file was created with columns for each reporting department as well as each item they were asked to report on. This “running” file became cumbersome. Retrieving information on past issues was not automated. Therefore, we enlisted the help of a data analyst to create an Access database. When it was complete, this new database allowed us to save information by individual dates, query number of days to issue resolution, and create reports noting unresolved issues for the leader to reference. Many data points can be queried in the access database. Real-time reports are available at all times and updated with every data entry. The database is able to identify departments not on the daily call and trend information, ie, how many listeners were on the DSB, number of falls, forensic patients in house, number of patients awaiting admission from the ED, number of ambulatory visits scheduled each day, equipment needed, number of cardiac arrest calls, and number of neonatal resuscitations.

At the conclusion of the call, the DSB report is completed and posted to a shared website on the hospital intranet for the entire hospital to access and read. Feedback from participant indicated that they found it cumbersome to access this. The communications department was enlisted to enable easy access and staff can now access the DSB report from the front page of the hospital intranet.

Outcomes

Since initiation of our DSB, we have tracked the average number of minutes spent on each call. When calls began, the average time on the call was 12.4 minutes. With the evolution of the DSB and coaching managers in various departments, the average time on the call is now 9.5 minutes in 2015, despite additional reporting departments joining the DSB.

Summary

The DSB has become an important tool in creating and moving towards a culture of safety and high reliability within the MetroHealth System. Over time, processes have become organized and engrained in all departments. This format has allowed issues to be brought forward timely where immediate attention can be given to achieve resolution in a nonthreatening manner, improving transparency. The fluidity of the DSB allows it to be enhanced and modified as improvements and opportunities are identified in the organization. The DSB has provided opportunities to create situational awareness which allows a look forward to prevention and creates a proactive environment. The results of these efforts has made MetroHealth a safer place for patients, visitors, and employees.

Corresponding author: Anne M. Aulisio, MSN, [email protected].

Financial disclosures: None.

From the MetroHealth Medical Center, Cleveland, OH.

Abstract

• Objective: To describe the process for the creation and development of the Daily Safety Brief (DSB) in our safety net hospital.
• Methods: We developed the DSB, a daily interdepartmental briefing intended to increase the safety of patients, employees, and visitors by improving communication and situational awareness. Situational awareness involves gathering the right information, analyzing it, and making predictions and projections based on the analysis. Reporting issues while they are small oftentimes makes them easier to manage. The average call length with 25 departments reporting is just 9.5 minutes.
• Results: Survey results reveal an overall average improvement in awareness among DSB participants about hospital safety issues. Average days to issue resolution is currently 2.3 days, with open issues tracked and reported on daily.
• Conclusion: The DSB has improved real-time communication and awareness about safety issues in our organization.

As health care organizations strive to ensure a culture of safety for patients and staff, they must also be able to demonstrate reliability in that culture. The concept of highly reliable organizations originated in aviation and military fields due to the high-stakes environment and need for rapid and effective communication across departments. High reliability in health care organizations is described by the Joint Commission as consistent excellence in quality and safety for every patient, every time [1].

Highly reliable organizations put systems in place that makes them resilient with methods that lead to consistent accomplishment of goals and strategies to avoid potentially catastrophic errors [2]. An integral component to success in all high reliability organizations is a method of “Plan-of-the-Day” meetings to keep staff apprised of critical updates throughout the health system impacting care delivery [3]. Leaders at MetroHealth Medical Center believed that a daily safety briefing would help support the hospital’s journey to high reliability. We developed the Daily Safety Brief (DSB), a daily interdepartmental briefing intended to increase the safety of patients, employees, and visitors by improving communication and situational awareness. Situational awareness involves gathering the right information, analyzing it, and making predictions and projections based on the analysis [4]. Reporting issues while they are small oftentimes makes them easier to manage. This article will describe the development and implementation of the DSB in our hospital.

Setting

MetroHealth Medical Center is an academic medical center in Cleveland, OH, affiliated with Case Western Reserve University. Metrohealth is a public safety net hospital with 731 licensed beds and a total of 1,160,773 patient visits in 2014, with 27,933 inpatient stays and 106,000 emergency department (ED) visits. The staff includes 507 physicians, 374 resident physicians, and 1222 nurses.

Program Development

As Metrohealth was contemplating the DSB, a group of senior leaders, including the chief medical officer, visited the Cincinnati Children’s Hospital, which had a DSB process in place. Following that visit, a larger group of physicians and administrators from intake points, procedural areas, and ancillary departments were invited to listen in live to Cincinnati’s DSB. This turned out to be a pivotal step in gaining buy-in. The initial concerns from participants were that this would be another scheduled meeting in an already busy day. What we learned from listening in was that the DSB was conducted in a manner that was succinct and professional. Issues were identified without accusations or unrelated agendas. Following the call, participants discussed how impressed they were and clearly saw the value of the information that was shared. They began to brainstorm about what they could report that would be relevant to the audience.

It was determined that a leader and 2 facilitators would be assigned to each call. The role of the DSB leader is to trigger individual department report outs and to ensure follow-up on unresolved safety issues from the previous DSB. Leaders are recruited by senior leadership and need to be familiar with the effects that issues can have across the health care system. Leaders need to be able to ask pertinent questions, have the credibility to raise concerns, and have access to senior administration when they need to bypass usual administrative channels.

The role of the facilitators, who are all members of the Center for Quality, is to connect to the conference bridge line, to keep the DSB leader on task, and to record all departmental data and pertinent details of the DSB. The facilitators maintain the daily DSB document, which outlines the order in which departments are called to report and identifies for the leader any open items identified in the previous day’s DSB.

The Daily Safety Brief

Rollout

The DSB began 3 days per week on Monday, Wednesday and Friday at 0830. The time was moved to 0800 since participants found the later time difficult as it fell in the middle of an hour, potentially conflicting with other meetings and preparation for the daily bed huddle. We recognized that many meetings began right at the start of the DSB. The CEO requested that all 0800 meetings begin with a call in to listen to the DSB. After 2 months, the frequency was increased to 5 days per week, Monday through Friday. The hospital trialed a weekend DSB, however, feedback from participants found this extremely difficult to attend due to leaner weekend staffing models and found that information shared was not impactful. In particular, items were identified on the weekend daily safety briefs but the staff needed to resolve those items were generally not available until Monday.

Refinements

Coaching occurred to help people be more succinct in sharing information that would impact other areas. Information that was relevant only internally to their department was streamlined. The participants were counseled to identify items that had potential impact on other departments or where other departments had resources that might improve operations.

After a year, participating departments requested the addition of the logistics and construction departments to the DSB. The addition of the logistics department offered the opportunity for clinical departments to communicate what equipment was needed to start the day and created the opportunity for logistics to close the feedback loop by giving an estimate on expected time of arrival of equipment. The addition of the construction department helped communicate issues that may impact the organization, and helps to coordinate care to minimally impact patients and operations.

Examples of Safety Improvements

The DSB keeps the departmental leadership aware of problems developing in all areas of the hospital. Upcoming safety risks are identified early so that plans can be put in place to ameliorate them. The expectation of the DSB leader is that a problem that isn’t readily solved during the DSB must be taken to senior administration for resolution. As an example, an issue involving delays in the purchase of a required neonatal ventilator was taken directly to the CEO by the DSB leader, resulting in completion of the purchase within days. Importantly, the requirement to report at the DSB leads to a preoccupation with risk and reporting and leads to transparency among interdependent departments.

Another issue effectively addressed by the DSB was when we received notification of a required mandatory power shutdown for an extended period of time. The local power company informed our facilities management department director that they discovered issues requiring urgent replacement of the transformer within 2 weeks. Facilities management reported this in the morning DSB. The DSB leader requested all stakeholders to stay on the call following completion of the DSB, and plans were set in motion to plan for the shutdown of power. The team agreed to conference call again at noon the same day to continue planning, and the affected building was prepared for the shutdown by the following day.

Another benefit of the DSB is illustrated by our inpatient psychiatry unit, which reports an acuity measure each day on a scale of 1 to 10. The MetroHealth Police Department utilizes the report to adjust their rounding schedule, with increased presence on days with high acuity, which has led to an improvement in morale among psychiatry unit staff.

Challenges and Solutions

Since these reports are available to a wide audience in the organization, it is important to assure the reporters that no repercussions will ensue from any information that they provide. Senior leadership was enlisted to communicate with their departments that no repercussions would occur from reporting. As an example, some managers reported to the DSB development team privately that their supervisors were concerned about reporting of staff shortages on the DSB. As the shortages had patient care implications and affected other clinical departments, the DSB development team met with the involved supervisors to address the need for open reporting. In fact, repeated reporting of shortages in one support department on the DSB resulted in that issue being taken to high levels of administration leading to an increase in their staffing levels.

Scheduling can be a challenge for DSB participants. Holding the DSB at 0800 has led some departments to delegate the reporting or information gathering. For the individual reporting departments, creating a reporting workflow was a challenge. The departments needed to ensure that their DSB report was ready to go by 0800. This timeline forced departments to improve their own interdepartmental communication structure. An unexpected benefit of this requirement is that some departments have created a morning huddle to share information, which has reportedly improved communication and morale. The ambulatory network created a separate shared database for clinics to post concerns meeting DSB reporting criteria. One designated staff member would access this collective information when preparing for the DSB report. While most departments have a senior manager providing their report, this is not a requirement. In many departments, that reporter varies from day to day, although consistently it is someone with some administrative or leadership role in the department.

Conference call technology presented the solution to the problem of acquiring a meeting space for a large group. The DSB is broadcast from one physical location, where the facilitators and leader convene. While this conference room is open to anyone who wants to attend in person, most departments choose to participate through the conference line. The DSB conference call is open to anyone in the organization to access. Typically 35 to 40 phones are accessing the line each DSB. Challenges included callers not muting their phones, creating distracting background noise, and callers placing their phones on hold, which prompted the hospital hold message to play continuously. Multiple repeated reminders via email and at the start of the DSB has rectified this issue for the most part, with occasional reminders made when the issue recurs.

Data Management

Initially, an Excel file was created with columns for each reporting department as well as each item they were asked to report on. This “running” file became cumbersome. Retrieving information on past issues was not automated. Therefore, we enlisted the help of a data analyst to create an Access database. When it was complete, this new database allowed us to save information by individual dates, query number of days to issue resolution, and create reports noting unresolved issues for the leader to reference. Many data points can be queried in the access database. Real-time reports are available at all times and updated with every data entry. The database is able to identify departments not on the daily call and trend information, ie, how many listeners were on the DSB, number of falls, forensic patients in house, number of patients awaiting admission from the ED, number of ambulatory visits scheduled each day, equipment needed, number of cardiac arrest calls, and number of neonatal resuscitations.

At the conclusion of the call, the DSB report is completed and posted to a shared website on the hospital intranet for the entire hospital to access and read. Feedback from participant indicated that they found it cumbersome to access this. The communications department was enlisted to enable easy access and staff can now access the DSB report from the front page of the hospital intranet.

Outcomes

Since initiation of our DSB, we have tracked the average number of minutes spent on each call. When calls began, the average time on the call was 12.4 minutes. With the evolution of the DSB and coaching managers in various departments, the average time on the call is now 9.5 minutes in 2015, despite additional reporting departments joining the DSB.

Summary

The DSB has become an important tool in creating and moving towards a culture of safety and high reliability within the MetroHealth System. Over time, processes have become organized and engrained in all departments. This format has allowed issues to be brought forward timely where immediate attention can be given to achieve resolution in a nonthreatening manner, improving transparency. The fluidity of the DSB allows it to be enhanced and modified as improvements and opportunities are identified in the organization. The DSB has provided opportunities to create situational awareness which allows a look forward to prevention and creates a proactive environment. The results of these efforts has made MetroHealth a safer place for patients, visitors, and employees.

Corresponding author: Anne M. Aulisio, MSN, [email protected].

Financial disclosures: None.

From the MetroHealth Medical Center, Cleveland, OH.

Abstract

• Objective: To describe the process for the creation and development of the Daily Safety Brief (DSB) in our safety net hospital.
• Methods: We developed the DSB, a daily interdepartmental briefing intended to increase the safety of patients, employees, and visitors by improving communication and situational awareness. Situational awareness involves gathering the right information, analyzing it, and making predictions and projections based on the analysis. Reporting issues while they are small oftentimes makes them easier to manage. The average call length with 25 departments reporting is just 9.5 minutes.
• Results: Survey results reveal an overall average improvement in awareness among DSB participants about hospital safety issues. Average days to issue resolution is currently 2.3 days, with open issues tracked and reported on daily.
• Conclusion: The DSB has improved real-time communication and awareness about safety issues in our organization.

As health care organizations strive to ensure a culture of safety for patients and staff, they must also be able to demonstrate reliability in that culture. The concept of highly reliable organizations originated in aviation and military fields due to the high-stakes environment and need for rapid and effective communication across departments. High reliability in health care organizations is described by the Joint Commission as consistent excellence in quality and safety for every patient, every time [1].

Highly reliable organizations put systems in place that makes them resilient with methods that lead to consistent accomplishment of goals and strategies to avoid potentially catastrophic errors [2]. An integral component to success in all high reliability organizations is a method of “Plan-of-the-Day” meetings to keep staff apprised of critical updates throughout the health system impacting care delivery [3]. Leaders at MetroHealth Medical Center believed that a daily safety briefing would help support the hospital’s journey to high reliability. We developed the Daily Safety Brief (DSB), a daily interdepartmental briefing intended to increase the safety of patients, employees, and visitors by improving communication and situational awareness. Situational awareness involves gathering the right information, analyzing it, and making predictions and projections based on the analysis [4]. Reporting issues while they are small oftentimes makes them easier to manage. This article will describe the development and implementation of the DSB in our hospital.

Setting

MetroHealth Medical Center is an academic medical center in Cleveland, OH, affiliated with Case Western Reserve University. Metrohealth is a public safety net hospital with 731 licensed beds and a total of 1,160,773 patient visits in 2014, with 27,933 inpatient stays and 106,000 emergency department (ED) visits. The staff includes 507 physicians, 374 resident physicians, and 1222 nurses.

Program Development

As Metrohealth was contemplating the DSB, a group of senior leaders, including the chief medical officer, visited the Cincinnati Children’s Hospital, which had a DSB process in place. Following that visit, a larger group of physicians and administrators from intake points, procedural areas, and ancillary departments were invited to listen in live to Cincinnati’s DSB. This turned out to be a pivotal step in gaining buy-in. The initial concerns from participants were that this would be another scheduled meeting in an already busy day. What we learned from listening in was that the DSB was conducted in a manner that was succinct and professional. Issues were identified without accusations or unrelated agendas. Following the call, participants discussed how impressed they were and clearly saw the value of the information that was shared. They began to brainstorm about what they could report that would be relevant to the audience.

It was determined that a leader and 2 facilitators would be assigned to each call. The role of the DSB leader is to trigger individual department report outs and to ensure follow-up on unresolved safety issues from the previous DSB. Leaders are recruited by senior leadership and need to be familiar with the effects that issues can have across the health care system. Leaders need to be able to ask pertinent questions, have the credibility to raise concerns, and have access to senior administration when they need to bypass usual administrative channels.

The role of the facilitators, who are all members of the Center for Quality, is to connect to the conference bridge line, to keep the DSB leader on task, and to record all departmental data and pertinent details of the DSB. The facilitators maintain the daily DSB document, which outlines the order in which departments are called to report and identifies for the leader any open items identified in the previous day’s DSB.

The Daily Safety Brief

Rollout

The DSB began 3 days per week on Monday, Wednesday and Friday at 0830. The time was moved to 0800 since participants found the later time difficult as it fell in the middle of an hour, potentially conflicting with other meetings and preparation for the daily bed huddle. We recognized that many meetings began right at the start of the DSB. The CEO requested that all 0800 meetings begin with a call in to listen to the DSB. After 2 months, the frequency was increased to 5 days per week, Monday through Friday. The hospital trialed a weekend DSB, however, feedback from participants found this extremely difficult to attend due to leaner weekend staffing models and found that information shared was not impactful. In particular, items were identified on the weekend daily safety briefs but the staff needed to resolve those items were generally not available until Monday.

Refinements

Coaching occurred to help people be more succinct in sharing information that would impact other areas. Information that was relevant only internally to their department was streamlined. The participants were counseled to identify items that had potential impact on other departments or where other departments had resources that might improve operations.

After a year, participating departments requested the addition of the logistics and construction departments to the DSB. The addition of the logistics department offered the opportunity for clinical departments to communicate what equipment was needed to start the day and created the opportunity for logistics to close the feedback loop by giving an estimate on expected time of arrival of equipment. The addition of the construction department helped communicate issues that may impact the organization, and helps to coordinate care to minimally impact patients and operations.

Examples of Safety Improvements

The DSB keeps the departmental leadership aware of problems developing in all areas of the hospital. Upcoming safety risks are identified early so that plans can be put in place to ameliorate them. The expectation of the DSB leader is that a problem that isn’t readily solved during the DSB must be taken to senior administration for resolution. As an example, an issue involving delays in the purchase of a required neonatal ventilator was taken directly to the CEO by the DSB leader, resulting in completion of the purchase within days. Importantly, the requirement to report at the DSB leads to a preoccupation with risk and reporting and leads to transparency among interdependent departments.

Another issue effectively addressed by the DSB was when we received notification of a required mandatory power shutdown for an extended period of time. The local power company informed our facilities management department director that they discovered issues requiring urgent replacement of the transformer within 2 weeks. Facilities management reported this in the morning DSB. The DSB leader requested all stakeholders to stay on the call following completion of the DSB, and plans were set in motion to plan for the shutdown of power. The team agreed to conference call again at noon the same day to continue planning, and the affected building was prepared for the shutdown by the following day.

Another benefit of the DSB is illustrated by our inpatient psychiatry unit, which reports an acuity measure each day on a scale of 1 to 10. The MetroHealth Police Department utilizes the report to adjust their rounding schedule, with increased presence on days with high acuity, which has led to an improvement in morale among psychiatry unit staff.

Challenges and Solutions

Since these reports are available to a wide audience in the organization, it is important to assure the reporters that no repercussions will ensue from any information that they provide. Senior leadership was enlisted to communicate with their departments that no repercussions would occur from reporting. As an example, some managers reported to the DSB development team privately that their supervisors were concerned about reporting of staff shortages on the DSB. As the shortages had patient care implications and affected other clinical departments, the DSB development team met with the involved supervisors to address the need for open reporting. In fact, repeated reporting of shortages in one support department on the DSB resulted in that issue being taken to high levels of administration leading to an increase in their staffing levels.

Scheduling can be a challenge for DSB participants. Holding the DSB at 0800 has led some departments to delegate the reporting or information gathering. For the individual reporting departments, creating a reporting workflow was a challenge. The departments needed to ensure that their DSB report was ready to go by 0800. This timeline forced departments to improve their own interdepartmental communication structure. An unexpected benefit of this requirement is that some departments have created a morning huddle to share information, which has reportedly improved communication and morale. The ambulatory network created a separate shared database for clinics to post concerns meeting DSB reporting criteria. One designated staff member would access this collective information when preparing for the DSB report. While most departments have a senior manager providing their report, this is not a requirement. In many departments, that reporter varies from day to day, although consistently it is someone with some administrative or leadership role in the department.

Conference call technology presented the solution to the problem of acquiring a meeting space for a large group. The DSB is broadcast from one physical location, where the facilitators and leader convene. While this conference room is open to anyone who wants to attend in person, most departments choose to participate through the conference line. The DSB conference call is open to anyone in the organization to access. Typically 35 to 40 phones are accessing the line each DSB. Challenges included callers not muting their phones, creating distracting background noise, and callers placing their phones on hold, which prompted the hospital hold message to play continuously. Multiple repeated reminders via email and at the start of the DSB has rectified this issue for the most part, with occasional reminders made when the issue recurs.

Data Management

Initially, an Excel file was created with columns for each reporting department as well as each item they were asked to report on. This “running” file became cumbersome. Retrieving information on past issues was not automated. Therefore, we enlisted the help of a data analyst to create an Access database. When it was complete, this new database allowed us to save information by individual dates, query number of days to issue resolution, and create reports noting unresolved issues for the leader to reference. Many data points can be queried in the access database. Real-time reports are available at all times and updated with every data entry. The database is able to identify departments not on the daily call and trend information, ie, how many listeners were on the DSB, number of falls, forensic patients in house, number of patients awaiting admission from the ED, number of ambulatory visits scheduled each day, equipment needed, number of cardiac arrest calls, and number of neonatal resuscitations.

At the conclusion of the call, the DSB report is completed and posted to a shared website on the hospital intranet for the entire hospital to access and read. Feedback from participant indicated that they found it cumbersome to access this. The communications department was enlisted to enable easy access and staff can now access the DSB report from the front page of the hospital intranet.

Outcomes

Since initiation of our DSB, we have tracked the average number of minutes spent on each call. When calls began, the average time on the call was 12.4 minutes. With the evolution of the DSB and coaching managers in various departments, the average time on the call is now 9.5 minutes in 2015, despite additional reporting departments joining the DSB.

Summary

The DSB has become an important tool in creating and moving towards a culture of safety and high reliability within the MetroHealth System. Over time, processes have become organized and engrained in all departments. This format has allowed issues to be brought forward timely where immediate attention can be given to achieve resolution in a nonthreatening manner, improving transparency. The fluidity of the DSB allows it to be enhanced and modified as improvements and opportunities are identified in the organization. The DSB has provided opportunities to create situational awareness which allows a look forward to prevention and creates a proactive environment. The results of these efforts has made MetroHealth a safer place for patients, visitors, and employees.

Corresponding author: Anne M. Aulisio, MSN, [email protected].

Financial disclosures: None.

Study Overview

Objective. To determine the effectiveness of high-dose vitamin D versus low-dose vitamin D in reducing the risk of functional decline in older adults.

Design. Double-blind randomized controlled trial.

Setting and participants. This single-center study was conducted at the University of Zurich. Home-dwelling adults aged 70 and over were recruited through newspaper advertisement in Zurich from December 2009 to May 2010. Inclusion criteria included maintenance of mobility with or without a walking aid, having the ability to use public transportation to attend clinic visits, and scoring at least 27 on the Mini-Mental State Examination. Exclusion criteria include supplemental vitamin D use exceeding 800 IU per day and unwillingness to discontinue additional calcium and vitamin D supplementation, current cancer, malabsorption syndrome, heavy alcohol consumption, uncontrolled hypocalcemia, severe visual or hearing impairment, use of medications affecting calcium metabolism, diseases causing hypercalcemia, planned travel to sunny locations for longer than 2 months per year, maximum calcium supplement dose of 250 mg/day, use of medications affecting serum 25-hydroxyvitamin D (25[OH]D) level, body mass index ≥ 40, diseases predisposing to falls, hypercalcemia, kidney disease with creatinine clearance < 15, or kidney stone within 10 years prior to enrollment.

Intervention. Participants were randomized to receive either monthly supplementation of 24,000 IU of vitamin D3 per month (low-dose group), 60,000 IU of vitamin D3 once per month (high-dose group), or 24,000 IU of vitamin D3 plus 300 µg of calcifediol once per month. It was hypothesized that higher monthly doses of vitamin D or in combination with calcifediol, which is a liver metabolite approximately 2 to 3 times more potent than vitamin D3, will increase levels of 25(OH)D and reduce the risk of functional decline.

Main outcome measures. Lower extremity function using the Short Physical Performance Battery and 25(OH)D levels at 6 and 12 months. Study nurses called participants monthly to assess falls, adverse events, and adherence to study medications.

Main results. A total of 200 participants were enrolled. Average age was 78 years (SD = 5) and 67% were female; all had a history of falls in the previous year and average baseline 25(OH)D levels ranged from 18.4 to 20.9 ng/mL in the three groups. Adherence to the study medication exceeded 94% throughout the study trial in all treatment groups.

At 6 and 12 months, 25(OH)D levels increased by an average of 12.7 and 11.7 ng/mL in the low-dose group, an average of 18.3 and 19.2 ng/mL in the high-dose group, and an average of 27.6 and 25.8 ng/mL in the calcifediol-added group. The mean changes in physical performance score indicating lower extremity function did not differ significantly among treatment groups (P = 0.26), but for one measure—the 5 successive chair stands—the 2 high-dose groups had less improvement when compared with the low-dose group. At 12 months, 66.9% of the high-dose group and 66.1% in the group with calcifediol fell during the study period, which was more than the low-dose group (47.9%, P = 0.048). The mean number of falls was also higher among the high-dose and calcifediol groups when compared with the low-dose group.

Conclusion. Higher doses of vitamin D were not better than lower doses of vitamin D in improving lower extremity function and were associated with higher risk of falls.

Commentary

Vitamin D deficiency is common among older adults and is associated with sarcopenia, functional decline, falls, and fractures [1,2]. Prior meta-analysis has supported that supplementation with vitamin D may lead to improved outcomes in fracture prevention [3]. However, the US Preventive Services Task Force, using more recent evidence reviews and an updated meta-analysis [4], found evidence lacking regarding the benefit of supplementation with vitamin D in community-dwelling postmenopausal women at doses > 400 IU, found no benefit in this group for doses ≤ 400, and found evidence lacking for supplementation in men or premenopausal women at any dose [5]. At the same time, the USPSTF also recommends exercise or physical therapy and vitamin D supplementation (800 IU daily) to prevent falls in community-dwelling adults ≥ 65 years at increased risk for falls [6]. This is consistent with the Institute of Medicine’s recommendation of 800 IU per day for older adults [7].

The current study attempted to elucidate the potential impact of high-dose vitamin D supplementation, hypothesizing that higher doses will achieve improvement in vitamin D levels and better outcomes in terms of lower extremity function and falls. However, the investigators found that rather than lowering risk of falls, higher-dose vitamin D was associated with elevated risk of falls without the benefit of improving lower extremity function. This is not the first study that has demonstrated that higher doses of vitamin D supplementation may be associated with harm. A prior randomized controlled trial utilizing a different dosing strategy of annual high- dose vitamin D supplementation also found that higher doses were associated with increased risks of falls [8]. Nonetheless, it helps support the notion that in vitamin D supplementation, more is not necessarily better.

The study is not without its drawbacks. The sample size was relatively small and the trial may have been underpowered to detect whether there may be certain patients for whom high-dose vitamin D supplementation may have a role. Also, the study was based in Zurich, which has a relatively uniform population, and study results may not be generalizable to populations in other countries.

Applications for Clinical Practice

The study lends support to the current recommendation of the Institute of Medicine—800 IU a day—for fall prevention, which is equivalent in dose to the 24,000 IU per month utilized in the trial. One of the questions not answered by the study is whether high-dose supplementation for adults who have severe deficiency in vitamin D is beneficial or harmful when compared with lower-dose supplementation. In clinical practice, clinicians often check an initial level of vitamin D and aim for a target level with supplementation. Among those patients with extremely low baseline levels, a lower-dose regimen of 800 IU a day may not yield a normalized level of vitamin D. Further studies are needed to elucidate whether there may be a role for higher-dose supplementation in these individuals. Nonetheless, it is clear that the current evidence does not support the routine use of high-dose vitamin D supplementation; it does not lead to better lower extremity function and may cause harm.

 —William Hung, MD, MPH

Study Overview

Objective. To determine the effectiveness of high-dose vitamin D versus low-dose vitamin D in reducing the risk of functional decline in older adults.

Design. Double-blind randomized controlled trial.

Setting and participants. This single-center study was conducted at the University of Zurich. Home-dwelling adults aged 70 and over were recruited through newspaper advertisement in Zurich from December 2009 to May 2010. Inclusion criteria included maintenance of mobility with or without a walking aid, having the ability to use public transportation to attend clinic visits, and scoring at least 27 on the Mini-Mental State Examination. Exclusion criteria include supplemental vitamin D use exceeding 800 IU per day and unwillingness to discontinue additional calcium and vitamin D supplementation, current cancer, malabsorption syndrome, heavy alcohol consumption, uncontrolled hypocalcemia, severe visual or hearing impairment, use of medications affecting calcium metabolism, diseases causing hypercalcemia, planned travel to sunny locations for longer than 2 months per year, maximum calcium supplement dose of 250 mg/day, use of medications affecting serum 25-hydroxyvitamin D (25[OH]D) level, body mass index ≥ 40, diseases predisposing to falls, hypercalcemia, kidney disease with creatinine clearance < 15, or kidney stone within 10 years prior to enrollment.

Intervention. Participants were randomized to receive either monthly supplementation of 24,000 IU of vitamin D3 per month (low-dose group), 60,000 IU of vitamin D3 once per month (high-dose group), or 24,000 IU of vitamin D3 plus 300 µg of calcifediol once per month. It was hypothesized that higher monthly doses of vitamin D or in combination with calcifediol, which is a liver metabolite approximately 2 to 3 times more potent than vitamin D3, will increase levels of 25(OH)D and reduce the risk of functional decline.

Main outcome measures. Lower extremity function using the Short Physical Performance Battery and 25(OH)D levels at 6 and 12 months. Study nurses called participants monthly to assess falls, adverse events, and adherence to study medications.

Main results. A total of 200 participants were enrolled. Average age was 78 years (SD = 5) and 67% were female; all had a history of falls in the previous year and average baseline 25(OH)D levels ranged from 18.4 to 20.9 ng/mL in the three groups. Adherence to the study medication exceeded 94% throughout the study trial in all treatment groups.

At 6 and 12 months, 25(OH)D levels increased by an average of 12.7 and 11.7 ng/mL in the low-dose group, an average of 18.3 and 19.2 ng/mL in the high-dose group, and an average of 27.6 and 25.8 ng/mL in the calcifediol-added group. The mean changes in physical performance score indicating lower extremity function did not differ significantly among treatment groups (P = 0.26), but for one measure—the 5 successive chair stands—the 2 high-dose groups had less improvement when compared with the low-dose group. At 12 months, 66.9% of the high-dose group and 66.1% in the group with calcifediol fell during the study period, which was more than the low-dose group (47.9%, P = 0.048). The mean number of falls was also higher among the high-dose and calcifediol groups when compared with the low-dose group.

Conclusion. Higher doses of vitamin D were not better than lower doses of vitamin D in improving lower extremity function and were associated with higher risk of falls.

Commentary

Vitamin D deficiency is common among older adults and is associated with sarcopenia, functional decline, falls, and fractures [1,2]. Prior meta-analysis has supported that supplementation with vitamin D may lead to improved outcomes in fracture prevention [3]. However, the US Preventive Services Task Force, using more recent evidence reviews and an updated meta-analysis [4], found evidence lacking regarding the benefit of supplementation with vitamin D in community-dwelling postmenopausal women at doses > 400 IU, found no benefit in this group for doses ≤ 400, and found evidence lacking for supplementation in men or premenopausal women at any dose [5]. At the same time, the USPSTF also recommends exercise or physical therapy and vitamin D supplementation (800 IU daily) to prevent falls in community-dwelling adults ≥ 65 years at increased risk for falls [6]. This is consistent with the Institute of Medicine’s recommendation of 800 IU per day for older adults [7].

The current study attempted to elucidate the potential impact of high-dose vitamin D supplementation, hypothesizing that higher doses will achieve improvement in vitamin D levels and better outcomes in terms of lower extremity function and falls. However, the investigators found that rather than lowering risk of falls, higher-dose vitamin D was associated with elevated risk of falls without the benefit of improving lower extremity function. This is not the first study that has demonstrated that higher doses of vitamin D supplementation may be associated with harm. A prior randomized controlled trial utilizing a different dosing strategy of annual high- dose vitamin D supplementation also found that higher doses were associated with increased risks of falls [8]. Nonetheless, it helps support the notion that in vitamin D supplementation, more is not necessarily better.

The study is not without its drawbacks. The sample size was relatively small and the trial may have been underpowered to detect whether there may be certain patients for whom high-dose vitamin D supplementation may have a role. Also, the study was based in Zurich, which has a relatively uniform population, and study results may not be generalizable to populations in other countries.

Applications for Clinical Practice

The study lends support to the current recommendation of the Institute of Medicine—800 IU a day—for fall prevention, which is equivalent in dose to the 24,000 IU per month utilized in the trial. One of the questions not answered by the study is whether high-dose supplementation for adults who have severe deficiency in vitamin D is beneficial or harmful when compared with lower-dose supplementation. In clinical practice, clinicians often check an initial level of vitamin D and aim for a target level with supplementation. Among those patients with extremely low baseline levels, a lower-dose regimen of 800 IU a day may not yield a normalized level of vitamin D. Further studies are needed to elucidate whether there may be a role for higher-dose supplementation in these individuals. Nonetheless, it is clear that the current evidence does not support the routine use of high-dose vitamin D supplementation; it does not lead to better lower extremity function and may cause harm.

 —William Hung, MD, MPH

Study Overview

Objective. To determine the effectiveness of high-dose vitamin D versus low-dose vitamin D in reducing the risk of functional decline in older adults.

Design. Double-blind randomized controlled trial.

Setting and participants. This single-center study was conducted at the University of Zurich. Home-dwelling adults aged 70 and over were recruited through newspaper advertisement in Zurich from December 2009 to May 2010. Inclusion criteria included maintenance of mobility with or without a walking aid, having the ability to use public transportation to attend clinic visits, and scoring at least 27 on the Mini-Mental State Examination. Exclusion criteria include supplemental vitamin D use exceeding 800 IU per day and unwillingness to discontinue additional calcium and vitamin D supplementation, current cancer, malabsorption syndrome, heavy alcohol consumption, uncontrolled hypocalcemia, severe visual or hearing impairment, use of medications affecting calcium metabolism, diseases causing hypercalcemia, planned travel to sunny locations for longer than 2 months per year, maximum calcium supplement dose of 250 mg/day, use of medications affecting serum 25-hydroxyvitamin D (25[OH]D) level, body mass index ≥ 40, diseases predisposing to falls, hypercalcemia, kidney disease with creatinine clearance < 15, or kidney stone within 10 years prior to enrollment.

Intervention. Participants were randomized to receive either monthly supplementation of 24,000 IU of vitamin D3 per month (low-dose group), 60,000 IU of vitamin D3 once per month (high-dose group), or 24,000 IU of vitamin D3 plus 300 µg of calcifediol once per month. It was hypothesized that higher monthly doses of vitamin D or in combination with calcifediol, which is a liver metabolite approximately 2 to 3 times more potent than vitamin D3, will increase levels of 25(OH)D and reduce the risk of functional decline.

Main outcome measures. Lower extremity function using the Short Physical Performance Battery and 25(OH)D levels at 6 and 12 months. Study nurses called participants monthly to assess falls, adverse events, and adherence to study medications.

Main results. A total of 200 participants were enrolled. Average age was 78 years (SD = 5) and 67% were female; all had a history of falls in the previous year and average baseline 25(OH)D levels ranged from 18.4 to 20.9 ng/mL in the three groups. Adherence to the study medication exceeded 94% throughout the study trial in all treatment groups.

At 6 and 12 months, 25(OH)D levels increased by an average of 12.7 and 11.7 ng/mL in the low-dose group, an average of 18.3 and 19.2 ng/mL in the high-dose group, and an average of 27.6 and 25.8 ng/mL in the calcifediol-added group. The mean changes in physical performance score indicating lower extremity function did not differ significantly among treatment groups (P = 0.26), but for one measure—the 5 successive chair stands—the 2 high-dose groups had less improvement when compared with the low-dose group. At 12 months, 66.9% of the high-dose group and 66.1% in the group with calcifediol fell during the study period, which was more than the low-dose group (47.9%, P = 0.048). The mean number of falls was also higher among the high-dose and calcifediol groups when compared with the low-dose group.

Conclusion. Higher doses of vitamin D were not better than lower doses of vitamin D in improving lower extremity function and were associated with higher risk of falls.

Commentary

Vitamin D deficiency is common among older adults and is associated with sarcopenia, functional decline, falls, and fractures [1,2]. Prior meta-analysis has supported that supplementation with vitamin D may lead to improved outcomes in fracture prevention [3]. However, the US Preventive Services Task Force, using more recent evidence reviews and an updated meta-analysis [4], found evidence lacking regarding the benefit of supplementation with vitamin D in community-dwelling postmenopausal women at doses > 400 IU, found no benefit in this group for doses ≤ 400, and found evidence lacking for supplementation in men or premenopausal women at any dose [5]. At the same time, the USPSTF also recommends exercise or physical therapy and vitamin D supplementation (800 IU daily) to prevent falls in community-dwelling adults ≥ 65 years at increased risk for falls [6]. This is consistent with the Institute of Medicine’s recommendation of 800 IU per day for older adults [7].

The current study attempted to elucidate the potential impact of high-dose vitamin D supplementation, hypothesizing that higher doses will achieve improvement in vitamin D levels and better outcomes in terms of lower extremity function and falls. However, the investigators found that rather than lowering risk of falls, higher-dose vitamin D was associated with elevated risk of falls without the benefit of improving lower extremity function. This is not the first study that has demonstrated that higher doses of vitamin D supplementation may be associated with harm. A prior randomized controlled trial utilizing a different dosing strategy of annual high- dose vitamin D supplementation also found that higher doses were associated with increased risks of falls [8]. Nonetheless, it helps support the notion that in vitamin D supplementation, more is not necessarily better.

The study is not without its drawbacks. The sample size was relatively small and the trial may have been underpowered to detect whether there may be certain patients for whom high-dose vitamin D supplementation may have a role. Also, the study was based in Zurich, which has a relatively uniform population, and study results may not be generalizable to populations in other countries.

Applications for Clinical Practice

The study lends support to the current recommendation of the Institute of Medicine—800 IU a day—for fall prevention, which is equivalent in dose to the 24,000 IU per month utilized in the trial. One of the questions not answered by the study is whether high-dose supplementation for adults who have severe deficiency in vitamin D is beneficial or harmful when compared with lower-dose supplementation. In clinical practice, clinicians often check an initial level of vitamin D and aim for a target level with supplementation. Among those patients with extremely low baseline levels, a lower-dose regimen of 800 IU a day may not yield a normalized level of vitamin D. Further studies are needed to elucidate whether there may be a role for higher-dose supplementation in these individuals. Nonetheless, it is clear that the current evidence does not support the routine use of high-dose vitamin D supplementation; it does not lead to better lower extremity function and may cause harm.

 —William Hung, MD, MPH

Study Overview

Objective. To assess how patients look for patient-obtained medication information (POMI) to prepare for a clinical appointment, whether they share those findings with their provider, and how health literacy and patient activation relate to a patient’s perception of the physician’s reaction to POMI.

Design. Cross-sectional survey-based study.

Setting and participants. The study took place over 1 week at 2 academic medical centers located in Las Vegas, Nevada, and Washington, DC. At a central waiting area at each facility, patients aged 18 and older waiting for their clinical appointment were invited to complete a survey, either on a computer tablet or with paper and pencil, before and after their appointment.

Measures and analysis. The pre-survey included demographic measures (age, gender, education, and ethnicity), the reason for the visit (routine care, sick visit, follow-up after survey, and follow-up after emergency room visit), and an item to assess self-report of perceived general health (from poor to excellent). Health literacy was assessed by a self-report measure that included subscales for the 3 dimensions of health literacy: functional, communicative, and critical health literacy [1]; together, these capture the ability of patients to retain health knowledge, gather and communicate health concepts, and apply health information. Patient activation was scored using the Patient Activation Measure (13 Likert-style items, total scale range 0–100); patient activation combines a patient’s self-reported knowledge, skill, and confidence for self-management of general health or a chronic condition [2]. Information seeking was measured by time spent (did not look for information, 1 hour, 2 hours, 3 hours, or more than 3 hours), and information channels used to look for POMI (eg, magazines/newspapers, internet website or search engine) were presented dichotomously (yes/no).

The post-survey first asked whether the participant shared information with their provider (yes/no). If the participant said yes, 4 items assessed their perception of the provider’s response, including amount of time spent discussing POMI, how seriously the provider considered the information, and overall reaction (scored as a mean, each item measured from 1–5, with 5 indicating the most positive reactions). For hypothesis testing, logistic regression models were used to test the effects of the independent variables. To explore the relationship between health literacy/patient activation and physician response, correlations were calculated.

Main results. Over 400 patients were asked to participate, and of these a total of 243 (60.75%) patients were eligible, consented, and completed surveys. Participants were predominantly white (57.6%), female (63%), had some college education or higher (80.2%), and had a clinical appointment for routine care (69.3%). The mean age was 47.04 years (SD, 15.78), the mean health status was 3.20 (SD, 0.94), and the mean Patient Activation Measure was 72.43 (SD, 16.00).

More than half of participants (58.26%) who responded to the item about information seeking indicated seeking POMI prior to their clinical appointment. Of these, the majority (88.7%) reported using the internet, particularly WebMD, as an information channel. Significant predictors of information seeking included age (P = 0.01, OR = 0.973), communicative health literacy (P = 0.01, or = 1.975), and critical health literacy (P = 0.05, OR = 1.518). Lower age, higher communicative health literacy, and higher critical health literacy increased the likelihood of the patient seeking POMI prior to the clinical appointment. Other assessed predictors were not significant, including gender, functional health literacy, patient activation, reason for visit, and reported health status.

58.2% of the 141 information-seeking patients talked to their health care provider about the information they found. However, no predictor variables included in a logistic regression analysis were significant, including age, gender, reason for visit, reported health status, functional health literacy, communicative health literacy, critical health literacy, and patient activation. For the research question (how do health literacy and patient activation relate to a patient’s perception of the physician’s reaction to POMI), the mean score on the 4-item measure was 4.08 (SD, 0.90), indicating a generally positive response; most reported the physician response was good or higher. Patient activation correlated positively with perceived physician response (r = 0.245, P = 0.03).

Conclusion. The lack of data to predict who will introduce POMI at the medical visit is disconcerting. Providers might consider directly asking or passively surveying what outside information sources the patient has engaged with, regardless of whether patient introduces the information or does not introduce it.

Commentary

Patient engagement plays an important role in health care [3]. Activated patients often have skills and confidence to engage in their health care and with their provider, which often contributes to better health outcomes and care experiences [2,4] as well as lower health care costs [5]. Health information is needed to make informed decisions, manage health, and practice healthy behaviors [6], and patients are increasingly taking an active role in seeking out medical or health information outside of the clinical encounter in order to make shared health decisions with their provider [7]. Indeed, one of the Healthy People 2020 goals is to “Use health communication strategies and health information technology  to improve population health outcomes and health care quality, and to achieve health equity” [8].

However, seeking POMI requires health literacy skills and supportive relationships, particularly when navigating the many channels and complexities of publicly available health information [8]. This is especially true on the internet, where there is often varying accuracy and clarity of information presented. According to 2011 data from the Pew Research Center [9], 74% of adults in the United States use the internet, and of those adults 80% have looked online for health information; 34% have read another person’s commentary or experience about health or medical issues on an online news group, website, or blog; 25% have watched an online video about health or medical issues; and 24% have consulted online reviews of particular drugs or medical treatments.

A general strength of this study was the cross-sectional design, which allowed for surveying patients around attitudes, motivations, and behaviors immediately before and after their clinical encounter. According to the authors, this study design was aimed to extend knowledge around information seeking and provider discussions that have occurred distally and relied on patient long-term recall. Additionally, this study surveyed a variety of patients (not limited to either primary or specialist appointments) at 2 different academic medical centers, and gave patients a choice to either take the survey on a computer tablet or traditional paper and pencil. Further, the authors assessed the reliability of scales used and included a number of predictor variables in the logistic regression models for hypothesis testing.

The authors acknowledged several limitations, including the use of convenience sampling and self-reported data with volunteer participants, which can result in self-selection bias and social desirability bias. As study participants were self-selecting, low health literacy patients may have been more likely to not volunteer to take the survey, which might explain the relatively high mean scores on the health literacy measures. Further, participants were mostly white, female, college-educated, health literate, and scheduled for a routine visit, which limits the generalizability of the study findings and the ability to identify significant predictors.

Regarding the study design, pre-/post-tests are usually used to measure the change in a situation, phenomenon, problem, or attitude. However, as the authors did not aim to measure any change during the clinical encounter itself, the use of only a post-test may have been more appropriate. The use of a pre-/post-test design may have increased the likelihood of patients both recalling POMI before the encounter and then sharing POMI with their provider. Also, in the post-survey, the authors only asked follow-up questions of patients that shared POMI with their provider. An open-response question could have been included to explore further why some patients chose not to introduce POMI during the clinical encounter. Lastly, the authors may have been able to reach more patients with lower health literacy if surveys were administered at public hospitals as opposed to academic medical centers. While some providers may perceive that patients in academic medical centers are more complex or may have limited access to care [10], patients at public hospitals and safety net hospitals tend to be of lower income and have limited or no insurance [11,12].

Applications For Clinical Practice

There are documented communication-enhancing techniques and strategies that providers and other health professionals use, particularly among patients with low health literacy [13]. Based on this study, the authors conclude that providers may try another strategy of directly asking or passively surveying any POMI, regardless of whether the patient initiates this conversation. Other research has acknowledged that recognition of health literacy status allows for the use of appropriate communication tools [14]. However, providers need to recognize barriers to health information seeking, particularly among minorities and underserved populations [15], as well as the potential for embarrassment that patients might experience as a result of revealing misunderstandings of health information or general reading difficulties [16]. This study highlights the need for further research to identify predictors of health information seeking and especially health information sharing by patients during the clinical encounter.

—Katrina F. Mateo, MPH

Study Overview

Objective. To assess how patients look for patient-obtained medication information (POMI) to prepare for a clinical appointment, whether they share those findings with their provider, and how health literacy and patient activation relate to a patient’s perception of the physician’s reaction to POMI.

Design. Cross-sectional survey-based study.

Setting and participants. The study took place over 1 week at 2 academic medical centers located in Las Vegas, Nevada, and Washington, DC. At a central waiting area at each facility, patients aged 18 and older waiting for their clinical appointment were invited to complete a survey, either on a computer tablet or with paper and pencil, before and after their appointment.

Measures and analysis. The pre-survey included demographic measures (age, gender, education, and ethnicity), the reason for the visit (routine care, sick visit, follow-up after survey, and follow-up after emergency room visit), and an item to assess self-report of perceived general health (from poor to excellent). Health literacy was assessed by a self-report measure that included subscales for the 3 dimensions of health literacy: functional, communicative, and critical health literacy [1]; together, these capture the ability of patients to retain health knowledge, gather and communicate health concepts, and apply health information. Patient activation was scored using the Patient Activation Measure (13 Likert-style items, total scale range 0–100); patient activation combines a patient’s self-reported knowledge, skill, and confidence for self-management of general health or a chronic condition [2]. Information seeking was measured by time spent (did not look for information, 1 hour, 2 hours, 3 hours, or more than 3 hours), and information channels used to look for POMI (eg, magazines/newspapers, internet website or search engine) were presented dichotomously (yes/no).

The post-survey first asked whether the participant shared information with their provider (yes/no). If the participant said yes, 4 items assessed their perception of the provider’s response, including amount of time spent discussing POMI, how seriously the provider considered the information, and overall reaction (scored as a mean, each item measured from 1–5, with 5 indicating the most positive reactions). For hypothesis testing, logistic regression models were used to test the effects of the independent variables. To explore the relationship between health literacy/patient activation and physician response, correlations were calculated.

Main results. Over 400 patients were asked to participate, and of these a total of 243 (60.75%) patients were eligible, consented, and completed surveys. Participants were predominantly white (57.6%), female (63%), had some college education or higher (80.2%), and had a clinical appointment for routine care (69.3%). The mean age was 47.04 years (SD, 15.78), the mean health status was 3.20 (SD, 0.94), and the mean Patient Activation Measure was 72.43 (SD, 16.00).

More than half of participants (58.26%) who responded to the item about information seeking indicated seeking POMI prior to their clinical appointment. Of these, the majority (88.7%) reported using the internet, particularly WebMD, as an information channel. Significant predictors of information seeking included age (P = 0.01, OR = 0.973), communicative health literacy (P = 0.01, or = 1.975), and critical health literacy (P = 0.05, OR = 1.518). Lower age, higher communicative health literacy, and higher critical health literacy increased the likelihood of the patient seeking POMI prior to the clinical appointment. Other assessed predictors were not significant, including gender, functional health literacy, patient activation, reason for visit, and reported health status.

58.2% of the 141 information-seeking patients talked to their health care provider about the information they found. However, no predictor variables included in a logistic regression analysis were significant, including age, gender, reason for visit, reported health status, functional health literacy, communicative health literacy, critical health literacy, and patient activation. For the research question (how do health literacy and patient activation relate to a patient’s perception of the physician’s reaction to POMI), the mean score on the 4-item measure was 4.08 (SD, 0.90), indicating a generally positive response; most reported the physician response was good or higher. Patient activation correlated positively with perceived physician response (r = 0.245, P = 0.03).

Conclusion. The lack of data to predict who will introduce POMI at the medical visit is disconcerting. Providers might consider directly asking or passively surveying what outside information sources the patient has engaged with, regardless of whether patient introduces the information or does not introduce it.

Commentary

Patient engagement plays an important role in health care [3]. Activated patients often have skills and confidence to engage in their health care and with their provider, which often contributes to better health outcomes and care experiences [2,4] as well as lower health care costs [5]. Health information is needed to make informed decisions, manage health, and practice healthy behaviors [6], and patients are increasingly taking an active role in seeking out medical or health information outside of the clinical encounter in order to make shared health decisions with their provider [7]. Indeed, one of the Healthy People 2020 goals is to “Use health communication strategies and health information technology  to improve population health outcomes and health care quality, and to achieve health equity” [8].

However, seeking POMI requires health literacy skills and supportive relationships, particularly when navigating the many channels and complexities of publicly available health information [8]. This is especially true on the internet, where there is often varying accuracy and clarity of information presented. According to 2011 data from the Pew Research Center [9], 74% of adults in the United States use the internet, and of those adults 80% have looked online for health information; 34% have read another person’s commentary or experience about health or medical issues on an online news group, website, or blog; 25% have watched an online video about health or medical issues; and 24% have consulted online reviews of particular drugs or medical treatments.

A general strength of this study was the cross-sectional design, which allowed for surveying patients around attitudes, motivations, and behaviors immediately before and after their clinical encounter. According to the authors, this study design was aimed to extend knowledge around information seeking and provider discussions that have occurred distally and relied on patient long-term recall. Additionally, this study surveyed a variety of patients (not limited to either primary or specialist appointments) at 2 different academic medical centers, and gave patients a choice to either take the survey on a computer tablet or traditional paper and pencil. Further, the authors assessed the reliability of scales used and included a number of predictor variables in the logistic regression models for hypothesis testing.

The authors acknowledged several limitations, including the use of convenience sampling and self-reported data with volunteer participants, which can result in self-selection bias and social desirability bias. As study participants were self-selecting, low health literacy patients may have been more likely to not volunteer to take the survey, which might explain the relatively high mean scores on the health literacy measures. Further, participants were mostly white, female, college-educated, health literate, and scheduled for a routine visit, which limits the generalizability of the study findings and the ability to identify significant predictors.

Regarding the study design, pre-/post-tests are usually used to measure the change in a situation, phenomenon, problem, or attitude. However, as the authors did not aim to measure any change during the clinical encounter itself, the use of only a post-test may have been more appropriate. The use of a pre-/post-test design may have increased the likelihood of patients both recalling POMI before the encounter and then sharing POMI with their provider. Also, in the post-survey, the authors only asked follow-up questions of patients that shared POMI with their provider. An open-response question could have been included to explore further why some patients chose not to introduce POMI during the clinical encounter. Lastly, the authors may have been able to reach more patients with lower health literacy if surveys were administered at public hospitals as opposed to academic medical centers. While some providers may perceive that patients in academic medical centers are more complex or may have limited access to care [10], patients at public hospitals and safety net hospitals tend to be of lower income and have limited or no insurance [11,12].

Applications For Clinical Practice

There are documented communication-enhancing techniques and strategies that providers and other health professionals use, particularly among patients with low health literacy [13]. Based on this study, the authors conclude that providers may try another strategy of directly asking or passively surveying any POMI, regardless of whether the patient initiates this conversation. Other research has acknowledged that recognition of health literacy status allows for the use of appropriate communication tools [14]. However, providers need to recognize barriers to health information seeking, particularly among minorities and underserved populations [15], as well as the potential for embarrassment that patients might experience as a result of revealing misunderstandings of health information or general reading difficulties [16]. This study highlights the need for further research to identify predictors of health information seeking and especially health information sharing by patients during the clinical encounter.

—Katrina F. Mateo, MPH

Study Overview

Objective. To assess how patients look for patient-obtained medication information (POMI) to prepare for a clinical appointment, whether they share those findings with their provider, and how health literacy and patient activation relate to a patient’s perception of the physician’s reaction to POMI.

Design. Cross-sectional survey-based study.

Setting and participants. The study took place over 1 week at 2 academic medical centers located in Las Vegas, Nevada, and Washington, DC. At a central waiting area at each facility, patients aged 18 and older waiting for their clinical appointment were invited to complete a survey, either on a computer tablet or with paper and pencil, before and after their appointment.

Measures and analysis. The pre-survey included demographic measures (age, gender, education, and ethnicity), the reason for the visit (routine care, sick visit, follow-up after survey, and follow-up after emergency room visit), and an item to assess self-report of perceived general health (from poor to excellent). Health literacy was assessed by a self-report measure that included subscales for the 3 dimensions of health literacy: functional, communicative, and critical health literacy [1]; together, these capture the ability of patients to retain health knowledge, gather and communicate health concepts, and apply health information. Patient activation was scored using the Patient Activation Measure (13 Likert-style items, total scale range 0–100); patient activation combines a patient’s self-reported knowledge, skill, and confidence for self-management of general health or a chronic condition [2]. Information seeking was measured by time spent (did not look for information, 1 hour, 2 hours, 3 hours, or more than 3 hours), and information channels used to look for POMI (eg, magazines/newspapers, internet website or search engine) were presented dichotomously (yes/no).

The post-survey first asked whether the participant shared information with their provider (yes/no). If the participant said yes, 4 items assessed their perception of the provider’s response, including amount of time spent discussing POMI, how seriously the provider considered the information, and overall reaction (scored as a mean, each item measured from 1–5, with 5 indicating the most positive reactions). For hypothesis testing, logistic regression models were used to test the effects of the independent variables. To explore the relationship between health literacy/patient activation and physician response, correlations were calculated.

Main results. Over 400 patients were asked to participate, and of these a total of 243 (60.75%) patients were eligible, consented, and completed surveys. Participants were predominantly white (57.6%), female (63%), had some college education or higher (80.2%), and had a clinical appointment for routine care (69.3%). The mean age was 47.04 years (SD, 15.78), the mean health status was 3.20 (SD, 0.94), and the mean Patient Activation Measure was 72.43 (SD, 16.00).

More than half of participants (58.26%) who responded to the item about information seeking indicated seeking POMI prior to their clinical appointment. Of these, the majority (88.7%) reported using the internet, particularly WebMD, as an information channel. Significant predictors of information seeking included age (P = 0.01, OR = 0.973), communicative health literacy (P = 0.01, or = 1.975), and critical health literacy (P = 0.05, OR = 1.518). Lower age, higher communicative health literacy, and higher critical health literacy increased the likelihood of the patient seeking POMI prior to the clinical appointment. Other assessed predictors were not significant, including gender, functional health literacy, patient activation, reason for visit, and reported health status.

58.2% of the 141 information-seeking patients talked to their health care provider about the information they found. However, no predictor variables included in a logistic regression analysis were significant, including age, gender, reason for visit, reported health status, functional health literacy, communicative health literacy, critical health literacy, and patient activation. For the research question (how do health literacy and patient activation relate to a patient’s perception of the physician’s reaction to POMI), the mean score on the 4-item measure was 4.08 (SD, 0.90), indicating a generally positive response; most reported the physician response was good or higher. Patient activation correlated positively with perceived physician response (r = 0.245, P = 0.03).

Conclusion. The lack of data to predict who will introduce POMI at the medical visit is disconcerting. Providers might consider directly asking or passively surveying what outside information sources the patient has engaged with, regardless of whether patient introduces the information or does not introduce it.

Commentary

Patient engagement plays an important role in health care [3]. Activated patients often have skills and confidence to engage in their health care and with their provider, which often contributes to better health outcomes and care experiences [2,4] as well as lower health care costs [5]. Health information is needed to make informed decisions, manage health, and practice healthy behaviors [6], and patients are increasingly taking an active role in seeking out medical or health information outside of the clinical encounter in order to make shared health decisions with their provider [7]. Indeed, one of the Healthy People 2020 goals is to “Use health communication strategies and health information technology  to improve population health outcomes and health care quality, and to achieve health equity” [8].

However, seeking POMI requires health literacy skills and supportive relationships, particularly when navigating the many channels and complexities of publicly available health information [8]. This is especially true on the internet, where there is often varying accuracy and clarity of information presented. According to 2011 data from the Pew Research Center [9], 74% of adults in the United States use the internet, and of those adults 80% have looked online for health information; 34% have read another person’s commentary or experience about health or medical issues on an online news group, website, or blog; 25% have watched an online video about health or medical issues; and 24% have consulted online reviews of particular drugs or medical treatments.

A general strength of this study was the cross-sectional design, which allowed for surveying patients around attitudes, motivations, and behaviors immediately before and after their clinical encounter. According to the authors, this study design was aimed to extend knowledge around information seeking and provider discussions that have occurred distally and relied on patient long-term recall. Additionally, this study surveyed a variety of patients (not limited to either primary or specialist appointments) at 2 different academic medical centers, and gave patients a choice to either take the survey on a computer tablet or traditional paper and pencil. Further, the authors assessed the reliability of scales used and included a number of predictor variables in the logistic regression models for hypothesis testing.

The authors acknowledged several limitations, including the use of convenience sampling and self-reported data with volunteer participants, which can result in self-selection bias and social desirability bias. As study participants were self-selecting, low health literacy patients may have been more likely to not volunteer to take the survey, which might explain the relatively high mean scores on the health literacy measures. Further, participants were mostly white, female, college-educated, health literate, and scheduled for a routine visit, which limits the generalizability of the study findings and the ability to identify significant predictors.

Regarding the study design, pre-/post-tests are usually used to measure the change in a situation, phenomenon, problem, or attitude. However, as the authors did not aim to measure any change during the clinical encounter itself, the use of only a post-test may have been more appropriate. The use of a pre-/post-test design may have increased the likelihood of patients both recalling POMI before the encounter and then sharing POMI with their provider. Also, in the post-survey, the authors only asked follow-up questions of patients that shared POMI with their provider. An open-response question could have been included to explore further why some patients chose not to introduce POMI during the clinical encounter. Lastly, the authors may have been able to reach more patients with lower health literacy if surveys were administered at public hospitals as opposed to academic medical centers. While some providers may perceive that patients in academic medical centers are more complex or may have limited access to care [10], patients at public hospitals and safety net hospitals tend to be of lower income and have limited or no insurance [11,12].

Applications For Clinical Practice

There are documented communication-enhancing techniques and strategies that providers and other health professionals use, particularly among patients with low health literacy [13]. Based on this study, the authors conclude that providers may try another strategy of directly asking or passively surveying any POMI, regardless of whether the patient initiates this conversation. Other research has acknowledged that recognition of health literacy status allows for the use of appropriate communication tools [14]. However, providers need to recognize barriers to health information seeking, particularly among minorities and underserved populations [15], as well as the potential for embarrassment that patients might experience as a result of revealing misunderstandings of health information or general reading difficulties [16]. This study highlights the need for further research to identify predictors of health information seeking and especially health information sharing by patients during the clinical encounter.

—Katrina F. Mateo, MPH

Light micrograph

of cancellous bone

Patients with acute lymphoblastic leukemia (ALL) may experience significant bone loss much earlier than previously assumed, according to a study published in the journal Bone.

Investigators analyzed a cohort of adolescent and young adult ALL patients before and after their first month of chemotherapy and observed “significant alterations” to cancellous and cortical bone in this short period of time.

Previous studies to determine the changes to bone density during ALL therapy had focused on the cumulative effects of chemotherapy after months or even years of treatment.

“In clinic, we would see patients with fractures and vertebral compression during the very first few weeks of treatment,” said study author Etan Orgel, MD, of Children’s Hospital Los Angeles in California.

“But we were unaware of any study that specifically examined bone before chemotherapy and immediately after the first 30 days of treatment, which would allow us to understand the impact of this early treatment phase.”

So Dr Orgel and his colleagues conducted a prospective study of 38 patients, ages 10 to 21, who were newly diagnosed with ALL.

The team used quantitative computerized tomography (QCT) to assess leukemia-related changes to bone at diagnosis and then the subsequent effects of the induction phase of chemotherapy.

All of the patients received a 28-day induction regimen consisting of vincristine, pegylated L-asparaginase, anthracycline (daunorubicin or doxorubicin), and a glucocorticoid (either prednisone at 60 mg/m²/day for 28 days or dexamethasone at 10 mg/m²/day for 14 days).

The investigators compared the patients to age- and sex-matched controls and found that leukemia did not dramatically alter the properties of bone before chemotherapy.

However, QCT revealed significant changes during the 30-day induction phase in the 35 patients who were well enough to undergo imaging after treatment.

The patients experienced a significant decrease in cancellous volumetric bone mineral density, which was measured in the spine. The median decrease was 27% (P<0.001).

There was no significant change in cortical volumetric bone mineral density, which was measured in the tibia (−0.0%, P=0.860) or femur (−0.7%, P=0.290).

But there was significant cortical thinning in the tibia. The average cortical thickness decreased 1.2% (P<0.001), and the cortical area decreased 0.4% (P=0.014).

The femur was less affected, the investigators said. There was a decrease in average cortical thickness, but this was not significant (-0.3%, P=0.740).

To help clinicians relate to these findings, the investigators also measured bone mineral density using the older but more widely available technique of dual-energy x-ray absorptiometry. They found that it underestimated these changes as compared to QCT measurements.

“Now that we know how soon bone toxicity occurs, we need to re-evaluate our approaches to managing these changes and focus research efforts on new ways to mitigate this common yet significant adverse effect,” said study author Steven Mittelman, MD, PhD, of Children’s Hospital Los Angeles.

Light micrograph

of cancellous bone

Patients with acute lymphoblastic leukemia (ALL) may experience significant bone loss much earlier than previously assumed, according to a study published in the journal Bone.

Investigators analyzed a cohort of adolescent and young adult ALL patients before and after their first month of chemotherapy and observed “significant alterations” to cancellous and cortical bone in this short period of time.

Previous studies to determine the changes to bone density during ALL therapy had focused on the cumulative effects of chemotherapy after months or even years of treatment.

“In clinic, we would see patients with fractures and vertebral compression during the very first few weeks of treatment,” said study author Etan Orgel, MD, of Children’s Hospital Los Angeles in California.

“But we were unaware of any study that specifically examined bone before chemotherapy and immediately after the first 30 days of treatment, which would allow us to understand the impact of this early treatment phase.”

So Dr Orgel and his colleagues conducted a prospective study of 38 patients, ages 10 to 21, who were newly diagnosed with ALL.

The team used quantitative computerized tomography (QCT) to assess leukemia-related changes to bone at diagnosis and then the subsequent effects of the induction phase of chemotherapy.

All of the patients received a 28-day induction regimen consisting of vincristine, pegylated L-asparaginase, anthracycline (daunorubicin or doxorubicin), and a glucocorticoid (either prednisone at 60 mg/m²/day for 28 days or dexamethasone at 10 mg/m²/day for 14 days).

The investigators compared the patients to age- and sex-matched controls and found that leukemia did not dramatically alter the properties of bone before chemotherapy.

However, QCT revealed significant changes during the 30-day induction phase in the 35 patients who were well enough to undergo imaging after treatment.

The patients experienced a significant decrease in cancellous volumetric bone mineral density, which was measured in the spine. The median decrease was 27% (P<0.001).

There was no significant change in cortical volumetric bone mineral density, which was measured in the tibia (−0.0%, P=0.860) or femur (−0.7%, P=0.290).

But there was significant cortical thinning in the tibia. The average cortical thickness decreased 1.2% (P<0.001), and the cortical area decreased 0.4% (P=0.014).

The femur was less affected, the investigators said. There was a decrease in average cortical thickness, but this was not significant (-0.3%, P=0.740).

To help clinicians relate to these findings, the investigators also measured bone mineral density using the older but more widely available technique of dual-energy x-ray absorptiometry. They found that it underestimated these changes as compared to QCT measurements.

“Now that we know how soon bone toxicity occurs, we need to re-evaluate our approaches to managing these changes and focus research efforts on new ways to mitigate this common yet significant adverse effect,” said study author Steven Mittelman, MD, PhD, of Children’s Hospital Los Angeles.

Light micrograph

of cancellous bone

Patients with acute lymphoblastic leukemia (ALL) may experience significant bone loss much earlier than previously assumed, according to a study published in the journal Bone.

Investigators analyzed a cohort of adolescent and young adult ALL patients before and after their first month of chemotherapy and observed “significant alterations” to cancellous and cortical bone in this short period of time.

Previous studies to determine the changes to bone density during ALL therapy had focused on the cumulative effects of chemotherapy after months or even years of treatment.

“In clinic, we would see patients with fractures and vertebral compression during the very first few weeks of treatment,” said study author Etan Orgel, MD, of Children’s Hospital Los Angeles in California.

“But we were unaware of any study that specifically examined bone before chemotherapy and immediately after the first 30 days of treatment, which would allow us to understand the impact of this early treatment phase.”

So Dr Orgel and his colleagues conducted a prospective study of 38 patients, ages 10 to 21, who were newly diagnosed with ALL.

The team used quantitative computerized tomography (QCT) to assess leukemia-related changes to bone at diagnosis and then the subsequent effects of the induction phase of chemotherapy.

All of the patients received a 28-day induction regimen consisting of vincristine, pegylated L-asparaginase, anthracycline (daunorubicin or doxorubicin), and a glucocorticoid (either prednisone at 60 mg/m²/day for 28 days or dexamethasone at 10 mg/m²/day for 14 days).

The investigators compared the patients to age- and sex-matched controls and found that leukemia did not dramatically alter the properties of bone before chemotherapy.

However, QCT revealed significant changes during the 30-day induction phase in the 35 patients who were well enough to undergo imaging after treatment.

The patients experienced a significant decrease in cancellous volumetric bone mineral density, which was measured in the spine. The median decrease was 27% (P<0.001).

There was no significant change in cortical volumetric bone mineral density, which was measured in the tibia (−0.0%, P=0.860) or femur (−0.7%, P=0.290).

But there was significant cortical thinning in the tibia. The average cortical thickness decreased 1.2% (P<0.001), and the cortical area decreased 0.4% (P=0.014).

The femur was less affected, the investigators said. There was a decrease in average cortical thickness, but this was not significant (-0.3%, P=0.740).

To help clinicians relate to these findings, the investigators also measured bone mineral density using the older but more widely available technique of dual-energy x-ray absorptiometry. They found that it underestimated these changes as compared to QCT measurements.

“Now that we know how soon bone toxicity occurs, we need to re-evaluate our approaches to managing these changes and focus research efforts on new ways to mitigate this common yet significant adverse effect,” said study author Steven Mittelman, MD, PhD, of Children’s Hospital Los Angeles.

I have become increasingly dismayed by reports of dermatologists who allow their nurse practitioners and physician assistants to practice independently.

That is, the employing dermatologists only see the patients, new or established, if they are asked to, and often are not even on the premises. In fact, they might be thousands of miles away.

A little background is in order. Physician assistants and nurse practitioners are formally trained in primary care, not in dermatology, although there are currently three 1-year programs to help them specialize in dermatology. When Congress authorized their independent payment in 1997, they envisioned primary care nurses traveling the hills, hollers, and inner cities improving health care. Unfortunately, this hasn’t happened, and instead they have moved into suburban America, and increasingly, are practicing specialty medicine.

It can be argued that decreased access to primary care, which was the reason midlevels were created, is more important than is access to dermatology. In particular, extenders have targeted office-based specialties such as dermatology, but also neurology and pain medicine. These specialties are office based, and credentialing by hospitals is not required to bill insurance plans. Also, these specialties have good-paying, seemingly simple, small procedures. They have accomplished this with the avid help of dermatologists, I might add. There will be an estimated 10,000 “dermatology” nurse practitioners and physician assistants next year.

Let me be clear: I am not opposed to a dermatology extender who works closely with a dermatologist and does intake histories and physicals, then staffs with the physician, assists with surgery, or sees routine follow-ups (think acne, psoriasis, atopy, suture removal, and warts) on an established protocol with the full knowledge of the patient.

This is not what we are seeing. We have nurse practitioners buying retiring dermatologists’ practices, physician assistants independently setting up remote clinics then hiring “supervising” dermatologists to visit once a week to sign and review charts, and independent “dermatology” clinics with a doctor thousands of miles away available, if really needed, by telephone or the Internet. (This is not really telemedicine, is it?) These extenders are listed as dermatologists on the Internet, or they hide behind the name of a dermatologist, and when you call their offices, and ask if you will see a “real” dermatologist, the answer is often “Oh, don’t worry, our nurse or PA specializes in dermatology.”

I think this is grossly unfair to patients, who, when they call the dermatology center listed on the Internet, can’t conceive that their dermatology appointment is not being made with a dermatologist, not even being made with a physician, but with a nurse practitioner or physician assistant! I also think it does a huge disservice to the specialty. The “collaborating” dermatologists enabling these extenders are renting out the good name of our specialty.

Patients seen by these extenders may also be subject to unnecessary biopsies. (If you don’t know what it is, you must biopsy it!) It also results in additional charges for pathology and additional medical misadventures.

In addition, I think it is unfair to the extender who is put in this situation. They may have worked in a dermatologist’s office for a few months or even years but are now being asked to pretend to be something they are not and being expected to perform at the level of a medical professional who has had many years of intense, focused training in dermatology. If they are not uncomfortable being thrust into this situation, then they are delusional.

I think it is unfair to the medical system who pays for the less informed opinion and unnecessary procedures. This is not a “good value” except to the rent-seeking dermatologists, who are the front men for this money-making deception.

This is an elephant in the room of dermatology, and I think we have to confront it. This trivializes our specialty and helps allow other specialties and regulatory agencies to ignore or exclude us from the networks and from the conversation. Unfortunately, many of our members and some of our leadership have been corrupted by the “easy money” or “easy time” afforded by this cheapening of the specialty.

Let me give you some examples. The rent seekers piously claim, “there is a shortage of dermatologists, and we are just trying to help save the world.” They also say “my nurses are special and great.”

The honest ones in private practice, however, say, “Man, I make $200,000 a year off my PA while I am off.” The honest academics say, “Listen, I work in a gulag, and I would never be able to travel if my nurses didn’t see my patients.” Time is money, and the academic who gets an extra 10 hours a week out of clinic is benefiting as much as the guy who makes $200,000 a year.

Of course, this situation is not sustainable and will become less viable because of a coming tsunami of malpractice claims, more focused insurer benchmarks revealing excessive test ordering and minor procedures, and patients getting wise. One obvious solution to this would be to reimburse extenders only for evaluation and management codes, which will take a change in law.

Meanwhile, I encourage all of you who feel the same nausea I do to ask candidates for your state and national dermatology organizations if they employ unsupervised extenders. Then check their website for the names of the extenders they employ. Then go to the Medicare data and look up their extenders and see if they bill independently for dermatologic procedures. I think you will be very disturbed, as I was and am.

I hope this stimulates a little self-examination among dermatologists.

Dr. Coldiron is a past-president of the American Academy of Dermatology. He is currently in private practice but maintains a clinical assistant professorship at the University of Cincinnati. He cares for patients, teaches medical students and residents, and has several active clinical research projects. Dr. Coldiron is the author of more than 80 scientific letters, papers, and several book chapters, and he speaks frequently on a variety of topics. Reach him at [email protected].

I have become increasingly dismayed by reports of dermatologists who allow their nurse practitioners and physician assistants to practice independently.

That is, the employing dermatologists only see the patients, new or established, if they are asked to, and often are not even on the premises. In fact, they might be thousands of miles away.

A little background is in order. Physician assistants and nurse practitioners are formally trained in primary care, not in dermatology, although there are currently three 1-year programs to help them specialize in dermatology. When Congress authorized their independent payment in 1997, they envisioned primary care nurses traveling the hills, hollers, and inner cities improving health care. Unfortunately, this hasn’t happened, and instead they have moved into suburban America, and increasingly, are practicing specialty medicine.

It can be argued that decreased access to primary care, which was the reason midlevels were created, is more important than is access to dermatology. In particular, extenders have targeted office-based specialties such as dermatology, but also neurology and pain medicine. These specialties are office based, and credentialing by hospitals is not required to bill insurance plans. Also, these specialties have good-paying, seemingly simple, small procedures. They have accomplished this with the avid help of dermatologists, I might add. There will be an estimated 10,000 “dermatology” nurse practitioners and physician assistants next year.

Let me be clear: I am not opposed to a dermatology extender who works closely with a dermatologist and does intake histories and physicals, then staffs with the physician, assists with surgery, or sees routine follow-ups (think acne, psoriasis, atopy, suture removal, and warts) on an established protocol with the full knowledge of the patient.

This is not what we are seeing. We have nurse practitioners buying retiring dermatologists’ practices, physician assistants independently setting up remote clinics then hiring “supervising” dermatologists to visit once a week to sign and review charts, and independent “dermatology” clinics with a doctor thousands of miles away available, if really needed, by telephone or the Internet. (This is not really telemedicine, is it?) These extenders are listed as dermatologists on the Internet, or they hide behind the name of a dermatologist, and when you call their offices, and ask if you will see a “real” dermatologist, the answer is often “Oh, don’t worry, our nurse or PA specializes in dermatology.”

I think this is grossly unfair to patients, who, when they call the dermatology center listed on the Internet, can’t conceive that their dermatology appointment is not being made with a dermatologist, not even being made with a physician, but with a nurse practitioner or physician assistant! I also think it does a huge disservice to the specialty. The “collaborating” dermatologists enabling these extenders are renting out the good name of our specialty.

Patients seen by these extenders may also be subject to unnecessary biopsies. (If you don’t know what it is, you must biopsy it!) It also results in additional charges for pathology and additional medical misadventures.

In addition, I think it is unfair to the extender who is put in this situation. They may have worked in a dermatologist’s office for a few months or even years but are now being asked to pretend to be something they are not and being expected to perform at the level of a medical professional who has had many years of intense, focused training in dermatology. If they are not uncomfortable being thrust into this situation, then they are delusional.

I think it is unfair to the medical system who pays for the less informed opinion and unnecessary procedures. This is not a “good value” except to the rent-seeking dermatologists, who are the front men for this money-making deception.

This is an elephant in the room of dermatology, and I think we have to confront it. This trivializes our specialty and helps allow other specialties and regulatory agencies to ignore or exclude us from the networks and from the conversation. Unfortunately, many of our members and some of our leadership have been corrupted by the “easy money” or “easy time” afforded by this cheapening of the specialty.

Let me give you some examples. The rent seekers piously claim, “there is a shortage of dermatologists, and we are just trying to help save the world.” They also say “my nurses are special and great.”

The honest ones in private practice, however, say, “Man, I make $200,000 a year off my PA while I am off.” The honest academics say, “Listen, I work in a gulag, and I would never be able to travel if my nurses didn’t see my patients.” Time is money, and the academic who gets an extra 10 hours a week out of clinic is benefiting as much as the guy who makes $200,000 a year.

Of course, this situation is not sustainable and will become less viable because of a coming tsunami of malpractice claims, more focused insurer benchmarks revealing excessive test ordering and minor procedures, and patients getting wise. One obvious solution to this would be to reimburse extenders only for evaluation and management codes, which will take a change in law.

Meanwhile, I encourage all of you who feel the same nausea I do to ask candidates for your state and national dermatology organizations if they employ unsupervised extenders. Then check their website for the names of the extenders they employ. Then go to the Medicare data and look up their extenders and see if they bill independently for dermatologic procedures. I think you will be very disturbed, as I was and am.

I hope this stimulates a little self-examination among dermatologists.

Dr. Coldiron is a past-president of the American Academy of Dermatology. He is currently in private practice but maintains a clinical assistant professorship at the University of Cincinnati. He cares for patients, teaches medical students and residents, and has several active clinical research projects. Dr. Coldiron is the author of more than 80 scientific letters, papers, and several book chapters, and he speaks frequently on a variety of topics. Reach him at [email protected].

I have become increasingly dismayed by reports of dermatologists who allow their nurse practitioners and physician assistants to practice independently.

That is, the employing dermatologists only see the patients, new or established, if they are asked to, and often are not even on the premises. In fact, they might be thousands of miles away.

A little background is in order. Physician assistants and nurse practitioners are formally trained in primary care, not in dermatology, although there are currently three 1-year programs to help them specialize in dermatology. When Congress authorized their independent payment in 1997, they envisioned primary care nurses traveling the hills, hollers, and inner cities improving health care. Unfortunately, this hasn’t happened, and instead they have moved into suburban America, and increasingly, are practicing specialty medicine.

It can be argued that decreased access to primary care, which was the reason midlevels were created, is more important than is access to dermatology. In particular, extenders have targeted office-based specialties such as dermatology, but also neurology and pain medicine. These specialties are office based, and credentialing by hospitals is not required to bill insurance plans. Also, these specialties have good-paying, seemingly simple, small procedures. They have accomplished this with the avid help of dermatologists, I might add. There will be an estimated 10,000 “dermatology” nurse practitioners and physician assistants next year.

Let me be clear: I am not opposed to a dermatology extender who works closely with a dermatologist and does intake histories and physicals, then staffs with the physician, assists with surgery, or sees routine follow-ups (think acne, psoriasis, atopy, suture removal, and warts) on an established protocol with the full knowledge of the patient.

This is not what we are seeing. We have nurse practitioners buying retiring dermatologists’ practices, physician assistants independently setting up remote clinics then hiring “supervising” dermatologists to visit once a week to sign and review charts, and independent “dermatology” clinics with a doctor thousands of miles away available, if really needed, by telephone or the Internet. (This is not really telemedicine, is it?) These extenders are listed as dermatologists on the Internet, or they hide behind the name of a dermatologist, and when you call their offices, and ask if you will see a “real” dermatologist, the answer is often “Oh, don’t worry, our nurse or PA specializes in dermatology.”

I think this is grossly unfair to patients, who, when they call the dermatology center listed on the Internet, can’t conceive that their dermatology appointment is not being made with a dermatologist, not even being made with a physician, but with a nurse practitioner or physician assistant! I also think it does a huge disservice to the specialty. The “collaborating” dermatologists enabling these extenders are renting out the good name of our specialty.

Patients seen by these extenders may also be subject to unnecessary biopsies. (If you don’t know what it is, you must biopsy it!) It also results in additional charges for pathology and additional medical misadventures.

In addition, I think it is unfair to the extender who is put in this situation. They may have worked in a dermatologist’s office for a few months or even years but are now being asked to pretend to be something they are not and being expected to perform at the level of a medical professional who has had many years of intense, focused training in dermatology. If they are not uncomfortable being thrust into this situation, then they are delusional.

I think it is unfair to the medical system who pays for the less informed opinion and unnecessary procedures. This is not a “good value” except to the rent-seeking dermatologists, who are the front men for this money-making deception.

This is an elephant in the room of dermatology, and I think we have to confront it. This trivializes our specialty and helps allow other specialties and regulatory agencies to ignore or exclude us from the networks and from the conversation. Unfortunately, many of our members and some of our leadership have been corrupted by the “easy money” or “easy time” afforded by this cheapening of the specialty.

Let me give you some examples. The rent seekers piously claim, “there is a shortage of dermatologists, and we are just trying to help save the world.” They also say “my nurses are special and great.”

The honest ones in private practice, however, say, “Man, I make $200,000 a year off my PA while I am off.” The honest academics say, “Listen, I work in a gulag, and I would never be able to travel if my nurses didn’t see my patients.” Time is money, and the academic who gets an extra 10 hours a week out of clinic is benefiting as much as the guy who makes $200,000 a year.

Of course, this situation is not sustainable and will become less viable because of a coming tsunami of malpractice claims, more focused insurer benchmarks revealing excessive test ordering and minor procedures, and patients getting wise. One obvious solution to this would be to reimburse extenders only for evaluation and management codes, which will take a change in law.

Meanwhile, I encourage all of you who feel the same nausea I do to ask candidates for your state and national dermatology organizations if they employ unsupervised extenders. Then check their website for the names of the extenders they employ. Then go to the Medicare data and look up their extenders and see if they bill independently for dermatologic procedures. I think you will be very disturbed, as I was and am.

I hope this stimulates a little self-examination among dermatologists.

Dr. Coldiron is a past-president of the American Academy of Dermatology. He is currently in private practice but maintains a clinical assistant professorship at the University of Cincinnati. He cares for patients, teaches medical students and residents, and has several active clinical research projects. Dr. Coldiron is the author of more than 80 scientific letters, papers, and several book chapters, and he speaks frequently on a variety of topics. Reach him at [email protected].

The world health community has lost ground in its fight to reduce end-stage renal disease in patients with lupus nephritis, a systematic review and meta-analysis concluded.

The risk of end-stage renal disease (ESRD) at 5 years of lupus nephritis decreased substantially from the 1970s, when it was 16%, to the mid-1990s, when it plateaued at 11%.

ESRD risks at 10 years and 15 years declined more sharply in the 1970s and 1980s but also plateaued in the mid-1990s at 17% and 22%, respectively.

This plateau was followed by a notable increase in risk in the late 2000s, particularly in the 10-year and 15-year estimates, Dr. Maria Tektonidou of the University of Athens and her coauthors reported (Arthritis Rheumatol. 2016 Jan 27. doi: 10.1002/art.39594).

“Despite extensive use of immunosuppressive medications through the 2000s, we did not find continued improvement in ESRD risks, but instead a slight increase in risks in the late 2000s,” they wrote.

The increase did not appear to be related to greater representation in recent studies of ethnic minorities, who may be more likely to develop ESRD. In the main analysis involving 148 of the 187 studies, “trends suggest this increase may have been temporary, but further follow-up will be needed to determine if this is sustained,” the investigators added.

Notably, patients with class-IV lupus nephritis had the greatest risk of ESRD during the 2000s, with a 15-year risk of 44%.

The 15-year risk of ESRD also was higher by 10 percentage points in developing countries than in developed countries during the 2000s.

The trends are worrisome because ESRD is a costly complication of lupus nephritis, which affects more than half of all patients with systemic lupus erythematosus (SLE). Patients with lupus nephritis have a 26-fold increased risk of death and estimated annual health care costs between $43,000 and $107,000 per patient, the authors noted.

The systematic review and Bayesian meta-analysis included 187 studies reporting on 18,309 adults with lupus nephritis from 1971 to 2015. The main analysis of ESRD risk included 102 studies from developed countries and 46 studies from developing countries.

Across all studies, 86% of patients were women, 32% had elevated serum creatinine levels at study entry, and proteinuria averaged 3.6 g daily. The average age was 31.2 years and mean duration of lupus nephritis was 2.7 years.

The proportion of patients treated with glucocorticoids alone in the studies declined from 54% in 1966 to 9% in 2010, while use of immunosuppressive therapies increased.

The decrease in ESRD risks early on coincided with increased use of immunosuppressives, particularly cyclophosphamide, and better control of hypertension and proteinuria. As for why those gains have stalled, Dr. Tektonidou and her colleagues said it’s possible that the limits of effectiveness of current treatments have been reached and better outcomes will require new therapies. “It is also possible that the plateau primarily reflects lack of progress in the way currently available and effective treatments are deployed,” they added. “This includes health system factors that result in delays in treatment initiation, and patient and health system factors that result in treatment interruptions and reduced adherence.”

In an accompanying editorial, Dr. Candace Feldman and Dr. Karen Costenbader, both of Brigham and Women’s Hospital in Boston, wrote, “While we have made advances over the past 50 years in our understanding of immunosuppressive medications, there have been few meaningful improvements in other domains that contribute to ESRD and to the persistent and disproportionate burden among vulnerable populations” (Ann Rheum Dis. 2016 Jan 27. doi: 10.1002/art.39593).

Despite the clear importance of medication adherence to SLE care, a recent systematic review of adherence interventions in rheumatic diseases (Ann Rheum Dis. 2015 Feb 9. doi: 10.1136/annrheumdis-2014-206593) found few SLE-specific interventions overall and none that significantly improved adherence outcomes, Dr. Feldman and Dr. Costenbader pointed out.

Dr. Tektonidou and her associates acknowledged that the new systematic review and meta-analysis were limited by the inability to estimate risks beyond 15 years and because the findings were similar only when observational studies were considered. Factors associated with ESRD, such as renal flares and uncontrolled hypertension, were not examined, and few studies were judged to be of high-quality.

Still, the results can be used to counsel patients on risks of ESRD and also will provide benchmarks to judge the effectiveness of future treatments, the authors concluded.

Dr. Feldman and Dr. Costenbader disagreed with this conclusion, citing various study limitations and the many nuanced factors that play into a patient’s risk of developing ESRD.

“This study should rather be used to provide a broad overview of our understanding of changes in SLE ESRD over time, rather than data to counsel an individual patient on his/her risks,” they wrote.

The study was supported by the intramural research program of the National Institute of Arthritis and Musculoskeletal and Skin Diseases. The authors reported having no conflicts of interest.

[email protected]

The world health community has lost ground in its fight to reduce end-stage renal disease in patients with lupus nephritis, a systematic review and meta-analysis concluded.

The risk of end-stage renal disease (ESRD) at 5 years of lupus nephritis decreased substantially from the 1970s, when it was 16%, to the mid-1990s, when it plateaued at 11%.

ESRD risks at 10 years and 15 years declined more sharply in the 1970s and 1980s but also plateaued in the mid-1990s at 17% and 22%, respectively.

This plateau was followed by a notable increase in risk in the late 2000s, particularly in the 10-year and 15-year estimates, Dr. Maria Tektonidou of the University of Athens and her coauthors reported (Arthritis Rheumatol. 2016 Jan 27. doi: 10.1002/art.39594).

“Despite extensive use of immunosuppressive medications through the 2000s, we did not find continued improvement in ESRD risks, but instead a slight increase in risks in the late 2000s,” they wrote.

The increase did not appear to be related to greater representation in recent studies of ethnic minorities, who may be more likely to develop ESRD. In the main analysis involving 148 of the 187 studies, “trends suggest this increase may have been temporary, but further follow-up will be needed to determine if this is sustained,” the investigators added.

Notably, patients with class-IV lupus nephritis had the greatest risk of ESRD during the 2000s, with a 15-year risk of 44%.

The 15-year risk of ESRD also was higher by 10 percentage points in developing countries than in developed countries during the 2000s.

The trends are worrisome because ESRD is a costly complication of lupus nephritis, which affects more than half of all patients with systemic lupus erythematosus (SLE). Patients with lupus nephritis have a 26-fold increased risk of death and estimated annual health care costs between $43,000 and $107,000 per patient, the authors noted.

The systematic review and Bayesian meta-analysis included 187 studies reporting on 18,309 adults with lupus nephritis from 1971 to 2015. The main analysis of ESRD risk included 102 studies from developed countries and 46 studies from developing countries.

Across all studies, 86% of patients were women, 32% had elevated serum creatinine levels at study entry, and proteinuria averaged 3.6 g daily. The average age was 31.2 years and mean duration of lupus nephritis was 2.7 years.

The proportion of patients treated with glucocorticoids alone in the studies declined from 54% in 1966 to 9% in 2010, while use of immunosuppressive therapies increased.

The decrease in ESRD risks early on coincided with increased use of immunosuppressives, particularly cyclophosphamide, and better control of hypertension and proteinuria. As for why those gains have stalled, Dr. Tektonidou and her colleagues said it’s possible that the limits of effectiveness of current treatments have been reached and better outcomes will require new therapies. “It is also possible that the plateau primarily reflects lack of progress in the way currently available and effective treatments are deployed,” they added. “This includes health system factors that result in delays in treatment initiation, and patient and health system factors that result in treatment interruptions and reduced adherence.”

In an accompanying editorial, Dr. Candace Feldman and Dr. Karen Costenbader, both of Brigham and Women’s Hospital in Boston, wrote, “While we have made advances over the past 50 years in our understanding of immunosuppressive medications, there have been few meaningful improvements in other domains that contribute to ESRD and to the persistent and disproportionate burden among vulnerable populations” (Ann Rheum Dis. 2016 Jan 27. doi: 10.1002/art.39593).

Despite the clear importance of medication adherence to SLE care, a recent systematic review of adherence interventions in rheumatic diseases (Ann Rheum Dis. 2015 Feb 9. doi: 10.1136/annrheumdis-2014-206593) found few SLE-specific interventions overall and none that significantly improved adherence outcomes, Dr. Feldman and Dr. Costenbader pointed out.

Dr. Tektonidou and her associates acknowledged that the new systematic review and meta-analysis were limited by the inability to estimate risks beyond 15 years and because the findings were similar only when observational studies were considered. Factors associated with ESRD, such as renal flares and uncontrolled hypertension, were not examined, and few studies were judged to be of high-quality.

Still, the results can be used to counsel patients on risks of ESRD and also will provide benchmarks to judge the effectiveness of future treatments, the authors concluded.

Dr. Feldman and Dr. Costenbader disagreed with this conclusion, citing various study limitations and the many nuanced factors that play into a patient’s risk of developing ESRD.

“This study should rather be used to provide a broad overview of our understanding of changes in SLE ESRD over time, rather than data to counsel an individual patient on his/her risks,” they wrote.

The study was supported by the intramural research program of the National Institute of Arthritis and Musculoskeletal and Skin Diseases. The authors reported having no conflicts of interest.

[email protected]

The world health community has lost ground in its fight to reduce end-stage renal disease in patients with lupus nephritis, a systematic review and meta-analysis concluded.

The risk of end-stage renal disease (ESRD) at 5 years of lupus nephritis decreased substantially from the 1970s, when it was 16%, to the mid-1990s, when it plateaued at 11%.

ESRD risks at 10 years and 15 years declined more sharply in the 1970s and 1980s but also plateaued in the mid-1990s at 17% and 22%, respectively.

This plateau was followed by a notable increase in risk in the late 2000s, particularly in the 10-year and 15-year estimates, Dr. Maria Tektonidou of the University of Athens and her coauthors reported (Arthritis Rheumatol. 2016 Jan 27. doi: 10.1002/art.39594).

“Despite extensive use of immunosuppressive medications through the 2000s, we did not find continued improvement in ESRD risks, but instead a slight increase in risks in the late 2000s,” they wrote.

The increase did not appear to be related to greater representation in recent studies of ethnic minorities, who may be more likely to develop ESRD. In the main analysis involving 148 of the 187 studies, “trends suggest this increase may have been temporary, but further follow-up will be needed to determine if this is sustained,” the investigators added.

Notably, patients with class-IV lupus nephritis had the greatest risk of ESRD during the 2000s, with a 15-year risk of 44%.

The 15-year risk of ESRD also was higher by 10 percentage points in developing countries than in developed countries during the 2000s.

The trends are worrisome because ESRD is a costly complication of lupus nephritis, which affects more than half of all patients with systemic lupus erythematosus (SLE). Patients with lupus nephritis have a 26-fold increased risk of death and estimated annual health care costs between $43,000 and $107,000 per patient, the authors noted.

The systematic review and Bayesian meta-analysis included 187 studies reporting on 18,309 adults with lupus nephritis from 1971 to 2015. The main analysis of ESRD risk included 102 studies from developed countries and 46 studies from developing countries.

Across all studies, 86% of patients were women, 32% had elevated serum creatinine levels at study entry, and proteinuria averaged 3.6 g daily. The average age was 31.2 years and mean duration of lupus nephritis was 2.7 years.

The proportion of patients treated with glucocorticoids alone in the studies declined from 54% in 1966 to 9% in 2010, while use of immunosuppressive therapies increased.

The decrease in ESRD risks early on coincided with increased use of immunosuppressives, particularly cyclophosphamide, and better control of hypertension and proteinuria. As for why those gains have stalled, Dr. Tektonidou and her colleagues said it’s possible that the limits of effectiveness of current treatments have been reached and better outcomes will require new therapies. “It is also possible that the plateau primarily reflects lack of progress in the way currently available and effective treatments are deployed,” they added. “This includes health system factors that result in delays in treatment initiation, and patient and health system factors that result in treatment interruptions and reduced adherence.”

In an accompanying editorial, Dr. Candace Feldman and Dr. Karen Costenbader, both of Brigham and Women’s Hospital in Boston, wrote, “While we have made advances over the past 50 years in our understanding of immunosuppressive medications, there have been few meaningful improvements in other domains that contribute to ESRD and to the persistent and disproportionate burden among vulnerable populations” (Ann Rheum Dis. 2016 Jan 27. doi: 10.1002/art.39593).

Despite the clear importance of medication adherence to SLE care, a recent systematic review of adherence interventions in rheumatic diseases (Ann Rheum Dis. 2015 Feb 9. doi: 10.1136/annrheumdis-2014-206593) found few SLE-specific interventions overall and none that significantly improved adherence outcomes, Dr. Feldman and Dr. Costenbader pointed out.

Dr. Tektonidou and her associates acknowledged that the new systematic review and meta-analysis were limited by the inability to estimate risks beyond 15 years and because the findings were similar only when observational studies were considered. Factors associated with ESRD, such as renal flares and uncontrolled hypertension, were not examined, and few studies were judged to be of high-quality.

Still, the results can be used to counsel patients on risks of ESRD and also will provide benchmarks to judge the effectiveness of future treatments, the authors concluded.

Dr. Feldman and Dr. Costenbader disagreed with this conclusion, citing various study limitations and the many nuanced factors that play into a patient’s risk of developing ESRD.

“This study should rather be used to provide a broad overview of our understanding of changes in SLE ESRD over time, rather than data to counsel an individual patient on his/her risks,” they wrote.

The study was supported by the intramural research program of the National Institute of Arthritis and Musculoskeletal and Skin Diseases. The authors reported having no conflicts of interest.

[email protected]