Editor’s note: “Everything We Say and Do” provides readers with thoughtful and actionable communication tactics that can positively impact patients’ experience of care. In the current series of columns, physicians share how their experiences as patients have shaped their professional approach.

I have been fortunate to have had very few major health issues throughout my life. I have, however, had three major surgical procedures in the last 10 years – two total hip arthroplasties and a cataract removal with lens implant in between. The most recent THA was October 2017. Going through each procedure helped me see things from a patient’s perspective, and that showed me how important little things are to a patient, things which we may not think are all that big a deal as a provider.

Almost all of the medical personnel who came to care for me during my stays identified themselves and why they were there, and that made me feel comfortable, knowing who they were and their role. However, there were a few who did not do this, and that made me uncomfortable, not knowing who they were and why they were in my room. Not knowing is an uncomfortable feeling for a patient.

Almost every registered nurse who came to me with medication explained what the medicine was and why they were administering it, with the exception of one preop RN I met before to my cataract procedure. She walked up to me, told me to open my eye wide, held the affected eye open, and started dripping cold drops into my eye without explanation. She then said she would be back every 10 minutes to repeat the process. I had to inquire as to what the medication was and why there was a need for this process. It was a jolting experience, and she showed no compassion toward me as a patient or a person, even after I inquired.

This was not a good experience. Although cataract surgery was a totally new experience for me, she had obviously done this many times before and had to do it many times that day. However, she acted as if I should have known what she was going to do and as if she need not explain herself to anyone – which she did not, even after being queried.

Everyone during the admission process for all three procedures was solicitous and warm except for one person. Unfortunately, this individual was the first person to greet my wife and me when we arrived for my last total hip arthroplasty. She was seated at the welcome desk with her head down. After we arrived, she kept her head down and asked “How can I help you?” without ever looking up. I did not realize how unwelcome I would feel when the first person I encountered in the surgical preop admissions area failed to make eye contact with me. Her demeanor was nice enough, but she did not even attempt to make a personal connection with me – and she was at the welcome desk!

Overall, I had tremendously good experiences at three facilities in three different parts of the United States, but as we all know, it is the things that do not go well that stand out. I choose to use those things, along with some of the good things, as “reinforcers” for many of the patient-experience behaviors we identify as best practices.

What I say and do

During each patient encounter, I make eye contact with the patient and each person in the room and identify who I am and why I am there. I sit down during each visit unless there is simply no place for me to do so. I explain the procedures that are to take place, set expectations for those procedures, and then use “teachback” to ensure that my discussion with the patient has been effective. Setting expectations is very important to me: If you do not ensure that patients have appropriate expectations, their expectations will never be met and they will never have a good experience. I explain any new medication I am ordering, what it is for, and any possible significant side effects and again use teachback. The last thing I do is ask “What questions do you have for me today?” giving the patient permission to have questions, and then I respond to those questions with plain talk and teachback.

Why I do it

Not knowing what was going on and feeling marginalized were the most uncomfortable things I experienced as a patient. Using best practices for patient experience shows courtesy and respect. These practices show a willingness to take time with the patient and demonstrate my concern that I am effectively communicating my message for that visit. All of these behaviors decrease uncertainty and/or raise the patient’s feelings of importance, thereby decreasing marginalization.

How I do it

I remind myself each day I am on a clinical shift that my goal is to treat each patient like I would want my family (or myself) to be treated, and then I go out and do it. After “forcing” myself to put these behaviors into my rounding routine, they have become second nature, and I feel better for providing this level of care because it made me feel so good when I was cared for in this manner.

Dr. Sharp is chief hospitalist with Sound Physicians at University of Florida Health in Jacksonville, Fla.

Editor’s note: “Everything We Say and Do” provides readers with thoughtful and actionable communication tactics that can positively impact patients’ experience of care. In the current series of columns, physicians share how their experiences as patients have shaped their professional approach.

I have been fortunate to have had very few major health issues throughout my life. I have, however, had three major surgical procedures in the last 10 years – two total hip arthroplasties and a cataract removal with lens implant in between. The most recent THA was October 2017. Going through each procedure helped me see things from a patient’s perspective, and that showed me how important little things are to a patient, things which we may not think are all that big a deal as a provider.

Almost all of the medical personnel who came to care for me during my stays identified themselves and why they were there, and that made me feel comfortable, knowing who they were and their role. However, there were a few who did not do this, and that made me uncomfortable, not knowing who they were and why they were in my room. Not knowing is an uncomfortable feeling for a patient.

Almost every registered nurse who came to me with medication explained what the medicine was and why they were administering it, with the exception of one preop RN I met before to my cataract procedure. She walked up to me, told me to open my eye wide, held the affected eye open, and started dripping cold drops into my eye without explanation. She then said she would be back every 10 minutes to repeat the process. I had to inquire as to what the medication was and why there was a need for this process. It was a jolting experience, and she showed no compassion toward me as a patient or a person, even after I inquired.

This was not a good experience. Although cataract surgery was a totally new experience for me, she had obviously done this many times before and had to do it many times that day. However, she acted as if I should have known what she was going to do and as if she need not explain herself to anyone – which she did not, even after being queried.

Everyone during the admission process for all three procedures was solicitous and warm except for one person. Unfortunately, this individual was the first person to greet my wife and me when we arrived for my last total hip arthroplasty. She was seated at the welcome desk with her head down. After we arrived, she kept her head down and asked “How can I help you?” without ever looking up. I did not realize how unwelcome I would feel when the first person I encountered in the surgical preop admissions area failed to make eye contact with me. Her demeanor was nice enough, but she did not even attempt to make a personal connection with me – and she was at the welcome desk!

Overall, I had tremendously good experiences at three facilities in three different parts of the United States, but as we all know, it is the things that do not go well that stand out. I choose to use those things, along with some of the good things, as “reinforcers” for many of the patient-experience behaviors we identify as best practices.

What I say and do

During each patient encounter, I make eye contact with the patient and each person in the room and identify who I am and why I am there. I sit down during each visit unless there is simply no place for me to do so. I explain the procedures that are to take place, set expectations for those procedures, and then use “teachback” to ensure that my discussion with the patient has been effective. Setting expectations is very important to me: If you do not ensure that patients have appropriate expectations, their expectations will never be met and they will never have a good experience. I explain any new medication I am ordering, what it is for, and any possible significant side effects and again use teachback. The last thing I do is ask “What questions do you have for me today?” giving the patient permission to have questions, and then I respond to those questions with plain talk and teachback.

Why I do it

Not knowing what was going on and feeling marginalized were the most uncomfortable things I experienced as a patient. Using best practices for patient experience shows courtesy and respect. These practices show a willingness to take time with the patient and demonstrate my concern that I am effectively communicating my message for that visit. All of these behaviors decrease uncertainty and/or raise the patient’s feelings of importance, thereby decreasing marginalization.

How I do it

I remind myself each day I am on a clinical shift that my goal is to treat each patient like I would want my family (or myself) to be treated, and then I go out and do it. After “forcing” myself to put these behaviors into my rounding routine, they have become second nature, and I feel better for providing this level of care because it made me feel so good when I was cared for in this manner.

Dr. Sharp is chief hospitalist with Sound Physicians at University of Florida Health in Jacksonville, Fla.

Editor’s note: “Everything We Say and Do” provides readers with thoughtful and actionable communication tactics that can positively impact patients’ experience of care. In the current series of columns, physicians share how their experiences as patients have shaped their professional approach.

I have been fortunate to have had very few major health issues throughout my life. I have, however, had three major surgical procedures in the last 10 years – two total hip arthroplasties and a cataract removal with lens implant in between. The most recent THA was October 2017. Going through each procedure helped me see things from a patient’s perspective, and that showed me how important little things are to a patient, things which we may not think are all that big a deal as a provider.

Almost all of the medical personnel who came to care for me during my stays identified themselves and why they were there, and that made me feel comfortable, knowing who they were and their role. However, there were a few who did not do this, and that made me uncomfortable, not knowing who they were and why they were in my room. Not knowing is an uncomfortable feeling for a patient.

Almost every registered nurse who came to me with medication explained what the medicine was and why they were administering it, with the exception of one preop RN I met before to my cataract procedure. She walked up to me, told me to open my eye wide, held the affected eye open, and started dripping cold drops into my eye without explanation. She then said she would be back every 10 minutes to repeat the process. I had to inquire as to what the medication was and why there was a need for this process. It was a jolting experience, and she showed no compassion toward me as a patient or a person, even after I inquired.

This was not a good experience. Although cataract surgery was a totally new experience for me, she had obviously done this many times before and had to do it many times that day. However, she acted as if I should have known what she was going to do and as if she need not explain herself to anyone – which she did not, even after being queried.

Everyone during the admission process for all three procedures was solicitous and warm except for one person. Unfortunately, this individual was the first person to greet my wife and me when we arrived for my last total hip arthroplasty. She was seated at the welcome desk with her head down. After we arrived, she kept her head down and asked “How can I help you?” without ever looking up. I did not realize how unwelcome I would feel when the first person I encountered in the surgical preop admissions area failed to make eye contact with me. Her demeanor was nice enough, but she did not even attempt to make a personal connection with me – and she was at the welcome desk!

Overall, I had tremendously good experiences at three facilities in three different parts of the United States, but as we all know, it is the things that do not go well that stand out. I choose to use those things, along with some of the good things, as “reinforcers” for many of the patient-experience behaviors we identify as best practices.

What I say and do

During each patient encounter, I make eye contact with the patient and each person in the room and identify who I am and why I am there. I sit down during each visit unless there is simply no place for me to do so. I explain the procedures that are to take place, set expectations for those procedures, and then use “teachback” to ensure that my discussion with the patient has been effective. Setting expectations is very important to me: If you do not ensure that patients have appropriate expectations, their expectations will never be met and they will never have a good experience. I explain any new medication I am ordering, what it is for, and any possible significant side effects and again use teachback. The last thing I do is ask “What questions do you have for me today?” giving the patient permission to have questions, and then I respond to those questions with plain talk and teachback.

Why I do it

Not knowing what was going on and feeling marginalized were the most uncomfortable things I experienced as a patient. Using best practices for patient experience shows courtesy and respect. These practices show a willingness to take time with the patient and demonstrate my concern that I am effectively communicating my message for that visit. All of these behaviors decrease uncertainty and/or raise the patient’s feelings of importance, thereby decreasing marginalization.

How I do it

I remind myself each day I am on a clinical shift that my goal is to treat each patient like I would want my family (or myself) to be treated, and then I go out and do it. After “forcing” myself to put these behaviors into my rounding routine, they have become second nature, and I feel better for providing this level of care because it made me feel so good when I was cared for in this manner.

Dr. Sharp is chief hospitalist with Sound Physicians at University of Florida Health in Jacksonville, Fla.

Take-Home Points

• At our institution, LALB has shortened our hospital stay.
• There is a trend towards decreased opioid consumption with LALB.
• With the opioid epidemic we face today, LALB can be one of many options in our toolbox towards a solution.
• As stated in prior publications, the effectiveness of LALB is definitely technique dependent.
• Additional clinical studies are warranted to better determine the efficacy and cost-effectiveness of LALB.

Almost 1 million total knee arthroplasties (TKAs) are performed in the United States each year, and the number continues to grow.^1.2 For patients about to undergo TKA, a significant concern is postoperative pain.³ Fear of postoperative pain is often cited as a reason for delaying surgery.³ Recent literature suggests that patients with poor pain management during the first 48 hours after surgery have a 50% chance of gaining satisfactory long-term pain relief.⁴ In addition, inadequate postoperative pain management can interfere with participation in and progression of physical rehabilitation, prolong hospital stay, and increase patient dissatisfaction.⁵ Poorly controlled pain results in decreased range of motion (ROM), strength, stability, and ambulation thereby prolongs hospital stays, and increases costs and overall dissatisfaction with the procedure.

Post-TKA pain management has received much attention in recent years. A multimodal pain management protocol is now a key component of clinical pathways in TKA. Appropriate postoperative pain control lowers postoperative complications and accelerates recovery.⁶ Pain-caused loss of function makes surgical patients more susceptible to edema, deep vein thrombosis, and pulmonary embolism.⁴ Various oral and intravenous medications are used to lessen the pain response during the perioperative period. In addition, regional or neuraxial anesthesia is often added to blunt the immediate surgical pain response.^7,8 At our institution, TKA traditionally has been performed with femoral nerve catheters (FNCs) for postoperative pain control. Although effective, this method often results in decreased quadriceps musculature function, which delays rehabilitation and increases the fall risk. Recently, there has been a shift toward using local anesthetic infusions about the knee to provide adequate pain relief and restore motor function, which is often sacrificed with use of regional nerve blocks and continuous catheter infusions.⁹

Many institutions have started using a new long-acting local anesthetic in their multimodal pain management pathways: Exparel (Pacira Pharmaceuticals), a liposomal membrane-bound bupivacaine with sustained release of approximately 72 hours. Several studies have verified the safety of this medication.¹⁰ A systemic review of prospective studies revealed that, compared with bupivacaine, long-acting liposomal bupivacaine (LALB) in therapeutic doses had a higher safety margin and a favorable safety profile.¹⁰ However, no study has compared the effectiveness of LALB and FNC in a matched TKA cohort with each patient serving as his or her own control.

We recently reviewed our multimodal pain management protocol for any areas in need of improvement and decided to compare the effects of the indwelling FNC protocol that was in use with the effects of injecting the local anesthetic LALB. We conducted a study to compare the 2 methods with respect to pain control, ROM, ability to ambulate, and hospital length of stay (LOS). We hypothesized that the longer acting local anesthetic would provide comparable post-TKA pain control and post-TKA opioid use but would accelerate post-TKA rehabilitation.

Materials and Methods

This retrospective, longitudinal, repeated- measures study was approved by the Greenville Hospital System Institutional Review Board and conducted at the Steadman Hawkins Clinic of the Carolinas, Greenville Health System.

Interventions

Twenty-three patients underwent separately staged bilateral TKAs between 2010 and 2013. For each TKA, a Genesis II implant (Smith & Nephew) was used, and the surgery was performed with the patient under spinal anesthesia. In each case, FNC was used for pain control after the first TKA, and periarticular injection (PAI) of LALB for pain control after the second TKA.

In the first TKAs, FNC-administered ropivacaine 0.2% (2 mg/mL) was maintained at a standard basal rate of 8 mL/h for 48 hours. In the second TKAs, LALB was administered along with bupivacaine/epinephrine. Twenty milliliters of LALB from a single-use vial was diluted in 40 mL of normal (0.9%) saline to obtain a 60-mL solution, and a 25-gauge needle was used to inject this solution into the periarticular soft tissues; another needle was used for PAI of 30 mL of bupivacaine 0.25% with epinephrine.

Continuous passive motion devices were not used. Most patients began therapy on day of surgery. Knee immobilizers were not used in the FNC group.

The same standardized multimodal pain management protocol was used for all TKAs. Non- narcotic medications, including acetaminophen, ketorolac, and celecoxib, were given on a scheduled basis. Tramadol and opioid medications were administered as needed for pain. The attending physician based patient discharge timing on pain control, ability to safely ambulate, and absence of complications.

Outcome Measures

Outcome measures were LOS; extension and flexion at discharge and 3-week follow-up; total ROM (extension plus flexion) at discharge and 3-week follow-up; per-day and total hospital stay morphine -equivalent doses (MEDs); and per-attempt walking distance during gait training.

ROM was measured with a standard goniometer. Flexion was tested with the patient supine and the hip and knee in neutral rotation. The goniometer axis was along the lateral epicondyle of the femur with the proximal arm of the goniometer parallel to the long axis of the femur and pointing at the greater trochanter and with the distal arm parallel to the long axis of the fibula and pointing at the lateral malleolus. The patient was instructed to flex the hip and knee by moving the heel toward the buttock. Expected normal ROM is 135°. The same landmarks were used for extension. The patient was instructed to push the back of the knee toward the plinth/bed, for maximal active extension. The same ROM assessment strategy was used during the hospitalization and at the 3-week follow-up.

Several opioid medications (eg, hydrocodone, oxycodone, tramadol, hydromorphone, morphine) with different dosages were used during hospitalization. Opioid doses were converted to MEDs to permit FNC–LALB comparisons. For each patient, total MEDs were divided by LOS to determine MEDs per day.

Mean per-attempt walking distance was calculated by dividing the total distance walked during hospitalization—the sum of the number of feet walked during each and every attempt, as measured by the treating physical therapist—by the total number of walking attempts.

Data Analysis

A paired-samples t test was used to calculate differences between all outcome measures: LOS; extension and flexion at discharge and 3-month follow-up; per-day and total MEDs; and mean per-attempt walking distance. P < .05 was considered significant. We elected not to adjust our α for a potential familywise error.

Results

Of the 23 patients, 14 were female and 9 were male, and 19 were white and 4 were black. Mean (SD) age was 64.4 (6.4) years for the FNC group and 66.0 (6.0) years for the LALB group. The age difference was not statistically significant.

Poor pain control during the post-TKA period may have a significant impact on recovery rate, standard of living, psychological health, and postoperative complications.¹⁰ Inadequate postoperative pain control increases postoperative morbidity, hinders physiotherapy, increases anxiety, disrupts sleep patterns, and decreases patient satisfaction.⁹ There has been increased interest in PAIs. Local anesthetics are additional sources of pain control at surgical sites. However, the half-life of most local anesthetics is short. Soft-tissue infiltration of LALB into a surgical site extends the duration of active analgesia. Our study found that, compared with patients who received FNC, patients who received LALB had comparable pain control, improved knee ROM, and shorter hospital stays. In addition, the LALB group had no reports of quadriceps weakness or falls, both of which are associated with femoral nerve blocks. The FNC group had no reported falls, either. PAIs have the benefit of avoiding the invasiveness of femoral nerve blocks and possible neuritis.

Many complications are associated with or indirectly related to delayed rehabilitation and immobility during the acute post-TKA period. From prolonged hospitalization to need for manipulation, the consequences of inadequate pain control and decreased function can be numerous and costly for patients and the healthcare system. In the present study, LALB use led to a statistically significant overall decrease in mean LOS (LALB group, 2.3 days; FNC, 2.8 days). With LALB, there was a higher likelihood of discharge the day after surgery; 20% of patients in the LALB group and no patients in the FNC group went home that day.

The implication is that inadequate pain control led to decreased motion and decreased progression during postoperative rehabilitation. Local infiltration resulted in increased total ROM (extension plus flexion) at 3-week follow-up (LALB, 116.3°; FNC, 107.2°). In addition, there was an increase in walking distance per day of hospital stay (LALB, 135.9 feet; FNC, 84.2 feet). Furthermore, patients indicated LALB when asked which anesthetic they preferred. To our knowledge, this is the first study to compare LALB and FNC data in a matched TKA cohort with each patient serving as his or her own control.

Our study had several limitations. First was the retrospective design. Second was the small sample size, which made definitive conclusions difficult. However, the statistically significant differences we noted validated our conclusions. A statistically significant difference favoring LALB over FNC was found for total MEDs during hospitalization, but there was no significant difference in per-day MEDs. A possible reason for this difference is that LALB patients had shorter hospital stays, and therefore received fewer doses overall. Another possible reason is the small sample size; whereas a larger study using our protocol may find a statistically significant difference between LALB and FNC, we found only a trend. In the FNC group, anesthetic infiltration occurred with use of a computerized pump, which was removed on postoperative day 2; most of these patients were discharged home that day or the morning of postoperative day 3. As it is possible that some of these patients could have gone home sooner, our LOS data may have been affected. We do not consider this limitation significant, as one of our discharge criteria was 150 feet of ambulation, and most patients who received FNCs could not ambulate that far until after FNC removal. Furthermore, this study compared LALB only with FNC. It is possible that our improved outcomes could have resulted from the PAIs themselves, irrespective of LALB. In a recent TKA study by Bagsby and colleagues,¹¹ pain was controlled better with the less expensive traditional PAI of ropivacaine, epinephrine, and morphine than with the PAI of liposomal bupivacaine. Last, in our study, the experience of undergoing the first TKA may have increased patients’ confidence going into the second TKA and then helped them make faster progress in rehabilitation. Regardless, the promising results of our study and the firsthand use of LALB at our institution led us to modify our intraoperative pain management protocol for surgeons who perform TKA.

As we continue to use LALB, our study numbers will increase, and we may discover other factors that, though now underpowered, will prove to be statistically significant. Additional clinical studies are needed to better determine the efficacy and cost-effectiveness of LALB and other long-acting local anesthetic formulations. 

Take-Home Points

• At our institution, LALB has shortened our hospital stay.
• There is a trend towards decreased opioid consumption with LALB.
• With the opioid epidemic we face today, LALB can be one of many options in our toolbox towards a solution.
• As stated in prior publications, the effectiveness of LALB is definitely technique dependent.
• Additional clinical studies are warranted to better determine the efficacy and cost-effectiveness of LALB.

Almost 1 million total knee arthroplasties (TKAs) are performed in the United States each year, and the number continues to grow.^1.2 For patients about to undergo TKA, a significant concern is postoperative pain.³ Fear of postoperative pain is often cited as a reason for delaying surgery.³ Recent literature suggests that patients with poor pain management during the first 48 hours after surgery have a 50% chance of gaining satisfactory long-term pain relief.⁴ In addition, inadequate postoperative pain management can interfere with participation in and progression of physical rehabilitation, prolong hospital stay, and increase patient dissatisfaction.⁵ Poorly controlled pain results in decreased range of motion (ROM), strength, stability, and ambulation thereby prolongs hospital stays, and increases costs and overall dissatisfaction with the procedure.

Post-TKA pain management has received much attention in recent years. A multimodal pain management protocol is now a key component of clinical pathways in TKA. Appropriate postoperative pain control lowers postoperative complications and accelerates recovery.⁶ Pain-caused loss of function makes surgical patients more susceptible to edema, deep vein thrombosis, and pulmonary embolism.⁴ Various oral and intravenous medications are used to lessen the pain response during the perioperative period. In addition, regional or neuraxial anesthesia is often added to blunt the immediate surgical pain response.^7,8 At our institution, TKA traditionally has been performed with femoral nerve catheters (FNCs) for postoperative pain control. Although effective, this method often results in decreased quadriceps musculature function, which delays rehabilitation and increases the fall risk. Recently, there has been a shift toward using local anesthetic infusions about the knee to provide adequate pain relief and restore motor function, which is often sacrificed with use of regional nerve blocks and continuous catheter infusions.⁹

Many institutions have started using a new long-acting local anesthetic in their multimodal pain management pathways: Exparel (Pacira Pharmaceuticals), a liposomal membrane-bound bupivacaine with sustained release of approximately 72 hours. Several studies have verified the safety of this medication.¹⁰ A systemic review of prospective studies revealed that, compared with bupivacaine, long-acting liposomal bupivacaine (LALB) in therapeutic doses had a higher safety margin and a favorable safety profile.¹⁰ However, no study has compared the effectiveness of LALB and FNC in a matched TKA cohort with each patient serving as his or her own control.

We recently reviewed our multimodal pain management protocol for any areas in need of improvement and decided to compare the effects of the indwelling FNC protocol that was in use with the effects of injecting the local anesthetic LALB. We conducted a study to compare the 2 methods with respect to pain control, ROM, ability to ambulate, and hospital length of stay (LOS). We hypothesized that the longer acting local anesthetic would provide comparable post-TKA pain control and post-TKA opioid use but would accelerate post-TKA rehabilitation.

Materials and Methods

This retrospective, longitudinal, repeated- measures study was approved by the Greenville Hospital System Institutional Review Board and conducted at the Steadman Hawkins Clinic of the Carolinas, Greenville Health System.

Interventions

Twenty-three patients underwent separately staged bilateral TKAs between 2010 and 2013. For each TKA, a Genesis II implant (Smith & Nephew) was used, and the surgery was performed with the patient under spinal anesthesia. In each case, FNC was used for pain control after the first TKA, and periarticular injection (PAI) of LALB for pain control after the second TKA.

In the first TKAs, FNC-administered ropivacaine 0.2% (2 mg/mL) was maintained at a standard basal rate of 8 mL/h for 48 hours. In the second TKAs, LALB was administered along with bupivacaine/epinephrine. Twenty milliliters of LALB from a single-use vial was diluted in 40 mL of normal (0.9%) saline to obtain a 60-mL solution, and a 25-gauge needle was used to inject this solution into the periarticular soft tissues; another needle was used for PAI of 30 mL of bupivacaine 0.25% with epinephrine.

Continuous passive motion devices were not used. Most patients began therapy on day of surgery. Knee immobilizers were not used in the FNC group.

The same standardized multimodal pain management protocol was used for all TKAs. Non- narcotic medications, including acetaminophen, ketorolac, and celecoxib, were given on a scheduled basis. Tramadol and opioid medications were administered as needed for pain. The attending physician based patient discharge timing on pain control, ability to safely ambulate, and absence of complications.

Outcome Measures

Outcome measures were LOS; extension and flexion at discharge and 3-week follow-up; total ROM (extension plus flexion) at discharge and 3-week follow-up; per-day and total hospital stay morphine -equivalent doses (MEDs); and per-attempt walking distance during gait training.

ROM was measured with a standard goniometer. Flexion was tested with the patient supine and the hip and knee in neutral rotation. The goniometer axis was along the lateral epicondyle of the femur with the proximal arm of the goniometer parallel to the long axis of the femur and pointing at the greater trochanter and with the distal arm parallel to the long axis of the fibula and pointing at the lateral malleolus. The patient was instructed to flex the hip and knee by moving the heel toward the buttock. Expected normal ROM is 135°. The same landmarks were used for extension. The patient was instructed to push the back of the knee toward the plinth/bed, for maximal active extension. The same ROM assessment strategy was used during the hospitalization and at the 3-week follow-up.

Several opioid medications (eg, hydrocodone, oxycodone, tramadol, hydromorphone, morphine) with different dosages were used during hospitalization. Opioid doses were converted to MEDs to permit FNC–LALB comparisons. For each patient, total MEDs were divided by LOS to determine MEDs per day.

Mean per-attempt walking distance was calculated by dividing the total distance walked during hospitalization—the sum of the number of feet walked during each and every attempt, as measured by the treating physical therapist—by the total number of walking attempts.

Data Analysis

A paired-samples t test was used to calculate differences between all outcome measures: LOS; extension and flexion at discharge and 3-month follow-up; per-day and total MEDs; and mean per-attempt walking distance. P < .05 was considered significant. We elected not to adjust our α for a potential familywise error.

Results

Of the 23 patients, 14 were female and 9 were male, and 19 were white and 4 were black. Mean (SD) age was 64.4 (6.4) years for the FNC group and 66.0 (6.0) years for the LALB group. The age difference was not statistically significant.

Poor pain control during the post-TKA period may have a significant impact on recovery rate, standard of living, psychological health, and postoperative complications.¹⁰ Inadequate postoperative pain control increases postoperative morbidity, hinders physiotherapy, increases anxiety, disrupts sleep patterns, and decreases patient satisfaction.⁹ There has been increased interest in PAIs. Local anesthetics are additional sources of pain control at surgical sites. However, the half-life of most local anesthetics is short. Soft-tissue infiltration of LALB into a surgical site extends the duration of active analgesia. Our study found that, compared with patients who received FNC, patients who received LALB had comparable pain control, improved knee ROM, and shorter hospital stays. In addition, the LALB group had no reports of quadriceps weakness or falls, both of which are associated with femoral nerve blocks. The FNC group had no reported falls, either. PAIs have the benefit of avoiding the invasiveness of femoral nerve blocks and possible neuritis.

Many complications are associated with or indirectly related to delayed rehabilitation and immobility during the acute post-TKA period. From prolonged hospitalization to need for manipulation, the consequences of inadequate pain control and decreased function can be numerous and costly for patients and the healthcare system. In the present study, LALB use led to a statistically significant overall decrease in mean LOS (LALB group, 2.3 days; FNC, 2.8 days). With LALB, there was a higher likelihood of discharge the day after surgery; 20% of patients in the LALB group and no patients in the FNC group went home that day.

The implication is that inadequate pain control led to decreased motion and decreased progression during postoperative rehabilitation. Local infiltration resulted in increased total ROM (extension plus flexion) at 3-week follow-up (LALB, 116.3°; FNC, 107.2°). In addition, there was an increase in walking distance per day of hospital stay (LALB, 135.9 feet; FNC, 84.2 feet). Furthermore, patients indicated LALB when asked which anesthetic they preferred. To our knowledge, this is the first study to compare LALB and FNC data in a matched TKA cohort with each patient serving as his or her own control.

Our study had several limitations. First was the retrospective design. Second was the small sample size, which made definitive conclusions difficult. However, the statistically significant differences we noted validated our conclusions. A statistically significant difference favoring LALB over FNC was found for total MEDs during hospitalization, but there was no significant difference in per-day MEDs. A possible reason for this difference is that LALB patients had shorter hospital stays, and therefore received fewer doses overall. Another possible reason is the small sample size; whereas a larger study using our protocol may find a statistically significant difference between LALB and FNC, we found only a trend. In the FNC group, anesthetic infiltration occurred with use of a computerized pump, which was removed on postoperative day 2; most of these patients were discharged home that day or the morning of postoperative day 3. As it is possible that some of these patients could have gone home sooner, our LOS data may have been affected. We do not consider this limitation significant, as one of our discharge criteria was 150 feet of ambulation, and most patients who received FNCs could not ambulate that far until after FNC removal. Furthermore, this study compared LALB only with FNC. It is possible that our improved outcomes could have resulted from the PAIs themselves, irrespective of LALB. In a recent TKA study by Bagsby and colleagues,¹¹ pain was controlled better with the less expensive traditional PAI of ropivacaine, epinephrine, and morphine than with the PAI of liposomal bupivacaine. Last, in our study, the experience of undergoing the first TKA may have increased patients’ confidence going into the second TKA and then helped them make faster progress in rehabilitation. Regardless, the promising results of our study and the firsthand use of LALB at our institution led us to modify our intraoperative pain management protocol for surgeons who perform TKA.

As we continue to use LALB, our study numbers will increase, and we may discover other factors that, though now underpowered, will prove to be statistically significant. Additional clinical studies are needed to better determine the efficacy and cost-effectiveness of LALB and other long-acting local anesthetic formulations. 

Take-Home Points

• At our institution, LALB has shortened our hospital stay.
• There is a trend towards decreased opioid consumption with LALB.
• With the opioid epidemic we face today, LALB can be one of many options in our toolbox towards a solution.
• As stated in prior publications, the effectiveness of LALB is definitely technique dependent.
• Additional clinical studies are warranted to better determine the efficacy and cost-effectiveness of LALB.

Almost 1 million total knee arthroplasties (TKAs) are performed in the United States each year, and the number continues to grow.^1.2 For patients about to undergo TKA, a significant concern is postoperative pain.³ Fear of postoperative pain is often cited as a reason for delaying surgery.³ Recent literature suggests that patients with poor pain management during the first 48 hours after surgery have a 50% chance of gaining satisfactory long-term pain relief.⁴ In addition, inadequate postoperative pain management can interfere with participation in and progression of physical rehabilitation, prolong hospital stay, and increase patient dissatisfaction.⁵ Poorly controlled pain results in decreased range of motion (ROM), strength, stability, and ambulation thereby prolongs hospital stays, and increases costs and overall dissatisfaction with the procedure.

Post-TKA pain management has received much attention in recent years. A multimodal pain management protocol is now a key component of clinical pathways in TKA. Appropriate postoperative pain control lowers postoperative complications and accelerates recovery.⁶ Pain-caused loss of function makes surgical patients more susceptible to edema, deep vein thrombosis, and pulmonary embolism.⁴ Various oral and intravenous medications are used to lessen the pain response during the perioperative period. In addition, regional or neuraxial anesthesia is often added to blunt the immediate surgical pain response.^7,8 At our institution, TKA traditionally has been performed with femoral nerve catheters (FNCs) for postoperative pain control. Although effective, this method often results in decreased quadriceps musculature function, which delays rehabilitation and increases the fall risk. Recently, there has been a shift toward using local anesthetic infusions about the knee to provide adequate pain relief and restore motor function, which is often sacrificed with use of regional nerve blocks and continuous catheter infusions.⁹

Many institutions have started using a new long-acting local anesthetic in their multimodal pain management pathways: Exparel (Pacira Pharmaceuticals), a liposomal membrane-bound bupivacaine with sustained release of approximately 72 hours. Several studies have verified the safety of this medication.¹⁰ A systemic review of prospective studies revealed that, compared with bupivacaine, long-acting liposomal bupivacaine (LALB) in therapeutic doses had a higher safety margin and a favorable safety profile.¹⁰ However, no study has compared the effectiveness of LALB and FNC in a matched TKA cohort with each patient serving as his or her own control.

We recently reviewed our multimodal pain management protocol for any areas in need of improvement and decided to compare the effects of the indwelling FNC protocol that was in use with the effects of injecting the local anesthetic LALB. We conducted a study to compare the 2 methods with respect to pain control, ROM, ability to ambulate, and hospital length of stay (LOS). We hypothesized that the longer acting local anesthetic would provide comparable post-TKA pain control and post-TKA opioid use but would accelerate post-TKA rehabilitation.

Materials and Methods

This retrospective, longitudinal, repeated- measures study was approved by the Greenville Hospital System Institutional Review Board and conducted at the Steadman Hawkins Clinic of the Carolinas, Greenville Health System.

Interventions

Twenty-three patients underwent separately staged bilateral TKAs between 2010 and 2013. For each TKA, a Genesis II implant (Smith & Nephew) was used, and the surgery was performed with the patient under spinal anesthesia. In each case, FNC was used for pain control after the first TKA, and periarticular injection (PAI) of LALB for pain control after the second TKA.

In the first TKAs, FNC-administered ropivacaine 0.2% (2 mg/mL) was maintained at a standard basal rate of 8 mL/h for 48 hours. In the second TKAs, LALB was administered along with bupivacaine/epinephrine. Twenty milliliters of LALB from a single-use vial was diluted in 40 mL of normal (0.9%) saline to obtain a 60-mL solution, and a 25-gauge needle was used to inject this solution into the periarticular soft tissues; another needle was used for PAI of 30 mL of bupivacaine 0.25% with epinephrine.

Continuous passive motion devices were not used. Most patients began therapy on day of surgery. Knee immobilizers were not used in the FNC group.

The same standardized multimodal pain management protocol was used for all TKAs. Non- narcotic medications, including acetaminophen, ketorolac, and celecoxib, were given on a scheduled basis. Tramadol and opioid medications were administered as needed for pain. The attending physician based patient discharge timing on pain control, ability to safely ambulate, and absence of complications.

Outcome Measures

Outcome measures were LOS; extension and flexion at discharge and 3-week follow-up; total ROM (extension plus flexion) at discharge and 3-week follow-up; per-day and total hospital stay morphine -equivalent doses (MEDs); and per-attempt walking distance during gait training.

ROM was measured with a standard goniometer. Flexion was tested with the patient supine and the hip and knee in neutral rotation. The goniometer axis was along the lateral epicondyle of the femur with the proximal arm of the goniometer parallel to the long axis of the femur and pointing at the greater trochanter and with the distal arm parallel to the long axis of the fibula and pointing at the lateral malleolus. The patient was instructed to flex the hip and knee by moving the heel toward the buttock. Expected normal ROM is 135°. The same landmarks were used for extension. The patient was instructed to push the back of the knee toward the plinth/bed, for maximal active extension. The same ROM assessment strategy was used during the hospitalization and at the 3-week follow-up.

Several opioid medications (eg, hydrocodone, oxycodone, tramadol, hydromorphone, morphine) with different dosages were used during hospitalization. Opioid doses were converted to MEDs to permit FNC–LALB comparisons. For each patient, total MEDs were divided by LOS to determine MEDs per day.

Mean per-attempt walking distance was calculated by dividing the total distance walked during hospitalization—the sum of the number of feet walked during each and every attempt, as measured by the treating physical therapist—by the total number of walking attempts.

Data Analysis

A paired-samples t test was used to calculate differences between all outcome measures: LOS; extension and flexion at discharge and 3-month follow-up; per-day and total MEDs; and mean per-attempt walking distance. P < .05 was considered significant. We elected not to adjust our α for a potential familywise error.

Results

Of the 23 patients, 14 were female and 9 were male, and 19 were white and 4 were black. Mean (SD) age was 64.4 (6.4) years for the FNC group and 66.0 (6.0) years for the LALB group. The age difference was not statistically significant.

Poor pain control during the post-TKA period may have a significant impact on recovery rate, standard of living, psychological health, and postoperative complications.¹⁰ Inadequate postoperative pain control increases postoperative morbidity, hinders physiotherapy, increases anxiety, disrupts sleep patterns, and decreases patient satisfaction.⁹ There has been increased interest in PAIs. Local anesthetics are additional sources of pain control at surgical sites. However, the half-life of most local anesthetics is short. Soft-tissue infiltration of LALB into a surgical site extends the duration of active analgesia. Our study found that, compared with patients who received FNC, patients who received LALB had comparable pain control, improved knee ROM, and shorter hospital stays. In addition, the LALB group had no reports of quadriceps weakness or falls, both of which are associated with femoral nerve blocks. The FNC group had no reported falls, either. PAIs have the benefit of avoiding the invasiveness of femoral nerve blocks and possible neuritis.

Many complications are associated with or indirectly related to delayed rehabilitation and immobility during the acute post-TKA period. From prolonged hospitalization to need for manipulation, the consequences of inadequate pain control and decreased function can be numerous and costly for patients and the healthcare system. In the present study, LALB use led to a statistically significant overall decrease in mean LOS (LALB group, 2.3 days; FNC, 2.8 days). With LALB, there was a higher likelihood of discharge the day after surgery; 20% of patients in the LALB group and no patients in the FNC group went home that day.

The implication is that inadequate pain control led to decreased motion and decreased progression during postoperative rehabilitation. Local infiltration resulted in increased total ROM (extension plus flexion) at 3-week follow-up (LALB, 116.3°; FNC, 107.2°). In addition, there was an increase in walking distance per day of hospital stay (LALB, 135.9 feet; FNC, 84.2 feet). Furthermore, patients indicated LALB when asked which anesthetic they preferred. To our knowledge, this is the first study to compare LALB and FNC data in a matched TKA cohort with each patient serving as his or her own control.

Our study had several limitations. First was the retrospective design. Second was the small sample size, which made definitive conclusions difficult. However, the statistically significant differences we noted validated our conclusions. A statistically significant difference favoring LALB over FNC was found for total MEDs during hospitalization, but there was no significant difference in per-day MEDs. A possible reason for this difference is that LALB patients had shorter hospital stays, and therefore received fewer doses overall. Another possible reason is the small sample size; whereas a larger study using our protocol may find a statistically significant difference between LALB and FNC, we found only a trend. In the FNC group, anesthetic infiltration occurred with use of a computerized pump, which was removed on postoperative day 2; most of these patients were discharged home that day or the morning of postoperative day 3. As it is possible that some of these patients could have gone home sooner, our LOS data may have been affected. We do not consider this limitation significant, as one of our discharge criteria was 150 feet of ambulation, and most patients who received FNCs could not ambulate that far until after FNC removal. Furthermore, this study compared LALB only with FNC. It is possible that our improved outcomes could have resulted from the PAIs themselves, irrespective of LALB. In a recent TKA study by Bagsby and colleagues,¹¹ pain was controlled better with the less expensive traditional PAI of ropivacaine, epinephrine, and morphine than with the PAI of liposomal bupivacaine. Last, in our study, the experience of undergoing the first TKA may have increased patients’ confidence going into the second TKA and then helped them make faster progress in rehabilitation. Regardless, the promising results of our study and the firsthand use of LALB at our institution led us to modify our intraoperative pain management protocol for surgeons who perform TKA.

As we continue to use LALB, our study numbers will increase, and we may discover other factors that, though now underpowered, will prove to be statistically significant. Additional clinical studies are needed to better determine the efficacy and cost-effectiveness of LALB and other long-acting local anesthetic formulations. 

The smoking cessation aid varenicline tartrate is effective for reducing heavy drinking in men with alcohol use disorder and comorbid cigarette smoking, according to findings published Dec. 20, 2017. The drug also increased smoking abstinence in participants overall, reported Stephanie S. O’Malley, PhD, of the department of psychiatry at Yale University, New Haven, Conn., and her coauthors.

Bunyos/Thinkstock

SOURCE: O’Malley SS et al. JAMA Psychiatry. 2017 Dec 20. doi: 10.1001/jamapsychiatry.2017.3544.
 

The smoking cessation aid varenicline tartrate is effective for reducing heavy drinking in men with alcohol use disorder and comorbid cigarette smoking, according to findings published Dec. 20, 2017. The drug also increased smoking abstinence in participants overall, reported Stephanie S. O’Malley, PhD, of the department of psychiatry at Yale University, New Haven, Conn., and her coauthors.

Bunyos/Thinkstock

SOURCE: O’Malley SS et al. JAMA Psychiatry. 2017 Dec 20. doi: 10.1001/jamapsychiatry.2017.3544.
 

The smoking cessation aid varenicline tartrate is effective for reducing heavy drinking in men with alcohol use disorder and comorbid cigarette smoking, according to findings published Dec. 20, 2017. The drug also increased smoking abstinence in participants overall, reported Stephanie S. O’Malley, PhD, of the department of psychiatry at Yale University, New Haven, Conn., and her coauthors.

Bunyos/Thinkstock

SOURCE: O’Malley SS et al. JAMA Psychiatry. 2017 Dec 20. doi: 10.1001/jamapsychiatry.2017.3544.
 

Based on the appearance and location of the lesions, a diagnosis of recurrent herpes simplex virus-2 (HSV-2) was made. HSV-2 is generally a genital eruption but can also occur on the buttocks, especially in women. (Our patient was not aware that she’d had a genital primary HSV-2 infection.) HSV-2 infects an estimated 5% to 25% of adults in western nations. In 2012, approximately 417 million people ages 15 to 49 were living with HSV-2 worldwide, including 19 million who were newly infected.

Following a genital primary infection, HSV-2 lies dormant in the sacral nerve root ganglia, which innervate both the genitals and sacrum. Reactivation can thus result in recurrences anywhere over the sacral dermatome. The sacral area is the most common nongenital site for recurrent HSV-2. Reactivation of HSV-2 is more common and more severe in patients with human immunodeficiency virus infection.

The mainstay of treatment for HSV is antiviral therapy with acyclovir. Famciclovir and valacyclovir can be used, as well. These antivirals inhibit viral DNA replication, shorten duration of symptoms, increase lesion healing, and decrease viral shedding time. They are generally safe; the main adverse effects of oral therapy are nausea, vomiting, and diarrhea.

In general, nongenital recurrences of HSV are treated the same as genital recurrences. Dosing during prodromal symptoms or at the first sign of a recurrence is recommended for maximum efficacy. Suppressive therapy can be effective in patients who experience frequent recurrences and is generally recommended for 6 months to a year (or longer). Patients should also be warned that because of increased genital viral shedding during sacral recurrences, they should avoid sexual contact during outbreaks.

After a discussion about the benefits and risks of antiviral suppression, the patient decided she was ready to proceed with treatment. The physician prescribed oral valacyclovir 1 g daily for treatment and suppression. She had no recurrences over the next year.

Adapted from: Flowers H, Brodell RT. Recurrent vesicular rash over the sacrum. J Fam Pract. 2015;64:577-579.

Based on the appearance and location of the lesions, a diagnosis of recurrent herpes simplex virus-2 (HSV-2) was made. HSV-2 is generally a genital eruption but can also occur on the buttocks, especially in women. (Our patient was not aware that she’d had a genital primary HSV-2 infection.) HSV-2 infects an estimated 5% to 25% of adults in western nations. In 2012, approximately 417 million people ages 15 to 49 were living with HSV-2 worldwide, including 19 million who were newly infected.

Following a genital primary infection, HSV-2 lies dormant in the sacral nerve root ganglia, which innervate both the genitals and sacrum. Reactivation can thus result in recurrences anywhere over the sacral dermatome. The sacral area is the most common nongenital site for recurrent HSV-2. Reactivation of HSV-2 is more common and more severe in patients with human immunodeficiency virus infection.

The mainstay of treatment for HSV is antiviral therapy with acyclovir. Famciclovir and valacyclovir can be used, as well. These antivirals inhibit viral DNA replication, shorten duration of symptoms, increase lesion healing, and decrease viral shedding time. They are generally safe; the main adverse effects of oral therapy are nausea, vomiting, and diarrhea.

In general, nongenital recurrences of HSV are treated the same as genital recurrences. Dosing during prodromal symptoms or at the first sign of a recurrence is recommended for maximum efficacy. Suppressive therapy can be effective in patients who experience frequent recurrences and is generally recommended for 6 months to a year (or longer). Patients should also be warned that because of increased genital viral shedding during sacral recurrences, they should avoid sexual contact during outbreaks.

After a discussion about the benefits and risks of antiviral suppression, the patient decided she was ready to proceed with treatment. The physician prescribed oral valacyclovir 1 g daily for treatment and suppression. She had no recurrences over the next year.

Adapted from: Flowers H, Brodell RT. Recurrent vesicular rash over the sacrum. J Fam Pract. 2015;64:577-579.

Based on the appearance and location of the lesions, a diagnosis of recurrent herpes simplex virus-2 (HSV-2) was made. HSV-2 is generally a genital eruption but can also occur on the buttocks, especially in women. (Our patient was not aware that she’d had a genital primary HSV-2 infection.) HSV-2 infects an estimated 5% to 25% of adults in western nations. In 2012, approximately 417 million people ages 15 to 49 were living with HSV-2 worldwide, including 19 million who were newly infected.

Following a genital primary infection, HSV-2 lies dormant in the sacral nerve root ganglia, which innervate both the genitals and sacrum. Reactivation can thus result in recurrences anywhere over the sacral dermatome. The sacral area is the most common nongenital site for recurrent HSV-2. Reactivation of HSV-2 is more common and more severe in patients with human immunodeficiency virus infection.

The mainstay of treatment for HSV is antiviral therapy with acyclovir. Famciclovir and valacyclovir can be used, as well. These antivirals inhibit viral DNA replication, shorten duration of symptoms, increase lesion healing, and decrease viral shedding time. They are generally safe; the main adverse effects of oral therapy are nausea, vomiting, and diarrhea.

In general, nongenital recurrences of HSV are treated the same as genital recurrences. Dosing during prodromal symptoms or at the first sign of a recurrence is recommended for maximum efficacy. Suppressive therapy can be effective in patients who experience frequent recurrences and is generally recommended for 6 months to a year (or longer). Patients should also be warned that because of increased genital viral shedding during sacral recurrences, they should avoid sexual contact during outbreaks.

After a discussion about the benefits and risks of antiviral suppression, the patient decided she was ready to proceed with treatment. The physician prescribed oral valacyclovir 1 g daily for treatment and suppression. She had no recurrences over the next year.

Adapted from: Flowers H, Brodell RT. Recurrent vesicular rash over the sacrum. J Fam Pract. 2015;64:577-579.

Gadolinium-based contrast agents (GBCAs) used for MRI will now carry a warning regarding their potential retention in the bodies and brains of treated patients, according to the Food and Drug Administration.

The FDA is requiring the new class warning, along with other safety measures, based on evidence showing that trace amounts of gadolinium can be retained in the body for months to years after treatment.

Wikimedia Commons/FitzColinGerald/Creative Commons License

[email protected]

Gadolinium-based contrast agents (GBCAs) used for MRI will now carry a warning regarding their potential retention in the bodies and brains of treated patients, according to the Food and Drug Administration.

The FDA is requiring the new class warning, along with other safety measures, based on evidence showing that trace amounts of gadolinium can be retained in the body for months to years after treatment.

Wikimedia Commons/FitzColinGerald/Creative Commons License

[email protected]

Gadolinium-based contrast agents (GBCAs) used for MRI will now carry a warning regarding their potential retention in the bodies and brains of treated patients, according to the Food and Drug Administration.

The FDA is requiring the new class warning, along with other safety measures, based on evidence showing that trace amounts of gadolinium can be retained in the body for months to years after treatment.

Wikimedia Commons/FitzColinGerald/Creative Commons License

[email protected]

Clinical question: Can the dual-antiplatelet therapy scoring system be used to determine which patients undergoing percutaneous coronary intervention (PCI) would benefit from prolonged (24 months) DAPT?

Background: Prolonged DAPT therapy has been estimated to prevent 8 myocardial infarctions per 1,000 persons treated for 1 year but at the cost of 6 major bleeding events with no clear mortality benefit. Given these trade-offs, the DAPT score could be used to identify patients who would benefit or would be harmed from prolonged DAPT. The safety and efficacy of DAPT duration as guided by the DAPT score has not been assessed outside the derivation cohort. This study applied the DAPT score to the PRODIGY trial patients to evaluate safety and outcomes of DAPT for 24 months versus a less than 6-month regimen.

Dr. Setji is a hospitalist and medical director, Duke University Hospital.

Clinical question: Can the dual-antiplatelet therapy scoring system be used to determine which patients undergoing percutaneous coronary intervention (PCI) would benefit from prolonged (24 months) DAPT?

Background: Prolonged DAPT therapy has been estimated to prevent 8 myocardial infarctions per 1,000 persons treated for 1 year but at the cost of 6 major bleeding events with no clear mortality benefit. Given these trade-offs, the DAPT score could be used to identify patients who would benefit or would be harmed from prolonged DAPT. The safety and efficacy of DAPT duration as guided by the DAPT score has not been assessed outside the derivation cohort. This study applied the DAPT score to the PRODIGY trial patients to evaluate safety and outcomes of DAPT for 24 months versus a less than 6-month regimen.

Dr. Setji is a hospitalist and medical director, Duke University Hospital.

Clinical question: Can the dual-antiplatelet therapy scoring system be used to determine which patients undergoing percutaneous coronary intervention (PCI) would benefit from prolonged (24 months) DAPT?

Background: Prolonged DAPT therapy has been estimated to prevent 8 myocardial infarctions per 1,000 persons treated for 1 year but at the cost of 6 major bleeding events with no clear mortality benefit. Given these trade-offs, the DAPT score could be used to identify patients who would benefit or would be harmed from prolonged DAPT. The safety and efficacy of DAPT duration as guided by the DAPT score has not been assessed outside the derivation cohort. This study applied the DAPT score to the PRODIGY trial patients to evaluate safety and outcomes of DAPT for 24 months versus a less than 6-month regimen.

Dr. Setji is a hospitalist and medical director, Duke University Hospital.

The aim of palliative care (PC) is to improve quality of life for patients facing serious, life-threatening illness and their families.¹ Due to insufficient numbers of PC specialists to meet the PC needs for every hospitalized patient,² all hospitalists should maintain basic PC skills as recognized by PC being a core competency for hospitalists.^3,4

We summarize and critique PC research articles published between January 1, 2016, and December 31, 2016, that have a high likelihood of impacting the practice of hospital medicine. We hand searched 15 journals and conducted a MEDLINE keyword search of PC terms (see Table). All titles and/or abstracts were reviewed and selected for full review based on the following factors: palliative medicine content, scientific rigor, impact on practice, and relevance to hospital medicine. Fifty-five articles were individually reviewed and scored by all authors according to rigor, impact, and relevance. Articles were ranked according to their mean scores, and 9 articles were chosen for inclusion through consensus discussion.

Antipsychotics Were Inferior to a Placebo in Treating Nonterminal Delirium

Agar MR, Lawlor PG, Quinn S, et al. Efficacy of oral risperidone, haloperidol, or placebo for symptoms of delirium among patients in palliative care: a randomized clinical trial. JAMA Intern Med. 2017;177(1):34-42.

Background

Delirium is highly prevalent in PC and is associated with significant distress.⁵ Antipsychotics are widely used for symptoms of delirium, although current evidence does not support this practice in hospitalized adults.^6,7

Findings

This was a double-blind, parallel-arm, placebo randomized controlled trial (RCT) of 247 patients with delirium with an estimated life expectancy of ≥7 days in 11 PC or hospice units across Australia. Patients were randomized to receive risperidone, haloperidol, or a placebo in addition to nonpharmacological management of delirium. Delirium symptom scores after 3 days of treatment, the use of midazolam as a rescue medication, and the presence of extrapyramidal symptoms (EPS) were measured. The risperidone and haloperidol arms had significantly higher delirium symptom scores (P = .02 and P = .009, respectively), mean EPS symptoms (P < .001), and more use of rescue midazolam than the placebo arm. Mortality was higher for antipsychotics, with a hazard ratio of 1.73 for haloperidol (P = .003), 1.29 for risperidone (P = .14), and 1.47 for any antipsychotic (P = .01).

Cautions

The study population was elderly (mean age >70 years) with mild delirium scores. The use of antipsychotics was associated with more benzodiazepine use, which could itself worsen delirium. As patients with clinician-predicted life expectancy of <7 days were excluded, findings cannot be extrapolated to the treatment of terminal delirium, which can often be more symptomatic and difficult to treat.

Implications

Avoid scheduled antipsychotics in patients with nonterminal delirium, as they can increase risk of harm without advantages, over nonpharmacologic interventions.

Low-Dose Morphine Was Superior to Weak Opioids in the Treatment of Moderate Cancer Pain

Bandieri E, Romero M, Ripamonti CI, et al. Randomized trial of low-dose morphine versus weak opioids in moderate cancer pain. J Clin Oncol. 2016;34(5):436-442.

Background

The World Health Organization guidelines recommend the use of weak opioids (WOs), such as codeine or tramadol, as a sequential step in the management of cancer pain.⁸ This strategy has not been tested against low doses of stronger opioids.

Findings

In this multicenter, open-label RCT, 240 patients in Italy were randomized and stratified by age (<75 years or ≥75 years) to either the WO group or low-dose morphine (M) group. The primary outcome measure was a reduction in pain intensity by 20% or more. Secondary outcomes included an improvement in symptom scores, a ≥30% and ≥50% reduction in pain, increased opioid dosage, and adverse side effects. Compared with the WO group, the M group had more patients with a 20% reduction in pain (88.2% vs 54.7%; P < .001), more evidence of pain control in the first week (80.9% vs 43.6%; P < .001), more patients with a ≥30% and ≥50% reduction in pain, and less need to switch to a stronger opioid (15.5% vs 35.0%; P = .001) or require dose increases. Adverse effects were similar in both groups.

Cautions

Patients with chronic kidney disease (CKD) were excluded due to concerns about the accumulation of morphine metabolites. Additionally, this study was open label, increasing the risk of bias.

Implications

Low-dose morphine should be considered over the use of WOs to achieve better and more rapid pain control in patients without CKD.

The Use of Methadone as a Coanalgesic May Improve Moderate Cancer Pain

Courtemanche F, Dao D, Gagné F, et al. Methadone as a coanalgesic for palliative care cancer patients. J Palliat Med. 2016;19(9):972-978.

Background

Methadone is effective at treating cancer pain and is often utilized when patients have neuropathic pain, fail to respond to traditional opioids, or have renal failure.^9,10 However, its long half-life and many drug interactions make methadone challenging to use.

Findings

This cohort study looked at 153 inpatient or outpatient PC patients in Montreal who received methadone as a coanalgesic for cancer pain. The patients’ median morphine equivalent dose was 120 mg when initiating methadone. The median starting dose of methadone was 3 mg per day. Of patients, 49.3% had a significant response (≥30% pain reduction), with a median response time of 7 days, and 30.1% achieved a substantial response (≥50% pain reduction), with a median response time of 3 days. Patients with higher initial pain scores were more likely to respond to adjuvant methadone. Those who had not responded after a week of methadone were unlikely to respond despite dose escalations. Adverse effects included drowsiness (51.4%), confusion (27.4%), constipation (24.7%), nausea (19.9%), and myoclonia (16.4%).

Cautions

This was an observational study with retrospective data, leading to higher levels of missing data. A high rate of adverse side effects was reported (90.4%). Further study is needed to validate and reproduce the findings.

Implications

The use of adjuvant low-dose methadone may be considered in patients with moderate pain despite high-dose opioids. If a response is not seen within 7 days, then methadone use should be reconsidered.

Many Hospitalized Patients on Comfort Care Still Receive Antimicrobials

Merel SE, Meier CA, McKinney CM, Pottinger PS. Antimicrobial use in patients on a comfort care protocol: a retrospective cohort study. J Palliat Med. 2016;19(11):1210-1214.

Background

It is unknown how often patients who are hospitalized at the end of life continue to receive antimicrobials and what factors are associated with antimicrobial use.

Findings

This retrospective cohort study of 1881 hospitalized adults transitioned to a comfort care order (CCO) set at 2 academic medical centers found that 77% of these patients received antimicrobials during their hospital stay (62.4% at 24 hours prior to CCO). Of the 711 still alive at ≥24 hours after CCO, 111 (15.6%) were still on antimicrobials, with that proportion remaining stable for the remainder of hospitalization. In comparing those who did and did not receive antimicrobials after 24 hours of CCO, the presence of a documented infection was not significantly different after adjusting for age. Those with a cancer diagnosis (adjusted risk ratio [ARR] = 1.44: P = .04), a longer length of stay (≥7 days vs <7 days; ARR = 1.49; P = .05), and those discharged home (ARR 2.93; P < .001) or to a facility (ARR 3.63; P < .001) versus dying in the hospital were more likely to be on antimicrobials 24 hours after CCO. Compared with those on a medicine service, patients in the medical and surgical intensive care units (ICUs) were less likely to receive antimicrobials (medical ICU ARR = 0.32; P = .01; surgical ICU and/or neuro-ICU ARR = 0.32; P = .02). The most commonly administered antimicrobials were fluoroquinolones and vancomycin.

Cautions

Only 111 patients were still on antimicrobials at 24 hours, which limited analysis. Investigators relied on retrospective data for medication administration and diagnoses.

Implications

Further work is needed to understand and address the expectations of clinicians, patients, and families regarding the role of antimicrobials at the end of life.

Video Decision Aids Improved Rates of Advance Care Planning and Hospice Use and Decreased Costs

Volandes, AE, Paasche-Orlow MK, Davis AD et al. Use of video decision aids to promote advance care planning in Hilo, Hawai‘i. J Gen Intern Med. 2016;31(9):1035-1040.

Background

Advance care planning (ACP) can be enhanced with the use of video decision aids, which may help address scalability and cost.¹¹ The Hawaii Medical Service Association began an initiative to improve ACP rates, which included a financial incentive. Clinician training and patient access to ACP videos were implemented 1 year into this campaign, which was intended for patients with late-stage disease.

Findings

This study tested the impact of the video intervention on the rates of ACP documentation in Hilo, Hawaii, along with secondary outcomes of hospice use, hospital deaths, and costs. The intervention was sequentially rolled out to Hilo Medical Center (HMC), followed by hospice and primary care practices. Following the video introduction, the proportion of patients discharged from HMC with ACP documentation markedly increased (3.2% to 39.9%; P < .001). The percentage of hospital patients discharged to hospice increased from 5.7% to 13.8% (P < .001). Overall admissions to the Hospice of Hilo increased at a greater rate than in other parts of Hawaii. After the intervention in Hilo, the in-hospital death rate among patients >65 years old declined slightly (P = .14), while in the rest of the state, the rate remained essentially unchanged. ACP planning did not reduce healthcare costs at the end of life, but costs seemed to increase more slowly in Hilo after the intervention than they did in the rest of Hawaii (P < .05).

Cautions

This report relies on before-and-after comparisons, with potential confounding by a background pay-for-quality initiative; however, the timing of the changes in outcomes correlates well with the introduction of the videos. ACP videos have been studied in other settings, so the intervention is likely generalizable to other states.

Implications

A widespread distribution of ACP videos and training for physicians in their use may lead to significant increases in ACP documentation and other beneficial clinical outcomes for patients and health systems.

A Standardized Palliative Care-Led Intervention Did Not Improve Psychological Outcomes in Families of Patients with Chronic Critical Illness

Carson SS, Cox CE, Wallenstein S, et al. Effect of palliative care-led meetings for families of patients with chronic critical illness: a randomized clinical trial. JAMA. 2016;316(1):51-62.

Background

Chronic critical illness (CCI) occurs when a patient neither recovers nor dies for days to weeks after an acute illness requiring aggressive intensive care. CCI is associated with poor patient and family outcomes.¹² Does a protocol-driven support and information meeting led by PC providers improve these outcomes?

Findings

This multicenter RCT compared 130 CCI patients (184 surrogates) who received a structured intervention to 126 patients (181 surrogates) with usual care. The structured intervention was led by PC clinicians in order to provide supportive conversations and information about CCI and prognosis compared with the usual intensivist communication. The support and information team met with the families of patients in the intervention group after day 7 of mechanical ventilation (MV) and again 10 days later. Both the intervention and control groups received validated information about CCI, and all were eligible for specialty PC consultation, as indicated. The primary outcome of the study was the Hospital Anxiety and Depression Scale (HADS) at 90-day follow-up with the surrogates. Secondary endpoints included posttraumatic stress disorder (PTSD) assessment and other communication measures as well as patient outcomes (hospital mortality, 90-day survival, length of stay, and days of MV). At least 1 meeting took place for 89% of patients (82% of surrogates) in the intervention arm. Fewer patients in the intervention arm had nonstudy PC consultations (13% vs 22%). Ninety-day HADS results were similar in the 2 groups. PTSD symptoms, however, were higher in the intervention group (Impact of Event Scale-Revised score: 25.9 for intervention and 21.3 for control; intergroup difference 4.6 [95% confidence interval, 0.01-9.10]). There were no statistically significant differences among the patient-focused measures, including survival.

Cautions

Although the teams contained skilled clinicians led by PC practitioners, this was not an ordinary PC intervention. The intervention included information and emotional support meetings alone rather than support from a PC team driven by clinical considerations. This study included surrogates of patients with CCI but not other conditions.

Implications

Protocol-driven support and information meetings may not improve, and may slightly worsen, outcomes in families of patients with CCI. This study did not evaluate and should not be applied to clinically indicated, specialty PC consultation in the ICU.

Caregivers of Patients Surviving Prolonged Critical Illness Experience High and Persistent Rates of Depression

Cameron JI, Chu LM, Matte A, et al. One-year outcomes in caregivers of critically ill patients. N Engl J Med. 2016;374(19):1831-1841.

Background

More than half of patients with a CCI require caregiver support 1 year after hospitalization.¹³ Caregivers provide tremendous physical and psychosocial support to their loved ones, but that care is often associated with significant burden.¹⁴

Findings

This prospective parallel cohort study followed caregivers of surviving patients ventilated for at least 7 days from 10 academic hospitals in Canada. The prevalence of depression (Center for Epidemiologic Studies–Depression scale ≥16) in this cohort of 280 caregivers (70% were women) was 67%, 49%, 43%, and 43% at the survey intervals of 7 days, 3 months, 6 months, and 12 months after ICU discharge, respectively. Using latent-class linear mixed models, the investigators identified 2 groups of caregivers: those whose depressive symptoms decreased over time (84%) and those whose depressive symptoms persisted at a high level for the year (16%). Patient characteristics (such as age, comorbidity, sex, and functional status) were not associated with caregiver outcomes. Younger caregiver age, greater effect of patient care on other activities, less social support, less mastery (sense of control), and less personal growth were associated with worse caregiver mental health outcomes.

Cautions

Although this is a high-quality prospective study, causality of caregiving on the high rates of depressive symptoms cannot be confirmed without a control group or knowledge of the caregivers’ mental health status prior to the episode of prolonged critical illness.

Implications

Patient critical illness may have serious impacts on caregiver health and well-being. Hospitalists should be attentive to factors associated with caregiver vulnerability and offer support. Improving caregivers’ sense of control and social support may be targets for interventions.

People with Non-normative Sexuality or Gender Face Additional Barriers and Stressors with Partner Loss

Bristowe K, Marshall S, Harding R. The bereavement experiences of lesbian, gay, bisexual and/or trans* people who have lost a partner: A systematic review, thematic synthesis and modelling of the literature. Palliat Med. 2016;30(8):730-744.

Background

Grief and bereavement impact individuals differently as they adjust to a death. Increasingly, it is recognized that lesbian, gay, bisexual, and/or transgender (LGBT) communities may face additional barriers when interacting with the healthcare system. This review sought to identify and appraise the evidence of the bereavement experiences among LGBT communities.

Findings

This systematic review summarized quantitative and qualitative data from 23 articles (13 studies). The synthesis noted that the pain associated with the loss of a partner was a universal experience regardless of sexual identity or gender history. Additional barriers and stressors of bereavement were reported for LGBT people, including homophobia, failure to acknowledge the relationship, additional legal and financial issues, and the shadow of human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS). LGBT people turned to additional resources for bereavement help: professional support, social and familial support, and societal and community support. Caregiver bereavement support experiences were shaped by whether the relationships were disclosed and accepted (acceptance-disclosure model).

Cautions

The quantitative data was mostly from the 1990s and described the context of HIV/AIDS. The qualitative studies, however, were done in the last decade. Very little research was available for transgender or bisexual caregivers.

Implications

People who identify as LGBT face additional barriers and stressors with the loss of a partner. The described acceptance-disclosure model may help providers be mindful of the additional barriers to LGBT bereavement support.

Physician Trainees Experience Significant Moral Distress with Futile Treatments

Dzeng E, Colaianni A, Roland M, et al. Moral distress amongst American physician trainees regarding futile treatments at the end of life: a qualitative study. J Gen Intern Med. 2016;31(1):93-99.

Background

Physician trainees are often faced with ethical challenges in providing end-of-life care. These ethical challenges can create confusion and conflict about the balance between the benefits and burdens experienced by patients.

Findings

The authors used semistructured, in-depth, qualitative interviews of 22 internal medicine trainees from 3 academic medical centers. An analysis of these interviews revealed several themes. Trainees reported moral distress when (1) many of the treatments provided in end-of-life care (ie, feeding tubes in advanced dementia) were perceived to be futile; (2) they felt obligated to provide end-of-life care that was not in the patient’s best interest, leading to “torture” or “suffering” for the patient; (3) they provided care they felt not to be in the patient’s best interest; (4) they perceived themselves to be powerless to affect change in these dilemmas; (5) they attributed some of their powerlessness to the hierarchy of their academic institutions; and (6) they feared that dehumanization and cynicism would be required to endure this distress.

Cautions

Resident recruitment occurred by solicitation, which may invite bias. Generalizability of qualitative studies to other settings can be limited.

Implications

Trainees may experience several dimensions of moral distress in end-of-life care. These findings challenge training programs to find ways to reduce the dehumanization, sense of powerlessness, and cynicism that this distress may cause.

Disclosure

The authors declare that they have no relevant financial conflicts of interest.

The aim of palliative care (PC) is to improve quality of life for patients facing serious, life-threatening illness and their families.¹ Due to insufficient numbers of PC specialists to meet the PC needs for every hospitalized patient,² all hospitalists should maintain basic PC skills as recognized by PC being a core competency for hospitalists.^3,4

We summarize and critique PC research articles published between January 1, 2016, and December 31, 2016, that have a high likelihood of impacting the practice of hospital medicine. We hand searched 15 journals and conducted a MEDLINE keyword search of PC terms (see Table). All titles and/or abstracts were reviewed and selected for full review based on the following factors: palliative medicine content, scientific rigor, impact on practice, and relevance to hospital medicine. Fifty-five articles were individually reviewed and scored by all authors according to rigor, impact, and relevance. Articles were ranked according to their mean scores, and 9 articles were chosen for inclusion through consensus discussion.

Antipsychotics Were Inferior to a Placebo in Treating Nonterminal Delirium

Agar MR, Lawlor PG, Quinn S, et al. Efficacy of oral risperidone, haloperidol, or placebo for symptoms of delirium among patients in palliative care: a randomized clinical trial. JAMA Intern Med. 2017;177(1):34-42.

Background

Delirium is highly prevalent in PC and is associated with significant distress.⁵ Antipsychotics are widely used for symptoms of delirium, although current evidence does not support this practice in hospitalized adults.^6,7

Findings

This was a double-blind, parallel-arm, placebo randomized controlled trial (RCT) of 247 patients with delirium with an estimated life expectancy of ≥7 days in 11 PC or hospice units across Australia. Patients were randomized to receive risperidone, haloperidol, or a placebo in addition to nonpharmacological management of delirium. Delirium symptom scores after 3 days of treatment, the use of midazolam as a rescue medication, and the presence of extrapyramidal symptoms (EPS) were measured. The risperidone and haloperidol arms had significantly higher delirium symptom scores (P = .02 and P = .009, respectively), mean EPS symptoms (P < .001), and more use of rescue midazolam than the placebo arm. Mortality was higher for antipsychotics, with a hazard ratio of 1.73 for haloperidol (P = .003), 1.29 for risperidone (P = .14), and 1.47 for any antipsychotic (P = .01).

Cautions

The study population was elderly (mean age >70 years) with mild delirium scores. The use of antipsychotics was associated with more benzodiazepine use, which could itself worsen delirium. As patients with clinician-predicted life expectancy of <7 days were excluded, findings cannot be extrapolated to the treatment of terminal delirium, which can often be more symptomatic and difficult to treat.

Implications

Avoid scheduled antipsychotics in patients with nonterminal delirium, as they can increase risk of harm without advantages, over nonpharmacologic interventions.

Low-Dose Morphine Was Superior to Weak Opioids in the Treatment of Moderate Cancer Pain

Bandieri E, Romero M, Ripamonti CI, et al. Randomized trial of low-dose morphine versus weak opioids in moderate cancer pain. J Clin Oncol. 2016;34(5):436-442.

Background

The World Health Organization guidelines recommend the use of weak opioids (WOs), such as codeine or tramadol, as a sequential step in the management of cancer pain.⁸ This strategy has not been tested against low doses of stronger opioids.

Findings

In this multicenter, open-label RCT, 240 patients in Italy were randomized and stratified by age (<75 years or ≥75 years) to either the WO group or low-dose morphine (M) group. The primary outcome measure was a reduction in pain intensity by 20% or more. Secondary outcomes included an improvement in symptom scores, a ≥30% and ≥50% reduction in pain, increased opioid dosage, and adverse side effects. Compared with the WO group, the M group had more patients with a 20% reduction in pain (88.2% vs 54.7%; P < .001), more evidence of pain control in the first week (80.9% vs 43.6%; P < .001), more patients with a ≥30% and ≥50% reduction in pain, and less need to switch to a stronger opioid (15.5% vs 35.0%; P = .001) or require dose increases. Adverse effects were similar in both groups.

Cautions

Patients with chronic kidney disease (CKD) were excluded due to concerns about the accumulation of morphine metabolites. Additionally, this study was open label, increasing the risk of bias.

Implications

Low-dose morphine should be considered over the use of WOs to achieve better and more rapid pain control in patients without CKD.

The Use of Methadone as a Coanalgesic May Improve Moderate Cancer Pain

Courtemanche F, Dao D, Gagné F, et al. Methadone as a coanalgesic for palliative care cancer patients. J Palliat Med. 2016;19(9):972-978.

Background

Methadone is effective at treating cancer pain and is often utilized when patients have neuropathic pain, fail to respond to traditional opioids, or have renal failure.^9,10 However, its long half-life and many drug interactions make methadone challenging to use.

Findings

This cohort study looked at 153 inpatient or outpatient PC patients in Montreal who received methadone as a coanalgesic for cancer pain. The patients’ median morphine equivalent dose was 120 mg when initiating methadone. The median starting dose of methadone was 3 mg per day. Of patients, 49.3% had a significant response (≥30% pain reduction), with a median response time of 7 days, and 30.1% achieved a substantial response (≥50% pain reduction), with a median response time of 3 days. Patients with higher initial pain scores were more likely to respond to adjuvant methadone. Those who had not responded after a week of methadone were unlikely to respond despite dose escalations. Adverse effects included drowsiness (51.4%), confusion (27.4%), constipation (24.7%), nausea (19.9%), and myoclonia (16.4%).

Cautions

This was an observational study with retrospective data, leading to higher levels of missing data. A high rate of adverse side effects was reported (90.4%). Further study is needed to validate and reproduce the findings.

Implications

The use of adjuvant low-dose methadone may be considered in patients with moderate pain despite high-dose opioids. If a response is not seen within 7 days, then methadone use should be reconsidered.

Many Hospitalized Patients on Comfort Care Still Receive Antimicrobials

Merel SE, Meier CA, McKinney CM, Pottinger PS. Antimicrobial use in patients on a comfort care protocol: a retrospective cohort study. J Palliat Med. 2016;19(11):1210-1214.

Background

It is unknown how often patients who are hospitalized at the end of life continue to receive antimicrobials and what factors are associated with antimicrobial use.

Findings

This retrospective cohort study of 1881 hospitalized adults transitioned to a comfort care order (CCO) set at 2 academic medical centers found that 77% of these patients received antimicrobials during their hospital stay (62.4% at 24 hours prior to CCO). Of the 711 still alive at ≥24 hours after CCO, 111 (15.6%) were still on antimicrobials, with that proportion remaining stable for the remainder of hospitalization. In comparing those who did and did not receive antimicrobials after 24 hours of CCO, the presence of a documented infection was not significantly different after adjusting for age. Those with a cancer diagnosis (adjusted risk ratio [ARR] = 1.44: P = .04), a longer length of stay (≥7 days vs <7 days; ARR = 1.49; P = .05), and those discharged home (ARR 2.93; P < .001) or to a facility (ARR 3.63; P < .001) versus dying in the hospital were more likely to be on antimicrobials 24 hours after CCO. Compared with those on a medicine service, patients in the medical and surgical intensive care units (ICUs) were less likely to receive antimicrobials (medical ICU ARR = 0.32; P = .01; surgical ICU and/or neuro-ICU ARR = 0.32; P = .02). The most commonly administered antimicrobials were fluoroquinolones and vancomycin.

Cautions

Only 111 patients were still on antimicrobials at 24 hours, which limited analysis. Investigators relied on retrospective data for medication administration and diagnoses.

Implications

Further work is needed to understand and address the expectations of clinicians, patients, and families regarding the role of antimicrobials at the end of life.

Video Decision Aids Improved Rates of Advance Care Planning and Hospice Use and Decreased Costs

Volandes, AE, Paasche-Orlow MK, Davis AD et al. Use of video decision aids to promote advance care planning in Hilo, Hawai‘i. J Gen Intern Med. 2016;31(9):1035-1040.

Background

Advance care planning (ACP) can be enhanced with the use of video decision aids, which may help address scalability and cost.¹¹ The Hawaii Medical Service Association began an initiative to improve ACP rates, which included a financial incentive. Clinician training and patient access to ACP videos were implemented 1 year into this campaign, which was intended for patients with late-stage disease.

Findings

This study tested the impact of the video intervention on the rates of ACP documentation in Hilo, Hawaii, along with secondary outcomes of hospice use, hospital deaths, and costs. The intervention was sequentially rolled out to Hilo Medical Center (HMC), followed by hospice and primary care practices. Following the video introduction, the proportion of patients discharged from HMC with ACP documentation markedly increased (3.2% to 39.9%; P < .001). The percentage of hospital patients discharged to hospice increased from 5.7% to 13.8% (P < .001). Overall admissions to the Hospice of Hilo increased at a greater rate than in other parts of Hawaii. After the intervention in Hilo, the in-hospital death rate among patients >65 years old declined slightly (P = .14), while in the rest of the state, the rate remained essentially unchanged. ACP planning did not reduce healthcare costs at the end of life, but costs seemed to increase more slowly in Hilo after the intervention than they did in the rest of Hawaii (P < .05).

Cautions

This report relies on before-and-after comparisons, with potential confounding by a background pay-for-quality initiative; however, the timing of the changes in outcomes correlates well with the introduction of the videos. ACP videos have been studied in other settings, so the intervention is likely generalizable to other states.

Implications

A widespread distribution of ACP videos and training for physicians in their use may lead to significant increases in ACP documentation and other beneficial clinical outcomes for patients and health systems.

A Standardized Palliative Care-Led Intervention Did Not Improve Psychological Outcomes in Families of Patients with Chronic Critical Illness

Carson SS, Cox CE, Wallenstein S, et al. Effect of palliative care-led meetings for families of patients with chronic critical illness: a randomized clinical trial. JAMA. 2016;316(1):51-62.

Background

Chronic critical illness (CCI) occurs when a patient neither recovers nor dies for days to weeks after an acute illness requiring aggressive intensive care. CCI is associated with poor patient and family outcomes.¹² Does a protocol-driven support and information meeting led by PC providers improve these outcomes?

Findings

This multicenter RCT compared 130 CCI patients (184 surrogates) who received a structured intervention to 126 patients (181 surrogates) with usual care. The structured intervention was led by PC clinicians in order to provide supportive conversations and information about CCI and prognosis compared with the usual intensivist communication. The support and information team met with the families of patients in the intervention group after day 7 of mechanical ventilation (MV) and again 10 days later. Both the intervention and control groups received validated information about CCI, and all were eligible for specialty PC consultation, as indicated. The primary outcome of the study was the Hospital Anxiety and Depression Scale (HADS) at 90-day follow-up with the surrogates. Secondary endpoints included posttraumatic stress disorder (PTSD) assessment and other communication measures as well as patient outcomes (hospital mortality, 90-day survival, length of stay, and days of MV). At least 1 meeting took place for 89% of patients (82% of surrogates) in the intervention arm. Fewer patients in the intervention arm had nonstudy PC consultations (13% vs 22%). Ninety-day HADS results were similar in the 2 groups. PTSD symptoms, however, were higher in the intervention group (Impact of Event Scale-Revised score: 25.9 for intervention and 21.3 for control; intergroup difference 4.6 [95% confidence interval, 0.01-9.10]). There were no statistically significant differences among the patient-focused measures, including survival.

Cautions

Although the teams contained skilled clinicians led by PC practitioners, this was not an ordinary PC intervention. The intervention included information and emotional support meetings alone rather than support from a PC team driven by clinical considerations. This study included surrogates of patients with CCI but not other conditions.

Implications

Protocol-driven support and information meetings may not improve, and may slightly worsen, outcomes in families of patients with CCI. This study did not evaluate and should not be applied to clinically indicated, specialty PC consultation in the ICU.

Caregivers of Patients Surviving Prolonged Critical Illness Experience High and Persistent Rates of Depression

Cameron JI, Chu LM, Matte A, et al. One-year outcomes in caregivers of critically ill patients. N Engl J Med. 2016;374(19):1831-1841.

Background

More than half of patients with a CCI require caregiver support 1 year after hospitalization.¹³ Caregivers provide tremendous physical and psychosocial support to their loved ones, but that care is often associated with significant burden.¹⁴

Findings

This prospective parallel cohort study followed caregivers of surviving patients ventilated for at least 7 days from 10 academic hospitals in Canada. The prevalence of depression (Center for Epidemiologic Studies–Depression scale ≥16) in this cohort of 280 caregivers (70% were women) was 67%, 49%, 43%, and 43% at the survey intervals of 7 days, 3 months, 6 months, and 12 months after ICU discharge, respectively. Using latent-class linear mixed models, the investigators identified 2 groups of caregivers: those whose depressive symptoms decreased over time (84%) and those whose depressive symptoms persisted at a high level for the year (16%). Patient characteristics (such as age, comorbidity, sex, and functional status) were not associated with caregiver outcomes. Younger caregiver age, greater effect of patient care on other activities, less social support, less mastery (sense of control), and less personal growth were associated with worse caregiver mental health outcomes.

Cautions

Although this is a high-quality prospective study, causality of caregiving on the high rates of depressive symptoms cannot be confirmed without a control group or knowledge of the caregivers’ mental health status prior to the episode of prolonged critical illness.

Implications

Patient critical illness may have serious impacts on caregiver health and well-being. Hospitalists should be attentive to factors associated with caregiver vulnerability and offer support. Improving caregivers’ sense of control and social support may be targets for interventions.

People with Non-normative Sexuality or Gender Face Additional Barriers and Stressors with Partner Loss

Bristowe K, Marshall S, Harding R. The bereavement experiences of lesbian, gay, bisexual and/or trans* people who have lost a partner: A systematic review, thematic synthesis and modelling of the literature. Palliat Med. 2016;30(8):730-744.

Background

Grief and bereavement impact individuals differently as they adjust to a death. Increasingly, it is recognized that lesbian, gay, bisexual, and/or transgender (LGBT) communities may face additional barriers when interacting with the healthcare system. This review sought to identify and appraise the evidence of the bereavement experiences among LGBT communities.

Findings

This systematic review summarized quantitative and qualitative data from 23 articles (13 studies). The synthesis noted that the pain associated with the loss of a partner was a universal experience regardless of sexual identity or gender history. Additional barriers and stressors of bereavement were reported for LGBT people, including homophobia, failure to acknowledge the relationship, additional legal and financial issues, and the shadow of human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS). LGBT people turned to additional resources for bereavement help: professional support, social and familial support, and societal and community support. Caregiver bereavement support experiences were shaped by whether the relationships were disclosed and accepted (acceptance-disclosure model).

Cautions

The quantitative data was mostly from the 1990s and described the context of HIV/AIDS. The qualitative studies, however, were done in the last decade. Very little research was available for transgender or bisexual caregivers.

Implications

People who identify as LGBT face additional barriers and stressors with the loss of a partner. The described acceptance-disclosure model may help providers be mindful of the additional barriers to LGBT bereavement support.

Physician Trainees Experience Significant Moral Distress with Futile Treatments

Dzeng E, Colaianni A, Roland M, et al. Moral distress amongst American physician trainees regarding futile treatments at the end of life: a qualitative study. J Gen Intern Med. 2016;31(1):93-99.

Background

Physician trainees are often faced with ethical challenges in providing end-of-life care. These ethical challenges can create confusion and conflict about the balance between the benefits and burdens experienced by patients.

Findings

The authors used semistructured, in-depth, qualitative interviews of 22 internal medicine trainees from 3 academic medical centers. An analysis of these interviews revealed several themes. Trainees reported moral distress when (1) many of the treatments provided in end-of-life care (ie, feeding tubes in advanced dementia) were perceived to be futile; (2) they felt obligated to provide end-of-life care that was not in the patient’s best interest, leading to “torture” or “suffering” for the patient; (3) they provided care they felt not to be in the patient’s best interest; (4) they perceived themselves to be powerless to affect change in these dilemmas; (5) they attributed some of their powerlessness to the hierarchy of their academic institutions; and (6) they feared that dehumanization and cynicism would be required to endure this distress.

Cautions

Resident recruitment occurred by solicitation, which may invite bias. Generalizability of qualitative studies to other settings can be limited.

Implications

Trainees may experience several dimensions of moral distress in end-of-life care. These findings challenge training programs to find ways to reduce the dehumanization, sense of powerlessness, and cynicism that this distress may cause.

Disclosure

The authors declare that they have no relevant financial conflicts of interest.

The aim of palliative care (PC) is to improve quality of life for patients facing serious, life-threatening illness and their families.¹ Due to insufficient numbers of PC specialists to meet the PC needs for every hospitalized patient,² all hospitalists should maintain basic PC skills as recognized by PC being a core competency for hospitalists.^3,4

We summarize and critique PC research articles published between January 1, 2016, and December 31, 2016, that have a high likelihood of impacting the practice of hospital medicine. We hand searched 15 journals and conducted a MEDLINE keyword search of PC terms (see Table). All titles and/or abstracts were reviewed and selected for full review based on the following factors: palliative medicine content, scientific rigor, impact on practice, and relevance to hospital medicine. Fifty-five articles were individually reviewed and scored by all authors according to rigor, impact, and relevance. Articles were ranked according to their mean scores, and 9 articles were chosen for inclusion through consensus discussion.

Antipsychotics Were Inferior to a Placebo in Treating Nonterminal Delirium

Agar MR, Lawlor PG, Quinn S, et al. Efficacy of oral risperidone, haloperidol, or placebo for symptoms of delirium among patients in palliative care: a randomized clinical trial. JAMA Intern Med. 2017;177(1):34-42.

Background

Delirium is highly prevalent in PC and is associated with significant distress.⁵ Antipsychotics are widely used for symptoms of delirium, although current evidence does not support this practice in hospitalized adults.^6,7

Findings

This was a double-blind, parallel-arm, placebo randomized controlled trial (RCT) of 247 patients with delirium with an estimated life expectancy of ≥7 days in 11 PC or hospice units across Australia. Patients were randomized to receive risperidone, haloperidol, or a placebo in addition to nonpharmacological management of delirium. Delirium symptom scores after 3 days of treatment, the use of midazolam as a rescue medication, and the presence of extrapyramidal symptoms (EPS) were measured. The risperidone and haloperidol arms had significantly higher delirium symptom scores (P = .02 and P = .009, respectively), mean EPS symptoms (P < .001), and more use of rescue midazolam than the placebo arm. Mortality was higher for antipsychotics, with a hazard ratio of 1.73 for haloperidol (P = .003), 1.29 for risperidone (P = .14), and 1.47 for any antipsychotic (P = .01).

Cautions

The study population was elderly (mean age >70 years) with mild delirium scores. The use of antipsychotics was associated with more benzodiazepine use, which could itself worsen delirium. As patients with clinician-predicted life expectancy of <7 days were excluded, findings cannot be extrapolated to the treatment of terminal delirium, which can often be more symptomatic and difficult to treat.

Implications

Avoid scheduled antipsychotics in patients with nonterminal delirium, as they can increase risk of harm without advantages, over nonpharmacologic interventions.

Low-Dose Morphine Was Superior to Weak Opioids in the Treatment of Moderate Cancer Pain

Bandieri E, Romero M, Ripamonti CI, et al. Randomized trial of low-dose morphine versus weak opioids in moderate cancer pain. J Clin Oncol. 2016;34(5):436-442.

Background

The World Health Organization guidelines recommend the use of weak opioids (WOs), such as codeine or tramadol, as a sequential step in the management of cancer pain.⁸ This strategy has not been tested against low doses of stronger opioids.

Findings

In this multicenter, open-label RCT, 240 patients in Italy were randomized and stratified by age (<75 years or ≥75 years) to either the WO group or low-dose morphine (M) group. The primary outcome measure was a reduction in pain intensity by 20% or more. Secondary outcomes included an improvement in symptom scores, a ≥30% and ≥50% reduction in pain, increased opioid dosage, and adverse side effects. Compared with the WO group, the M group had more patients with a 20% reduction in pain (88.2% vs 54.7%; P < .001), more evidence of pain control in the first week (80.9% vs 43.6%; P < .001), more patients with a ≥30% and ≥50% reduction in pain, and less need to switch to a stronger opioid (15.5% vs 35.0%; P = .001) or require dose increases. Adverse effects were similar in both groups.

Cautions

Patients with chronic kidney disease (CKD) were excluded due to concerns about the accumulation of morphine metabolites. Additionally, this study was open label, increasing the risk of bias.

Implications

Low-dose morphine should be considered over the use of WOs to achieve better and more rapid pain control in patients without CKD.

The Use of Methadone as a Coanalgesic May Improve Moderate Cancer Pain

Courtemanche F, Dao D, Gagné F, et al. Methadone as a coanalgesic for palliative care cancer patients. J Palliat Med. 2016;19(9):972-978.

Background

Methadone is effective at treating cancer pain and is often utilized when patients have neuropathic pain, fail to respond to traditional opioids, or have renal failure.^9,10 However, its long half-life and many drug interactions make methadone challenging to use.

Findings

This cohort study looked at 153 inpatient or outpatient PC patients in Montreal who received methadone as a coanalgesic for cancer pain. The patients’ median morphine equivalent dose was 120 mg when initiating methadone. The median starting dose of methadone was 3 mg per day. Of patients, 49.3% had a significant response (≥30% pain reduction), with a median response time of 7 days, and 30.1% achieved a substantial response (≥50% pain reduction), with a median response time of 3 days. Patients with higher initial pain scores were more likely to respond to adjuvant methadone. Those who had not responded after a week of methadone were unlikely to respond despite dose escalations. Adverse effects included drowsiness (51.4%), confusion (27.4%), constipation (24.7%), nausea (19.9%), and myoclonia (16.4%).

Cautions

This was an observational study with retrospective data, leading to higher levels of missing data. A high rate of adverse side effects was reported (90.4%). Further study is needed to validate and reproduce the findings.

Implications

The use of adjuvant low-dose methadone may be considered in patients with moderate pain despite high-dose opioids. If a response is not seen within 7 days, then methadone use should be reconsidered.

Many Hospitalized Patients on Comfort Care Still Receive Antimicrobials

Merel SE, Meier CA, McKinney CM, Pottinger PS. Antimicrobial use in patients on a comfort care protocol: a retrospective cohort study. J Palliat Med. 2016;19(11):1210-1214.

Background

It is unknown how often patients who are hospitalized at the end of life continue to receive antimicrobials and what factors are associated with antimicrobial use.

Findings

This retrospective cohort study of 1881 hospitalized adults transitioned to a comfort care order (CCO) set at 2 academic medical centers found that 77% of these patients received antimicrobials during their hospital stay (62.4% at 24 hours prior to CCO). Of the 711 still alive at ≥24 hours after CCO, 111 (15.6%) were still on antimicrobials, with that proportion remaining stable for the remainder of hospitalization. In comparing those who did and did not receive antimicrobials after 24 hours of CCO, the presence of a documented infection was not significantly different after adjusting for age. Those with a cancer diagnosis (adjusted risk ratio [ARR] = 1.44: P = .04), a longer length of stay (≥7 days vs <7 days; ARR = 1.49; P = .05), and those discharged home (ARR 2.93; P < .001) or to a facility (ARR 3.63; P < .001) versus dying in the hospital were more likely to be on antimicrobials 24 hours after CCO. Compared with those on a medicine service, patients in the medical and surgical intensive care units (ICUs) were less likely to receive antimicrobials (medical ICU ARR = 0.32; P = .01; surgical ICU and/or neuro-ICU ARR = 0.32; P = .02). The most commonly administered antimicrobials were fluoroquinolones and vancomycin.

Cautions

Only 111 patients were still on antimicrobials at 24 hours, which limited analysis. Investigators relied on retrospective data for medication administration and diagnoses.

Implications

Further work is needed to understand and address the expectations of clinicians, patients, and families regarding the role of antimicrobials at the end of life.

Video Decision Aids Improved Rates of Advance Care Planning and Hospice Use and Decreased Costs

Volandes, AE, Paasche-Orlow MK, Davis AD et al. Use of video decision aids to promote advance care planning in Hilo, Hawai‘i. J Gen Intern Med. 2016;31(9):1035-1040.

Background

Advance care planning (ACP) can be enhanced with the use of video decision aids, which may help address scalability and cost.¹¹ The Hawaii Medical Service Association began an initiative to improve ACP rates, which included a financial incentive. Clinician training and patient access to ACP videos were implemented 1 year into this campaign, which was intended for patients with late-stage disease.

Findings

This study tested the impact of the video intervention on the rates of ACP documentation in Hilo, Hawaii, along with secondary outcomes of hospice use, hospital deaths, and costs. The intervention was sequentially rolled out to Hilo Medical Center (HMC), followed by hospice and primary care practices. Following the video introduction, the proportion of patients discharged from HMC with ACP documentation markedly increased (3.2% to 39.9%; P < .001). The percentage of hospital patients discharged to hospice increased from 5.7% to 13.8% (P < .001). Overall admissions to the Hospice of Hilo increased at a greater rate than in other parts of Hawaii. After the intervention in Hilo, the in-hospital death rate among patients >65 years old declined slightly (P = .14), while in the rest of the state, the rate remained essentially unchanged. ACP planning did not reduce healthcare costs at the end of life, but costs seemed to increase more slowly in Hilo after the intervention than they did in the rest of Hawaii (P < .05).

Cautions

This report relies on before-and-after comparisons, with potential confounding by a background pay-for-quality initiative; however, the timing of the changes in outcomes correlates well with the introduction of the videos. ACP videos have been studied in other settings, so the intervention is likely generalizable to other states.

Implications

A widespread distribution of ACP videos and training for physicians in their use may lead to significant increases in ACP documentation and other beneficial clinical outcomes for patients and health systems.

A Standardized Palliative Care-Led Intervention Did Not Improve Psychological Outcomes in Families of Patients with Chronic Critical Illness

Carson SS, Cox CE, Wallenstein S, et al. Effect of palliative care-led meetings for families of patients with chronic critical illness: a randomized clinical trial. JAMA. 2016;316(1):51-62.

Background

Chronic critical illness (CCI) occurs when a patient neither recovers nor dies for days to weeks after an acute illness requiring aggressive intensive care. CCI is associated with poor patient and family outcomes.¹² Does a protocol-driven support and information meeting led by PC providers improve these outcomes?

Findings

This multicenter RCT compared 130 CCI patients (184 surrogates) who received a structured intervention to 126 patients (181 surrogates) with usual care. The structured intervention was led by PC clinicians in order to provide supportive conversations and information about CCI and prognosis compared with the usual intensivist communication. The support and information team met with the families of patients in the intervention group after day 7 of mechanical ventilation (MV) and again 10 days later. Both the intervention and control groups received validated information about CCI, and all were eligible for specialty PC consultation, as indicated. The primary outcome of the study was the Hospital Anxiety and Depression Scale (HADS) at 90-day follow-up with the surrogates. Secondary endpoints included posttraumatic stress disorder (PTSD) assessment and other communication measures as well as patient outcomes (hospital mortality, 90-day survival, length of stay, and days of MV). At least 1 meeting took place for 89% of patients (82% of surrogates) in the intervention arm. Fewer patients in the intervention arm had nonstudy PC consultations (13% vs 22%). Ninety-day HADS results were similar in the 2 groups. PTSD symptoms, however, were higher in the intervention group (Impact of Event Scale-Revised score: 25.9 for intervention and 21.3 for control; intergroup difference 4.6 [95% confidence interval, 0.01-9.10]). There were no statistically significant differences among the patient-focused measures, including survival.

Cautions

Although the teams contained skilled clinicians led by PC practitioners, this was not an ordinary PC intervention. The intervention included information and emotional support meetings alone rather than support from a PC team driven by clinical considerations. This study included surrogates of patients with CCI but not other conditions.

Implications

Protocol-driven support and information meetings may not improve, and may slightly worsen, outcomes in families of patients with CCI. This study did not evaluate and should not be applied to clinically indicated, specialty PC consultation in the ICU.

Caregivers of Patients Surviving Prolonged Critical Illness Experience High and Persistent Rates of Depression

Cameron JI, Chu LM, Matte A, et al. One-year outcomes in caregivers of critically ill patients. N Engl J Med. 2016;374(19):1831-1841.

Background

More than half of patients with a CCI require caregiver support 1 year after hospitalization.¹³ Caregivers provide tremendous physical and psychosocial support to their loved ones, but that care is often associated with significant burden.¹⁴

Findings

This prospective parallel cohort study followed caregivers of surviving patients ventilated for at least 7 days from 10 academic hospitals in Canada. The prevalence of depression (Center for Epidemiologic Studies–Depression scale ≥16) in this cohort of 280 caregivers (70% were women) was 67%, 49%, 43%, and 43% at the survey intervals of 7 days, 3 months, 6 months, and 12 months after ICU discharge, respectively. Using latent-class linear mixed models, the investigators identified 2 groups of caregivers: those whose depressive symptoms decreased over time (84%) and those whose depressive symptoms persisted at a high level for the year (16%). Patient characteristics (such as age, comorbidity, sex, and functional status) were not associated with caregiver outcomes. Younger caregiver age, greater effect of patient care on other activities, less social support, less mastery (sense of control), and less personal growth were associated with worse caregiver mental health outcomes.

Cautions

Although this is a high-quality prospective study, causality of caregiving on the high rates of depressive symptoms cannot be confirmed without a control group or knowledge of the caregivers’ mental health status prior to the episode of prolonged critical illness.

Implications

Patient critical illness may have serious impacts on caregiver health and well-being. Hospitalists should be attentive to factors associated with caregiver vulnerability and offer support. Improving caregivers’ sense of control and social support may be targets for interventions.

People with Non-normative Sexuality or Gender Face Additional Barriers and Stressors with Partner Loss

Bristowe K, Marshall S, Harding R. The bereavement experiences of lesbian, gay, bisexual and/or trans* people who have lost a partner: A systematic review, thematic synthesis and modelling of the literature. Palliat Med. 2016;30(8):730-744.

Background

Grief and bereavement impact individuals differently as they adjust to a death. Increasingly, it is recognized that lesbian, gay, bisexual, and/or transgender (LGBT) communities may face additional barriers when interacting with the healthcare system. This review sought to identify and appraise the evidence of the bereavement experiences among LGBT communities.

Findings

This systematic review summarized quantitative and qualitative data from 23 articles (13 studies). The synthesis noted that the pain associated with the loss of a partner was a universal experience regardless of sexual identity or gender history. Additional barriers and stressors of bereavement were reported for LGBT people, including homophobia, failure to acknowledge the relationship, additional legal and financial issues, and the shadow of human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS). LGBT people turned to additional resources for bereavement help: professional support, social and familial support, and societal and community support. Caregiver bereavement support experiences were shaped by whether the relationships were disclosed and accepted (acceptance-disclosure model).

Cautions

The quantitative data was mostly from the 1990s and described the context of HIV/AIDS. The qualitative studies, however, were done in the last decade. Very little research was available for transgender or bisexual caregivers.

Implications

People who identify as LGBT face additional barriers and stressors with the loss of a partner. The described acceptance-disclosure model may help providers be mindful of the additional barriers to LGBT bereavement support.

Physician Trainees Experience Significant Moral Distress with Futile Treatments

Dzeng E, Colaianni A, Roland M, et al. Moral distress amongst American physician trainees regarding futile treatments at the end of life: a qualitative study. J Gen Intern Med. 2016;31(1):93-99.

Background

Physician trainees are often faced with ethical challenges in providing end-of-life care. These ethical challenges can create confusion and conflict about the balance between the benefits and burdens experienced by patients.

Findings

The authors used semistructured, in-depth, qualitative interviews of 22 internal medicine trainees from 3 academic medical centers. An analysis of these interviews revealed several themes. Trainees reported moral distress when (1) many of the treatments provided in end-of-life care (ie, feeding tubes in advanced dementia) were perceived to be futile; (2) they felt obligated to provide end-of-life care that was not in the patient’s best interest, leading to “torture” or “suffering” for the patient; (3) they provided care they felt not to be in the patient’s best interest; (4) they perceived themselves to be powerless to affect change in these dilemmas; (5) they attributed some of their powerlessness to the hierarchy of their academic institutions; and (6) they feared that dehumanization and cynicism would be required to endure this distress.

Cautions

Resident recruitment occurred by solicitation, which may invite bias. Generalizability of qualitative studies to other settings can be limited.

Implications

Trainees may experience several dimensions of moral distress in end-of-life care. These findings challenge training programs to find ways to reduce the dehumanization, sense of powerlessness, and cynicism that this distress may cause.

Disclosure

The authors declare that they have no relevant financial conflicts of interest.

Engaging patients and their caregivers in care improves health outcomes^1-3 and is endorsed by leading healthcare organizations as essential to improving care quality and safety.^4-6 Patient engagement emphasizes that patients, caregivers, and healthcare providers work together to “promote and support active patient and public involvement in health and healthcare and to strengthen their influence on healthcare decisions.”⁷ Patient portals, web-based personal health records linked to electronic health record (EHR) data, are intended to promote engagement by providing patients and their caregivers with timely electronic access to their healthcare information and supporting communication through secure messaging with their healthcare team.⁸ The use of patient portals has also been suggested as a way for patients and/or caregivers to identify and intercept medical errors, thus having the potential to also improve patient safety.^8,9

As a requirement for meaningful use, access to health information through patient portals in the ambulatory setting has increased dramatically.¹⁰ Studies evaluating the use of these patient portals to promote patient-centered care are growing, but evidence supporting their impact on improved health outcomes is currently insufficient.^11-15 Although research and policy focus on the use of patient portals in the ambulatory setting, recent literature suggests that patient portals may be used to share inpatient clinical information to engage patients and their caregivers during their hospitalization.^16-18 Before the widespread use of patient portals in the inpatient setting is endorsed, systematic research is needed to understand optimal portal design requirements, if and how these portals are used, and whether their use provides value to the hospitalized patient and/or caregiver.⁸

Prior literature summarized early findings regarding the use of various technologies designed to engage hospitalized patients.^17,19,20 In this systematic review, we describe the emerging literature examining the design, use, and impact of inpatient portals for hospitalized patients and/or caregivers over the last 10 years. Inpatient portals are defined here as electronic patient portals tethered to EHRs that are designed to provide hospitalized patients and/or caregivers secure access to personalized, inpatient clinical information with the intent of engaging them in their hospital care. After analyzing and summarizing these data, we then identify knowledge gaps and potential future research directions.

Search Strategy, Study Selection, and Analysis

This systematic review included available, peer-reviewed, and grey literature published from January 1, 2006, to August 8, 2017, in PubMed, Web of Science (including the Institute of Electrical and Electronics Engineers Xplore), Cochrane, CINAHLPlus, and Scopus databases. Terms and phrases, including those found in the Medical Subject Heading (MeSH) index, were used to identify studies evaluating (1) patient portals (“health record, personal [MeSH],” “personal health record,” “patient portal,” “inpatient portal,” “ipad,” “tablet,” or “bedside information technology”), (2) engagement (“engagement,” “empowerment,” “participation,” “activation,” or “self-efficacy”), and (3) in the hospital (“inpatient [MeSH],” “hospital [MeSH],” “hospitalized patient [MeSH],” or “unit”). MeSH terms were used when applicable. Based on previous literature, free-text terms were also used when subject headings were not applied consistently, such as with terms related to engagement.^17,21 Studies were excluded if they were not written in English, if they evaluated portals exclusively in the emergency department or ambulatory setting, and/or if they described future study protocols. Studies describing general inpatient technology or evaluating portals used in the hospital but not tethered to inpatient EHR clinical data were also excluded.

By using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines,²² 2 researchers (M.K. and P.H.) completed the literature search and potential article screening. Results were aggregated and studies were screened and excluded from full review based on title and abstract information. Additional studies were included after reference list review. During a full review of included studies, 2 researchers independently extracted data, including the study objective, design, setting, sample, data collection instruments, outcomes, and a description of results. Guided by our study objective, findings were reconciled by consensus and analyzed and described according to the following 3 themes: (1) inpatient portal design, (2) inpatient portal use and usability, and (3) the impact of inpatient portal use on patient or caregiver and healthcare team outcomes as defined by retrieved studies.

The quality of studies was evaluated by the same 2 researchers independently by using the Downs and Black checklist for assessing the methodological quality of randomized and nonrandomized healthcare interventions.²³ Qualitative studies describing the development of portal prototypes and/or portal redesign efforts were excluded from these analyses. Discrepancies were resolved by consensus.Because of the wide variability in study designs, populations, and outcomes, a meta-analysis of pooled data was not performed.

Of the 731 studies identified through database searching and reference review, 36 were included for full-text review and 17 met inclusion criteria (Figure; Table 1). Studies excluded after full-text review described portal use outside of the inpatient setting, portals not linked to hospital EHR clinical data, portals not designed for inpatients, and/or inpatient technology in general. The inpatient portal platforms, hardware used, and functionalities varied within included studies (Table 2). The majority of studies used custom, web-based inpatient portal applications on tablet computers. Most provided information about the patients’ hospital medications, healthcare team, and education about their condition and/or a medical glossary. Many included the patient’s schedule, hospital problem list, discharge information, and a way to keep notes.

There has been a recent increase in inpatient portal study publication, with 9 studies published during or after 2016. Five were conducted in the pediatric setting and all but 1³⁰ with English-speaking participants. Twelve studies were qualitative, many of which were conducted in multiple phases by using semi-structured interviews and/or focus groups to develop or redesign inpatient portals. Of the remaining studies, 3 used a cross-sectional design, 1 used a before and after design without a control group, and 1 was a nonrandomized trial. Studies were rated as having medium-to-high risk of bias because of design flaws (Table 1 in supplementary Appendix). Because many studies were small pilot studies and all were single-centered studies, the generalizability of findings to different healthcare settings or patient populations is limited.

Inpatient Portal Design

Most included studies evaluated patient and/or caregiver information needs to design and/or enhance inpatient portals.^16,24-37 In 1 study, patients described an overall lack of information provided in the hospital and insufficient time to understand and remember information, which, when shared, was often presented by using medical terminology.³⁰ They wanted information to help them understand their daily hospital routine, confirm and compare medications and test results, learn about care, and prepare for discharge. Participants in multiple studies echoed these results, indicating the need for a schedule of upcoming clinical events (eg, medication administration, procedures, imaging), secure and timely clinical information (eg, list of diagnoses and medications, test results), personalized education, a medical glossary, discharge information, and a way to take notes and recognize and communicate with providers.

Patients also requested further information transparency,^34,37 including physicians’ notes, radiology results, operative reports, and billing information, along with general hospital information,¹⁶ meal ordering,³³ and video conferencing.²⁷ ln designing and refining an inpatient medication-tracking tool, participants identified the need for information about medication dosage, frequency, timing, administration method, criticality, alternative medications or forms, and education.^26,36 Patients and/or caregivers also indicated interest in communicating with inpatient providers by using the portal.^{16,27,28,30-37} In 1 study, patients highlighted the need to be involved in care plan development,²⁷ which led to portal refinement to allow for patient-generated data entry, including care goals and a way to communicate real-time concerns and feedback.²⁸

Studies also considered healthcare team perspectives to inform portal design.^{25,26,28,30,35,37} Although information needs usually overlapped, patient and healthcare team priorities differed in some areas. Although patients wanted to “know what was going to happen to them,” nurses in 1 study were more concerned about providing information to protect patients, such as safety and precaution materials.²⁵ Similarly, when designing a medication-tracking tool, patients sought information that helped them understand what to expect, while pharmacists focused on medication safety and providing information that fit their workflow (eg, abstract medication schedules).³⁶

Identified study data raised important portal interface design considerations. Results suggested clinical data should be presented by using simple displays,²⁸ accommodating real-time information. Participants recommended links^16,29 to personalized patient-friendly³⁷ education accessed with minimal steps.²⁶ Interfaces may be personalized for target users, such as patient or proxy and younger or older individuals. For example, older patients reported less familiarity with touch screens, internal keyboards, and handwriting recognition, favoring voice recognition for recording notes.²⁷ This raised questions about how portals can be designed to best maintain patient privacy.²⁵ Interface design, such as navigation, also relied heavily on hardware choice, such as tablet versus mobile phone.²⁸

Inpatient Portal Use and Usability

Most patient and/or caregiver participants in included studies were interested in using an inpatient portal, used it when offered, found it easy to use, useful, and/or were satisfied with it.^16,18,24-37 Most used and liked functionalities that provided healthcare team, test result, and medication information.^22,33,37 In the 1 identified controlled trial,¹⁸ researchers evaluated an inpatient portal given to adult inpatients that included a problem list, schedule, medication list, and healthcare team information. Of the intervention unit patients, 80% used the portal, 76% indicated it was easy to use, and 71% thought it provided useful information. When a portal was given to 239 adult patients and caregivers in another study, 66% sent a total of 291 messages to the healthcare team.³¹ Of these, 153 provided feedback, 76 expressed preferences, and 16 communicated concerns. In a pediatric study, an inpatient portal was given to 296 parents who sent a total of 36 messages and 176 requests.³³ Messages sent included information regarding caregiver needs, questions, updates, and/or positive endorsements of the healthcare team and/or care.

Impact of Inpatient Portal Use

Multiple studies evaluated the impact of inpatient portal use on patient and/or caregiver engagement, empowerment, activation, and/or knowledge, which had mixed results. Most adult patients interviewed in one study had positive experiences using a portal to answer their questions between physician visits and learn about, remember, and engage in care.³⁷ A majority of adult inpatient portal users in another study agreed that portal use helped them feel in control and understand their condition; however, they did not report having improved discharge timing knowledge.²⁹ In a pediatric study, most parent inpatient portal users agreed use improved their ability to monitor, understand, and make decisions about their child’s care.³³ In the controlled trial,¹⁸ a higher percentage of portal intervention patients could identify their physician or role; however, patient activation was not statistically different between intervention and control patients.

Results from included studies also evaluated the impact of portal use on communication. Some suggest inpatient portal use may replace and/or facilitate verbal communication between patients, caregivers, and providers.³⁵ In a pediatric study, 51% of parent portal users reported it gave them the information they needed, reducing the amount of questions they had for their healthcare team.³³ Similarly 43% of 14 adult inpatient portal users in another study thought the portal could replace at least some face-to-face communication.³⁷ Some providers indicated portal use enhanced rounding discussion quality.³⁵ Another study suggested that patient-provider communication via electronic messaging may provide benefits for some patients and not others.³⁷

Multiple studies evaluated patient, caregiver, and/or healthcare team perceptions of the impact of inpatient portal use on detection of errors and patient safety.^29,31,33,35 In adult inpatients, 6% agreed portal use could help them find errors.²⁹ In a pediatric study, 8% reported finding at least 1 medication error by using the portal, and 89% thought use reduced errors in their child’s care.³³ One patient in a qualitative study of adult inpatients cited an example of a dosing error discovered by using the portal.³⁷ Healthcare providers in another study also reported that use facilitated patient error identification.³⁵

Included studies evaluated the potential impact of portal use on patient anxiety, confusion, and/or worry, and the work of healthcare teams. In 1 study, nurses voiced concerns about giving information subject to change or that couldn’t always be achieved because of competing hospital priorities, such as discharge timing.²⁵ They also worried about giving medical information that would create cognitive overload for patients and/or require professional interpretation. Although providers in another study perceived little negative impact on their workflow after portal implementation, they worried about the potential of adding other information to the portal.³⁵ For example, they were concerned that the future release of abnormal test results or sensitive data would lead to confusion and more time spent answering patient questions. Physicians also worried that secure messaging could be overused by patients, would be used to inappropriately express acute concerns, or might adversely affect verbal communication. Providers in 2 studies expressed concerns about potential negative implications of portal use on their work before implementation, which were subsequently reduced after portal implementation.^29,38 Conversely, no parent portal users in another study thought portal information was confusing.³³ One parent participant noted portal use may actually decrease anxiety: “Access to their medical information gives patients and their caregivers perspective and insight into their hospital care and empowers them with knowledge about [what is going on], which reduces anxiety.”³⁷

We identified multiple studies evaluating the design, use, and impact of inpatient patient portals for hospitalized patients and caregivers. Based on the information needs identified by patients and healthcare team participants, multiple key content and design recommendations are suggested, including presenting (1) timely, personalized clinical and educational information in lay terms, (2) the care trajectory, including care plan and patient schedule, and (3) a way to recognize and communicate with the inpatient healthcare team. Design challenges still exist, such as translating medical terminology from EHRs into patient-friendly language, proxy access, and portal integration across transitions. Data from identified studies suggest hospitalized patients and caregivers are interested in and willing to use inpatient portals, but there is less information about the use of each functionality. Evidence supporting the role of inpatient portal use in improving patient and/or caregiver engagement, knowledge, communication, and the quality and safety of care is currently limited. Included studies indicate that healthcare team members had concerns about using portals to share clinical information and communicate electronically in the hospital. The extent to which these concerns translate to demonstrable problems remains to be seen.

Early studies focus on patient and caregiver information needs and portal interface design. Although the necessity for certain core functionalities and design requirements are becoming clear,²⁰ best practices regarding the amount and timing of information released (eg, physician notes, lab results), optimal hardware decisions (eg, large-screen displays, hospital-owned tablets, bring-your-own-device model), and details around secure-messaging implementation in the acute hospital setting are still lacking. Future work is needed to understand optimal patient-provider communication architectures that support improved synchronous and asynchronous messaging and privacy-preserving approaches to the design of these systems to handle patient-generated data as it becomes more commonplace. Although patient participants in these studies were generally satisfied using inpatient portals, many indicated the need for even more transparency, such as the release of results in real time and inclusion of physician notes (even if they could not be fully comprehended).³⁷ As the movement of sharing notes with patients in the ambulatory setting grows,³⁹ it will inevitably extend to the inpatient setting.⁴⁰ Further research is needed to understand the impact of increased transparency on health outcomes, patient anxiety, and inpatient healthcare team workload. Although the majority of studies described the design and/or use of custom portal platforms, EHR vendors are now developing inpatient portals that integrate into preexisting systems (eg, MyChart Bedside, Epic Systems). This will increase the likelihood of broad inpatient portal adoption and may facilitate multicenter trials evaluating the impact of their use.

The next steps will need to focus on the evaluation of specific inpatient portal functionalities and the impact of their use on objective process and outcome measures by using rigorous, experimental study designs. Akin to ambulatory portal research, measures of interest will include patient activation,^41,42 patient and/or caregiver satisfaction,⁴³ care processes (eg, length of stay, readmissions), and patient safety (eg, safety perceptions, adverse drug events, hospital-acquired conditions, and diagnostic errors). More than a mechanism for unidirectional sharing information from providers to the patient, inpatient portals will also provide a platform for the reciprocal exchange of information from the patient to the provider through patient-generated data, such as goal setting and feedback. Patients may play a larger role in reporting hospital satisfaction in real time, reconciling medications, contributing to the treatment plan, and identifying medical errors. As portals are integrated across the care continuum,²⁰ our understanding of their impact may become more clear.

In this review, only 5 studies were conducted in the pediatric hospital setting.^24,32-34,38 With hospitalized children experiencing 3 times more harm from medical errors than adults,⁴⁴ engaging parents in inpatient care to improve safety has become a national priority.⁴⁵ Giving patient portals, or “parent portals,” to parents of hospitalized children may provide a unique opportunity to share healthcare information and promote engagement, a direction for future study. There is also a research gap in evaluating adolescent inpatient portal use. Future portals may be designed to incentivize young children to learn about their hospitalization through games linked to health-related education.

Finally, as patients and caregivers begin using inpatient portals, there will almost certainly be consequences for healthcare teams. Understanding and anticipating human and work system factors influencing inpatient portal adoption and use from the perspectives of both patients and healthcare teams are needed.^46,47 Engaging healthcare team members as valuable stakeholders during implementation and measuring the impact of portal use on their workload is necessary, especially as portal use spreads beyond pilot units. The success of inpatient portals is dependent upon both the positive benefits for patients and their acceptance by healthcare teams.⁴⁸

Limitations exist in conducting a systematic literature review.⁴⁹ The conceptual definition of a portal for hospitalized patients and patient/caregiver engagement is evolving; therefore, our definition may not have captured all relevant studies. We intentionally did not include all inpatient technology, as we were interested in a narrow definition of portals designed for inpatients that provided clinical information from the inpatient EHR. Because of rapid technology changes, we also limited our search to studies published within the last 10 years; prior literature has been described elsewhere.¹⁷ We excluded non-English language studies, limiting our ability to capture the full scope of inpatient portal research. These patients already experience healthcare delivery disparities, widened by the inaccessibility of innovative health information technologies.⁵⁰ Future studies would be enhanced with the inclusion of these participants.

Inpatient portal research is in its infancy but growing rapidly. Studies to date are primarily focused on portal design and have small sample sizes. Early findings suggest that patients and caregivers are, in general, enthusiastic about using inpatient portals. Further research is needed, however, to determine the impact of inpatient portal use on patient engagement and hospital-care quality, safety, and cost.

Disclosure

This work was supported by a Department of Pediatrics Research and Development Grant at the University of Wisconsin School of Medicine and Public Health. This publication was also supported by the Clinical and Translational Science Award program through the National Center for Advancing Translational Sciences, grant UL1TR000427. Dr. Hoonakker’s involvement was also partially supported by the National Science Foundation, grant CMMI 1536987. Funding sources had no involvement in study design, analysis, or interpretation of data. The authors have no conflicts of interest to declare.

Engaging patients and their caregivers in care improves health outcomes^1-3 and is endorsed by leading healthcare organizations as essential to improving care quality and safety.^4-6 Patient engagement emphasizes that patients, caregivers, and healthcare providers work together to “promote and support active patient and public involvement in health and healthcare and to strengthen their influence on healthcare decisions.”⁷ Patient portals, web-based personal health records linked to electronic health record (EHR) data, are intended to promote engagement by providing patients and their caregivers with timely electronic access to their healthcare information and supporting communication through secure messaging with their healthcare team.⁸ The use of patient portals has also been suggested as a way for patients and/or caregivers to identify and intercept medical errors, thus having the potential to also improve patient safety.^8,9

As a requirement for meaningful use, access to health information through patient portals in the ambulatory setting has increased dramatically.¹⁰ Studies evaluating the use of these patient portals to promote patient-centered care are growing, but evidence supporting their impact on improved health outcomes is currently insufficient.^11-15 Although research and policy focus on the use of patient portals in the ambulatory setting, recent literature suggests that patient portals may be used to share inpatient clinical information to engage patients and their caregivers during their hospitalization.^16-18 Before the widespread use of patient portals in the inpatient setting is endorsed, systematic research is needed to understand optimal portal design requirements, if and how these portals are used, and whether their use provides value to the hospitalized patient and/or caregiver.⁸

Prior literature summarized early findings regarding the use of various technologies designed to engage hospitalized patients.^17,19,20 In this systematic review, we describe the emerging literature examining the design, use, and impact of inpatient portals for hospitalized patients and/or caregivers over the last 10 years. Inpatient portals are defined here as electronic patient portals tethered to EHRs that are designed to provide hospitalized patients and/or caregivers secure access to personalized, inpatient clinical information with the intent of engaging them in their hospital care. After analyzing and summarizing these data, we then identify knowledge gaps and potential future research directions.

Search Strategy, Study Selection, and Analysis

This systematic review included available, peer-reviewed, and grey literature published from January 1, 2006, to August 8, 2017, in PubMed, Web of Science (including the Institute of Electrical and Electronics Engineers Xplore), Cochrane, CINAHLPlus, and Scopus databases. Terms and phrases, including those found in the Medical Subject Heading (MeSH) index, were used to identify studies evaluating (1) patient portals (“health record, personal [MeSH],” “personal health record,” “patient portal,” “inpatient portal,” “ipad,” “tablet,” or “bedside information technology”), (2) engagement (“engagement,” “empowerment,” “participation,” “activation,” or “self-efficacy”), and (3) in the hospital (“inpatient [MeSH],” “hospital [MeSH],” “hospitalized patient [MeSH],” or “unit”). MeSH terms were used when applicable. Based on previous literature, free-text terms were also used when subject headings were not applied consistently, such as with terms related to engagement.^17,21 Studies were excluded if they were not written in English, if they evaluated portals exclusively in the emergency department or ambulatory setting, and/or if they described future study protocols. Studies describing general inpatient technology or evaluating portals used in the hospital but not tethered to inpatient EHR clinical data were also excluded.

By using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines,²² 2 researchers (M.K. and P.H.) completed the literature search and potential article screening. Results were aggregated and studies were screened and excluded from full review based on title and abstract information. Additional studies were included after reference list review. During a full review of included studies, 2 researchers independently extracted data, including the study objective, design, setting, sample, data collection instruments, outcomes, and a description of results. Guided by our study objective, findings were reconciled by consensus and analyzed and described according to the following 3 themes: (1) inpatient portal design, (2) inpatient portal use and usability, and (3) the impact of inpatient portal use on patient or caregiver and healthcare team outcomes as defined by retrieved studies.

The quality of studies was evaluated by the same 2 researchers independently by using the Downs and Black checklist for assessing the methodological quality of randomized and nonrandomized healthcare interventions.²³ Qualitative studies describing the development of portal prototypes and/or portal redesign efforts were excluded from these analyses. Discrepancies were resolved by consensus.Because of the wide variability in study designs, populations, and outcomes, a meta-analysis of pooled data was not performed.

Of the 731 studies identified through database searching and reference review, 36 were included for full-text review and 17 met inclusion criteria (Figure; Table 1). Studies excluded after full-text review described portal use outside of the inpatient setting, portals not linked to hospital EHR clinical data, portals not designed for inpatients, and/or inpatient technology in general. The inpatient portal platforms, hardware used, and functionalities varied within included studies (Table 2). The majority of studies used custom, web-based inpatient portal applications on tablet computers. Most provided information about the patients’ hospital medications, healthcare team, and education about their condition and/or a medical glossary. Many included the patient’s schedule, hospital problem list, discharge information, and a way to keep notes.

There has been a recent increase in inpatient portal study publication, with 9 studies published during or after 2016. Five were conducted in the pediatric setting and all but 1³⁰ with English-speaking participants. Twelve studies were qualitative, many of which were conducted in multiple phases by using semi-structured interviews and/or focus groups to develop or redesign inpatient portals. Of the remaining studies, 3 used a cross-sectional design, 1 used a before and after design without a control group, and 1 was a nonrandomized trial. Studies were rated as having medium-to-high risk of bias because of design flaws (Table 1 in supplementary Appendix). Because many studies were small pilot studies and all were single-centered studies, the generalizability of findings to different healthcare settings or patient populations is limited.

Inpatient Portal Design

Most included studies evaluated patient and/or caregiver information needs to design and/or enhance inpatient portals.^16,24-37 In 1 study, patients described an overall lack of information provided in the hospital and insufficient time to understand and remember information, which, when shared, was often presented by using medical terminology.³⁰ They wanted information to help them understand their daily hospital routine, confirm and compare medications and test results, learn about care, and prepare for discharge. Participants in multiple studies echoed these results, indicating the need for a schedule of upcoming clinical events (eg, medication administration, procedures, imaging), secure and timely clinical information (eg, list of diagnoses and medications, test results), personalized education, a medical glossary, discharge information, and a way to take notes and recognize and communicate with providers.

Patients also requested further information transparency,^34,37 including physicians’ notes, radiology results, operative reports, and billing information, along with general hospital information,¹⁶ meal ordering,³³ and video conferencing.²⁷ ln designing and refining an inpatient medication-tracking tool, participants identified the need for information about medication dosage, frequency, timing, administration method, criticality, alternative medications or forms, and education.^26,36 Patients and/or caregivers also indicated interest in communicating with inpatient providers by using the portal.^{16,27,28,30-37} In 1 study, patients highlighted the need to be involved in care plan development,²⁷ which led to portal refinement to allow for patient-generated data entry, including care goals and a way to communicate real-time concerns and feedback.²⁸

Studies also considered healthcare team perspectives to inform portal design.^{25,26,28,30,35,37} Although information needs usually overlapped, patient and healthcare team priorities differed in some areas. Although patients wanted to “know what was going to happen to them,” nurses in 1 study were more concerned about providing information to protect patients, such as safety and precaution materials.²⁵ Similarly, when designing a medication-tracking tool, patients sought information that helped them understand what to expect, while pharmacists focused on medication safety and providing information that fit their workflow (eg, abstract medication schedules).³⁶

Identified study data raised important portal interface design considerations. Results suggested clinical data should be presented by using simple displays,²⁸ accommodating real-time information. Participants recommended links^16,29 to personalized patient-friendly³⁷ education accessed with minimal steps.²⁶ Interfaces may be personalized for target users, such as patient or proxy and younger or older individuals. For example, older patients reported less familiarity with touch screens, internal keyboards, and handwriting recognition, favoring voice recognition for recording notes.²⁷ This raised questions about how portals can be designed to best maintain patient privacy.²⁵ Interface design, such as navigation, also relied heavily on hardware choice, such as tablet versus mobile phone.²⁸

Inpatient Portal Use and Usability

Most patient and/or caregiver participants in included studies were interested in using an inpatient portal, used it when offered, found it easy to use, useful, and/or were satisfied with it.^16,18,24-37 Most used and liked functionalities that provided healthcare team, test result, and medication information.^22,33,37 In the 1 identified controlled trial,¹⁸ researchers evaluated an inpatient portal given to adult inpatients that included a problem list, schedule, medication list, and healthcare team information. Of the intervention unit patients, 80% used the portal, 76% indicated it was easy to use, and 71% thought it provided useful information. When a portal was given to 239 adult patients and caregivers in another study, 66% sent a total of 291 messages to the healthcare team.³¹ Of these, 153 provided feedback, 76 expressed preferences, and 16 communicated concerns. In a pediatric study, an inpatient portal was given to 296 parents who sent a total of 36 messages and 176 requests.³³ Messages sent included information regarding caregiver needs, questions, updates, and/or positive endorsements of the healthcare team and/or care.

Impact of Inpatient Portal Use

Multiple studies evaluated the impact of inpatient portal use on patient and/or caregiver engagement, empowerment, activation, and/or knowledge, which had mixed results. Most adult patients interviewed in one study had positive experiences using a portal to answer their questions between physician visits and learn about, remember, and engage in care.³⁷ A majority of adult inpatient portal users in another study agreed that portal use helped them feel in control and understand their condition; however, they did not report having improved discharge timing knowledge.²⁹ In a pediatric study, most parent inpatient portal users agreed use improved their ability to monitor, understand, and make decisions about their child’s care.³³ In the controlled trial,¹⁸ a higher percentage of portal intervention patients could identify their physician or role; however, patient activation was not statistically different between intervention and control patients.

Results from included studies also evaluated the impact of portal use on communication. Some suggest inpatient portal use may replace and/or facilitate verbal communication between patients, caregivers, and providers.³⁵ In a pediatric study, 51% of parent portal users reported it gave them the information they needed, reducing the amount of questions they had for their healthcare team.³³ Similarly 43% of 14 adult inpatient portal users in another study thought the portal could replace at least some face-to-face communication.³⁷ Some providers indicated portal use enhanced rounding discussion quality.³⁵ Another study suggested that patient-provider communication via electronic messaging may provide benefits for some patients and not others.³⁷

Multiple studies evaluated patient, caregiver, and/or healthcare team perceptions of the impact of inpatient portal use on detection of errors and patient safety.^29,31,33,35 In adult inpatients, 6% agreed portal use could help them find errors.²⁹ In a pediatric study, 8% reported finding at least 1 medication error by using the portal, and 89% thought use reduced errors in their child’s care.³³ One patient in a qualitative study of adult inpatients cited an example of a dosing error discovered by using the portal.³⁷ Healthcare providers in another study also reported that use facilitated patient error identification.³⁵

Included studies evaluated the potential impact of portal use on patient anxiety, confusion, and/or worry, and the work of healthcare teams. In 1 study, nurses voiced concerns about giving information subject to change or that couldn’t always be achieved because of competing hospital priorities, such as discharge timing.²⁵ They also worried about giving medical information that would create cognitive overload for patients and/or require professional interpretation. Although providers in another study perceived little negative impact on their workflow after portal implementation, they worried about the potential of adding other information to the portal.³⁵ For example, they were concerned that the future release of abnormal test results or sensitive data would lead to confusion and more time spent answering patient questions. Physicians also worried that secure messaging could be overused by patients, would be used to inappropriately express acute concerns, or might adversely affect verbal communication. Providers in 2 studies expressed concerns about potential negative implications of portal use on their work before implementation, which were subsequently reduced after portal implementation.^29,38 Conversely, no parent portal users in another study thought portal information was confusing.³³ One parent participant noted portal use may actually decrease anxiety: “Access to their medical information gives patients and their caregivers perspective and insight into their hospital care and empowers them with knowledge about [what is going on], which reduces anxiety.”³⁷

We identified multiple studies evaluating the design, use, and impact of inpatient patient portals for hospitalized patients and caregivers. Based on the information needs identified by patients and healthcare team participants, multiple key content and design recommendations are suggested, including presenting (1) timely, personalized clinical and educational information in lay terms, (2) the care trajectory, including care plan and patient schedule, and (3) a way to recognize and communicate with the inpatient healthcare team. Design challenges still exist, such as translating medical terminology from EHRs into patient-friendly language, proxy access, and portal integration across transitions. Data from identified studies suggest hospitalized patients and caregivers are interested in and willing to use inpatient portals, but there is less information about the use of each functionality. Evidence supporting the role of inpatient portal use in improving patient and/or caregiver engagement, knowledge, communication, and the quality and safety of care is currently limited. Included studies indicate that healthcare team members had concerns about using portals to share clinical information and communicate electronically in the hospital. The extent to which these concerns translate to demonstrable problems remains to be seen.

Early studies focus on patient and caregiver information needs and portal interface design. Although the necessity for certain core functionalities and design requirements are becoming clear,²⁰ best practices regarding the amount and timing of information released (eg, physician notes, lab results), optimal hardware decisions (eg, large-screen displays, hospital-owned tablets, bring-your-own-device model), and details around secure-messaging implementation in the acute hospital setting are still lacking. Future work is needed to understand optimal patient-provider communication architectures that support improved synchronous and asynchronous messaging and privacy-preserving approaches to the design of these systems to handle patient-generated data as it becomes more commonplace. Although patient participants in these studies were generally satisfied using inpatient portals, many indicated the need for even more transparency, such as the release of results in real time and inclusion of physician notes (even if they could not be fully comprehended).³⁷ As the movement of sharing notes with patients in the ambulatory setting grows,³⁹ it will inevitably extend to the inpatient setting.⁴⁰ Further research is needed to understand the impact of increased transparency on health outcomes, patient anxiety, and inpatient healthcare team workload. Although the majority of studies described the design and/or use of custom portal platforms, EHR vendors are now developing inpatient portals that integrate into preexisting systems (eg, MyChart Bedside, Epic Systems). This will increase the likelihood of broad inpatient portal adoption and may facilitate multicenter trials evaluating the impact of their use.

The next steps will need to focus on the evaluation of specific inpatient portal functionalities and the impact of their use on objective process and outcome measures by using rigorous, experimental study designs. Akin to ambulatory portal research, measures of interest will include patient activation,^41,42 patient and/or caregiver satisfaction,⁴³ care processes (eg, length of stay, readmissions), and patient safety (eg, safety perceptions, adverse drug events, hospital-acquired conditions, and diagnostic errors). More than a mechanism for unidirectional sharing information from providers to the patient, inpatient portals will also provide a platform for the reciprocal exchange of information from the patient to the provider through patient-generated data, such as goal setting and feedback. Patients may play a larger role in reporting hospital satisfaction in real time, reconciling medications, contributing to the treatment plan, and identifying medical errors. As portals are integrated across the care continuum,²⁰ our understanding of their impact may become more clear.

In this review, only 5 studies were conducted in the pediatric hospital setting.^24,32-34,38 With hospitalized children experiencing 3 times more harm from medical errors than adults,⁴⁴ engaging parents in inpatient care to improve safety has become a national priority.⁴⁵ Giving patient portals, or “parent portals,” to parents of hospitalized children may provide a unique opportunity to share healthcare information and promote engagement, a direction for future study. There is also a research gap in evaluating adolescent inpatient portal use. Future portals may be designed to incentivize young children to learn about their hospitalization through games linked to health-related education.

Finally, as patients and caregivers begin using inpatient portals, there will almost certainly be consequences for healthcare teams. Understanding and anticipating human and work system factors influencing inpatient portal adoption and use from the perspectives of both patients and healthcare teams are needed.^46,47 Engaging healthcare team members as valuable stakeholders during implementation and measuring the impact of portal use on their workload is necessary, especially as portal use spreads beyond pilot units. The success of inpatient portals is dependent upon both the positive benefits for patients and their acceptance by healthcare teams.⁴⁸

Limitations exist in conducting a systematic literature review.⁴⁹ The conceptual definition of a portal for hospitalized patients and patient/caregiver engagement is evolving; therefore, our definition may not have captured all relevant studies. We intentionally did not include all inpatient technology, as we were interested in a narrow definition of portals designed for inpatients that provided clinical information from the inpatient EHR. Because of rapid technology changes, we also limited our search to studies published within the last 10 years; prior literature has been described elsewhere.¹⁷ We excluded non-English language studies, limiting our ability to capture the full scope of inpatient portal research. These patients already experience healthcare delivery disparities, widened by the inaccessibility of innovative health information technologies.⁵⁰ Future studies would be enhanced with the inclusion of these participants.

Inpatient portal research is in its infancy but growing rapidly. Studies to date are primarily focused on portal design and have small sample sizes. Early findings suggest that patients and caregivers are, in general, enthusiastic about using inpatient portals. Further research is needed, however, to determine the impact of inpatient portal use on patient engagement and hospital-care quality, safety, and cost.

Disclosure

This work was supported by a Department of Pediatrics Research and Development Grant at the University of Wisconsin School of Medicine and Public Health. This publication was also supported by the Clinical and Translational Science Award program through the National Center for Advancing Translational Sciences, grant UL1TR000427. Dr. Hoonakker’s involvement was also partially supported by the National Science Foundation, grant CMMI 1536987. Funding sources had no involvement in study design, analysis, or interpretation of data. The authors have no conflicts of interest to declare.

Engaging patients and their caregivers in care improves health outcomes^1-3 and is endorsed by leading healthcare organizations as essential to improving care quality and safety.^4-6 Patient engagement emphasizes that patients, caregivers, and healthcare providers work together to “promote and support active patient and public involvement in health and healthcare and to strengthen their influence on healthcare decisions.”⁷ Patient portals, web-based personal health records linked to electronic health record (EHR) data, are intended to promote engagement by providing patients and their caregivers with timely electronic access to their healthcare information and supporting communication through secure messaging with their healthcare team.⁸ The use of patient portals has also been suggested as a way for patients and/or caregivers to identify and intercept medical errors, thus having the potential to also improve patient safety.^8,9

As a requirement for meaningful use, access to health information through patient portals in the ambulatory setting has increased dramatically.¹⁰ Studies evaluating the use of these patient portals to promote patient-centered care are growing, but evidence supporting their impact on improved health outcomes is currently insufficient.^11-15 Although research and policy focus on the use of patient portals in the ambulatory setting, recent literature suggests that patient portals may be used to share inpatient clinical information to engage patients and their caregivers during their hospitalization.^16-18 Before the widespread use of patient portals in the inpatient setting is endorsed, systematic research is needed to understand optimal portal design requirements, if and how these portals are used, and whether their use provides value to the hospitalized patient and/or caregiver.⁸

Prior literature summarized early findings regarding the use of various technologies designed to engage hospitalized patients.^17,19,20 In this systematic review, we describe the emerging literature examining the design, use, and impact of inpatient portals for hospitalized patients and/or caregivers over the last 10 years. Inpatient portals are defined here as electronic patient portals tethered to EHRs that are designed to provide hospitalized patients and/or caregivers secure access to personalized, inpatient clinical information with the intent of engaging them in their hospital care. After analyzing and summarizing these data, we then identify knowledge gaps and potential future research directions.

Search Strategy, Study Selection, and Analysis

This systematic review included available, peer-reviewed, and grey literature published from January 1, 2006, to August 8, 2017, in PubMed, Web of Science (including the Institute of Electrical and Electronics Engineers Xplore), Cochrane, CINAHLPlus, and Scopus databases. Terms and phrases, including those found in the Medical Subject Heading (MeSH) index, were used to identify studies evaluating (1) patient portals (“health record, personal [MeSH],” “personal health record,” “patient portal,” “inpatient portal,” “ipad,” “tablet,” or “bedside information technology”), (2) engagement (“engagement,” “empowerment,” “participation,” “activation,” or “self-efficacy”), and (3) in the hospital (“inpatient [MeSH],” “hospital [MeSH],” “hospitalized patient [MeSH],” or “unit”). MeSH terms were used when applicable. Based on previous literature, free-text terms were also used when subject headings were not applied consistently, such as with terms related to engagement.^17,21 Studies were excluded if they were not written in English, if they evaluated portals exclusively in the emergency department or ambulatory setting, and/or if they described future study protocols. Studies describing general inpatient technology or evaluating portals used in the hospital but not tethered to inpatient EHR clinical data were also excluded.

By using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines,²² 2 researchers (M.K. and P.H.) completed the literature search and potential article screening. Results were aggregated and studies were screened and excluded from full review based on title and abstract information. Additional studies were included after reference list review. During a full review of included studies, 2 researchers independently extracted data, including the study objective, design, setting, sample, data collection instruments, outcomes, and a description of results. Guided by our study objective, findings were reconciled by consensus and analyzed and described according to the following 3 themes: (1) inpatient portal design, (2) inpatient portal use and usability, and (3) the impact of inpatient portal use on patient or caregiver and healthcare team outcomes as defined by retrieved studies.

The quality of studies was evaluated by the same 2 researchers independently by using the Downs and Black checklist for assessing the methodological quality of randomized and nonrandomized healthcare interventions.²³ Qualitative studies describing the development of portal prototypes and/or portal redesign efforts were excluded from these analyses. Discrepancies were resolved by consensus.Because of the wide variability in study designs, populations, and outcomes, a meta-analysis of pooled data was not performed.

Of the 731 studies identified through database searching and reference review, 36 were included for full-text review and 17 met inclusion criteria (Figure; Table 1). Studies excluded after full-text review described portal use outside of the inpatient setting, portals not linked to hospital EHR clinical data, portals not designed for inpatients, and/or inpatient technology in general. The inpatient portal platforms, hardware used, and functionalities varied within included studies (Table 2). The majority of studies used custom, web-based inpatient portal applications on tablet computers. Most provided information about the patients’ hospital medications, healthcare team, and education about their condition and/or a medical glossary. Many included the patient’s schedule, hospital problem list, discharge information, and a way to keep notes.

There has been a recent increase in inpatient portal study publication, with 9 studies published during or after 2016. Five were conducted in the pediatric setting and all but 1³⁰ with English-speaking participants. Twelve studies were qualitative, many of which were conducted in multiple phases by using semi-structured interviews and/or focus groups to develop or redesign inpatient portals. Of the remaining studies, 3 used a cross-sectional design, 1 used a before and after design without a control group, and 1 was a nonrandomized trial. Studies were rated as having medium-to-high risk of bias because of design flaws (Table 1 in supplementary Appendix). Because many studies were small pilot studies and all were single-centered studies, the generalizability of findings to different healthcare settings or patient populations is limited.

Inpatient Portal Design

Most included studies evaluated patient and/or caregiver information needs to design and/or enhance inpatient portals.^16,24-37 In 1 study, patients described an overall lack of information provided in the hospital and insufficient time to understand and remember information, which, when shared, was often presented by using medical terminology.³⁰ They wanted information to help them understand their daily hospital routine, confirm and compare medications and test results, learn about care, and prepare for discharge. Participants in multiple studies echoed these results, indicating the need for a schedule of upcoming clinical events (eg, medication administration, procedures, imaging), secure and timely clinical information (eg, list of diagnoses and medications, test results), personalized education, a medical glossary, discharge information, and a way to take notes and recognize and communicate with providers.

Patients also requested further information transparency,^34,37 including physicians’ notes, radiology results, operative reports, and billing information, along with general hospital information,¹⁶ meal ordering,³³ and video conferencing.²⁷ ln designing and refining an inpatient medication-tracking tool, participants identified the need for information about medication dosage, frequency, timing, administration method, criticality, alternative medications or forms, and education.^26,36 Patients and/or caregivers also indicated interest in communicating with inpatient providers by using the portal.^{16,27,28,30-37} In 1 study, patients highlighted the need to be involved in care plan development,²⁷ which led to portal refinement to allow for patient-generated data entry, including care goals and a way to communicate real-time concerns and feedback.²⁸

Studies also considered healthcare team perspectives to inform portal design.^{25,26,28,30,35,37} Although information needs usually overlapped, patient and healthcare team priorities differed in some areas. Although patients wanted to “know what was going to happen to them,” nurses in 1 study were more concerned about providing information to protect patients, such as safety and precaution materials.²⁵ Similarly, when designing a medication-tracking tool, patients sought information that helped them understand what to expect, while pharmacists focused on medication safety and providing information that fit their workflow (eg, abstract medication schedules).³⁶

Identified study data raised important portal interface design considerations. Results suggested clinical data should be presented by using simple displays,²⁸ accommodating real-time information. Participants recommended links^16,29 to personalized patient-friendly³⁷ education accessed with minimal steps.²⁶ Interfaces may be personalized for target users, such as patient or proxy and younger or older individuals. For example, older patients reported less familiarity with touch screens, internal keyboards, and handwriting recognition, favoring voice recognition for recording notes.²⁷ This raised questions about how portals can be designed to best maintain patient privacy.²⁵ Interface design, such as navigation, also relied heavily on hardware choice, such as tablet versus mobile phone.²⁸

Inpatient Portal Use and Usability

Most patient and/or caregiver participants in included studies were interested in using an inpatient portal, used it when offered, found it easy to use, useful, and/or were satisfied with it.^16,18,24-37 Most used and liked functionalities that provided healthcare team, test result, and medication information.^22,33,37 In the 1 identified controlled trial,¹⁸ researchers evaluated an inpatient portal given to adult inpatients that included a problem list, schedule, medication list, and healthcare team information. Of the intervention unit patients, 80% used the portal, 76% indicated it was easy to use, and 71% thought it provided useful information. When a portal was given to 239 adult patients and caregivers in another study, 66% sent a total of 291 messages to the healthcare team.³¹ Of these, 153 provided feedback, 76 expressed preferences, and 16 communicated concerns. In a pediatric study, an inpatient portal was given to 296 parents who sent a total of 36 messages and 176 requests.³³ Messages sent included information regarding caregiver needs, questions, updates, and/or positive endorsements of the healthcare team and/or care.

Impact of Inpatient Portal Use

Multiple studies evaluated the impact of inpatient portal use on patient and/or caregiver engagement, empowerment, activation, and/or knowledge, which had mixed results. Most adult patients interviewed in one study had positive experiences using a portal to answer their questions between physician visits and learn about, remember, and engage in care.³⁷ A majority of adult inpatient portal users in another study agreed that portal use helped them feel in control and understand their condition; however, they did not report having improved discharge timing knowledge.²⁹ In a pediatric study, most parent inpatient portal users agreed use improved their ability to monitor, understand, and make decisions about their child’s care.³³ In the controlled trial,¹⁸ a higher percentage of portal intervention patients could identify their physician or role; however, patient activation was not statistically different between intervention and control patients.

Results from included studies also evaluated the impact of portal use on communication. Some suggest inpatient portal use may replace and/or facilitate verbal communication between patients, caregivers, and providers.³⁵ In a pediatric study, 51% of parent portal users reported it gave them the information they needed, reducing the amount of questions they had for their healthcare team.³³ Similarly 43% of 14 adult inpatient portal users in another study thought the portal could replace at least some face-to-face communication.³⁷ Some providers indicated portal use enhanced rounding discussion quality.³⁵ Another study suggested that patient-provider communication via electronic messaging may provide benefits for some patients and not others.³⁷

Multiple studies evaluated patient, caregiver, and/or healthcare team perceptions of the impact of inpatient portal use on detection of errors and patient safety.^29,31,33,35 In adult inpatients, 6% agreed portal use could help them find errors.²⁹ In a pediatric study, 8% reported finding at least 1 medication error by using the portal, and 89% thought use reduced errors in their child’s care.³³ One patient in a qualitative study of adult inpatients cited an example of a dosing error discovered by using the portal.³⁷ Healthcare providers in another study also reported that use facilitated patient error identification.³⁵

Included studies evaluated the potential impact of portal use on patient anxiety, confusion, and/or worry, and the work of healthcare teams. In 1 study, nurses voiced concerns about giving information subject to change or that couldn’t always be achieved because of competing hospital priorities, such as discharge timing.²⁵ They also worried about giving medical information that would create cognitive overload for patients and/or require professional interpretation. Although providers in another study perceived little negative impact on their workflow after portal implementation, they worried about the potential of adding other information to the portal.³⁵ For example, they were concerned that the future release of abnormal test results or sensitive data would lead to confusion and more time spent answering patient questions. Physicians also worried that secure messaging could be overused by patients, would be used to inappropriately express acute concerns, or might adversely affect verbal communication. Providers in 2 studies expressed concerns about potential negative implications of portal use on their work before implementation, which were subsequently reduced after portal implementation.^29,38 Conversely, no parent portal users in another study thought portal information was confusing.³³ One parent participant noted portal use may actually decrease anxiety: “Access to their medical information gives patients and their caregivers perspective and insight into their hospital care and empowers them with knowledge about [what is going on], which reduces anxiety.”³⁷

We identified multiple studies evaluating the design, use, and impact of inpatient patient portals for hospitalized patients and caregivers. Based on the information needs identified by patients and healthcare team participants, multiple key content and design recommendations are suggested, including presenting (1) timely, personalized clinical and educational information in lay terms, (2) the care trajectory, including care plan and patient schedule, and (3) a way to recognize and communicate with the inpatient healthcare team. Design challenges still exist, such as translating medical terminology from EHRs into patient-friendly language, proxy access, and portal integration across transitions. Data from identified studies suggest hospitalized patients and caregivers are interested in and willing to use inpatient portals, but there is less information about the use of each functionality. Evidence supporting the role of inpatient portal use in improving patient and/or caregiver engagement, knowledge, communication, and the quality and safety of care is currently limited. Included studies indicate that healthcare team members had concerns about using portals to share clinical information and communicate electronically in the hospital. The extent to which these concerns translate to demonstrable problems remains to be seen.

Early studies focus on patient and caregiver information needs and portal interface design. Although the necessity for certain core functionalities and design requirements are becoming clear,²⁰ best practices regarding the amount and timing of information released (eg, physician notes, lab results), optimal hardware decisions (eg, large-screen displays, hospital-owned tablets, bring-your-own-device model), and details around secure-messaging implementation in the acute hospital setting are still lacking. Future work is needed to understand optimal patient-provider communication architectures that support improved synchronous and asynchronous messaging and privacy-preserving approaches to the design of these systems to handle patient-generated data as it becomes more commonplace. Although patient participants in these studies were generally satisfied using inpatient portals, many indicated the need for even more transparency, such as the release of results in real time and inclusion of physician notes (even if they could not be fully comprehended).³⁷ As the movement of sharing notes with patients in the ambulatory setting grows,³⁹ it will inevitably extend to the inpatient setting.⁴⁰ Further research is needed to understand the impact of increased transparency on health outcomes, patient anxiety, and inpatient healthcare team workload. Although the majority of studies described the design and/or use of custom portal platforms, EHR vendors are now developing inpatient portals that integrate into preexisting systems (eg, MyChart Bedside, Epic Systems). This will increase the likelihood of broad inpatient portal adoption and may facilitate multicenter trials evaluating the impact of their use.

The next steps will need to focus on the evaluation of specific inpatient portal functionalities and the impact of their use on objective process and outcome measures by using rigorous, experimental study designs. Akin to ambulatory portal research, measures of interest will include patient activation,^41,42 patient and/or caregiver satisfaction,⁴³ care processes (eg, length of stay, readmissions), and patient safety (eg, safety perceptions, adverse drug events, hospital-acquired conditions, and diagnostic errors). More than a mechanism for unidirectional sharing information from providers to the patient, inpatient portals will also provide a platform for the reciprocal exchange of information from the patient to the provider through patient-generated data, such as goal setting and feedback. Patients may play a larger role in reporting hospital satisfaction in real time, reconciling medications, contributing to the treatment plan, and identifying medical errors. As portals are integrated across the care continuum,²⁰ our understanding of their impact may become more clear.

In this review, only 5 studies were conducted in the pediatric hospital setting.^24,32-34,38 With hospitalized children experiencing 3 times more harm from medical errors than adults,⁴⁴ engaging parents in inpatient care to improve safety has become a national priority.⁴⁵ Giving patient portals, or “parent portals,” to parents of hospitalized children may provide a unique opportunity to share healthcare information and promote engagement, a direction for future study. There is also a research gap in evaluating adolescent inpatient portal use. Future portals may be designed to incentivize young children to learn about their hospitalization through games linked to health-related education.

Finally, as patients and caregivers begin using inpatient portals, there will almost certainly be consequences for healthcare teams. Understanding and anticipating human and work system factors influencing inpatient portal adoption and use from the perspectives of both patients and healthcare teams are needed.^46,47 Engaging healthcare team members as valuable stakeholders during implementation and measuring the impact of portal use on their workload is necessary, especially as portal use spreads beyond pilot units. The success of inpatient portals is dependent upon both the positive benefits for patients and their acceptance by healthcare teams.⁴⁸

Limitations exist in conducting a systematic literature review.⁴⁹ The conceptual definition of a portal for hospitalized patients and patient/caregiver engagement is evolving; therefore, our definition may not have captured all relevant studies. We intentionally did not include all inpatient technology, as we were interested in a narrow definition of portals designed for inpatients that provided clinical information from the inpatient EHR. Because of rapid technology changes, we also limited our search to studies published within the last 10 years; prior literature has been described elsewhere.¹⁷ We excluded non-English language studies, limiting our ability to capture the full scope of inpatient portal research. These patients already experience healthcare delivery disparities, widened by the inaccessibility of innovative health information technologies.⁵⁰ Future studies would be enhanced with the inclusion of these participants.

Inpatient portal research is in its infancy but growing rapidly. Studies to date are primarily focused on portal design and have small sample sizes. Early findings suggest that patients and caregivers are, in general, enthusiastic about using inpatient portals. Further research is needed, however, to determine the impact of inpatient portal use on patient engagement and hospital-care quality, safety, and cost.

Disclosure

This work was supported by a Department of Pediatrics Research and Development Grant at the University of Wisconsin School of Medicine and Public Health. This publication was also supported by the Clinical and Translational Science Award program through the National Center for Advancing Translational Sciences, grant UL1TR000427. Dr. Hoonakker’s involvement was also partially supported by the National Science Foundation, grant CMMI 1536987. Funding sources had no involvement in study design, analysis, or interpretation of data. The authors have no conflicts of interest to declare.

Hospitalists’ performance is routinely evaluated by third-party payers, employers, and patients. As hospitalist programs mature, there is a need to develop processes to identify, internally measure, and report on individual and group performance. We know from Society of Hospital Medicine (SHM) data that a significant amount of hospitalists’ total compensation is at least partially based on performance. Often this is based at least in part on quality data. In 2006, SHM issued a white paper detailing the key elements of a successful performance monitoring and reporting process.^1,2 Recommendations included the identification of meaningful operational and clinical performance metrics, and the ability to monitor and report both group and individual metrics was highlighted as an essential component. There is evidence that comparison of individual provider performance with that of their peers is a necessary element of successful provider dashboards.³ Additionally, regular feedback and a clear, visual presentation of the data are important components of successful provider feedback dashboards.^3-6

Much of the literature regarding provider feedback dashboards has been based in the outpatient setting. The majority of these dashboards focus on the management of chronic illnesses (eg, diabetes and hypertension), rates of preventative care services (eg, colonoscopy or mammogram), or avoidance of unnecessary care (eg, antibiotics for sinusitis).^4,5 Unlike in the outpatient setting, in which 1 provider often provides a majority of the care for a given episode of care, hospitalized patients are often cared for by multiple providers, challenging the appropriate attribution of patient-level metrics to specific providers. Under the standard approach, an entire hospitalization is attributed to 1 physician, generally the attending of record for the hospitalization, which may be the admitting provider or the discharging provider, depending on the approach used by the hospital. However, assigning responsibility for an entire hospitalization to a provider who may have only seen the patient for a small percentage of a hospitalization may jeopardize the validity of metrics. As provider metrics are increasingly being used for compensation, it is important to ensure that the method for attribution correctly identifies the providers caring for patients. To our knowledge there is no gold standard approach for attributing metrics to providers when patients are cared for by multiple providers, and the standard attending of record–based approach may lack face validity in many cases.

We aimed to develop and operationalize a system to more fairly attribute patient-level data to individual providers across a single hospitalization even when multiple providers cared for the patient. We then compared our methodology to the standard approach, in which the attending of record receives full attribution for each metric, to determine the difference on a provider level between the 2 models.

Clinical Setting

The Johns Hopkins Hospital is a 1145-bed, tertiary-care hospital. Over the years of this project, the Johns Hopkins Hospitalist Program was an approximately 20-physician group providing care in a variety of settings, including a dedicated hospitalist floor, where this metrics program was initiated. Hospitalists in this setting work Monday through Friday, with 1 hospitalist and a moonlighter covering on the weekends. Admissions are performed by an admitter, and overnight care is provided by a nocturnist. Initially 17 beds, this unit expanded to 24 beds in June 2012. For the purposes of this article, we included all general medicine patients admitted to this floor between July 1, 2010, and June 30, 2014, who were cared for by hospitalists. During this period, all patients were inpatients; no patients were admitted under observation status. All of these patients were cared for by hospitalists without housestaff or advanced practitioners. Since 2014, the metrics program has been expanded to other hospitalist-run services in the hospital, but for simplicity, we have not presented these more recent data.

Individual Provider Metrics

Metrics were chosen to reflect institutional quality and efficiency priorities. Our choice of metrics was restricted to those that (1) plausibly reflect provider performance, at least in part, and (2) could be accessed in electronic form (without any manual chart review). Whenever possible, we chose metrics with objective data. Additionally, because funding for this effort was provided by the hospital, we sought to ensure that enough of the metrics were related to cost to justify ongoing hospital support of the project. SAS 9.2 (SAS Institute Inc, Cary, NC) was used to calculate metric weights. Specific metrics included American College of Chest Physicians (ACCP)–compliant venous thromboembolism (VTE) prophylaxis,⁷ observed-to-expected length of stay (LOS) ratio, percentage of discharges per day, discharges before 3 pm, depth of coding, patient satisfaction, readmissions, communication with the primary care provider, and time to signature for discharge summaries (Table 1).

Appropriate prophylaxis for VTE was calculated by using an algorithm embedded within the computerized provider order entry system, which assessed the prescription of ACCP-compliant VTE prophylaxis within 24 hours following admission. This included a risk assessment, and credit was given for no prophylaxis and/or mechanical and/or pharmacologic prophylaxis per the ACCP guidelines.⁷

Observed-to-expected LOS was defined by using the University HealthSystem Consortium (UHC; now Vizient Inc) expected LOS for the given calendar year. This approach incorporates patient diagnoses, demographics, and other administrative variables to define an expected LOS for each patient.

The percent of patients discharged per day was defined from billing data as the percentage of a provider’s evaluation and management charges that were the final charge of a patient’s stay (regardless of whether a discharge day service was coded).

Discharge prior to 3 pm was defined from administrative data as the time a patient was discharged from the electronic medical system.

Depth of coding was defined as the number of coded diagnoses submitted to the Maryland Health Services Cost Review Commission for determining payment and was viewed as an indicator of the thoroughness of provider documentation.

Patient satisfaction was defined at the patient level (for those patients who turned in patient satisfaction surveys) as the pooled value of the 5 provider questions on the hospital’s patient satisfaction survey administered by Press Ganey: “time the physician spent with you,” “did the physician show concern for your questions/worries,” “did the physician keep you informed,” “friendliness/courtesy of the physician,” and “skill of the physician.”⁸

Readmission rates were defined as same-hospital readmissions divided by the total number of patients discharged by a given provider, with exclusions based on the Centers for Medicare and Medicaid Services hospital-wide, all-cause readmission measure.¹ The expected same-hospital readmission rate was defined for each patient as the observed readmission rate in the entire UHC (Vizient) data set for all patients with the same All Patient Refined Diagnosis Related Group and severity of illness, as we have described previously.⁹

Communication with the primary care provider was the only self-reported metric used. It was based on a mandatory prompt on the discharge worksheet in the electronic medical record (EMR). Successful communication with the outpatient provider was defined as verbal or electronic communication by the hospitalist with the outpatient provider. Partial (50%) credit was given for providers who attempted but were unsuccessful in communicating with the outpatient provider, for patients for whom the provider had access to the Johns Hopkins EMR system, and for planned admissions without new or important information to convey. No credit was given for providers who indicated that communication was not indicated, who indicated that a patient and/or family would update the provider, or who indicated that the discharge summary would be sufficient.⁹ Because the discharge worksheet could be initiated at any time during the hospitalization, providers could document communication with the outpatient provider at any point during hospitalization.

Discharge summary turnaround was defined as the average number of days elapsed between the day of discharge and the signing of the discharge summary in the EMR.

Assigning Ownership of Patients to Individual Providers

Using billing data, we assigned ownership of patient care based on the type, timing, and number of charges that occurred during each hospitalization (Figure 1). Eligible charges included all history and physical (codes 99221, 99222, and 99223), subsequent care (codes 99231, 99232, and 99233), and discharge charges (codes 99238 and 99239).

By using a unique identifier assigned for each hospitalization, professional fees submitted by providers were used to identify which provider saw the patient on the admission day, discharge day, as well as subsequent care days. Providers’ productivity, bonus supplements, and policy compliance were determined by using billing data, which encouraged the prompt submittal of charges.

The provider who billed the admission history and physical (codes 99221, 99222, and 99223) within 1 calendar date of the patient’s initial admission was defined as the admitting provider. Patients transferred to the hospitalist service from other services were not assigned an admitting hospitalist. The sole metric assigned to the admitting hospitalist was ACCP-compliant VTE prophylaxis.

The provider who billed the final subsequent care or discharge code (codes 99231, 99232, 99233, 99238, and 99239) within 1 calendar date of discharge was defined as the discharging provider. For hospitalizations characterized by a single provider charge (eg, for patients admitted and discharged on the same day), the provider billing this charge was assigned as both the admitting and discharging physician. Patients upgraded to the intensive care unit (ICU) were not counted as a discharge unless the patient was downgraded and discharged from the hospitalist service. The discharging provider was assigned responsibility for the time of discharge, the percent of patients discharged per day, the discharge summary turnaround time, and hospital readmissions.

Metrics that were assigned to multiple providers for a single hospitalization were termed “provider day–weighted” metrics. The formula for calculating the weight for each provider day–weighted metric was as follows: weight for provider A = [number of daily charges billed by provider A] divided by [LOS +1]. The initial hospital day was counted as day 0. LOS plus 1 was used to recognize that a typical hospitalization will have a charge on the day of admission (day 0) and a charge on the day of discharge such that an LOS of 2 days (eg, a patient admitted on Monday and discharged on Wednesday) will have 3 daily charges. Provider day–weighted metrics included patient satisfaction, communication with the outpatient provider, depth of coding, and observed-to-expected LOS.

Our billing software prevented providers from the same group from billing multiple daily charges, thus ensuring that there were no duplicated charges submitted for a given day.

Presenting Results

Providers were only shown data from the day-weighted approach. For ease of visual interpretation, scores for each metric were scaled ordinally from 1 (worst performance) to 9 (best performance; Table 1). Data were displayed in a dashboard format on a password-protected website for each provider to view his or her own data relative to that of the hospitalist peer group. The dashboard was implemented in this format on July 1, 2011. Data were updated quarterly (Figure 2).

Results were displayed in a polyhedral or spider-web graph (Figure 2). Provider and group metrics were scaled according to predefined benchmarks established for each metric and standardized to a scale ranging from 1 to 9. The scale for each metric was set based on examining historical data and group median performance on the metrics to ensure that there was a range of performance (ie, to avoid having most hospitalists scoring a 1 or 9). Scaling thresholds were periodically adjusted as appropriate to maintain good visual discrimination. Higher scores (creating a larger-volume polygon) are desirable even for metrics such as LOS, for which a low value is desirable. Both a spider-web graph and trends over time were available to the provider (Figure 2). These graphs display a comparison of the individual provider scores for each metric to the hospitalist group average for that metric.

Comparison with the Standard (Attending of Record) Method of Attribution

For the purposes of this report, we sought to determine whether there were meaningful differences between our day-weighted approach versus the standard method of attribution, in which the attending of record is assigned responsibility for each metric that would not have been attributed to the discharging attending under both methods. Our goal was to determine where and whether there was a meaningful difference between the 2 methodologies, recognizing that the degree of difference between these 2 methodologies might vary in other institutions and settings. In our hospital, the attending of record is generally the discharging attending. In order to compare the 2 methodologies, we arbitrarily picked 2015 to retrospectively evaluate the differences between these 2 methods of attribution. We did not display or provide data using the standard methodology to providers at any point; this approach was used only for the purposes of this report. Because these metrics are intended to evaluate relative provider performance, we assigned a percentile to each provider for his or her performance on the given metric using our attribution methodology and then, similarly, assigned a percentile to each provider using the standard methodology. This yielded 2 percentile scores for each provider and each metric. We then compared these percentile ranks for providers in 2 ways: (1) we determined how often providers who scored in the top half of the group for a given metric (above the 50th percentile) also scored in the top half of the group for that metric by using the other calculation method, and (2) we calculated the absolute value of the difference in percentiles between the 2 methods to characterize the impact on a provider’s ranking for that metric that might result from switching to the other method. For instance, if a provider scored at the 20th percentile for the group in patient satisfaction with 1 attribution method and scored at the 40th percentile for the group in patient satisfaction using the other method, the absolute change in percentile would be 20 percentile points. But, this provider would still be below the 50th percentile by both methods (concordant bottom half performance). We did not perform this comparison for metrics assigned to the discharging provider (such as discharge summary turnaround time or readmissions) because the attending of record designation is assigned to the discharging provider at our hospital.

The dashboard was successfully operationalized on July 1, 2011, with displays visible to providers as shown in Figure 2. Consistent with the principles of providing effective performance feedback to providers, the display simultaneously showed providers their individual performance as well as the performance of their peers. Providers were able to view their spider-web plot for prior quarters. Not shown are additional views that allowed providers to see quarterly trends in their data versus their peers across several fiscal years. Also available to providers was their ranking relative to their peers for each metric; specific peers were deidentified in the display.

There was notable discordance between provider rankings between the 2 methodologies, as shown in Table 2. Provider performance above or below the median was concordant 56% to 75% of the time (depending on the particular metric), indicating substantial discordance because top-half or bottom-half concordance would be expected to occur by chance 50% of the time. Although the provider percentile differences between the 2 methods tended to be modest for most providers (the median difference between the methods was 13 to 22 percentile points for the various metrics), there were some providers for whom the method of calculation dramatically impacted their rankings. For 5 of the 6 metrics we examined, at least 1 provider had a 50-percentile or greater change in his or her ranking based on the method used. This indicates that at least some providers would have had markedly different scores relative to their peers had we used the alternative methodology (Table 2). In VTE prophylaxis, for example, at least 1 provider had a 94-percentile change in his or her ranking; similarly, a provider had an 88-perentile change in his or her LOS ranking between the 2 methodologies.

We found that it is possible to assign metrics across 1 hospital stay to multiple providers by using billing data. We also found a meaningful discrepancy in how well providers scored (relative to their peers) based on the method used for attribution. These results imply that hospitals should consider attributing performance metrics based on ascribed ownership from billing data and not just from attending of record status.

As hospitalist programs and providers in general are increasingly being asked to develop dashboards to monitor individual and group performance, correctly attributing care to providers is likely to become increasingly important. Experts agree that principles of effective provider performance dashboards include ranking individual provider performance relative to peers, clearly displaying data in an easily accessible format, and ensuring that data can be credibly attributed to the individual provider.^3,4,6 However, there appears to be no gold standard method for attribution, especially in the inpatient setting. Our results imply that hospitals should consider attributing performance metrics based on ascribed ownership from billing data and not just from attending of record status.

Several limitations of our findings are important to consider. First, our program is a relatively small, academic group with handoffs that typically occur every 1 to 2 weeks and sometimes with additional handoffs on weekends. Different care patterns and settings might impact the utility of our attribution methodology relative to the standard methodology. Additionally, it is important to note that the relative merits of the different methodologies cannot be ascertained from our comparison. We can demonstrate discordance between the attribution methodologies, but we cannot say that 1 method is correct and the other is flawed. Although we believe that our day-weighted approach feels fairer to providers based on group input and feedback, we did not conduct a formal survey to examine providers’ preferences for the standard versus day-weighted approaches. The appropriateness of a particular attribution method needs to be assessed locally and may vary based on the clinical setting. For instance, on a service in which patients are admitted for procedures, it may make more sense to attribute the outcome of the case to the proceduralist even if that provider did not bill for the patient’s care on a daily basis. Finally, the computational requirements of our methodology are not trivial and require linking billing data with administrative patient-level data, which may be challenging to operationalize in some institutions.

These limitations aside, we believe that our attribution methodology has face validity. For example, a provider might be justifiably frustrated if, using the standard methodology, he or she is charged with the LOS of a patient who had been hospitalized for months, particularly if that patient is discharged shortly after the provider assumes care. Our method addresses this type of misattribution. Particularly when individual provider compensation is based on performance on metrics (as is the case at our institution), optimizing provider attribution to particular patients may be important, and face validity may be required for group buy-in.

In summary, we have demonstrated that it is possible to use billing data to assign ownership of patients to multiple providers over 1 hospital stay. This could be applied to other hospitalist programs as well as other healthcare settings in which multiple providers care for patients during 1 healthcare encounter (eg, ICUs).

Disclosure

The authors declare they have no relevant conflicts of interest.

Hospitalists’ performance is routinely evaluated by third-party payers, employers, and patients. As hospitalist programs mature, there is a need to develop processes to identify, internally measure, and report on individual and group performance. We know from Society of Hospital Medicine (SHM) data that a significant amount of hospitalists’ total compensation is at least partially based on performance. Often this is based at least in part on quality data. In 2006, SHM issued a white paper detailing the key elements of a successful performance monitoring and reporting process.^1,2 Recommendations included the identification of meaningful operational and clinical performance metrics, and the ability to monitor and report both group and individual metrics was highlighted as an essential component. There is evidence that comparison of individual provider performance with that of their peers is a necessary element of successful provider dashboards.³ Additionally, regular feedback and a clear, visual presentation of the data are important components of successful provider feedback dashboards.^3-6

Much of the literature regarding provider feedback dashboards has been based in the outpatient setting. The majority of these dashboards focus on the management of chronic illnesses (eg, diabetes and hypertension), rates of preventative care services (eg, colonoscopy or mammogram), or avoidance of unnecessary care (eg, antibiotics for sinusitis).^4,5 Unlike in the outpatient setting, in which 1 provider often provides a majority of the care for a given episode of care, hospitalized patients are often cared for by multiple providers, challenging the appropriate attribution of patient-level metrics to specific providers. Under the standard approach, an entire hospitalization is attributed to 1 physician, generally the attending of record for the hospitalization, which may be the admitting provider or the discharging provider, depending on the approach used by the hospital. However, assigning responsibility for an entire hospitalization to a provider who may have only seen the patient for a small percentage of a hospitalization may jeopardize the validity of metrics. As provider metrics are increasingly being used for compensation, it is important to ensure that the method for attribution correctly identifies the providers caring for patients. To our knowledge there is no gold standard approach for attributing metrics to providers when patients are cared for by multiple providers, and the standard attending of record–based approach may lack face validity in many cases.

We aimed to develop and operationalize a system to more fairly attribute patient-level data to individual providers across a single hospitalization even when multiple providers cared for the patient. We then compared our methodology to the standard approach, in which the attending of record receives full attribution for each metric, to determine the difference on a provider level between the 2 models.

Clinical Setting

The Johns Hopkins Hospital is a 1145-bed, tertiary-care hospital. Over the years of this project, the Johns Hopkins Hospitalist Program was an approximately 20-physician group providing care in a variety of settings, including a dedicated hospitalist floor, where this metrics program was initiated. Hospitalists in this setting work Monday through Friday, with 1 hospitalist and a moonlighter covering on the weekends. Admissions are performed by an admitter, and overnight care is provided by a nocturnist. Initially 17 beds, this unit expanded to 24 beds in June 2012. For the purposes of this article, we included all general medicine patients admitted to this floor between July 1, 2010, and June 30, 2014, who were cared for by hospitalists. During this period, all patients were inpatients; no patients were admitted under observation status. All of these patients were cared for by hospitalists without housestaff or advanced practitioners. Since 2014, the metrics program has been expanded to other hospitalist-run services in the hospital, but for simplicity, we have not presented these more recent data.

Individual Provider Metrics

Metrics were chosen to reflect institutional quality and efficiency priorities. Our choice of metrics was restricted to those that (1) plausibly reflect provider performance, at least in part, and (2) could be accessed in electronic form (without any manual chart review). Whenever possible, we chose metrics with objective data. Additionally, because funding for this effort was provided by the hospital, we sought to ensure that enough of the metrics were related to cost to justify ongoing hospital support of the project. SAS 9.2 (SAS Institute Inc, Cary, NC) was used to calculate metric weights. Specific metrics included American College of Chest Physicians (ACCP)–compliant venous thromboembolism (VTE) prophylaxis,⁷ observed-to-expected length of stay (LOS) ratio, percentage of discharges per day, discharges before 3 pm, depth of coding, patient satisfaction, readmissions, communication with the primary care provider, and time to signature for discharge summaries (Table 1).

Appropriate prophylaxis for VTE was calculated by using an algorithm embedded within the computerized provider order entry system, which assessed the prescription of ACCP-compliant VTE prophylaxis within 24 hours following admission. This included a risk assessment, and credit was given for no prophylaxis and/or mechanical and/or pharmacologic prophylaxis per the ACCP guidelines.⁷

Observed-to-expected LOS was defined by using the University HealthSystem Consortium (UHC; now Vizient Inc) expected LOS for the given calendar year. This approach incorporates patient diagnoses, demographics, and other administrative variables to define an expected LOS for each patient.

The percent of patients discharged per day was defined from billing data as the percentage of a provider’s evaluation and management charges that were the final charge of a patient’s stay (regardless of whether a discharge day service was coded).

Discharge prior to 3 pm was defined from administrative data as the time a patient was discharged from the electronic medical system.

Depth of coding was defined as the number of coded diagnoses submitted to the Maryland Health Services Cost Review Commission for determining payment and was viewed as an indicator of the thoroughness of provider documentation.

Patient satisfaction was defined at the patient level (for those patients who turned in patient satisfaction surveys) as the pooled value of the 5 provider questions on the hospital’s patient satisfaction survey administered by Press Ganey: “time the physician spent with you,” “did the physician show concern for your questions/worries,” “did the physician keep you informed,” “friendliness/courtesy of the physician,” and “skill of the physician.”⁸

Readmission rates were defined as same-hospital readmissions divided by the total number of patients discharged by a given provider, with exclusions based on the Centers for Medicare and Medicaid Services hospital-wide, all-cause readmission measure.¹ The expected same-hospital readmission rate was defined for each patient as the observed readmission rate in the entire UHC (Vizient) data set for all patients with the same All Patient Refined Diagnosis Related Group and severity of illness, as we have described previously.⁹

Communication with the primary care provider was the only self-reported metric used. It was based on a mandatory prompt on the discharge worksheet in the electronic medical record (EMR). Successful communication with the outpatient provider was defined as verbal or electronic communication by the hospitalist with the outpatient provider. Partial (50%) credit was given for providers who attempted but were unsuccessful in communicating with the outpatient provider, for patients for whom the provider had access to the Johns Hopkins EMR system, and for planned admissions without new or important information to convey. No credit was given for providers who indicated that communication was not indicated, who indicated that a patient and/or family would update the provider, or who indicated that the discharge summary would be sufficient.⁹ Because the discharge worksheet could be initiated at any time during the hospitalization, providers could document communication with the outpatient provider at any point during hospitalization.

Discharge summary turnaround was defined as the average number of days elapsed between the day of discharge and the signing of the discharge summary in the EMR.

Assigning Ownership of Patients to Individual Providers

Using billing data, we assigned ownership of patient care based on the type, timing, and number of charges that occurred during each hospitalization (Figure 1). Eligible charges included all history and physical (codes 99221, 99222, and 99223), subsequent care (codes 99231, 99232, and 99233), and discharge charges (codes 99238 and 99239).

By using a unique identifier assigned for each hospitalization, professional fees submitted by providers were used to identify which provider saw the patient on the admission day, discharge day, as well as subsequent care days. Providers’ productivity, bonus supplements, and policy compliance were determined by using billing data, which encouraged the prompt submittal of charges.

The provider who billed the admission history and physical (codes 99221, 99222, and 99223) within 1 calendar date of the patient’s initial admission was defined as the admitting provider. Patients transferred to the hospitalist service from other services were not assigned an admitting hospitalist. The sole metric assigned to the admitting hospitalist was ACCP-compliant VTE prophylaxis.

The provider who billed the final subsequent care or discharge code (codes 99231, 99232, 99233, 99238, and 99239) within 1 calendar date of discharge was defined as the discharging provider. For hospitalizations characterized by a single provider charge (eg, for patients admitted and discharged on the same day), the provider billing this charge was assigned as both the admitting and discharging physician. Patients upgraded to the intensive care unit (ICU) were not counted as a discharge unless the patient was downgraded and discharged from the hospitalist service. The discharging provider was assigned responsibility for the time of discharge, the percent of patients discharged per day, the discharge summary turnaround time, and hospital readmissions.

Metrics that were assigned to multiple providers for a single hospitalization were termed “provider day–weighted” metrics. The formula for calculating the weight for each provider day–weighted metric was as follows: weight for provider A = [number of daily charges billed by provider A] divided by [LOS +1]. The initial hospital day was counted as day 0. LOS plus 1 was used to recognize that a typical hospitalization will have a charge on the day of admission (day 0) and a charge on the day of discharge such that an LOS of 2 days (eg, a patient admitted on Monday and discharged on Wednesday) will have 3 daily charges. Provider day–weighted metrics included patient satisfaction, communication with the outpatient provider, depth of coding, and observed-to-expected LOS.

Our billing software prevented providers from the same group from billing multiple daily charges, thus ensuring that there were no duplicated charges submitted for a given day.

Presenting Results

Providers were only shown data from the day-weighted approach. For ease of visual interpretation, scores for each metric were scaled ordinally from 1 (worst performance) to 9 (best performance; Table 1). Data were displayed in a dashboard format on a password-protected website for each provider to view his or her own data relative to that of the hospitalist peer group. The dashboard was implemented in this format on July 1, 2011. Data were updated quarterly (Figure 2).

Results were displayed in a polyhedral or spider-web graph (Figure 2). Provider and group metrics were scaled according to predefined benchmarks established for each metric and standardized to a scale ranging from 1 to 9. The scale for each metric was set based on examining historical data and group median performance on the metrics to ensure that there was a range of performance (ie, to avoid having most hospitalists scoring a 1 or 9). Scaling thresholds were periodically adjusted as appropriate to maintain good visual discrimination. Higher scores (creating a larger-volume polygon) are desirable even for metrics such as LOS, for which a low value is desirable. Both a spider-web graph and trends over time were available to the provider (Figure 2). These graphs display a comparison of the individual provider scores for each metric to the hospitalist group average for that metric.

Comparison with the Standard (Attending of Record) Method of Attribution

For the purposes of this report, we sought to determine whether there were meaningful differences between our day-weighted approach versus the standard method of attribution, in which the attending of record is assigned responsibility for each metric that would not have been attributed to the discharging attending under both methods. Our goal was to determine where and whether there was a meaningful difference between the 2 methodologies, recognizing that the degree of difference between these 2 methodologies might vary in other institutions and settings. In our hospital, the attending of record is generally the discharging attending. In order to compare the 2 methodologies, we arbitrarily picked 2015 to retrospectively evaluate the differences between these 2 methods of attribution. We did not display or provide data using the standard methodology to providers at any point; this approach was used only for the purposes of this report. Because these metrics are intended to evaluate relative provider performance, we assigned a percentile to each provider for his or her performance on the given metric using our attribution methodology and then, similarly, assigned a percentile to each provider using the standard methodology. This yielded 2 percentile scores for each provider and each metric. We then compared these percentile ranks for providers in 2 ways: (1) we determined how often providers who scored in the top half of the group for a given metric (above the 50th percentile) also scored in the top half of the group for that metric by using the other calculation method, and (2) we calculated the absolute value of the difference in percentiles between the 2 methods to characterize the impact on a provider’s ranking for that metric that might result from switching to the other method. For instance, if a provider scored at the 20th percentile for the group in patient satisfaction with 1 attribution method and scored at the 40th percentile for the group in patient satisfaction using the other method, the absolute change in percentile would be 20 percentile points. But, this provider would still be below the 50th percentile by both methods (concordant bottom half performance). We did not perform this comparison for metrics assigned to the discharging provider (such as discharge summary turnaround time or readmissions) because the attending of record designation is assigned to the discharging provider at our hospital.

The dashboard was successfully operationalized on July 1, 2011, with displays visible to providers as shown in Figure 2. Consistent with the principles of providing effective performance feedback to providers, the display simultaneously showed providers their individual performance as well as the performance of their peers. Providers were able to view their spider-web plot for prior quarters. Not shown are additional views that allowed providers to see quarterly trends in their data versus their peers across several fiscal years. Also available to providers was their ranking relative to their peers for each metric; specific peers were deidentified in the display.

There was notable discordance between provider rankings between the 2 methodologies, as shown in Table 2. Provider performance above or below the median was concordant 56% to 75% of the time (depending on the particular metric), indicating substantial discordance because top-half or bottom-half concordance would be expected to occur by chance 50% of the time. Although the provider percentile differences between the 2 methods tended to be modest for most providers (the median difference between the methods was 13 to 22 percentile points for the various metrics), there were some providers for whom the method of calculation dramatically impacted their rankings. For 5 of the 6 metrics we examined, at least 1 provider had a 50-percentile or greater change in his or her ranking based on the method used. This indicates that at least some providers would have had markedly different scores relative to their peers had we used the alternative methodology (Table 2). In VTE prophylaxis, for example, at least 1 provider had a 94-percentile change in his or her ranking; similarly, a provider had an 88-perentile change in his or her LOS ranking between the 2 methodologies.

We found that it is possible to assign metrics across 1 hospital stay to multiple providers by using billing data. We also found a meaningful discrepancy in how well providers scored (relative to their peers) based on the method used for attribution. These results imply that hospitals should consider attributing performance metrics based on ascribed ownership from billing data and not just from attending of record status.

As hospitalist programs and providers in general are increasingly being asked to develop dashboards to monitor individual and group performance, correctly attributing care to providers is likely to become increasingly important. Experts agree that principles of effective provider performance dashboards include ranking individual provider performance relative to peers, clearly displaying data in an easily accessible format, and ensuring that data can be credibly attributed to the individual provider.^3,4,6 However, there appears to be no gold standard method for attribution, especially in the inpatient setting. Our results imply that hospitals should consider attributing performance metrics based on ascribed ownership from billing data and not just from attending of record status.

Several limitations of our findings are important to consider. First, our program is a relatively small, academic group with handoffs that typically occur every 1 to 2 weeks and sometimes with additional handoffs on weekends. Different care patterns and settings might impact the utility of our attribution methodology relative to the standard methodology. Additionally, it is important to note that the relative merits of the different methodologies cannot be ascertained from our comparison. We can demonstrate discordance between the attribution methodologies, but we cannot say that 1 method is correct and the other is flawed. Although we believe that our day-weighted approach feels fairer to providers based on group input and feedback, we did not conduct a formal survey to examine providers’ preferences for the standard versus day-weighted approaches. The appropriateness of a particular attribution method needs to be assessed locally and may vary based on the clinical setting. For instance, on a service in which patients are admitted for procedures, it may make more sense to attribute the outcome of the case to the proceduralist even if that provider did not bill for the patient’s care on a daily basis. Finally, the computational requirements of our methodology are not trivial and require linking billing data with administrative patient-level data, which may be challenging to operationalize in some institutions.

These limitations aside, we believe that our attribution methodology has face validity. For example, a provider might be justifiably frustrated if, using the standard methodology, he or she is charged with the LOS of a patient who had been hospitalized for months, particularly if that patient is discharged shortly after the provider assumes care. Our method addresses this type of misattribution. Particularly when individual provider compensation is based on performance on metrics (as is the case at our institution), optimizing provider attribution to particular patients may be important, and face validity may be required for group buy-in.

In summary, we have demonstrated that it is possible to use billing data to assign ownership of patients to multiple providers over 1 hospital stay. This could be applied to other hospitalist programs as well as other healthcare settings in which multiple providers care for patients during 1 healthcare encounter (eg, ICUs).

Disclosure

The authors declare they have no relevant conflicts of interest.

Hospitalists’ performance is routinely evaluated by third-party payers, employers, and patients. As hospitalist programs mature, there is a need to develop processes to identify, internally measure, and report on individual and group performance. We know from Society of Hospital Medicine (SHM) data that a significant amount of hospitalists’ total compensation is at least partially based on performance. Often this is based at least in part on quality data. In 2006, SHM issued a white paper detailing the key elements of a successful performance monitoring and reporting process.^1,2 Recommendations included the identification of meaningful operational and clinical performance metrics, and the ability to monitor and report both group and individual metrics was highlighted as an essential component. There is evidence that comparison of individual provider performance with that of their peers is a necessary element of successful provider dashboards.³ Additionally, regular feedback and a clear, visual presentation of the data are important components of successful provider feedback dashboards.^3-6

Much of the literature regarding provider feedback dashboards has been based in the outpatient setting. The majority of these dashboards focus on the management of chronic illnesses (eg, diabetes and hypertension), rates of preventative care services (eg, colonoscopy or mammogram), or avoidance of unnecessary care (eg, antibiotics for sinusitis).^4,5 Unlike in the outpatient setting, in which 1 provider often provides a majority of the care for a given episode of care, hospitalized patients are often cared for by multiple providers, challenging the appropriate attribution of patient-level metrics to specific providers. Under the standard approach, an entire hospitalization is attributed to 1 physician, generally the attending of record for the hospitalization, which may be the admitting provider or the discharging provider, depending on the approach used by the hospital. However, assigning responsibility for an entire hospitalization to a provider who may have only seen the patient for a small percentage of a hospitalization may jeopardize the validity of metrics. As provider metrics are increasingly being used for compensation, it is important to ensure that the method for attribution correctly identifies the providers caring for patients. To our knowledge there is no gold standard approach for attributing metrics to providers when patients are cared for by multiple providers, and the standard attending of record–based approach may lack face validity in many cases.

We aimed to develop and operationalize a system to more fairly attribute patient-level data to individual providers across a single hospitalization even when multiple providers cared for the patient. We then compared our methodology to the standard approach, in which the attending of record receives full attribution for each metric, to determine the difference on a provider level between the 2 models.

Clinical Setting

The Johns Hopkins Hospital is a 1145-bed, tertiary-care hospital. Over the years of this project, the Johns Hopkins Hospitalist Program was an approximately 20-physician group providing care in a variety of settings, including a dedicated hospitalist floor, where this metrics program was initiated. Hospitalists in this setting work Monday through Friday, with 1 hospitalist and a moonlighter covering on the weekends. Admissions are performed by an admitter, and overnight care is provided by a nocturnist. Initially 17 beds, this unit expanded to 24 beds in June 2012. For the purposes of this article, we included all general medicine patients admitted to this floor between July 1, 2010, and June 30, 2014, who were cared for by hospitalists. During this period, all patients were inpatients; no patients were admitted under observation status. All of these patients were cared for by hospitalists without housestaff or advanced practitioners. Since 2014, the metrics program has been expanded to other hospitalist-run services in the hospital, but for simplicity, we have not presented these more recent data.

Individual Provider Metrics

Metrics were chosen to reflect institutional quality and efficiency priorities. Our choice of metrics was restricted to those that (1) plausibly reflect provider performance, at least in part, and (2) could be accessed in electronic form (without any manual chart review). Whenever possible, we chose metrics with objective data. Additionally, because funding for this effort was provided by the hospital, we sought to ensure that enough of the metrics were related to cost to justify ongoing hospital support of the project. SAS 9.2 (SAS Institute Inc, Cary, NC) was used to calculate metric weights. Specific metrics included American College of Chest Physicians (ACCP)–compliant venous thromboembolism (VTE) prophylaxis,⁷ observed-to-expected length of stay (LOS) ratio, percentage of discharges per day, discharges before 3 pm, depth of coding, patient satisfaction, readmissions, communication with the primary care provider, and time to signature for discharge summaries (Table 1).

Appropriate prophylaxis for VTE was calculated by using an algorithm embedded within the computerized provider order entry system, which assessed the prescription of ACCP-compliant VTE prophylaxis within 24 hours following admission. This included a risk assessment, and credit was given for no prophylaxis and/or mechanical and/or pharmacologic prophylaxis per the ACCP guidelines.⁷

Observed-to-expected LOS was defined by using the University HealthSystem Consortium (UHC; now Vizient Inc) expected LOS for the given calendar year. This approach incorporates patient diagnoses, demographics, and other administrative variables to define an expected LOS for each patient.

The percent of patients discharged per day was defined from billing data as the percentage of a provider’s evaluation and management charges that were the final charge of a patient’s stay (regardless of whether a discharge day service was coded).

Discharge prior to 3 pm was defined from administrative data as the time a patient was discharged from the electronic medical system.

Depth of coding was defined as the number of coded diagnoses submitted to the Maryland Health Services Cost Review Commission for determining payment and was viewed as an indicator of the thoroughness of provider documentation.

Patient satisfaction was defined at the patient level (for those patients who turned in patient satisfaction surveys) as the pooled value of the 5 provider questions on the hospital’s patient satisfaction survey administered by Press Ganey: “time the physician spent with you,” “did the physician show concern for your questions/worries,” “did the physician keep you informed,” “friendliness/courtesy of the physician,” and “skill of the physician.”⁸

Readmission rates were defined as same-hospital readmissions divided by the total number of patients discharged by a given provider, with exclusions based on the Centers for Medicare and Medicaid Services hospital-wide, all-cause readmission measure.¹ The expected same-hospital readmission rate was defined for each patient as the observed readmission rate in the entire UHC (Vizient) data set for all patients with the same All Patient Refined Diagnosis Related Group and severity of illness, as we have described previously.⁹

Communication with the primary care provider was the only self-reported metric used. It was based on a mandatory prompt on the discharge worksheet in the electronic medical record (EMR). Successful communication with the outpatient provider was defined as verbal or electronic communication by the hospitalist with the outpatient provider. Partial (50%) credit was given for providers who attempted but were unsuccessful in communicating with the outpatient provider, for patients for whom the provider had access to the Johns Hopkins EMR system, and for planned admissions without new or important information to convey. No credit was given for providers who indicated that communication was not indicated, who indicated that a patient and/or family would update the provider, or who indicated that the discharge summary would be sufficient.⁹ Because the discharge worksheet could be initiated at any time during the hospitalization, providers could document communication with the outpatient provider at any point during hospitalization.

Discharge summary turnaround was defined as the average number of days elapsed between the day of discharge and the signing of the discharge summary in the EMR.

Assigning Ownership of Patients to Individual Providers

Using billing data, we assigned ownership of patient care based on the type, timing, and number of charges that occurred during each hospitalization (Figure 1). Eligible charges included all history and physical (codes 99221, 99222, and 99223), subsequent care (codes 99231, 99232, and 99233), and discharge charges (codes 99238 and 99239).

By using a unique identifier assigned for each hospitalization, professional fees submitted by providers were used to identify which provider saw the patient on the admission day, discharge day, as well as subsequent care days. Providers’ productivity, bonus supplements, and policy compliance were determined by using billing data, which encouraged the prompt submittal of charges.

The provider who billed the admission history and physical (codes 99221, 99222, and 99223) within 1 calendar date of the patient’s initial admission was defined as the admitting provider. Patients transferred to the hospitalist service from other services were not assigned an admitting hospitalist. The sole metric assigned to the admitting hospitalist was ACCP-compliant VTE prophylaxis.

The provider who billed the final subsequent care or discharge code (codes 99231, 99232, 99233, 99238, and 99239) within 1 calendar date of discharge was defined as the discharging provider. For hospitalizations characterized by a single provider charge (eg, for patients admitted and discharged on the same day), the provider billing this charge was assigned as both the admitting and discharging physician. Patients upgraded to the intensive care unit (ICU) were not counted as a discharge unless the patient was downgraded and discharged from the hospitalist service. The discharging provider was assigned responsibility for the time of discharge, the percent of patients discharged per day, the discharge summary turnaround time, and hospital readmissions.

Metrics that were assigned to multiple providers for a single hospitalization were termed “provider day–weighted” metrics. The formula for calculating the weight for each provider day–weighted metric was as follows: weight for provider A = [number of daily charges billed by provider A] divided by [LOS +1]. The initial hospital day was counted as day 0. LOS plus 1 was used to recognize that a typical hospitalization will have a charge on the day of admission (day 0) and a charge on the day of discharge such that an LOS of 2 days (eg, a patient admitted on Monday and discharged on Wednesday) will have 3 daily charges. Provider day–weighted metrics included patient satisfaction, communication with the outpatient provider, depth of coding, and observed-to-expected LOS.

Our billing software prevented providers from the same group from billing multiple daily charges, thus ensuring that there were no duplicated charges submitted for a given day.

Presenting Results

Providers were only shown data from the day-weighted approach. For ease of visual interpretation, scores for each metric were scaled ordinally from 1 (worst performance) to 9 (best performance; Table 1). Data were displayed in a dashboard format on a password-protected website for each provider to view his or her own data relative to that of the hospitalist peer group. The dashboard was implemented in this format on July 1, 2011. Data were updated quarterly (Figure 2).

Results were displayed in a polyhedral or spider-web graph (Figure 2). Provider and group metrics were scaled according to predefined benchmarks established for each metric and standardized to a scale ranging from 1 to 9. The scale for each metric was set based on examining historical data and group median performance on the metrics to ensure that there was a range of performance (ie, to avoid having most hospitalists scoring a 1 or 9). Scaling thresholds were periodically adjusted as appropriate to maintain good visual discrimination. Higher scores (creating a larger-volume polygon) are desirable even for metrics such as LOS, for which a low value is desirable. Both a spider-web graph and trends over time were available to the provider (Figure 2). These graphs display a comparison of the individual provider scores for each metric to the hospitalist group average for that metric.

Comparison with the Standard (Attending of Record) Method of Attribution

For the purposes of this report, we sought to determine whether there were meaningful differences between our day-weighted approach versus the standard method of attribution, in which the attending of record is assigned responsibility for each metric that would not have been attributed to the discharging attending under both methods. Our goal was to determine where and whether there was a meaningful difference between the 2 methodologies, recognizing that the degree of difference between these 2 methodologies might vary in other institutions and settings. In our hospital, the attending of record is generally the discharging attending. In order to compare the 2 methodologies, we arbitrarily picked 2015 to retrospectively evaluate the differences between these 2 methods of attribution. We did not display or provide data using the standard methodology to providers at any point; this approach was used only for the purposes of this report. Because these metrics are intended to evaluate relative provider performance, we assigned a percentile to each provider for his or her performance on the given metric using our attribution methodology and then, similarly, assigned a percentile to each provider using the standard methodology. This yielded 2 percentile scores for each provider and each metric. We then compared these percentile ranks for providers in 2 ways: (1) we determined how often providers who scored in the top half of the group for a given metric (above the 50th percentile) also scored in the top half of the group for that metric by using the other calculation method, and (2) we calculated the absolute value of the difference in percentiles between the 2 methods to characterize the impact on a provider’s ranking for that metric that might result from switching to the other method. For instance, if a provider scored at the 20th percentile for the group in patient satisfaction with 1 attribution method and scored at the 40th percentile for the group in patient satisfaction using the other method, the absolute change in percentile would be 20 percentile points. But, this provider would still be below the 50th percentile by both methods (concordant bottom half performance). We did not perform this comparison for metrics assigned to the discharging provider (such as discharge summary turnaround time or readmissions) because the attending of record designation is assigned to the discharging provider at our hospital.

The dashboard was successfully operationalized on July 1, 2011, with displays visible to providers as shown in Figure 2. Consistent with the principles of providing effective performance feedback to providers, the display simultaneously showed providers their individual performance as well as the performance of their peers. Providers were able to view their spider-web plot for prior quarters. Not shown are additional views that allowed providers to see quarterly trends in their data versus their peers across several fiscal years. Also available to providers was their ranking relative to their peers for each metric; specific peers were deidentified in the display.

There was notable discordance between provider rankings between the 2 methodologies, as shown in Table 2. Provider performance above or below the median was concordant 56% to 75% of the time (depending on the particular metric), indicating substantial discordance because top-half or bottom-half concordance would be expected to occur by chance 50% of the time. Although the provider percentile differences between the 2 methods tended to be modest for most providers (the median difference between the methods was 13 to 22 percentile points for the various metrics), there were some providers for whom the method of calculation dramatically impacted their rankings. For 5 of the 6 metrics we examined, at least 1 provider had a 50-percentile or greater change in his or her ranking based on the method used. This indicates that at least some providers would have had markedly different scores relative to their peers had we used the alternative methodology (Table 2). In VTE prophylaxis, for example, at least 1 provider had a 94-percentile change in his or her ranking; similarly, a provider had an 88-perentile change in his or her LOS ranking between the 2 methodologies.

We found that it is possible to assign metrics across 1 hospital stay to multiple providers by using billing data. We also found a meaningful discrepancy in how well providers scored (relative to their peers) based on the method used for attribution. These results imply that hospitals should consider attributing performance metrics based on ascribed ownership from billing data and not just from attending of record status.

As hospitalist programs and providers in general are increasingly being asked to develop dashboards to monitor individual and group performance, correctly attributing care to providers is likely to become increasingly important. Experts agree that principles of effective provider performance dashboards include ranking individual provider performance relative to peers, clearly displaying data in an easily accessible format, and ensuring that data can be credibly attributed to the individual provider.^3,4,6 However, there appears to be no gold standard method for attribution, especially in the inpatient setting. Our results imply that hospitals should consider attributing performance metrics based on ascribed ownership from billing data and not just from attending of record status.

Several limitations of our findings are important to consider. First, our program is a relatively small, academic group with handoffs that typically occur every 1 to 2 weeks and sometimes with additional handoffs on weekends. Different care patterns and settings might impact the utility of our attribution methodology relative to the standard methodology. Additionally, it is important to note that the relative merits of the different methodologies cannot be ascertained from our comparison. We can demonstrate discordance between the attribution methodologies, but we cannot say that 1 method is correct and the other is flawed. Although we believe that our day-weighted approach feels fairer to providers based on group input and feedback, we did not conduct a formal survey to examine providers’ preferences for the standard versus day-weighted approaches. The appropriateness of a particular attribution method needs to be assessed locally and may vary based on the clinical setting. For instance, on a service in which patients are admitted for procedures, it may make more sense to attribute the outcome of the case to the proceduralist even if that provider did not bill for the patient’s care on a daily basis. Finally, the computational requirements of our methodology are not trivial and require linking billing data with administrative patient-level data, which may be challenging to operationalize in some institutions.

These limitations aside, we believe that our attribution methodology has face validity. For example, a provider might be justifiably frustrated if, using the standard methodology, he or she is charged with the LOS of a patient who had been hospitalized for months, particularly if that patient is discharged shortly after the provider assumes care. Our method addresses this type of misattribution. Particularly when individual provider compensation is based on performance on metrics (as is the case at our institution), optimizing provider attribution to particular patients may be important, and face validity may be required for group buy-in.

In summary, we have demonstrated that it is possible to use billing data to assign ownership of patients to multiple providers over 1 hospital stay. This could be applied to other hospitalist programs as well as other healthcare settings in which multiple providers care for patients during 1 healthcare encounter (eg, ICUs).

Disclosure

The authors declare they have no relevant conflicts of interest.

A previously healthy 30-year-old woman presented to the emergency department with 2 weeks of weakness.

True muscle weakness must be distinguished from the more common causes of asthenia. Many systemic disorders produce fatigue, with resulting functional limitation that is often interpreted by patients as weakness. Initial history should focus on conditions producing fatigue, such as cardiopulmonary disease, anemia, connective tissue disease, depression or cachexia related to malignancy, infection, or other inflammatory states. Careful questioning may reveal evidence of dyspnea, poor exercise tolerance, or joint pain as an alternative to actual loss of muscle power. If true weakness is still suspected, attention should be focused on the pattern, onset, anatomic site, and progression of weakness. Muscle weakness is often characterized by difficulty with specific tasks, such as climbing stairs, rising from a chair, raising a hand, or using cutlery. The physical examination is critical in determining whether weakness is due to true loss of motor power. The differential diagnosis of weakness is broad and includes neurologic, infectious, endocrine, inflammatory, genetic, metabolic, and drug-induced etiologies.

She initially experienced 3 days of mild cramps and soreness in her thighs. She then developed weakness that began in her thighs and progressed to involve her lower legs and upper and lower arms. She had difficulty combing her hair. She required the use of her arms to get up from a chair. She grasped onto objects to aid in ambulation around the house. In addition, she described 1 year of moderate fatigue but no fever, weight loss, dyspnea, dysphagia, visual changes, paresthesias, bowel or bladder incontinence, back pain, or preceding gastrointestinal or respiratory illness. She had experienced diffuse intermittent hives, most prominent in her chest and upper arms, for the past several weeks.

History certainly supports true weakness but will need to be confirmed on examination. The distribution began as proximal but now appears diffuse. The presence of myalgia and cramping raises the possibility of noninflammatory myopathies, which are usually more insidious in onset. A severe electrolyte disturbance would be possible, based on the diffuse nature of weakness that was preceded by cramping. The distribution of weakness and lack of bowel or bladder incontinence is reassuring and suggests against a spinal cord disorder; however, a high index of suspicion must be maintained for myelopathy because delayed treatment might result in irreversible paralysis.

The patient’s course also includes hives. Common causes of hives include infections and allergic reactions to medications, foods, and insect stings. Urticaria may also result from systemic disorders, such as vasculitis, lupus, lymphoma, mastocytosis, and paraproteinemias, which can be associated with weakness and fatigue. Although severe weakness in combination with hives makes an infectious and allergic reaction less likely, we still seek to ascertain if the evolving chief complaints of weakness and hives are the result of a single unifying and evolving multisystem disorder or are distinct and unrelated processes.

Her past medical history included fibromyalgia, kidney stones, and gastroesophageal reflux disease. One week prior to presentation, she was prescribed prednisone 60 mg daily for the treatment of hives; the dose had been tapered to 40 mg at presentation, with mild improvement of hives. She recently started doxepin for fibromyalgia and insomnia. She lived at home with her husband and 8-year-old child. She worked as a clerk in a pest control office and denied any pesticide exposure. She denied tobacco, alcohol, or illicit drug use. Her family history included systemic lupus erythematosus (SLE) in her mother and maternal aunt.

Glucocorticoids are associated with myopathy; however, the weakness preceded steroid therapy. Thus, unless there was unknown exposure to high-dose steroid medication to treat recurrent episodes of urticaria earlier in her course, glucocorticoid-related myopathy is unlikely. Fibromyalgia might cause the perception of weakness from pain. However, the history of difficulty combing her hair and rising from a chair suggests actual loss of motor power. The side effects of her medications, such as newly started doxepin, must be reviewed. A family history of SLE raises concern for rheumatologic conditions; however, one might expect improvement with steroid therapy.

On physical examination, her temperature was 36.9 °C, blood pressure 126/93 mmHg, pulse 81 beats per minute, respiratory rate 16 breaths per minute, and oxygen saturation 100% on ambient air. Her cardiopulmonary examination was normal. Her abdomen was nontender and without hepatosplenomegaly. Her strength was 2 out of 5 in proximal and distal legs, bilaterally, and 4 out of 5 in proximal and distal upper extremities. She had normal muscle tone without fasciculations or atrophy. Her joints were without edema, erythema, or impaired range of motion. She had normal sensation to light touch in arms and legs. Her reflexes were 2+ in the patellar, Achilles, and brachioradialis tendons. She had no lymphadenopathy, mucosal ulcerations, or alopecia. A skin examination revealed smooth, slightly elevated, and faded pink wheals that were diffuse but most prominent in upper arms and chest.

Physical examination confirms the presence of true muscle weakness. The differential diagnosis is narrowed by several findings, both positive and negative, elicited in the examination. The diffuse nature of the weakness eliminates focal central nervous system lesions, such as stroke, intracranial mass lesions, or demyelinating white matter foci. Combining this finding with normal reflexes and history of preceding myalgias makes electrolyte-induced and inflammatory (eg, polymyositis) myopathies more likely. The normal deep tendon reflexes and the absence of a delayed relaxation phase lower the likelihood of hypothyroidism. 

Diseases originating from the neuromuscular junction, such as myasthenia gravis, may also present with weakness and normal reflexes, although this pattern of weakness would be atypical; myasthenia gravis classically presents with fatigable weakness and ocular findings of diplopia and/or ptosis. First-tier testing should include a complete blood count to evaluate for eosinophilia, comprehensive metabolic panel, and urinalysis for myoglobinuria, thyroid stimulating hormone, and muscle enzymes. 


Results of a complete blood count demonstrated a leukocyte count of 16.1 k/uL with 82% neutrophils, 13% lymphocytes, 5% monocytes, and 0% eosinophils. Hemoglobin was 13.2 g/dL, and platelet count 226 k/uL. Sodium was 136 mmol/L, potassium 1.5 mmol/L, chloride 115 mmol/L, bicarbonate 12 mmol/L, blood urea nitrogen 26 mg/dL, creatinine 1.0 mg/dL (baseline creatinine: 0.6), and glucose 102 mg/dL. Calcium was 9.4 mg/dL, magnesium 2.6 mg/dL, phosphorus 1.8 mg/dL, CK 501 U/L (normal: 40-230), and TSH 5.48 uIU/mL (normal: 0.5-4). Aspartate aminotransferase was 64 U/L, alanine aminotransferase 23 U/L, alkaline phosphatase 66 U/L, bilirubin 0.9 mg/dL, albumin 3.8 g/dL, and total protein 8.7 g/dL (normal: 6.2-7.8). Human immunodeficiency virus antibody screen was negative. An electrocardiogram revealed normal sinus rhythm, flattened T waves, and prominent U waves.

Potassium losses are classically categorized into 1 of 3 groups: renal losses, gastrointestinal losses, or transcellular shifts. Without a clear history of diuretic use, renal losses may not be apparent on history and examination. In contrast, gastrointestinal losses are almost always evidenced by a history of vomiting and/or diarrhea, with rare exceptions, including unreported laxative abuse or surreptitious vomiting. Transcellular potassium shifts can be seen in states of increased insulin or beta-adrenergic activity and alkalosis and result from both primary and secondary causes of hypokalemic periodic paralysis.

The presence of a reduced serum bicarbonate and elevated chloride concentration suggests a normal anion gap metabolic acidosis. Many conditions associated with normal anion gap metabolic acidosis are evident by history, such as diarrhea. In enigmatic cases such as this, it will be important to take a stepwise approach that includes an evaluation for urinary potassium losses and assessment of acid-base status. An unexplained normal anion gap metabolic acidosis combined with hypokalemia raises suspicion for a distal renal tubular acidosis (RTA). Additional testing to evaluate for a possible RTA should include the assessment of urinary electrolytes and urinary pH. The hypokalemia explains her weakness, but the etiology of such profound hypokalemia is not evident, nor is it clear how it relates to her hives.

The severity of the hypokalemia, combined with electrocardiogram changes, necessitates rapid intravenous potassium repletion, telemetry monitoring, and frequent serum potassium measurement. Treatment of her metabolic acidosis is more nuanced and depends upon both the severity of disturbance and the suspicion of whether the etiology is transcellular shift, potassium depletion, or both.

Urine studies demonstrated a urine specific gravity of 1.006 (normal: 1.001-1.030), urine pH was 6.5 (normal: 5-6.5), trace leukocyte esterase, negative nitrite, 30 mg/dL of protein (normal: <15), sodium 64 mmol/L (normal: 40-220), potassium 17 mmol/L (normal: 25-125), and chloride 71 mmol/L (normal: 110-250). Urine microscopy demonstrated 3 red blood cells per high power field (normal: 0-1), 4 white blood cells per high power field (normal: 0-4), 4+ bacteria per high power field, and no red blood cell casts. Urine protein-to-creatinine ratio was 1.6. C3 and C4 complement levels were 53 mg/dL (normal: 80-165) and 12 mg/dL (normal: 15-49), respectively. C-reactive protein was <0.5 (normal: 0-0.9), and erythrocyte sedimentation rate was 16 mm/hour (normal: 0-20).

A calculation of the urine anion gap (UAG; [urine sodium + urine potassium] – urine chloride) yields a UAG of 10 mq/L. A positive UAG, together with a nongap metabolic acidosis, should prompt the consideration of RTA. The normal renal response to acidosis is to reduce the urine pH to less than 5.3 through an increase in hydrogen ion excretion in the form of ammonium. A urine pH of 6.5 is highly suggestive of type 1 (distal) RTA and its associated impairment of distal acidification. Treatment with sodium bicarbonate to correct the acidosis and associated complications is warranted.

A distal RTA would account for her past medical history of renal stones. Acidemia promotes both increased calcium phosphate release from bone (with subsequent hypercalciuria) and enhanced citrate reabsorption in the proximal renal tubules, leading to decreased urinary citrate. Citrate inhibits calcium stone formation. The increased calcium load to renal tubules in addition to decreased urinary citrate both lead to increased precipitation of calcium stones in the genitourinary tract.

A diagnosis of distal RTA should prompt evaluation for specific etiologies, such as Sjögren’s syndrome or SLE. While not diagnostic of any specific condition, low C3 and C4 levels suggest immune complex formation with related complement consumption, contributing to hypocomplementemia. The diagnosis of RTA may occur among patients with Sjögren’s syndrome in the absence of overt evidence of sicca syndrome (xerostomia and keratoconjunctivitis sicca). Other etiologies of distal RTA include conditions leading to hypercalciuria, such as hyperparathyroidism and idiopathic hypercalciuria, hereditary causes, toxins such as toluene, and drugs such as amphotericin B, lithium carbonate, and ibuprofen.

Her antinuclear antibody titer was >1:1280 (normal: <80). Anti-SSA and -SSB antibodies were both positive, with a titer >100 (normal: <20). Rheumatoid factor was positive at 22 IU/mL (normal: 0-14). Anti-smith, anti-double stranded DNA, and anti-ribonucleoprotein antibodies were negative.

Sjögren’s syndrome appears to be the ultimate etiology of this patient’s distal RTA. The diagnosis of Sjögren’s is more classically made in the presence of lacrimal and/or salivary dysfunction and confirmed with compatible autoantibodies. In the absence of dry eyes or dry mouth, attention should be focused on her skin findings. Cutaneous vasculitis does occur in a small percentage of Sjögren’s syndrome cases. Urticarial lesions have been reported in this subset, and skin biopsy would further support the diagnosis.

Treatment of Sjögren’s syndrome with immunosuppressive therapy may ameliorate renal parenchymal pathology and improve her profound metabolic disturbances.

On further questioning, she described several months of mild xerostomia, which resulted in increased consumption of fluids. She did not have keratoconjunctivitis sicca. Biopsy of her urticarial rash demonstrated a leukocytoclastic vasculitis with eosinophilic infiltration (Figure 1). Renal biopsy with hematoxylin and eosin staining, immunofluorescence, and electron microscopy demonstrated an immune complex-mediated glomerulonephritis and moderate tubulointerstitial nephritis (Figure 2). A diagnosis of Sjögren’s syndrome was made based on the patient’s xerostomia, high titers of antinuclear antibodies, SSA and SSB antibodies, positive rheumatoid factor, hypocomplementemia, and systemic manifestations associated with Sjögren’s syndrome, including distal RTA, nephrolithiasis, and hives, with histologic evidence of leukocytoclastic vasculitis.

She received aggressive potassium and bicarbonate repletion and, several days later, had normalization of both. Her weakness and myalgia rapidly improved concomitantly with the correction of her hypokalemia. Five days later she was ambulating independently and discharged with potassium citrate and prednisone therapy. She had improved fatigue and rash at a 1-month follow-up with rheumatology. As an outpatient, she was started on azathioprine and slowly tapered off her steroids. Over the next several months, she had normal potassium, bicarbonate, and renal function, although she did require lithotripsy for an obstructive renal stone.

RTA should be considered in the differential diagnosis of an unexplained normal anion gap metabolic acidosis. There are 3 major types of RTAs, with different characteristics. In type 1 (distal) RTA, the primary defect is impaired distal acidification of the urine. Distal RTA commonly presents with hypokalemia, calciuria (often presenting as renal stones), and a positive UAG.¹ In type 2 (proximal) RTA, the primary defect is impaired bicarbonate reabsorption, leading to bicarbonate wasting in the urine. Proximal RTAs can be secondary to an isolated defect in bicarbonate reabsorption or generalized proximal renal tubule dysfunction (Fanconi syndrome).¹ A type 4 RTA is characterized by hypoaldosteronism, presenting usually with a mild nonanion gap metabolic acidosis and hyperkalemia. This patient’s history of renal stones, hypokalemia, and positive UAG supported a type 1 (distal) RTA. Distal RTA is often idiopathic, but initial evaluation should include a review of medications and investigation into an underlying systemic disorder (eg, plasma cell dyscrasia or autoimmune disease). This would include eliciting a possible history of xerostomia and xerophthalmia, together with testing of SSA (Ro) and SSB (La) antibodies, to assess for Sjögren’s syndrome. In addition, checking serum calcium to assess for hyperparathyroidism or familial idiopathic hypercalciuria and a review of medications, such as lithium and amphotericin,¹ may uncover other secondary causes of distal RTA.

While Sjögren’s syndrome primarily affects salivary and lacrimal glands, leading to dry mouth and dry eyes, respectively, extraglandular manifestations are common, with fatigue and arthralgia occurring in half of patients. Extra-glandular involvement also often includes the skin and kidneys but can affect several other organ systems, including the central nervous system, heart, lungs, bone marrow, and lymph nodes.²

There are many cutaneous manifestations of Sjögren’s syndrome.³ Xerosis, or xeroderma, is the most common and is characterized by dry, scaly skin. Cutaneous vasculitis can occur in 10% of patients with Sjögren’s syndrome and often presents with palpable purpura or diffuse urticarial lesions, as in our patient.⁴ Erythematous maculopapules and cryoglobulinemic vasculitis may also occur.⁴ A less common skin manifestation is annular erythema, presenting as an indurated, ring-like lesion.⁵

Chronic tubulointerstitial nephritis is the most common renal manifestation of Sjögren’s syndrome.⁶ This often pre-sents with a mild elevated serum creatinine and a distal RTA, leading to hypokalemia, as in the case discussed. Distal RTA is well described, occurring in one-quarter of patients with Sjögren’s syndrome.⁷ The pathophysiology leading to distal RTA in Sjögren’s syndrome is thought to arise from autoimmune injury to the H(+)-ATPase pump in the renal collecting tubules, leading to decreased distal proton secretion.^8,9 Younger adults with Sjögren’s syndrome, in the third and fourth decades of life, have a predilection to develop tubulointerstitial inflammation, distal RTA, and nephrolithiasis, as in the present case.⁶ Sjögren’s syndrome less commonly presents with membranoproliferative glomerulonephritis or membranous nephropathy.^10,11 Cryoglobulinemia-associated hypocomplementemia and glomerulonephritis may also occur with Sjögren’s syndrome, yet glomerular lesions are less common than is tubulointerstitial inflammation. The patient discussed had proteinuria and evidence of immune complex-mediated glomerulonephritis.

Treatment of sicca symptoms is generally supportive. It includes artificial tears, encouragement of good hydration, salivary stimulants, and maintaining good oral hygiene. Pilocarpine, a cholinergic parasympathomimetic agent, is approved by the Food and Drug Administration to treat dry mouth associated with Sjögren’s syndrome. The treatment of extraglandular manifestations depends on the organ(s) involved. More severe presentations, such as vasculitis and glomerulonephritis, often require immunosuppressive therapy with systemic glucocorticoids, cyclophosphamide, azathioprine, or other immunosuppressive agents,¹² including rituximab. RTA often necessitates treatment with oral bicarbonate and supplemental potassium repletion.

The base rate of disease (ie, prevalence of disease) influences a diagnostician’s pretest probability of a given diagnosis. The discussant briefly considered rare causes of hives (eg, vasculitis) but appropriately fine-tuned their differential for the patient’s hypokalemia and RTA. Once the diagnosis of Sjögren’s syndrome was made with certainty, the clinician was able to revisit the patient’s rash with a new lens. Urticarial vasculitis suddenly became a plausible consideration, despite its rarity (compared to allergic causes of hives) because of the direct link to the underlying autoimmune condition, which affected both the proximal muscles and distal nephrons.

• Evaluation of patients with weakness starts with determining true muscle weakness (ie, pathology involving the brain, spinal cord, peripheral nerve, neuromuscular junction, and/or muscle) from asthenia.
• Distal RTA should be considered in patients with a nonanion gap metabolic acidosis and hypokalemia.
• Sjögren’s syndrome has many extraglandular clinical manifestations, including vasculitis, urticaria, tubulointerstitial renal inflammation, glomerulonephritis, and lymphoma.

Acknowledgment

The authors thank Virgilius Cornea, MD, for his interpretation of the pathologic images.

Disclosure

Dr. Manesh is supported by the Jeremiah A. Barondess Fellowship in the Clinical Transaction of the New York Academy of Medicine, in collaboration with the Accreditation Council for Graduate Medical Education (ACGME). The authors declare no conflicts of interests.

A previously healthy 30-year-old woman presented to the emergency department with 2 weeks of weakness.

True muscle weakness must be distinguished from the more common causes of asthenia. Many systemic disorders produce fatigue, with resulting functional limitation that is often interpreted by patients as weakness. Initial history should focus on conditions producing fatigue, such as cardiopulmonary disease, anemia, connective tissue disease, depression or cachexia related to malignancy, infection, or other inflammatory states. Careful questioning may reveal evidence of dyspnea, poor exercise tolerance, or joint pain as an alternative to actual loss of muscle power. If true weakness is still suspected, attention should be focused on the pattern, onset, anatomic site, and progression of weakness. Muscle weakness is often characterized by difficulty with specific tasks, such as climbing stairs, rising from a chair, raising a hand, or using cutlery. The physical examination is critical in determining whether weakness is due to true loss of motor power. The differential diagnosis of weakness is broad and includes neurologic, infectious, endocrine, inflammatory, genetic, metabolic, and drug-induced etiologies.

She initially experienced 3 days of mild cramps and soreness in her thighs. She then developed weakness that began in her thighs and progressed to involve her lower legs and upper and lower arms. She had difficulty combing her hair. She required the use of her arms to get up from a chair. She grasped onto objects to aid in ambulation around the house. In addition, she described 1 year of moderate fatigue but no fever, weight loss, dyspnea, dysphagia, visual changes, paresthesias, bowel or bladder incontinence, back pain, or preceding gastrointestinal or respiratory illness. She had experienced diffuse intermittent hives, most prominent in her chest and upper arms, for the past several weeks.

History certainly supports true weakness but will need to be confirmed on examination. The distribution began as proximal but now appears diffuse. The presence of myalgia and cramping raises the possibility of noninflammatory myopathies, which are usually more insidious in onset. A severe electrolyte disturbance would be possible, based on the diffuse nature of weakness that was preceded by cramping. The distribution of weakness and lack of bowel or bladder incontinence is reassuring and suggests against a spinal cord disorder; however, a high index of suspicion must be maintained for myelopathy because delayed treatment might result in irreversible paralysis.

The patient’s course also includes hives. Common causes of hives include infections and allergic reactions to medications, foods, and insect stings. Urticaria may also result from systemic disorders, such as vasculitis, lupus, lymphoma, mastocytosis, and paraproteinemias, which can be associated with weakness and fatigue. Although severe weakness in combination with hives makes an infectious and allergic reaction less likely, we still seek to ascertain if the evolving chief complaints of weakness and hives are the result of a single unifying and evolving multisystem disorder or are distinct and unrelated processes.

Her past medical history included fibromyalgia, kidney stones, and gastroesophageal reflux disease. One week prior to presentation, she was prescribed prednisone 60 mg daily for the treatment of hives; the dose had been tapered to 40 mg at presentation, with mild improvement of hives. She recently started doxepin for fibromyalgia and insomnia. She lived at home with her husband and 8-year-old child. She worked as a clerk in a pest control office and denied any pesticide exposure. She denied tobacco, alcohol, or illicit drug use. Her family history included systemic lupus erythematosus (SLE) in her mother and maternal aunt.

Glucocorticoids are associated with myopathy; however, the weakness preceded steroid therapy. Thus, unless there was unknown exposure to high-dose steroid medication to treat recurrent episodes of urticaria earlier in her course, glucocorticoid-related myopathy is unlikely. Fibromyalgia might cause the perception of weakness from pain. However, the history of difficulty combing her hair and rising from a chair suggests actual loss of motor power. The side effects of her medications, such as newly started doxepin, must be reviewed. A family history of SLE raises concern for rheumatologic conditions; however, one might expect improvement with steroid therapy.

On physical examination, her temperature was 36.9 °C, blood pressure 126/93 mmHg, pulse 81 beats per minute, respiratory rate 16 breaths per minute, and oxygen saturation 100% on ambient air. Her cardiopulmonary examination was normal. Her abdomen was nontender and without hepatosplenomegaly. Her strength was 2 out of 5 in proximal and distal legs, bilaterally, and 4 out of 5 in proximal and distal upper extremities. She had normal muscle tone without fasciculations or atrophy. Her joints were without edema, erythema, or impaired range of motion. She had normal sensation to light touch in arms and legs. Her reflexes were 2+ in the patellar, Achilles, and brachioradialis tendons. She had no lymphadenopathy, mucosal ulcerations, or alopecia. A skin examination revealed smooth, slightly elevated, and faded pink wheals that were diffuse but most prominent in upper arms and chest.

Physical examination confirms the presence of true muscle weakness. The differential diagnosis is narrowed by several findings, both positive and negative, elicited in the examination. The diffuse nature of the weakness eliminates focal central nervous system lesions, such as stroke, intracranial mass lesions, or demyelinating white matter foci. Combining this finding with normal reflexes and history of preceding myalgias makes electrolyte-induced and inflammatory (eg, polymyositis) myopathies more likely. The normal deep tendon reflexes and the absence of a delayed relaxation phase lower the likelihood of hypothyroidism. 

Diseases originating from the neuromuscular junction, such as myasthenia gravis, may also present with weakness and normal reflexes, although this pattern of weakness would be atypical; myasthenia gravis classically presents with fatigable weakness and ocular findings of diplopia and/or ptosis. First-tier testing should include a complete blood count to evaluate for eosinophilia, comprehensive metabolic panel, and urinalysis for myoglobinuria, thyroid stimulating hormone, and muscle enzymes. 


Results of a complete blood count demonstrated a leukocyte count of 16.1 k/uL with 82% neutrophils, 13% lymphocytes, 5% monocytes, and 0% eosinophils. Hemoglobin was 13.2 g/dL, and platelet count 226 k/uL. Sodium was 136 mmol/L, potassium 1.5 mmol/L, chloride 115 mmol/L, bicarbonate 12 mmol/L, blood urea nitrogen 26 mg/dL, creatinine 1.0 mg/dL (baseline creatinine: 0.6), and glucose 102 mg/dL. Calcium was 9.4 mg/dL, magnesium 2.6 mg/dL, phosphorus 1.8 mg/dL, CK 501 U/L (normal: 40-230), and TSH 5.48 uIU/mL (normal: 0.5-4). Aspartate aminotransferase was 64 U/L, alanine aminotransferase 23 U/L, alkaline phosphatase 66 U/L, bilirubin 0.9 mg/dL, albumin 3.8 g/dL, and total protein 8.7 g/dL (normal: 6.2-7.8). Human immunodeficiency virus antibody screen was negative. An electrocardiogram revealed normal sinus rhythm, flattened T waves, and prominent U waves.

Potassium losses are classically categorized into 1 of 3 groups: renal losses, gastrointestinal losses, or transcellular shifts. Without a clear history of diuretic use, renal losses may not be apparent on history and examination. In contrast, gastrointestinal losses are almost always evidenced by a history of vomiting and/or diarrhea, with rare exceptions, including unreported laxative abuse or surreptitious vomiting. Transcellular potassium shifts can be seen in states of increased insulin or beta-adrenergic activity and alkalosis and result from both primary and secondary causes of hypokalemic periodic paralysis.

The presence of a reduced serum bicarbonate and elevated chloride concentration suggests a normal anion gap metabolic acidosis. Many conditions associated with normal anion gap metabolic acidosis are evident by history, such as diarrhea. In enigmatic cases such as this, it will be important to take a stepwise approach that includes an evaluation for urinary potassium losses and assessment of acid-base status. An unexplained normal anion gap metabolic acidosis combined with hypokalemia raises suspicion for a distal renal tubular acidosis (RTA). Additional testing to evaluate for a possible RTA should include the assessment of urinary electrolytes and urinary pH. The hypokalemia explains her weakness, but the etiology of such profound hypokalemia is not evident, nor is it clear how it relates to her hives.

The severity of the hypokalemia, combined with electrocardiogram changes, necessitates rapid intravenous potassium repletion, telemetry monitoring, and frequent serum potassium measurement. Treatment of her metabolic acidosis is more nuanced and depends upon both the severity of disturbance and the suspicion of whether the etiology is transcellular shift, potassium depletion, or both.

Urine studies demonstrated a urine specific gravity of 1.006 (normal: 1.001-1.030), urine pH was 6.5 (normal: 5-6.5), trace leukocyte esterase, negative nitrite, 30 mg/dL of protein (normal: <15), sodium 64 mmol/L (normal: 40-220), potassium 17 mmol/L (normal: 25-125), and chloride 71 mmol/L (normal: 110-250). Urine microscopy demonstrated 3 red blood cells per high power field (normal: 0-1), 4 white blood cells per high power field (normal: 0-4), 4+ bacteria per high power field, and no red blood cell casts. Urine protein-to-creatinine ratio was 1.6. C3 and C4 complement levels were 53 mg/dL (normal: 80-165) and 12 mg/dL (normal: 15-49), respectively. C-reactive protein was <0.5 (normal: 0-0.9), and erythrocyte sedimentation rate was 16 mm/hour (normal: 0-20).

A calculation of the urine anion gap (UAG; [urine sodium + urine potassium] – urine chloride) yields a UAG of 10 mq/L. A positive UAG, together with a nongap metabolic acidosis, should prompt the consideration of RTA. The normal renal response to acidosis is to reduce the urine pH to less than 5.3 through an increase in hydrogen ion excretion in the form of ammonium. A urine pH of 6.5 is highly suggestive of type 1 (distal) RTA and its associated impairment of distal acidification. Treatment with sodium bicarbonate to correct the acidosis and associated complications is warranted.

A distal RTA would account for her past medical history of renal stones. Acidemia promotes both increased calcium phosphate release from bone (with subsequent hypercalciuria) and enhanced citrate reabsorption in the proximal renal tubules, leading to decreased urinary citrate. Citrate inhibits calcium stone formation. The increased calcium load to renal tubules in addition to decreased urinary citrate both lead to increased precipitation of calcium stones in the genitourinary tract.

A diagnosis of distal RTA should prompt evaluation for specific etiologies, such as Sjögren’s syndrome or SLE. While not diagnostic of any specific condition, low C3 and C4 levels suggest immune complex formation with related complement consumption, contributing to hypocomplementemia. The diagnosis of RTA may occur among patients with Sjögren’s syndrome in the absence of overt evidence of sicca syndrome (xerostomia and keratoconjunctivitis sicca). Other etiologies of distal RTA include conditions leading to hypercalciuria, such as hyperparathyroidism and idiopathic hypercalciuria, hereditary causes, toxins such as toluene, and drugs such as amphotericin B, lithium carbonate, and ibuprofen.

Her antinuclear antibody titer was >1:1280 (normal: <80). Anti-SSA and -SSB antibodies were both positive, with a titer >100 (normal: <20). Rheumatoid factor was positive at 22 IU/mL (normal: 0-14). Anti-smith, anti-double stranded DNA, and anti-ribonucleoprotein antibodies were negative.

Sjögren’s syndrome appears to be the ultimate etiology of this patient’s distal RTA. The diagnosis of Sjögren’s is more classically made in the presence of lacrimal and/or salivary dysfunction and confirmed with compatible autoantibodies. In the absence of dry eyes or dry mouth, attention should be focused on her skin findings. Cutaneous vasculitis does occur in a small percentage of Sjögren’s syndrome cases. Urticarial lesions have been reported in this subset, and skin biopsy would further support the diagnosis.

Treatment of Sjögren’s syndrome with immunosuppressive therapy may ameliorate renal parenchymal pathology and improve her profound metabolic disturbances.

On further questioning, she described several months of mild xerostomia, which resulted in increased consumption of fluids. She did not have keratoconjunctivitis sicca. Biopsy of her urticarial rash demonstrated a leukocytoclastic vasculitis with eosinophilic infiltration (Figure 1). Renal biopsy with hematoxylin and eosin staining, immunofluorescence, and electron microscopy demonstrated an immune complex-mediated glomerulonephritis and moderate tubulointerstitial nephritis (Figure 2). A diagnosis of Sjögren’s syndrome was made based on the patient’s xerostomia, high titers of antinuclear antibodies, SSA and SSB antibodies, positive rheumatoid factor, hypocomplementemia, and systemic manifestations associated with Sjögren’s syndrome, including distal RTA, nephrolithiasis, and hives, with histologic evidence of leukocytoclastic vasculitis.

She received aggressive potassium and bicarbonate repletion and, several days later, had normalization of both. Her weakness and myalgia rapidly improved concomitantly with the correction of her hypokalemia. Five days later she was ambulating independently and discharged with potassium citrate and prednisone therapy. She had improved fatigue and rash at a 1-month follow-up with rheumatology. As an outpatient, she was started on azathioprine and slowly tapered off her steroids. Over the next several months, she had normal potassium, bicarbonate, and renal function, although she did require lithotripsy for an obstructive renal stone.

RTA should be considered in the differential diagnosis of an unexplained normal anion gap metabolic acidosis. There are 3 major types of RTAs, with different characteristics. In type 1 (distal) RTA, the primary defect is impaired distal acidification of the urine. Distal RTA commonly presents with hypokalemia, calciuria (often presenting as renal stones), and a positive UAG.¹ In type 2 (proximal) RTA, the primary defect is impaired bicarbonate reabsorption, leading to bicarbonate wasting in the urine. Proximal RTAs can be secondary to an isolated defect in bicarbonate reabsorption or generalized proximal renal tubule dysfunction (Fanconi syndrome).¹ A type 4 RTA is characterized by hypoaldosteronism, presenting usually with a mild nonanion gap metabolic acidosis and hyperkalemia. This patient’s history of renal stones, hypokalemia, and positive UAG supported a type 1 (distal) RTA. Distal RTA is often idiopathic, but initial evaluation should include a review of medications and investigation into an underlying systemic disorder (eg, plasma cell dyscrasia or autoimmune disease). This would include eliciting a possible history of xerostomia and xerophthalmia, together with testing of SSA (Ro) and SSB (La) antibodies, to assess for Sjögren’s syndrome. In addition, checking serum calcium to assess for hyperparathyroidism or familial idiopathic hypercalciuria and a review of medications, such as lithium and amphotericin,¹ may uncover other secondary causes of distal RTA.

While Sjögren’s syndrome primarily affects salivary and lacrimal glands, leading to dry mouth and dry eyes, respectively, extraglandular manifestations are common, with fatigue and arthralgia occurring in half of patients. Extra-glandular involvement also often includes the skin and kidneys but can affect several other organ systems, including the central nervous system, heart, lungs, bone marrow, and lymph nodes.²

There are many cutaneous manifestations of Sjögren’s syndrome.³ Xerosis, or xeroderma, is the most common and is characterized by dry, scaly skin. Cutaneous vasculitis can occur in 10% of patients with Sjögren’s syndrome and often presents with palpable purpura or diffuse urticarial lesions, as in our patient.⁴ Erythematous maculopapules and cryoglobulinemic vasculitis may also occur.⁴ A less common skin manifestation is annular erythema, presenting as an indurated, ring-like lesion.⁵

Chronic tubulointerstitial nephritis is the most common renal manifestation of Sjögren’s syndrome.⁶ This often pre-sents with a mild elevated serum creatinine and a distal RTA, leading to hypokalemia, as in the case discussed. Distal RTA is well described, occurring in one-quarter of patients with Sjögren’s syndrome.⁷ The pathophysiology leading to distal RTA in Sjögren’s syndrome is thought to arise from autoimmune injury to the H(+)-ATPase pump in the renal collecting tubules, leading to decreased distal proton secretion.^8,9 Younger adults with Sjögren’s syndrome, in the third and fourth decades of life, have a predilection to develop tubulointerstitial inflammation, distal RTA, and nephrolithiasis, as in the present case.⁶ Sjögren’s syndrome less commonly presents with membranoproliferative glomerulonephritis or membranous nephropathy.^10,11 Cryoglobulinemia-associated hypocomplementemia and glomerulonephritis may also occur with Sjögren’s syndrome, yet glomerular lesions are less common than is tubulointerstitial inflammation. The patient discussed had proteinuria and evidence of immune complex-mediated glomerulonephritis.

Treatment of sicca symptoms is generally supportive. It includes artificial tears, encouragement of good hydration, salivary stimulants, and maintaining good oral hygiene. Pilocarpine, a cholinergic parasympathomimetic agent, is approved by the Food and Drug Administration to treat dry mouth associated with Sjögren’s syndrome. The treatment of extraglandular manifestations depends on the organ(s) involved. More severe presentations, such as vasculitis and glomerulonephritis, often require immunosuppressive therapy with systemic glucocorticoids, cyclophosphamide, azathioprine, or other immunosuppressive agents,¹² including rituximab. RTA often necessitates treatment with oral bicarbonate and supplemental potassium repletion.

The base rate of disease (ie, prevalence of disease) influences a diagnostician’s pretest probability of a given diagnosis. The discussant briefly considered rare causes of hives (eg, vasculitis) but appropriately fine-tuned their differential for the patient’s hypokalemia and RTA. Once the diagnosis of Sjögren’s syndrome was made with certainty, the clinician was able to revisit the patient’s rash with a new lens. Urticarial vasculitis suddenly became a plausible consideration, despite its rarity (compared to allergic causes of hives) because of the direct link to the underlying autoimmune condition, which affected both the proximal muscles and distal nephrons.

• Evaluation of patients with weakness starts with determining true muscle weakness (ie, pathology involving the brain, spinal cord, peripheral nerve, neuromuscular junction, and/or muscle) from asthenia.
• Distal RTA should be considered in patients with a nonanion gap metabolic acidosis and hypokalemia.
• Sjögren’s syndrome has many extraglandular clinical manifestations, including vasculitis, urticaria, tubulointerstitial renal inflammation, glomerulonephritis, and lymphoma.

Acknowledgment

The authors thank Virgilius Cornea, MD, for his interpretation of the pathologic images.

Disclosure

Dr. Manesh is supported by the Jeremiah A. Barondess Fellowship in the Clinical Transaction of the New York Academy of Medicine, in collaboration with the Accreditation Council for Graduate Medical Education (ACGME). The authors declare no conflicts of interests.

A previously healthy 30-year-old woman presented to the emergency department with 2 weeks of weakness.

True muscle weakness must be distinguished from the more common causes of asthenia. Many systemic disorders produce fatigue, with resulting functional limitation that is often interpreted by patients as weakness. Initial history should focus on conditions producing fatigue, such as cardiopulmonary disease, anemia, connective tissue disease, depression or cachexia related to malignancy, infection, or other inflammatory states. Careful questioning may reveal evidence of dyspnea, poor exercise tolerance, or joint pain as an alternative to actual loss of muscle power. If true weakness is still suspected, attention should be focused on the pattern, onset, anatomic site, and progression of weakness. Muscle weakness is often characterized by difficulty with specific tasks, such as climbing stairs, rising from a chair, raising a hand, or using cutlery. The physical examination is critical in determining whether weakness is due to true loss of motor power. The differential diagnosis of weakness is broad and includes neurologic, infectious, endocrine, inflammatory, genetic, metabolic, and drug-induced etiologies.

She initially experienced 3 days of mild cramps and soreness in her thighs. She then developed weakness that began in her thighs and progressed to involve her lower legs and upper and lower arms. She had difficulty combing her hair. She required the use of her arms to get up from a chair. She grasped onto objects to aid in ambulation around the house. In addition, she described 1 year of moderate fatigue but no fever, weight loss, dyspnea, dysphagia, visual changes, paresthesias, bowel or bladder incontinence, back pain, or preceding gastrointestinal or respiratory illness. She had experienced diffuse intermittent hives, most prominent in her chest and upper arms, for the past several weeks.

History certainly supports true weakness but will need to be confirmed on examination. The distribution began as proximal but now appears diffuse. The presence of myalgia and cramping raises the possibility of noninflammatory myopathies, which are usually more insidious in onset. A severe electrolyte disturbance would be possible, based on the diffuse nature of weakness that was preceded by cramping. The distribution of weakness and lack of bowel or bladder incontinence is reassuring and suggests against a spinal cord disorder; however, a high index of suspicion must be maintained for myelopathy because delayed treatment might result in irreversible paralysis.

The patient’s course also includes hives. Common causes of hives include infections and allergic reactions to medications, foods, and insect stings. Urticaria may also result from systemic disorders, such as vasculitis, lupus, lymphoma, mastocytosis, and paraproteinemias, which can be associated with weakness and fatigue. Although severe weakness in combination with hives makes an infectious and allergic reaction less likely, we still seek to ascertain if the evolving chief complaints of weakness and hives are the result of a single unifying and evolving multisystem disorder or are distinct and unrelated processes.

Her past medical history included fibromyalgia, kidney stones, and gastroesophageal reflux disease. One week prior to presentation, she was prescribed prednisone 60 mg daily for the treatment of hives; the dose had been tapered to 40 mg at presentation, with mild improvement of hives. She recently started doxepin for fibromyalgia and insomnia. She lived at home with her husband and 8-year-old child. She worked as a clerk in a pest control office and denied any pesticide exposure. She denied tobacco, alcohol, or illicit drug use. Her family history included systemic lupus erythematosus (SLE) in her mother and maternal aunt.

Glucocorticoids are associated with myopathy; however, the weakness preceded steroid therapy. Thus, unless there was unknown exposure to high-dose steroid medication to treat recurrent episodes of urticaria earlier in her course, glucocorticoid-related myopathy is unlikely. Fibromyalgia might cause the perception of weakness from pain. However, the history of difficulty combing her hair and rising from a chair suggests actual loss of motor power. The side effects of her medications, such as newly started doxepin, must be reviewed. A family history of SLE raises concern for rheumatologic conditions; however, one might expect improvement with steroid therapy.

On physical examination, her temperature was 36.9 °C, blood pressure 126/93 mmHg, pulse 81 beats per minute, respiratory rate 16 breaths per minute, and oxygen saturation 100% on ambient air. Her cardiopulmonary examination was normal. Her abdomen was nontender and without hepatosplenomegaly. Her strength was 2 out of 5 in proximal and distal legs, bilaterally, and 4 out of 5 in proximal and distal upper extremities. She had normal muscle tone without fasciculations or atrophy. Her joints were without edema, erythema, or impaired range of motion. She had normal sensation to light touch in arms and legs. Her reflexes were 2+ in the patellar, Achilles, and brachioradialis tendons. She had no lymphadenopathy, mucosal ulcerations, or alopecia. A skin examination revealed smooth, slightly elevated, and faded pink wheals that were diffuse but most prominent in upper arms and chest.

Physical examination confirms the presence of true muscle weakness. The differential diagnosis is narrowed by several findings, both positive and negative, elicited in the examination. The diffuse nature of the weakness eliminates focal central nervous system lesions, such as stroke, intracranial mass lesions, or demyelinating white matter foci. Combining this finding with normal reflexes and history of preceding myalgias makes electrolyte-induced and inflammatory (eg, polymyositis) myopathies more likely. The normal deep tendon reflexes and the absence of a delayed relaxation phase lower the likelihood of hypothyroidism. 

Diseases originating from the neuromuscular junction, such as myasthenia gravis, may also present with weakness and normal reflexes, although this pattern of weakness would be atypical; myasthenia gravis classically presents with fatigable weakness and ocular findings of diplopia and/or ptosis. First-tier testing should include a complete blood count to evaluate for eosinophilia, comprehensive metabolic panel, and urinalysis for myoglobinuria, thyroid stimulating hormone, and muscle enzymes. 


Results of a complete blood count demonstrated a leukocyte count of 16.1 k/uL with 82% neutrophils, 13% lymphocytes, 5% monocytes, and 0% eosinophils. Hemoglobin was 13.2 g/dL, and platelet count 226 k/uL. Sodium was 136 mmol/L, potassium 1.5 mmol/L, chloride 115 mmol/L, bicarbonate 12 mmol/L, blood urea nitrogen 26 mg/dL, creatinine 1.0 mg/dL (baseline creatinine: 0.6), and glucose 102 mg/dL. Calcium was 9.4 mg/dL, magnesium 2.6 mg/dL, phosphorus 1.8 mg/dL, CK 501 U/L (normal: 40-230), and TSH 5.48 uIU/mL (normal: 0.5-4). Aspartate aminotransferase was 64 U/L, alanine aminotransferase 23 U/L, alkaline phosphatase 66 U/L, bilirubin 0.9 mg/dL, albumin 3.8 g/dL, and total protein 8.7 g/dL (normal: 6.2-7.8). Human immunodeficiency virus antibody screen was negative. An electrocardiogram revealed normal sinus rhythm, flattened T waves, and prominent U waves.

Potassium losses are classically categorized into 1 of 3 groups: renal losses, gastrointestinal losses, or transcellular shifts. Without a clear history of diuretic use, renal losses may not be apparent on history and examination. In contrast, gastrointestinal losses are almost always evidenced by a history of vomiting and/or diarrhea, with rare exceptions, including unreported laxative abuse or surreptitious vomiting. Transcellular potassium shifts can be seen in states of increased insulin or beta-adrenergic activity and alkalosis and result from both primary and secondary causes of hypokalemic periodic paralysis.

The presence of a reduced serum bicarbonate and elevated chloride concentration suggests a normal anion gap metabolic acidosis. Many conditions associated with normal anion gap metabolic acidosis are evident by history, such as diarrhea. In enigmatic cases such as this, it will be important to take a stepwise approach that includes an evaluation for urinary potassium losses and assessment of acid-base status. An unexplained normal anion gap metabolic acidosis combined with hypokalemia raises suspicion for a distal renal tubular acidosis (RTA). Additional testing to evaluate for a possible RTA should include the assessment of urinary electrolytes and urinary pH. The hypokalemia explains her weakness, but the etiology of such profound hypokalemia is not evident, nor is it clear how it relates to her hives.

The severity of the hypokalemia, combined with electrocardiogram changes, necessitates rapid intravenous potassium repletion, telemetry monitoring, and frequent serum potassium measurement. Treatment of her metabolic acidosis is more nuanced and depends upon both the severity of disturbance and the suspicion of whether the etiology is transcellular shift, potassium depletion, or both.

Urine studies demonstrated a urine specific gravity of 1.006 (normal: 1.001-1.030), urine pH was 6.5 (normal: 5-6.5), trace leukocyte esterase, negative nitrite, 30 mg/dL of protein (normal: <15), sodium 64 mmol/L (normal: 40-220), potassium 17 mmol/L (normal: 25-125), and chloride 71 mmol/L (normal: 110-250). Urine microscopy demonstrated 3 red blood cells per high power field (normal: 0-1), 4 white blood cells per high power field (normal: 0-4), 4+ bacteria per high power field, and no red blood cell casts. Urine protein-to-creatinine ratio was 1.6. C3 and C4 complement levels were 53 mg/dL (normal: 80-165) and 12 mg/dL (normal: 15-49), respectively. C-reactive protein was <0.5 (normal: 0-0.9), and erythrocyte sedimentation rate was 16 mm/hour (normal: 0-20).

A calculation of the urine anion gap (UAG; [urine sodium + urine potassium] – urine chloride) yields a UAG of 10 mq/L. A positive UAG, together with a nongap metabolic acidosis, should prompt the consideration of RTA. The normal renal response to acidosis is to reduce the urine pH to less than 5.3 through an increase in hydrogen ion excretion in the form of ammonium. A urine pH of 6.5 is highly suggestive of type 1 (distal) RTA and its associated impairment of distal acidification. Treatment with sodium bicarbonate to correct the acidosis and associated complications is warranted.

A distal RTA would account for her past medical history of renal stones. Acidemia promotes both increased calcium phosphate release from bone (with subsequent hypercalciuria) and enhanced citrate reabsorption in the proximal renal tubules, leading to decreased urinary citrate. Citrate inhibits calcium stone formation. The increased calcium load to renal tubules in addition to decreased urinary citrate both lead to increased precipitation of calcium stones in the genitourinary tract.

A diagnosis of distal RTA should prompt evaluation for specific etiologies, such as Sjögren’s syndrome or SLE. While not diagnostic of any specific condition, low C3 and C4 levels suggest immune complex formation with related complement consumption, contributing to hypocomplementemia. The diagnosis of RTA may occur among patients with Sjögren’s syndrome in the absence of overt evidence of sicca syndrome (xerostomia and keratoconjunctivitis sicca). Other etiologies of distal RTA include conditions leading to hypercalciuria, such as hyperparathyroidism and idiopathic hypercalciuria, hereditary causes, toxins such as toluene, and drugs such as amphotericin B, lithium carbonate, and ibuprofen.

Her antinuclear antibody titer was >1:1280 (normal: <80). Anti-SSA and -SSB antibodies were both positive, with a titer >100 (normal: <20). Rheumatoid factor was positive at 22 IU/mL (normal: 0-14). Anti-smith, anti-double stranded DNA, and anti-ribonucleoprotein antibodies were negative.

Sjögren’s syndrome appears to be the ultimate etiology of this patient’s distal RTA. The diagnosis of Sjögren’s is more classically made in the presence of lacrimal and/or salivary dysfunction and confirmed with compatible autoantibodies. In the absence of dry eyes or dry mouth, attention should be focused on her skin findings. Cutaneous vasculitis does occur in a small percentage of Sjögren’s syndrome cases. Urticarial lesions have been reported in this subset, and skin biopsy would further support the diagnosis.

Treatment of Sjögren’s syndrome with immunosuppressive therapy may ameliorate renal parenchymal pathology and improve her profound metabolic disturbances.

On further questioning, she described several months of mild xerostomia, which resulted in increased consumption of fluids. She did not have keratoconjunctivitis sicca. Biopsy of her urticarial rash demonstrated a leukocytoclastic vasculitis with eosinophilic infiltration (Figure 1). Renal biopsy with hematoxylin and eosin staining, immunofluorescence, and electron microscopy demonstrated an immune complex-mediated glomerulonephritis and moderate tubulointerstitial nephritis (Figure 2). A diagnosis of Sjögren’s syndrome was made based on the patient’s xerostomia, high titers of antinuclear antibodies, SSA and SSB antibodies, positive rheumatoid factor, hypocomplementemia, and systemic manifestations associated with Sjögren’s syndrome, including distal RTA, nephrolithiasis, and hives, with histologic evidence of leukocytoclastic vasculitis.

She received aggressive potassium and bicarbonate repletion and, several days later, had normalization of both. Her weakness and myalgia rapidly improved concomitantly with the correction of her hypokalemia. Five days later she was ambulating independently and discharged with potassium citrate and prednisone therapy. She had improved fatigue and rash at a 1-month follow-up with rheumatology. As an outpatient, she was started on azathioprine and slowly tapered off her steroids. Over the next several months, she had normal potassium, bicarbonate, and renal function, although she did require lithotripsy for an obstructive renal stone.

RTA should be considered in the differential diagnosis of an unexplained normal anion gap metabolic acidosis. There are 3 major types of RTAs, with different characteristics. In type 1 (distal) RTA, the primary defect is impaired distal acidification of the urine. Distal RTA commonly presents with hypokalemia, calciuria (often presenting as renal stones), and a positive UAG.¹ In type 2 (proximal) RTA, the primary defect is impaired bicarbonate reabsorption, leading to bicarbonate wasting in the urine. Proximal RTAs can be secondary to an isolated defect in bicarbonate reabsorption or generalized proximal renal tubule dysfunction (Fanconi syndrome).¹ A type 4 RTA is characterized by hypoaldosteronism, presenting usually with a mild nonanion gap metabolic acidosis and hyperkalemia. This patient’s history of renal stones, hypokalemia, and positive UAG supported a type 1 (distal) RTA. Distal RTA is often idiopathic, but initial evaluation should include a review of medications and investigation into an underlying systemic disorder (eg, plasma cell dyscrasia or autoimmune disease). This would include eliciting a possible history of xerostomia and xerophthalmia, together with testing of SSA (Ro) and SSB (La) antibodies, to assess for Sjögren’s syndrome. In addition, checking serum calcium to assess for hyperparathyroidism or familial idiopathic hypercalciuria and a review of medications, such as lithium and amphotericin,¹ may uncover other secondary causes of distal RTA.

While Sjögren’s syndrome primarily affects salivary and lacrimal glands, leading to dry mouth and dry eyes, respectively, extraglandular manifestations are common, with fatigue and arthralgia occurring in half of patients. Extra-glandular involvement also often includes the skin and kidneys but can affect several other organ systems, including the central nervous system, heart, lungs, bone marrow, and lymph nodes.²

There are many cutaneous manifestations of Sjögren’s syndrome.³ Xerosis, or xeroderma, is the most common and is characterized by dry, scaly skin. Cutaneous vasculitis can occur in 10% of patients with Sjögren’s syndrome and often presents with palpable purpura or diffuse urticarial lesions, as in our patient.⁴ Erythematous maculopapules and cryoglobulinemic vasculitis may also occur.⁴ A less common skin manifestation is annular erythema, presenting as an indurated, ring-like lesion.⁵

Chronic tubulointerstitial nephritis is the most common renal manifestation of Sjögren’s syndrome.⁶ This often pre-sents with a mild elevated serum creatinine and a distal RTA, leading to hypokalemia, as in the case discussed. Distal RTA is well described, occurring in one-quarter of patients with Sjögren’s syndrome.⁷ The pathophysiology leading to distal RTA in Sjögren’s syndrome is thought to arise from autoimmune injury to the H(+)-ATPase pump in the renal collecting tubules, leading to decreased distal proton secretion.^8,9 Younger adults with Sjögren’s syndrome, in the third and fourth decades of life, have a predilection to develop tubulointerstitial inflammation, distal RTA, and nephrolithiasis, as in the present case.⁶ Sjögren’s syndrome less commonly presents with membranoproliferative glomerulonephritis or membranous nephropathy.^10,11 Cryoglobulinemia-associated hypocomplementemia and glomerulonephritis may also occur with Sjögren’s syndrome, yet glomerular lesions are less common than is tubulointerstitial inflammation. The patient discussed had proteinuria and evidence of immune complex-mediated glomerulonephritis.

Treatment of sicca symptoms is generally supportive. It includes artificial tears, encouragement of good hydration, salivary stimulants, and maintaining good oral hygiene. Pilocarpine, a cholinergic parasympathomimetic agent, is approved by the Food and Drug Administration to treat dry mouth associated with Sjögren’s syndrome. The treatment of extraglandular manifestations depends on the organ(s) involved. More severe presentations, such as vasculitis and glomerulonephritis, often require immunosuppressive therapy with systemic glucocorticoids, cyclophosphamide, azathioprine, or other immunosuppressive agents,¹² including rituximab. RTA often necessitates treatment with oral bicarbonate and supplemental potassium repletion.

The base rate of disease (ie, prevalence of disease) influences a diagnostician’s pretest probability of a given diagnosis. The discussant briefly considered rare causes of hives (eg, vasculitis) but appropriately fine-tuned their differential for the patient’s hypokalemia and RTA. Once the diagnosis of Sjögren’s syndrome was made with certainty, the clinician was able to revisit the patient’s rash with a new lens. Urticarial vasculitis suddenly became a plausible consideration, despite its rarity (compared to allergic causes of hives) because of the direct link to the underlying autoimmune condition, which affected both the proximal muscles and distal nephrons.

• Evaluation of patients with weakness starts with determining true muscle weakness (ie, pathology involving the brain, spinal cord, peripheral nerve, neuromuscular junction, and/or muscle) from asthenia.
• Distal RTA should be considered in patients with a nonanion gap metabolic acidosis and hypokalemia.
• Sjögren’s syndrome has many extraglandular clinical manifestations, including vasculitis, urticaria, tubulointerstitial renal inflammation, glomerulonephritis, and lymphoma.

Acknowledgment

The authors thank Virgilius Cornea, MD, for his interpretation of the pathologic images.

Disclosure

Dr. Manesh is supported by the Jeremiah A. Barondess Fellowship in the Clinical Transaction of the New York Academy of Medicine, in collaboration with the Accreditation Council for Graduate Medical Education (ACGME). The authors declare no conflicts of interests.