I recently received a group text from a friend voicing her frustration that her neighbor had acquired chickens, and she shared a photo of some roaming freely in the front yard. Naturally, my response was related to the potential infectious disease exposure and infections. Another friend chimed in “fresh eggs, and these are free range chickens. They don’t get sick. ... Many people in my area have chickens.” Unbeknownst to my friends, they had helped me select the ID Consult topic for this month.

Nontyphoidal Salmonella bacteria are associated with a wide spectrum of infections which range from asymptomatic gastrointestinal carriage to bacteremia, meningitis, osteomyelitis, and focal infections. Invasive disease is seen most often in children younger than 5 years of age, persons aged 65 years or older, and individuals with hemoglobinopathies including sickle cell disease and those with immunodeficiencies. Annually, the Centers for Disease Control and Prevention estimates that nontyphoidal salmonellosis is responsible for 1.2 million illnesses, 23,000 hospitalizations, and 450 deaths in the United States. Gastroenteritis is the most common manifestation of the disease and is characterized by abdominal cramps, diarrhea, and fever that develops 12-72 hours after exposure. It is usually self-limited. As previously reported in this column (June, 2017), Salmonella is one of the top two foodborne pathogens in the United States, and most outbreaks have been associated with consumption of contaminated food. But wait, contaminated food is not the only cause of some of our most recent outbreaks.

JasonJiron/Thinkstock

Live poultry-associated salmonellosis (LPAS)

LPAS was first reported in the 1950s. More recent epidemiologic data was published by C. Basler et al. (Emerging Infect Dis. 2016;22[10]:1705-11). LPAS was defined as two or more culture confirmed human Salmonella infections with a combination of epidemiologic, laboratory, or traceback evidence linking illnesses to contact with live poultry. From 1990 to 2014, a total of 53 LPAS outbreaks in the United States were documented and associated with 2,630 illnesses, 387 hospitalizations, and 5 deaths. The median outbreak size involved 26 cases (range, 4-363) and 77% (41 of 53) were multistate. The median age of the patients was 9 years (range, less than 1 to 92 years), and 31% were aged 5 years or younger. Exposure to chicks and ducklings was reported in 85% and 38%, respectively. High-risk practices included keeping poultry inside of the home (46%), snuggling baby birds (49%), and kissing baby birds (13%). The median time from purchase of poultry to onset of illness was 17 days (range, 1-672), and 66% reported onset of illness less than 30 days after purchase. Almost 52% reported owning poultry for less than 1 year.

The number of outbreaks continued to increase. From 1990 to 2005, there were a total of 17 outbreaks, compared with 36 between 2006 and 2014. Historically, outbreaks occurred in children around Easter when brightly colored dyed chicks were purchased. In the above review, 80% of outbreaks began in February, March, or April with an average duration of 4.9 months (range, 1-12).

Salmonella isolates

Backyard flocks and LPAS

More recently outbreaks have been associated with backyard flocks occurring year round and affecting both adults and children in contrast to seasonal peaks. The first multistate backyard flock outbreak was documented in 2007. Currently, the CDC is investigating 10 separate multistate outbreaks that began on Jan. 4, 2017. It involves 48 states, 961 infected individuals, 215 hospitalizations, and 1 death. At least 5 salmonella serotypes have been isolated.

What about the hatcheries?

It’s estimated that 50 million live poultry are sold annually. Birds are shipped within 24 hours after hatching via the U.S. Postal Service in boxes containing up to 100 chicks. Delivery occurs within 72 hours of hatching. Approximately 20 mail order hatcheries provide the majority of poultry sold to the general public. The National Poultry Improvement Plan (NPIP) is a voluntary state and federal testing and certification program whose goal is to eliminate poultry disease from breeder flocks to prevent egg-transmitted and hatchery-disseminated diseases. All hatcheries may participate. They also may participate in the voluntary Salmonella monitoring program. Note participation is not mandatory.

Preventing future outbreaks: patient/parental education is mandatory

1. Make sure your parents know about the association of Salmonella and live poultry. Reinforce these are farm animals, not pets. Purchase birds from hatcheries that participate in NPIP and the Salmonella monitoring programs.

2. Chicks, ducklings, or other live poultry should not be taken to schools, day care facilities, or nursing homes. Poultry should not be allowed in the home or in areas where food or drink is being prepared or consumed.

3. Poultry should not be snuggled, kissed, or allowed to touch one’s mouth. Hand washing with soap and water should occur after touching live poultry or any object touched in areas where they live or roam.

4. Contact with live poultry should be avoided in those at risk for developing serious infections including persons aged 5 years or younger, 65 years or older, immunocompromised individuals, and those with hemoglobinopathies.

5. All equipment used to care for live birds should be washed outdoors. Owners should have designated shoes when caring for poultry which should never be worn inside the home.

Hopefully, the next time you see a patient with fever and diarrhea you will recall this topic and ask about their contact with live poultry.

Additional resources to facilitate discussions can be found at www.cdc.gov/salmonella.

Dr. Word is a pediatric infectious disease specialist and director of the Houston Travel Medicine Clinic. She said she had no relevant financial disclosures. Email her at [email protected].

I recently received a group text from a friend voicing her frustration that her neighbor had acquired chickens, and she shared a photo of some roaming freely in the front yard. Naturally, my response was related to the potential infectious disease exposure and infections. Another friend chimed in “fresh eggs, and these are free range chickens. They don’t get sick. ... Many people in my area have chickens.” Unbeknownst to my friends, they had helped me select the ID Consult topic for this month.

Nontyphoidal Salmonella bacteria are associated with a wide spectrum of infections which range from asymptomatic gastrointestinal carriage to bacteremia, meningitis, osteomyelitis, and focal infections. Invasive disease is seen most often in children younger than 5 years of age, persons aged 65 years or older, and individuals with hemoglobinopathies including sickle cell disease and those with immunodeficiencies. Annually, the Centers for Disease Control and Prevention estimates that nontyphoidal salmonellosis is responsible for 1.2 million illnesses, 23,000 hospitalizations, and 450 deaths in the United States. Gastroenteritis is the most common manifestation of the disease and is characterized by abdominal cramps, diarrhea, and fever that develops 12-72 hours after exposure. It is usually self-limited. As previously reported in this column (June, 2017), Salmonella is one of the top two foodborne pathogens in the United States, and most outbreaks have been associated with consumption of contaminated food. But wait, contaminated food is not the only cause of some of our most recent outbreaks.

JasonJiron/Thinkstock

Live poultry-associated salmonellosis (LPAS)

LPAS was first reported in the 1950s. More recent epidemiologic data was published by C. Basler et al. (Emerging Infect Dis. 2016;22[10]:1705-11). LPAS was defined as two or more culture confirmed human Salmonella infections with a combination of epidemiologic, laboratory, or traceback evidence linking illnesses to contact with live poultry. From 1990 to 2014, a total of 53 LPAS outbreaks in the United States were documented and associated with 2,630 illnesses, 387 hospitalizations, and 5 deaths. The median outbreak size involved 26 cases (range, 4-363) and 77% (41 of 53) were multistate. The median age of the patients was 9 years (range, less than 1 to 92 years), and 31% were aged 5 years or younger. Exposure to chicks and ducklings was reported in 85% and 38%, respectively. High-risk practices included keeping poultry inside of the home (46%), snuggling baby birds (49%), and kissing baby birds (13%). The median time from purchase of poultry to onset of illness was 17 days (range, 1-672), and 66% reported onset of illness less than 30 days after purchase. Almost 52% reported owning poultry for less than 1 year.

The number of outbreaks continued to increase. From 1990 to 2005, there were a total of 17 outbreaks, compared with 36 between 2006 and 2014. Historically, outbreaks occurred in children around Easter when brightly colored dyed chicks were purchased. In the above review, 80% of outbreaks began in February, March, or April with an average duration of 4.9 months (range, 1-12).

Salmonella isolates

Backyard flocks and LPAS

More recently outbreaks have been associated with backyard flocks occurring year round and affecting both adults and children in contrast to seasonal peaks. The first multistate backyard flock outbreak was documented in 2007. Currently, the CDC is investigating 10 separate multistate outbreaks that began on Jan. 4, 2017. It involves 48 states, 961 infected individuals, 215 hospitalizations, and 1 death. At least 5 salmonella serotypes have been isolated.

What about the hatcheries?

It’s estimated that 50 million live poultry are sold annually. Birds are shipped within 24 hours after hatching via the U.S. Postal Service in boxes containing up to 100 chicks. Delivery occurs within 72 hours of hatching. Approximately 20 mail order hatcheries provide the majority of poultry sold to the general public. The National Poultry Improvement Plan (NPIP) is a voluntary state and federal testing and certification program whose goal is to eliminate poultry disease from breeder flocks to prevent egg-transmitted and hatchery-disseminated diseases. All hatcheries may participate. They also may participate in the voluntary Salmonella monitoring program. Note participation is not mandatory.

Preventing future outbreaks: patient/parental education is mandatory

1. Make sure your parents know about the association of Salmonella and live poultry. Reinforce these are farm animals, not pets. Purchase birds from hatcheries that participate in NPIP and the Salmonella monitoring programs.

2. Chicks, ducklings, or other live poultry should not be taken to schools, day care facilities, or nursing homes. Poultry should not be allowed in the home or in areas where food or drink is being prepared or consumed.

3. Poultry should not be snuggled, kissed, or allowed to touch one’s mouth. Hand washing with soap and water should occur after touching live poultry or any object touched in areas where they live or roam.

4. Contact with live poultry should be avoided in those at risk for developing serious infections including persons aged 5 years or younger, 65 years or older, immunocompromised individuals, and those with hemoglobinopathies.

5. All equipment used to care for live birds should be washed outdoors. Owners should have designated shoes when caring for poultry which should never be worn inside the home.

Hopefully, the next time you see a patient with fever and diarrhea you will recall this topic and ask about their contact with live poultry.

Additional resources to facilitate discussions can be found at www.cdc.gov/salmonella.

Dr. Word is a pediatric infectious disease specialist and director of the Houston Travel Medicine Clinic. She said she had no relevant financial disclosures. Email her at [email protected].

I recently received a group text from a friend voicing her frustration that her neighbor had acquired chickens, and she shared a photo of some roaming freely in the front yard. Naturally, my response was related to the potential infectious disease exposure and infections. Another friend chimed in “fresh eggs, and these are free range chickens. They don’t get sick. ... Many people in my area have chickens.” Unbeknownst to my friends, they had helped me select the ID Consult topic for this month.

Nontyphoidal Salmonella bacteria are associated with a wide spectrum of infections which range from asymptomatic gastrointestinal carriage to bacteremia, meningitis, osteomyelitis, and focal infections. Invasive disease is seen most often in children younger than 5 years of age, persons aged 65 years or older, and individuals with hemoglobinopathies including sickle cell disease and those with immunodeficiencies. Annually, the Centers for Disease Control and Prevention estimates that nontyphoidal salmonellosis is responsible for 1.2 million illnesses, 23,000 hospitalizations, and 450 deaths in the United States. Gastroenteritis is the most common manifestation of the disease and is characterized by abdominal cramps, diarrhea, and fever that develops 12-72 hours after exposure. It is usually self-limited. As previously reported in this column (June, 2017), Salmonella is one of the top two foodborne pathogens in the United States, and most outbreaks have been associated with consumption of contaminated food. But wait, contaminated food is not the only cause of some of our most recent outbreaks.

JasonJiron/Thinkstock

Live poultry-associated salmonellosis (LPAS)

LPAS was first reported in the 1950s. More recent epidemiologic data was published by C. Basler et al. (Emerging Infect Dis. 2016;22[10]:1705-11). LPAS was defined as two or more culture confirmed human Salmonella infections with a combination of epidemiologic, laboratory, or traceback evidence linking illnesses to contact with live poultry. From 1990 to 2014, a total of 53 LPAS outbreaks in the United States were documented and associated with 2,630 illnesses, 387 hospitalizations, and 5 deaths. The median outbreak size involved 26 cases (range, 4-363) and 77% (41 of 53) were multistate. The median age of the patients was 9 years (range, less than 1 to 92 years), and 31% were aged 5 years or younger. Exposure to chicks and ducklings was reported in 85% and 38%, respectively. High-risk practices included keeping poultry inside of the home (46%), snuggling baby birds (49%), and kissing baby birds (13%). The median time from purchase of poultry to onset of illness was 17 days (range, 1-672), and 66% reported onset of illness less than 30 days after purchase. Almost 52% reported owning poultry for less than 1 year.

The number of outbreaks continued to increase. From 1990 to 2005, there were a total of 17 outbreaks, compared with 36 between 2006 and 2014. Historically, outbreaks occurred in children around Easter when brightly colored dyed chicks were purchased. In the above review, 80% of outbreaks began in February, March, or April with an average duration of 4.9 months (range, 1-12).

Salmonella isolates

Backyard flocks and LPAS

More recently outbreaks have been associated with backyard flocks occurring year round and affecting both adults and children in contrast to seasonal peaks. The first multistate backyard flock outbreak was documented in 2007. Currently, the CDC is investigating 10 separate multistate outbreaks that began on Jan. 4, 2017. It involves 48 states, 961 infected individuals, 215 hospitalizations, and 1 death. At least 5 salmonella serotypes have been isolated.

What about the hatcheries?

It’s estimated that 50 million live poultry are sold annually. Birds are shipped within 24 hours after hatching via the U.S. Postal Service in boxes containing up to 100 chicks. Delivery occurs within 72 hours of hatching. Approximately 20 mail order hatcheries provide the majority of poultry sold to the general public. The National Poultry Improvement Plan (NPIP) is a voluntary state and federal testing and certification program whose goal is to eliminate poultry disease from breeder flocks to prevent egg-transmitted and hatchery-disseminated diseases. All hatcheries may participate. They also may participate in the voluntary Salmonella monitoring program. Note participation is not mandatory.

Preventing future outbreaks: patient/parental education is mandatory

1. Make sure your parents know about the association of Salmonella and live poultry. Reinforce these are farm animals, not pets. Purchase birds from hatcheries that participate in NPIP and the Salmonella monitoring programs.

2. Chicks, ducklings, or other live poultry should not be taken to schools, day care facilities, or nursing homes. Poultry should not be allowed in the home or in areas where food or drink is being prepared or consumed.

3. Poultry should not be snuggled, kissed, or allowed to touch one’s mouth. Hand washing with soap and water should occur after touching live poultry or any object touched in areas where they live or roam.

4. Contact with live poultry should be avoided in those at risk for developing serious infections including persons aged 5 years or younger, 65 years or older, immunocompromised individuals, and those with hemoglobinopathies.

5. All equipment used to care for live birds should be washed outdoors. Owners should have designated shoes when caring for poultry which should never be worn inside the home.

Hopefully, the next time you see a patient with fever and diarrhea you will recall this topic and ask about their contact with live poultry.

Additional resources to facilitate discussions can be found at www.cdc.gov/salmonella.

Dr. Word is a pediatric infectious disease specialist and director of the Houston Travel Medicine Clinic. She said she had no relevant financial disclosures. Email her at [email protected].

Adjuvant chemotherapy was associated with improved overall survival rates at 3 years in patients who had surgery for gastroesophageal cancer, based on retrospective data from more than 10,000 adults.

Preoperative chemoradiotherapy and resection has shown benefits in patients with gastroesophageal adenocarcinoma, but the potential benefits of adjuvant chemotherapy (AC) after surgery in these patients has not been well studied, wrote Ali A. El Mokdad, MD, of the University of Texas Southwestern Medical Center, Dallas, and his colleagues (JAMA Oncol. 2017 Sep 21. doi: 10.1001/jamaoncol.2017.2805).

The researchers reviewed data from 10,086 patients in the National Cancer Database during 2006-2013. Of these, 814 (8%) received adjuvant chemotherapy after surgery and 9,272 (94%) received no additional intervention beyond postoperative observation. The average age of the patients was 61 years, and 88% were men.

The average survival rates at 3 years after surgery were 40 months for the adjuvant group and 34 months for the observation group (hazard ratio, 0.79). The overall survival rates in the adjuvant group were 94%, 54%, and 38% at 1,3, and 5 years, respectively, compared with rates of 88%, 47%, and 34%, in the observation group.

The findings were limited in part by the retrospective nature of the study, the researchers said. In addition, “the estimated effect of AC on overall survival is subject to selection bias and immortal time bias given that the study was observational,” they noted.

However, the results support the addition of chemotherapy for gastroesophageal surgery patients, and “provide compelling motivation to explore the potential benefit of adjuvant chemotherapy in a randomized clinical trial,” they said. “A two-arm phase 2 trial design using recurrence-free survival as a primary endpoint is an appealing first step,” they added.

The researchers had no financial conflicts to disclose.

Adjuvant chemotherapy was associated with improved overall survival rates at 3 years in patients who had surgery for gastroesophageal cancer, based on retrospective data from more than 10,000 adults.

Preoperative chemoradiotherapy and resection has shown benefits in patients with gastroesophageal adenocarcinoma, but the potential benefits of adjuvant chemotherapy (AC) after surgery in these patients has not been well studied, wrote Ali A. El Mokdad, MD, of the University of Texas Southwestern Medical Center, Dallas, and his colleagues (JAMA Oncol. 2017 Sep 21. doi: 10.1001/jamaoncol.2017.2805).

The researchers reviewed data from 10,086 patients in the National Cancer Database during 2006-2013. Of these, 814 (8%) received adjuvant chemotherapy after surgery and 9,272 (94%) received no additional intervention beyond postoperative observation. The average age of the patients was 61 years, and 88% were men.

The average survival rates at 3 years after surgery were 40 months for the adjuvant group and 34 months for the observation group (hazard ratio, 0.79). The overall survival rates in the adjuvant group were 94%, 54%, and 38% at 1,3, and 5 years, respectively, compared with rates of 88%, 47%, and 34%, in the observation group.

The findings were limited in part by the retrospective nature of the study, the researchers said. In addition, “the estimated effect of AC on overall survival is subject to selection bias and immortal time bias given that the study was observational,” they noted.

However, the results support the addition of chemotherapy for gastroesophageal surgery patients, and “provide compelling motivation to explore the potential benefit of adjuvant chemotherapy in a randomized clinical trial,” they said. “A two-arm phase 2 trial design using recurrence-free survival as a primary endpoint is an appealing first step,” they added.

The researchers had no financial conflicts to disclose.

Adjuvant chemotherapy was associated with improved overall survival rates at 3 years in patients who had surgery for gastroesophageal cancer, based on retrospective data from more than 10,000 adults.

Preoperative chemoradiotherapy and resection has shown benefits in patients with gastroesophageal adenocarcinoma, but the potential benefits of adjuvant chemotherapy (AC) after surgery in these patients has not been well studied, wrote Ali A. El Mokdad, MD, of the University of Texas Southwestern Medical Center, Dallas, and his colleagues (JAMA Oncol. 2017 Sep 21. doi: 10.1001/jamaoncol.2017.2805).

The researchers reviewed data from 10,086 patients in the National Cancer Database during 2006-2013. Of these, 814 (8%) received adjuvant chemotherapy after surgery and 9,272 (94%) received no additional intervention beyond postoperative observation. The average age of the patients was 61 years, and 88% were men.

The average survival rates at 3 years after surgery were 40 months for the adjuvant group and 34 months for the observation group (hazard ratio, 0.79). The overall survival rates in the adjuvant group were 94%, 54%, and 38% at 1,3, and 5 years, respectively, compared with rates of 88%, 47%, and 34%, in the observation group.

The findings were limited in part by the retrospective nature of the study, the researchers said. In addition, “the estimated effect of AC on overall survival is subject to selection bias and immortal time bias given that the study was observational,” they noted.

However, the results support the addition of chemotherapy for gastroesophageal surgery patients, and “provide compelling motivation to explore the potential benefit of adjuvant chemotherapy in a randomized clinical trial,” they said. “A two-arm phase 2 trial design using recurrence-free survival as a primary endpoint is an appealing first step,” they added.

The researchers had no financial conflicts to disclose.

Performance of 6 bedside procedures (paracentesis, thoracentesis, lumbar puncture, arthrocentesis, central venous catheter [CVC] placement, and arterial line placement) are considered core competencies for hospitalists.¹ Yet, the American Board of Internal Medicine (ABIM) no longer requires demonstration of manual competency for bedside procedures, and graduates may enter the workforce with minimal or no experience performing such procedures.² As such, the burden falls on hospital privileging committees to ensure providers have the necessary training and experience to competently perform invasive procedures before granting institutional privileges to perform them.³ Although recommendations for privileging to perform certain surgical procedures have been proposed,^4,5 there are no widely accepted guidelines for initial or ongoing privileging of common invasive bedside procedures performed by hospitalists, and current privileging practices vary significantly.

In 2015, the Society of Hospital Medicine (SHM) set up a Point-of-Care Ultrasound (POCUS) Task Force to draft evidence-based guidelines on the use of ultrasound to perform bedside procedures. The recommendations for certification of competency in ultrasound-guided procedures may guide institutional privileging. The purpose of this study was to better understand current hospital privileging practices for invasive bedside procedures both with and without ultrasound guidance and how current practices are perceived by experts.

Study Design, Setting, and Participants

After approval by the University of Texas Health Science Center at San Antonio Institutional Review Board, we conducted a survey of hospital privileging processes for bedside procedures from a convenience sample of hospitalist procedure experts on the SHM POCUS Task Force. All 21 hospitalists on the task force were invited to participate, including the authors of this article. These hospitalists represent 21 unique institutions, and all have clinical, educational, and/or research expertise in ultrasound-guided bedside procedures.

Survey Design

A 26-question, electronic survey on privileging for bedside procedures was conducted (Appendix A). Twenty questions addressed procedures in general, such as minimum numbers of procedures required and use of simulation. Six questions focused on the use of ultrasound guidance. To provide context, many questions were framed to assess a privileging process being drafted by the task force. Answers were either multiple choice or free text.

Data Collection and Analysis

All members of the task force were invited to complete the survey by e-mail during November 2016. A reminder e-mail was sent on the day after initial distribution. No compensation was offered, and participation was not required. Survey results were compiled electronically through Research Electronic Data Capture, or “REDCap”^TM (Nashville, Tennessee), and data analysis was performed with Stata version 14 (College Station, Texas). Means of current and recommended minimum thresholds were calculated by excluding responses of “I don’t know,” and responses of “no minimum number threshold” were coded as 0.

The survey response rate was 100% (21 of 21). All experts were hospitalists, but 2 also identified themselves as intensivists. Experts practiced in a variety of hospital settings, including private university hospitals (43%), public university hospitals (19%), Veterans Affairs teaching hospitals (14%), community teaching hospitals (14%), and community nonteaching hospitals (10%). Most hospitals (90%) were teaching hospitals for internal medicine trainees. All experts have personally performed bedside procedures on a regular basis, and most (86%) had leadership roles in teaching procedures to students, residents, fellows, physician assistants, nurse practitioners, and/or physicians. Approximately half (57%) were involved in granting privileges for bedside procedures at their institutions.

Our survey identified 3 distinct differences between hospitalist procedure experts’ recommendations and their own hospitals’ current privileging practices. First, whereas experts recommended ultrasound guidance for thoracentesis, paracentesis, and CVC placement, it is rarely a current requirement. Second, experts recommend requiring minimum numbers of procedures for both initial and ongoing privileging even though such minimums are not currently required at half of their hospitals. Third, recommended minimum numbers were generally higher than those currently in place.

The routine use of ultrasound guidance for thoracentesis, paracentesis, and CVC placement is likely a result of increased adoption based on the literature showing clinical benefits.^6-9 Thus, the expert recommendations for required use of ultrasound guidance for these procedures seems both appropriate and feasible. The procedure minimums identified in our study are similar to prior ABIM guidelines when manual competency was required for board certification in internal medicine and are comparable to recent minimums proposed by the Society of Critical Care Medicine, both of which recommended a minimum of 5 to 10 per procedure.^10,11 Nevertheless, no commonly agreed-upon minimum number of procedures currently exists for certification of competency, and the variability seen in the experts’ responses further supports the idea that no specific number will guarantee competence. Thus, while requiring minimum numbers of procedures was generally considered necessary by our experts, minimums alone were also considered insufficient for initial privileging because most recommended that direct observation and simulation should be part of an initial privileging process.

These findings encourage more rigorous requirements for both initial and ongoing privileging of procedures. Nevertheless, our findings were rarely unanimous. The most frequently cited reason for disagreement on our findings was feasibility and capacity for direct observation, and the absence of ultrasound equipment or simulators, particularly in resource-limited clinical environments.

Our study has several strengths and limitations. One strength is the recruitment of study experts specifically composed of hospitalist procedure experts from diverse geographic and hospital settings. Yet, we acknowledge that our findings may not be generalizable to other specialties. Another strength is we obtained 100% participation from the experts surveyed. Weaknesses of this study include the relatively small number of experts who are likely to be biased in favor of both the use of ultrasound guidance and higher standards for privileging. We also relied on self-reported data about privileging processes rather than direct observation of those practices. Finally, questions were framed in the context of only 1 possible privileging pathway, and experts may respond differently to a different framing.

Our findings may guide the development of more standardized frameworks for initial and ongoing privileging of hospitalists for invasive bedside procedures. In particular, additional privileging requirements may include the routine use of ultrasound guidance for paracentesis, thoracentesis, and CVC insertion; simulation preceding direct observation of manual skills if possible; and higher required minimums of procedures for both initial and ongoing privileging. The goal of a standardized framework for privileging should be directed at improving the quality and safety of bedside procedures but must consider feasibility in diverse clinical settings where hospitalists work.

Acknowledgments

The authors thank the hospitalists on the SHM POCUS Task Force who provided data about their institutions’ privileging processes and requirements. They are also grateful to Loretta M. Grikis, MLS, AHIP, at the White River Junction Veterans Affairs Medical Center for her assistance as a medical librarian.

Disclosure

Brian P. Lucas (U.S. Department of Veterans Affairs, Veterans Health Administration, Office of Research and Development, Dartmouth SYNERGY, and the National Institutes of Health National Center for Advancing Translational Sciences [UL1TR001086]). Nilam Soni (U.S. Department of Veterans Affairs and Quality Enhancement Research Initiative Partnered Evaluation Initiative grant [HX002263-01A1]). The contents of this publication do not represent the views of the U.S. Department of Veterans Affairs or the U.S. Government.

Performance of 6 bedside procedures (paracentesis, thoracentesis, lumbar puncture, arthrocentesis, central venous catheter [CVC] placement, and arterial line placement) are considered core competencies for hospitalists.¹ Yet, the American Board of Internal Medicine (ABIM) no longer requires demonstration of manual competency for bedside procedures, and graduates may enter the workforce with minimal or no experience performing such procedures.² As such, the burden falls on hospital privileging committees to ensure providers have the necessary training and experience to competently perform invasive procedures before granting institutional privileges to perform them.³ Although recommendations for privileging to perform certain surgical procedures have been proposed,^4,5 there are no widely accepted guidelines for initial or ongoing privileging of common invasive bedside procedures performed by hospitalists, and current privileging practices vary significantly.

In 2015, the Society of Hospital Medicine (SHM) set up a Point-of-Care Ultrasound (POCUS) Task Force to draft evidence-based guidelines on the use of ultrasound to perform bedside procedures. The recommendations for certification of competency in ultrasound-guided procedures may guide institutional privileging. The purpose of this study was to better understand current hospital privileging practices for invasive bedside procedures both with and without ultrasound guidance and how current practices are perceived by experts.

Study Design, Setting, and Participants

After approval by the University of Texas Health Science Center at San Antonio Institutional Review Board, we conducted a survey of hospital privileging processes for bedside procedures from a convenience sample of hospitalist procedure experts on the SHM POCUS Task Force. All 21 hospitalists on the task force were invited to participate, including the authors of this article. These hospitalists represent 21 unique institutions, and all have clinical, educational, and/or research expertise in ultrasound-guided bedside procedures.

Survey Design

A 26-question, electronic survey on privileging for bedside procedures was conducted (Appendix A). Twenty questions addressed procedures in general, such as minimum numbers of procedures required and use of simulation. Six questions focused on the use of ultrasound guidance. To provide context, many questions were framed to assess a privileging process being drafted by the task force. Answers were either multiple choice or free text.

Data Collection and Analysis

All members of the task force were invited to complete the survey by e-mail during November 2016. A reminder e-mail was sent on the day after initial distribution. No compensation was offered, and participation was not required. Survey results were compiled electronically through Research Electronic Data Capture, or “REDCap”^TM (Nashville, Tennessee), and data analysis was performed with Stata version 14 (College Station, Texas). Means of current and recommended minimum thresholds were calculated by excluding responses of “I don’t know,” and responses of “no minimum number threshold” were coded as 0.

The survey response rate was 100% (21 of 21). All experts were hospitalists, but 2 also identified themselves as intensivists. Experts practiced in a variety of hospital settings, including private university hospitals (43%), public university hospitals (19%), Veterans Affairs teaching hospitals (14%), community teaching hospitals (14%), and community nonteaching hospitals (10%). Most hospitals (90%) were teaching hospitals for internal medicine trainees. All experts have personally performed bedside procedures on a regular basis, and most (86%) had leadership roles in teaching procedures to students, residents, fellows, physician assistants, nurse practitioners, and/or physicians. Approximately half (57%) were involved in granting privileges for bedside procedures at their institutions.

Our survey identified 3 distinct differences between hospitalist procedure experts’ recommendations and their own hospitals’ current privileging practices. First, whereas experts recommended ultrasound guidance for thoracentesis, paracentesis, and CVC placement, it is rarely a current requirement. Second, experts recommend requiring minimum numbers of procedures for both initial and ongoing privileging even though such minimums are not currently required at half of their hospitals. Third, recommended minimum numbers were generally higher than those currently in place.

The routine use of ultrasound guidance for thoracentesis, paracentesis, and CVC placement is likely a result of increased adoption based on the literature showing clinical benefits.^6-9 Thus, the expert recommendations for required use of ultrasound guidance for these procedures seems both appropriate and feasible. The procedure minimums identified in our study are similar to prior ABIM guidelines when manual competency was required for board certification in internal medicine and are comparable to recent minimums proposed by the Society of Critical Care Medicine, both of which recommended a minimum of 5 to 10 per procedure.^10,11 Nevertheless, no commonly agreed-upon minimum number of procedures currently exists for certification of competency, and the variability seen in the experts’ responses further supports the idea that no specific number will guarantee competence. Thus, while requiring minimum numbers of procedures was generally considered necessary by our experts, minimums alone were also considered insufficient for initial privileging because most recommended that direct observation and simulation should be part of an initial privileging process.

These findings encourage more rigorous requirements for both initial and ongoing privileging of procedures. Nevertheless, our findings were rarely unanimous. The most frequently cited reason for disagreement on our findings was feasibility and capacity for direct observation, and the absence of ultrasound equipment or simulators, particularly in resource-limited clinical environments.

Our study has several strengths and limitations. One strength is the recruitment of study experts specifically composed of hospitalist procedure experts from diverse geographic and hospital settings. Yet, we acknowledge that our findings may not be generalizable to other specialties. Another strength is we obtained 100% participation from the experts surveyed. Weaknesses of this study include the relatively small number of experts who are likely to be biased in favor of both the use of ultrasound guidance and higher standards for privileging. We also relied on self-reported data about privileging processes rather than direct observation of those practices. Finally, questions were framed in the context of only 1 possible privileging pathway, and experts may respond differently to a different framing.

Our findings may guide the development of more standardized frameworks for initial and ongoing privileging of hospitalists for invasive bedside procedures. In particular, additional privileging requirements may include the routine use of ultrasound guidance for paracentesis, thoracentesis, and CVC insertion; simulation preceding direct observation of manual skills if possible; and higher required minimums of procedures for both initial and ongoing privileging. The goal of a standardized framework for privileging should be directed at improving the quality and safety of bedside procedures but must consider feasibility in diverse clinical settings where hospitalists work.

Acknowledgments

The authors thank the hospitalists on the SHM POCUS Task Force who provided data about their institutions’ privileging processes and requirements. They are also grateful to Loretta M. Grikis, MLS, AHIP, at the White River Junction Veterans Affairs Medical Center for her assistance as a medical librarian.

Disclosure

Brian P. Lucas (U.S. Department of Veterans Affairs, Veterans Health Administration, Office of Research and Development, Dartmouth SYNERGY, and the National Institutes of Health National Center for Advancing Translational Sciences [UL1TR001086]). Nilam Soni (U.S. Department of Veterans Affairs and Quality Enhancement Research Initiative Partnered Evaluation Initiative grant [HX002263-01A1]). The contents of this publication do not represent the views of the U.S. Department of Veterans Affairs or the U.S. Government.

Performance of 6 bedside procedures (paracentesis, thoracentesis, lumbar puncture, arthrocentesis, central venous catheter [CVC] placement, and arterial line placement) are considered core competencies for hospitalists.¹ Yet, the American Board of Internal Medicine (ABIM) no longer requires demonstration of manual competency for bedside procedures, and graduates may enter the workforce with minimal or no experience performing such procedures.² As such, the burden falls on hospital privileging committees to ensure providers have the necessary training and experience to competently perform invasive procedures before granting institutional privileges to perform them.³ Although recommendations for privileging to perform certain surgical procedures have been proposed,^4,5 there are no widely accepted guidelines for initial or ongoing privileging of common invasive bedside procedures performed by hospitalists, and current privileging practices vary significantly.

In 2015, the Society of Hospital Medicine (SHM) set up a Point-of-Care Ultrasound (POCUS) Task Force to draft evidence-based guidelines on the use of ultrasound to perform bedside procedures. The recommendations for certification of competency in ultrasound-guided procedures may guide institutional privileging. The purpose of this study was to better understand current hospital privileging practices for invasive bedside procedures both with and without ultrasound guidance and how current practices are perceived by experts.

Study Design, Setting, and Participants

After approval by the University of Texas Health Science Center at San Antonio Institutional Review Board, we conducted a survey of hospital privileging processes for bedside procedures from a convenience sample of hospitalist procedure experts on the SHM POCUS Task Force. All 21 hospitalists on the task force were invited to participate, including the authors of this article. These hospitalists represent 21 unique institutions, and all have clinical, educational, and/or research expertise in ultrasound-guided bedside procedures.

Survey Design

A 26-question, electronic survey on privileging for bedside procedures was conducted (Appendix A). Twenty questions addressed procedures in general, such as minimum numbers of procedures required and use of simulation. Six questions focused on the use of ultrasound guidance. To provide context, many questions were framed to assess a privileging process being drafted by the task force. Answers were either multiple choice or free text.

Data Collection and Analysis

All members of the task force were invited to complete the survey by e-mail during November 2016. A reminder e-mail was sent on the day after initial distribution. No compensation was offered, and participation was not required. Survey results were compiled electronically through Research Electronic Data Capture, or “REDCap”^TM (Nashville, Tennessee), and data analysis was performed with Stata version 14 (College Station, Texas). Means of current and recommended minimum thresholds were calculated by excluding responses of “I don’t know,” and responses of “no minimum number threshold” were coded as 0.

The survey response rate was 100% (21 of 21). All experts were hospitalists, but 2 also identified themselves as intensivists. Experts practiced in a variety of hospital settings, including private university hospitals (43%), public university hospitals (19%), Veterans Affairs teaching hospitals (14%), community teaching hospitals (14%), and community nonteaching hospitals (10%). Most hospitals (90%) were teaching hospitals for internal medicine trainees. All experts have personally performed bedside procedures on a regular basis, and most (86%) had leadership roles in teaching procedures to students, residents, fellows, physician assistants, nurse practitioners, and/or physicians. Approximately half (57%) were involved in granting privileges for bedside procedures at their institutions.

Our survey identified 3 distinct differences between hospitalist procedure experts’ recommendations and their own hospitals’ current privileging practices. First, whereas experts recommended ultrasound guidance for thoracentesis, paracentesis, and CVC placement, it is rarely a current requirement. Second, experts recommend requiring minimum numbers of procedures for both initial and ongoing privileging even though such minimums are not currently required at half of their hospitals. Third, recommended minimum numbers were generally higher than those currently in place.

The routine use of ultrasound guidance for thoracentesis, paracentesis, and CVC placement is likely a result of increased adoption based on the literature showing clinical benefits.^6-9 Thus, the expert recommendations for required use of ultrasound guidance for these procedures seems both appropriate and feasible. The procedure minimums identified in our study are similar to prior ABIM guidelines when manual competency was required for board certification in internal medicine and are comparable to recent minimums proposed by the Society of Critical Care Medicine, both of which recommended a minimum of 5 to 10 per procedure.^10,11 Nevertheless, no commonly agreed-upon minimum number of procedures currently exists for certification of competency, and the variability seen in the experts’ responses further supports the idea that no specific number will guarantee competence. Thus, while requiring minimum numbers of procedures was generally considered necessary by our experts, minimums alone were also considered insufficient for initial privileging because most recommended that direct observation and simulation should be part of an initial privileging process.

These findings encourage more rigorous requirements for both initial and ongoing privileging of procedures. Nevertheless, our findings were rarely unanimous. The most frequently cited reason for disagreement on our findings was feasibility and capacity for direct observation, and the absence of ultrasound equipment or simulators, particularly in resource-limited clinical environments.

Our study has several strengths and limitations. One strength is the recruitment of study experts specifically composed of hospitalist procedure experts from diverse geographic and hospital settings. Yet, we acknowledge that our findings may not be generalizable to other specialties. Another strength is we obtained 100% participation from the experts surveyed. Weaknesses of this study include the relatively small number of experts who are likely to be biased in favor of both the use of ultrasound guidance and higher standards for privileging. We also relied on self-reported data about privileging processes rather than direct observation of those practices. Finally, questions were framed in the context of only 1 possible privileging pathway, and experts may respond differently to a different framing.

Our findings may guide the development of more standardized frameworks for initial and ongoing privileging of hospitalists for invasive bedside procedures. In particular, additional privileging requirements may include the routine use of ultrasound guidance for paracentesis, thoracentesis, and CVC insertion; simulation preceding direct observation of manual skills if possible; and higher required minimums of procedures for both initial and ongoing privileging. The goal of a standardized framework for privileging should be directed at improving the quality and safety of bedside procedures but must consider feasibility in diverse clinical settings where hospitalists work.

Acknowledgments

The authors thank the hospitalists on the SHM POCUS Task Force who provided data about their institutions’ privileging processes and requirements. They are also grateful to Loretta M. Grikis, MLS, AHIP, at the White River Junction Veterans Affairs Medical Center for her assistance as a medical librarian.

Disclosure

Brian P. Lucas (U.S. Department of Veterans Affairs, Veterans Health Administration, Office of Research and Development, Dartmouth SYNERGY, and the National Institutes of Health National Center for Advancing Translational Sciences [UL1TR001086]). Nilam Soni (U.S. Department of Veterans Affairs and Quality Enhancement Research Initiative Partnered Evaluation Initiative grant [HX002263-01A1]). The contents of this publication do not represent the views of the U.S. Department of Veterans Affairs or the U.S. Government.

In this issue of the Journal of Hospital Medicine, Ellimoottil and colleagues examine characteristics of readmissions identified as planned by the planned readmission algorithm developed for the Center for Medicare & Medicaid Services (CMS) by using Medicare claims data from 131 hospitals in Michigan.¹ They found that a substantial portion of readmissions currently classified as planned by the algorithm appear to be nonelective, as defined by the presence of a charge by an emergency medicine physician or an admission type of emergent or urgent, making those hospitalizations unlikely to be planned. They suggest that the algorithm could be modified to exclude such cases from the planned designation.

To determine whether modifying the algorithm as recommended is a good idea, it is helpful to examine the origins of the existing planned readmission algorithm. The algorithm originated as a consequence of hospital accountability measures for readmissions and was developed by this author in collaboration with colleagues at Yale University and elsewhere.² Readmission measures have been controversial in part because clearly some (undetermined) fraction of readmissions is unavoidable. Many commentators have asked that readmission measures therefore capture only avoidable or related readmissions. Avoidable readmissions are those that could have been prevented by members of the healthcare system through actions taken during or after hospitalization, such as patient counseling, communication among team members, and guideline-concordant medical care. Related readmissions are those directly stemming from the index admission. However, reliably and accurately defining such events has proven elusive. One study, for instance, found the rate of physician-assessed preventability in published studies ranged from 9% to 48%.³ The challenge is even greater in trying to determine preventability using just claims data, without physician review of charts. Imagine, for instance, a patient with heart failure who is readmitted with heart failure exacerbation. The readmission preceded by a large fast-food meal is likely preventable; although even in this case, some would argue the healthcare system should not be held accountable for a readmission if the patient had been properly counseled about avoiding salty food. The one preceded by progressively worsening systolic function in a patient who reliably takes medications, weighs herself daily, and watches her diet is likely not. But both appear identical in claims. Related is also a difficult concept to operationalize. A recently hospitalized patient readmitted with pneumonia might have acquired it in the hospital (related) or from her grandchild 2 weeks later (unrelated). Again, both appear identical in claims.

In the ideal world, clinicians would be held accountable only for preventable readmissions. In practice, that has not proven to be possible.

Instead, the CMS readmission measures omit readmissions that are thought to be planned in advance: necessary and intentional readmissions. Defining a planned readmission is conceptually easier than defining a preventable readmission, yet even this is not always straightforward. The clearest case might be a person with a longstanding plan to have an elective surgery (say, a hip replacement) who is briefly admitted with something minor enough not to delay a subsequent admission for the scheduled surgery. Other patients are admitted with acute problems that require follow-up hospitalization (for instance, an acute myocardial infarction that requires a coronary artery bypass graft 2 weeks later).⁴ More ambiguous are patients who are sent home on a course of treatment with a plan for rehospitalization if it fails; for instance, a patient with gangrene is sent home on intravenous antibiotics but fails to improve and is rehospitalized for an amputation. Is that readmission planned or unplanned? Reasonable people might disagree.

Nonetheless, assuming it is desirable to at least try to identify and remove planned readmissions from measures, there are a number of ways in which one might do so. Perhaps the simplest would be to classify each hospitalization as planned or not on the UB-04 claim form. Such a process would be very feasible but also subject to gaming or coding variability. Given that there is some ambiguity and no standard about what types of readmissions are planned and that current policy provides incentives to reduce unplanned readmission rates, hospitals might vary in the cases to which they would apply such a code. This approach, therefore, has not been favored by payers to date. An alternative is to prospectively flag admissions that are expected to result in planned readmissions. In fiscal year 2014, the CMS implemented this option for newborns and patients with acute myocardial infarction by creating new discharge status codes of “discharged to [location] with a planned acute care hospital inpatient readmission.” Institutions can flag discharges that they know at the time of discharge will be followed by a readmission, such as a newborn who requires a repeat hospitalization for repair of a congenital anomaly.⁵ There is no time span required for the planned readmission to qualify. However, the difficulty in broadening the applicability of this option to all discharges lies in identification and matching; there also remains a possibility for gaming. The code does not specify when the readmission is expected nor for what diagnosis or procedure. How, then, do we know if the subsequent readmission is the one anticipated? Unexpected readmissions may still occur in the interim. Conversely, what if the discharging clinicians don’t know about an anticipated planned procedure? What would stop hospitals from labeling every discharge as expected to be followed by a planned readmission? These considerations have largely prevented the CMS from asking hospitals to apply the new code widely or from applying the code to identify planned readmissions.

Instead, the existing algorithm attempts to identify procedures that might be done on an elective basis and assumes readmissions with these procedures are planned if paired with a nonurgent diagnosis. Ellimoottil and colleagues attempt to verify whether this is accurate using a creative approach of seeking emergency department (ED) charges and admission type of emergent or urgent, and they found that roughly half of planned readmissions are, in fact, likely unplanned. This figure agrees closely with the original chart review validation of the algorithm. In particular, they found that some procedures, such as percutaneous cardiac interventions, appear to be paired regularly with a nonurgent principal diagnosis, such as coronary artery disease, even when done on an urgent basis.

This validation was performed prior to the availability of version 4.0 of the planned readmission algorithm, which removes several high-frequency procedures from the potentially planned readmission list (including cardiac devices and diagnostic cardiac catheterizations) that were very frequently mischaracterized as planned in the original chart validation.⁶ At least 8 such cases were also identified in this validation according to the table. Therefore, the misclassification rate of the current algorithm version is probably less than that reported in this article. Nonetheless, percutaneous transluminal coronary angioplasty remains on the planned procedure list in version 4.0 and appears to account for a substantial error rate, and it is likely that the authors’ approach would improve the accuracy even of the newer version of the algorithm.

The advantages of the suggested modifications are that they do not require chart review and could be readily adopted by the CMS. Although seeking ED charges for Medicare is somewhat cumbersome in that they are recorded in a different data set than the inpatient hospitalizations, there is no absolute barrier to adding this step to the algorithm, and doing so has substantial face validity. That said, identifying ED visits is not straightforward because nonemergency services can be provided in the ED (ie, critical care or observation care) and because facilities and providers have different billing requirements, producing different estimates depending on the data set used.⁷ Including admission type would be easier, but it would be less conservative and likely less accurate, as this field has not been validated and is not typically audited. Nonetheless, adding the presence of ED charges seems likely to improve the accuracy of the algorithm. As the CMS continues to refine the planned readmission algorithm, these proposed changes would be very reasonable to study with chart validation and, if valid, to consider adopting.

Disclosure 

Dr. Horwitz reports grants from Center for Medicare & Medicaid Services, grants from Agency for Healthcare Research and Quality, during the conduct of the study.

In this issue of the Journal of Hospital Medicine, Ellimoottil and colleagues examine characteristics of readmissions identified as planned by the planned readmission algorithm developed for the Center for Medicare & Medicaid Services (CMS) by using Medicare claims data from 131 hospitals in Michigan.¹ They found that a substantial portion of readmissions currently classified as planned by the algorithm appear to be nonelective, as defined by the presence of a charge by an emergency medicine physician or an admission type of emergent or urgent, making those hospitalizations unlikely to be planned. They suggest that the algorithm could be modified to exclude such cases from the planned designation.

To determine whether modifying the algorithm as recommended is a good idea, it is helpful to examine the origins of the existing planned readmission algorithm. The algorithm originated as a consequence of hospital accountability measures for readmissions and was developed by this author in collaboration with colleagues at Yale University and elsewhere.² Readmission measures have been controversial in part because clearly some (undetermined) fraction of readmissions is unavoidable. Many commentators have asked that readmission measures therefore capture only avoidable or related readmissions. Avoidable readmissions are those that could have been prevented by members of the healthcare system through actions taken during or after hospitalization, such as patient counseling, communication among team members, and guideline-concordant medical care. Related readmissions are those directly stemming from the index admission. However, reliably and accurately defining such events has proven elusive. One study, for instance, found the rate of physician-assessed preventability in published studies ranged from 9% to 48%.³ The challenge is even greater in trying to determine preventability using just claims data, without physician review of charts. Imagine, for instance, a patient with heart failure who is readmitted with heart failure exacerbation. The readmission preceded by a large fast-food meal is likely preventable; although even in this case, some would argue the healthcare system should not be held accountable for a readmission if the patient had been properly counseled about avoiding salty food. The one preceded by progressively worsening systolic function in a patient who reliably takes medications, weighs herself daily, and watches her diet is likely not. But both appear identical in claims. Related is also a difficult concept to operationalize. A recently hospitalized patient readmitted with pneumonia might have acquired it in the hospital (related) or from her grandchild 2 weeks later (unrelated). Again, both appear identical in claims.

In the ideal world, clinicians would be held accountable only for preventable readmissions. In practice, that has not proven to be possible.

Instead, the CMS readmission measures omit readmissions that are thought to be planned in advance: necessary and intentional readmissions. Defining a planned readmission is conceptually easier than defining a preventable readmission, yet even this is not always straightforward. The clearest case might be a person with a longstanding plan to have an elective surgery (say, a hip replacement) who is briefly admitted with something minor enough not to delay a subsequent admission for the scheduled surgery. Other patients are admitted with acute problems that require follow-up hospitalization (for instance, an acute myocardial infarction that requires a coronary artery bypass graft 2 weeks later).⁴ More ambiguous are patients who are sent home on a course of treatment with a plan for rehospitalization if it fails; for instance, a patient with gangrene is sent home on intravenous antibiotics but fails to improve and is rehospitalized for an amputation. Is that readmission planned or unplanned? Reasonable people might disagree.

Nonetheless, assuming it is desirable to at least try to identify and remove planned readmissions from measures, there are a number of ways in which one might do so. Perhaps the simplest would be to classify each hospitalization as planned or not on the UB-04 claim form. Such a process would be very feasible but also subject to gaming or coding variability. Given that there is some ambiguity and no standard about what types of readmissions are planned and that current policy provides incentives to reduce unplanned readmission rates, hospitals might vary in the cases to which they would apply such a code. This approach, therefore, has not been favored by payers to date. An alternative is to prospectively flag admissions that are expected to result in planned readmissions. In fiscal year 2014, the CMS implemented this option for newborns and patients with acute myocardial infarction by creating new discharge status codes of “discharged to [location] with a planned acute care hospital inpatient readmission.” Institutions can flag discharges that they know at the time of discharge will be followed by a readmission, such as a newborn who requires a repeat hospitalization for repair of a congenital anomaly.⁵ There is no time span required for the planned readmission to qualify. However, the difficulty in broadening the applicability of this option to all discharges lies in identification and matching; there also remains a possibility for gaming. The code does not specify when the readmission is expected nor for what diagnosis or procedure. How, then, do we know if the subsequent readmission is the one anticipated? Unexpected readmissions may still occur in the interim. Conversely, what if the discharging clinicians don’t know about an anticipated planned procedure? What would stop hospitals from labeling every discharge as expected to be followed by a planned readmission? These considerations have largely prevented the CMS from asking hospitals to apply the new code widely or from applying the code to identify planned readmissions.

Instead, the existing algorithm attempts to identify procedures that might be done on an elective basis and assumes readmissions with these procedures are planned if paired with a nonurgent diagnosis. Ellimoottil and colleagues attempt to verify whether this is accurate using a creative approach of seeking emergency department (ED) charges and admission type of emergent or urgent, and they found that roughly half of planned readmissions are, in fact, likely unplanned. This figure agrees closely with the original chart review validation of the algorithm. In particular, they found that some procedures, such as percutaneous cardiac interventions, appear to be paired regularly with a nonurgent principal diagnosis, such as coronary artery disease, even when done on an urgent basis.

This validation was performed prior to the availability of version 4.0 of the planned readmission algorithm, which removes several high-frequency procedures from the potentially planned readmission list (including cardiac devices and diagnostic cardiac catheterizations) that were very frequently mischaracterized as planned in the original chart validation.⁶ At least 8 such cases were also identified in this validation according to the table. Therefore, the misclassification rate of the current algorithm version is probably less than that reported in this article. Nonetheless, percutaneous transluminal coronary angioplasty remains on the planned procedure list in version 4.0 and appears to account for a substantial error rate, and it is likely that the authors’ approach would improve the accuracy even of the newer version of the algorithm.

The advantages of the suggested modifications are that they do not require chart review and could be readily adopted by the CMS. Although seeking ED charges for Medicare is somewhat cumbersome in that they are recorded in a different data set than the inpatient hospitalizations, there is no absolute barrier to adding this step to the algorithm, and doing so has substantial face validity. That said, identifying ED visits is not straightforward because nonemergency services can be provided in the ED (ie, critical care or observation care) and because facilities and providers have different billing requirements, producing different estimates depending on the data set used.⁷ Including admission type would be easier, but it would be less conservative and likely less accurate, as this field has not been validated and is not typically audited. Nonetheless, adding the presence of ED charges seems likely to improve the accuracy of the algorithm. As the CMS continues to refine the planned readmission algorithm, these proposed changes would be very reasonable to study with chart validation and, if valid, to consider adopting.

Disclosure 

Dr. Horwitz reports grants from Center for Medicare & Medicaid Services, grants from Agency for Healthcare Research and Quality, during the conduct of the study.

In this issue of the Journal of Hospital Medicine, Ellimoottil and colleagues examine characteristics of readmissions identified as planned by the planned readmission algorithm developed for the Center for Medicare & Medicaid Services (CMS) by using Medicare claims data from 131 hospitals in Michigan.¹ They found that a substantial portion of readmissions currently classified as planned by the algorithm appear to be nonelective, as defined by the presence of a charge by an emergency medicine physician or an admission type of emergent or urgent, making those hospitalizations unlikely to be planned. They suggest that the algorithm could be modified to exclude such cases from the planned designation.

To determine whether modifying the algorithm as recommended is a good idea, it is helpful to examine the origins of the existing planned readmission algorithm. The algorithm originated as a consequence of hospital accountability measures for readmissions and was developed by this author in collaboration with colleagues at Yale University and elsewhere.² Readmission measures have been controversial in part because clearly some (undetermined) fraction of readmissions is unavoidable. Many commentators have asked that readmission measures therefore capture only avoidable or related readmissions. Avoidable readmissions are those that could have been prevented by members of the healthcare system through actions taken during or after hospitalization, such as patient counseling, communication among team members, and guideline-concordant medical care. Related readmissions are those directly stemming from the index admission. However, reliably and accurately defining such events has proven elusive. One study, for instance, found the rate of physician-assessed preventability in published studies ranged from 9% to 48%.³ The challenge is even greater in trying to determine preventability using just claims data, without physician review of charts. Imagine, for instance, a patient with heart failure who is readmitted with heart failure exacerbation. The readmission preceded by a large fast-food meal is likely preventable; although even in this case, some would argue the healthcare system should not be held accountable for a readmission if the patient had been properly counseled about avoiding salty food. The one preceded by progressively worsening systolic function in a patient who reliably takes medications, weighs herself daily, and watches her diet is likely not. But both appear identical in claims. Related is also a difficult concept to operationalize. A recently hospitalized patient readmitted with pneumonia might have acquired it in the hospital (related) or from her grandchild 2 weeks later (unrelated). Again, both appear identical in claims.

In the ideal world, clinicians would be held accountable only for preventable readmissions. In practice, that has not proven to be possible.

Instead, the CMS readmission measures omit readmissions that are thought to be planned in advance: necessary and intentional readmissions. Defining a planned readmission is conceptually easier than defining a preventable readmission, yet even this is not always straightforward. The clearest case might be a person with a longstanding plan to have an elective surgery (say, a hip replacement) who is briefly admitted with something minor enough not to delay a subsequent admission for the scheduled surgery. Other patients are admitted with acute problems that require follow-up hospitalization (for instance, an acute myocardial infarction that requires a coronary artery bypass graft 2 weeks later).⁴ More ambiguous are patients who are sent home on a course of treatment with a plan for rehospitalization if it fails; for instance, a patient with gangrene is sent home on intravenous antibiotics but fails to improve and is rehospitalized for an amputation. Is that readmission planned or unplanned? Reasonable people might disagree.

Nonetheless, assuming it is desirable to at least try to identify and remove planned readmissions from measures, there are a number of ways in which one might do so. Perhaps the simplest would be to classify each hospitalization as planned or not on the UB-04 claim form. Such a process would be very feasible but also subject to gaming or coding variability. Given that there is some ambiguity and no standard about what types of readmissions are planned and that current policy provides incentives to reduce unplanned readmission rates, hospitals might vary in the cases to which they would apply such a code. This approach, therefore, has not been favored by payers to date. An alternative is to prospectively flag admissions that are expected to result in planned readmissions. In fiscal year 2014, the CMS implemented this option for newborns and patients with acute myocardial infarction by creating new discharge status codes of “discharged to [location] with a planned acute care hospital inpatient readmission.” Institutions can flag discharges that they know at the time of discharge will be followed by a readmission, such as a newborn who requires a repeat hospitalization for repair of a congenital anomaly.⁵ There is no time span required for the planned readmission to qualify. However, the difficulty in broadening the applicability of this option to all discharges lies in identification and matching; there also remains a possibility for gaming. The code does not specify when the readmission is expected nor for what diagnosis or procedure. How, then, do we know if the subsequent readmission is the one anticipated? Unexpected readmissions may still occur in the interim. Conversely, what if the discharging clinicians don’t know about an anticipated planned procedure? What would stop hospitals from labeling every discharge as expected to be followed by a planned readmission? These considerations have largely prevented the CMS from asking hospitals to apply the new code widely or from applying the code to identify planned readmissions.

Instead, the existing algorithm attempts to identify procedures that might be done on an elective basis and assumes readmissions with these procedures are planned if paired with a nonurgent diagnosis. Ellimoottil and colleagues attempt to verify whether this is accurate using a creative approach of seeking emergency department (ED) charges and admission type of emergent or urgent, and they found that roughly half of planned readmissions are, in fact, likely unplanned. This figure agrees closely with the original chart review validation of the algorithm. In particular, they found that some procedures, such as percutaneous cardiac interventions, appear to be paired regularly with a nonurgent principal diagnosis, such as coronary artery disease, even when done on an urgent basis.

This validation was performed prior to the availability of version 4.0 of the planned readmission algorithm, which removes several high-frequency procedures from the potentially planned readmission list (including cardiac devices and diagnostic cardiac catheterizations) that were very frequently mischaracterized as planned in the original chart validation.⁶ At least 8 such cases were also identified in this validation according to the table. Therefore, the misclassification rate of the current algorithm version is probably less than that reported in this article. Nonetheless, percutaneous transluminal coronary angioplasty remains on the planned procedure list in version 4.0 and appears to account for a substantial error rate, and it is likely that the authors’ approach would improve the accuracy even of the newer version of the algorithm.

The advantages of the suggested modifications are that they do not require chart review and could be readily adopted by the CMS. Although seeking ED charges for Medicare is somewhat cumbersome in that they are recorded in a different data set than the inpatient hospitalizations, there is no absolute barrier to adding this step to the algorithm, and doing so has substantial face validity. That said, identifying ED visits is not straightforward because nonemergency services can be provided in the ED (ie, critical care or observation care) and because facilities and providers have different billing requirements, producing different estimates depending on the data set used.⁷ Including admission type would be easier, but it would be less conservative and likely less accurate, as this field has not been validated and is not typically audited. Nonetheless, adding the presence of ED charges seems likely to improve the accuracy of the algorithm. As the CMS continues to refine the planned readmission algorithm, these proposed changes would be very reasonable to study with chart validation and, if valid, to consider adopting.

Disclosure 

Dr. Horwitz reports grants from Center for Medicare & Medicaid Services, grants from Agency for Healthcare Research and Quality, during the conduct of the study.

“Unnecessary noise is the most cruel abuse of care which can be inflicted on either the sick or the well.”

–Florence Nightingale¹

Motivated by the “unsustainable” rise in noise pollution and its “direct, as well as cumulative, adverse health effects,” an expert World Health Organization (WHO) task force composed the Guidelines for Community Noise, outlining specific noise recommendations for public settings, including hospitals.² In ward settings, these guidelines mandate that background noise (which is defined as unwanted sound) levels average <35 decibels (dB; ie, a typical library) during the day, average <30 dB at night, and peak no higher than 40 dB (ie, a normal conversation), a level sufficient to awaken someone from sleep.

Since the publication of these guidelines in 1999, substantial new research has added to our understanding of hospital noise levels. Recent research has demonstrated that few, if any, hospitals comply with WHO noise recommendations.³ Moreover, since 1960, hospital sound levels have risen ~4 dB per decade; based on the logarithmic decibel scale, if this trend continues, this translates to a 528% increase in loudness by 2020.³

The overwhelming majority of research on hospital noise has focused on the intensive care unit (ICU), where beeping machines and busy staff often push peak nighttime noise levels over 80 dB (ie, a kitchen blender).⁴ When evaluated during sleep, noise in the ICU causes frequent arousals and awakenings. When noise is combined with other factors, such as bright light and patient care interactions, poor sleep quality invariably results.⁴

While it has been known for years that critically ill patients experience markedly fragmented and nonrestorative sleep,⁵ poor sleep has recently gained attention due to its potential role as a modifiable risk factor for delirium and its associated consequences, including prolonged length of stay and long-lasting neuropsychological and physical impairments.⁶ Due to this interest, numerous interventions have been attempted,⁷ including multicomponent bundles to promote sleep,⁸ which have been shown to reduce delirium in the ICU.^9-12 Therefore, efforts to promote sleep in the ICU, including interventions to minimize nighttime noise, are recommended in Society of Critical Care Medicine clinical practice guidelines¹³ and are listed as a top 5 research priority by an expert panel of ICU delirium researchers.¹⁴

In contrast to the ICU, there has been little attention paid to noise in other patient care areas. Existing studies in non-ICU ward settings suggest that excessive noise is common,³ similar to the ICU, and that patients experience poor sleep, with noise being a significant disruptor of sleep.^5,15,16 Such poor sleep is thought to contribute to uncontrolled pain, labile blood pressure, and dissatisfaction with care.^16,17

In this issue of the Journal of Hospital Medicine, Jaiswal and colleagues¹⁸ report on an important study evaluating sound and light levels in both non-ICU and ICU settings within a busy tertiary-care hospital. In 8 general ward, 8 telemetry, and 8 ICU patient rooms, the investigators used meters to record sound and light levels for 24 to 72 hours. In each of these locations, they detected average hourly sound levels ranging from 45 to 54 dB, 47 to 55 dB, and 56 to 60 dB, respectively, with ICUs consistently registering the highest hourly sound levels. Notably, all locations exceeded WHO noise limits at all hours of the day. As a novel measure, the investigators evaluated sound level changes (SLCs), or the difference between peak and background sound levels, based on research suggesting that dramatic SLCs (≥17.5 dB) are more disruptive than constant loud noise.¹⁹ The authors observed that SLCs ≥17.5 dB occur predominantly during daytime hours and, interestingly, at a similar rate in the wards versus the ICU.

Importantly, the authors do not link their findings with patient sleep or other patient outcomes but instead focus on employing rigorous methods to gather continuous recordings. By measuring light levels, the authors bring attention to an issue often considered less disruptive to sleep than noise.^6,10,20 Similar to prior research,²¹ Jaiswal and colleagues demonstrate low levels of light at night, with no substantial difference between non-ICU and ICU settings. As a key finding, the authors bring attention to low levels of light during daytime hours, particularly in the morning, when levels range from 22 to 101 lux in the wards and 16 to 39 lux in the ICU. While the optimal timing and brightness of light exposure remains unknown, it is well established that ambient light is the most potent cue for circadian rhythms, with levels >100 lux necessary to suppress melatonin, the key hormone involved in circadian entrainment. Hence, the levels of morning light observed in this study were likely insufficient to maintain healthy circadian rhythms. When exposed to abnormal light levels and factors such as noise, stress, and medications, hospitalized patients are at risk for circadian rhythm misalignment, which can disrupt sleep and trigger a complex molecular cascade, leading to end-organ dysfunction including depressed immunity, glucose dysregulation, arrhythmias, and delirium.^22-24

What are the major takeaway messages from this study? First, it confirms that sound levels are not only high in the ICU but also in non-ICU wards. As hospital ratings and reimbursements now rely on favorable patient ratings, future noise-reduction efforts will surely expand more vigorously across patient care areas.²⁵ Second, SLCs and daytime recordings must be included in efforts to understand and improve sleep and circadian rhythms in hospitalized patients. Finally, this study provides a sobering reminder of the challenge of meeting WHO guidelines and facilitating an optimal healing environment for patients. Sadly, hospital sound levels continue to rise, and quiet-time interventions consistently fail to lower noise to levels anywhere near WHO limits.²⁶ Hence, to make any progress, hospitals of the future must entertain novel design modifications (eg, sound-absorbing walls and alternative room layouts), fix common sources of noise pollution (eg, ventilation systems and alarms), and critically evaluate and update interventions aimed at improving sleep and aligning circadian rhythms for hospitalized patients.²⁷

Acknowledgments

B.B.K. is currently supported by a grant through the University of California, Los Angeles Clinical Translational Research Institute and the National Institutes of Health’s National Center for Advancing Translational Sciences (UL1TR000124).

Disclosure

The authors have nothing to disclose.

“Unnecessary noise is the most cruel abuse of care which can be inflicted on either the sick or the well.”

–Florence Nightingale¹

Motivated by the “unsustainable” rise in noise pollution and its “direct, as well as cumulative, adverse health effects,” an expert World Health Organization (WHO) task force composed the Guidelines for Community Noise, outlining specific noise recommendations for public settings, including hospitals.² In ward settings, these guidelines mandate that background noise (which is defined as unwanted sound) levels average <35 decibels (dB; ie, a typical library) during the day, average <30 dB at night, and peak no higher than 40 dB (ie, a normal conversation), a level sufficient to awaken someone from sleep.

Since the publication of these guidelines in 1999, substantial new research has added to our understanding of hospital noise levels. Recent research has demonstrated that few, if any, hospitals comply with WHO noise recommendations.³ Moreover, since 1960, hospital sound levels have risen ~4 dB per decade; based on the logarithmic decibel scale, if this trend continues, this translates to a 528% increase in loudness by 2020.³

The overwhelming majority of research on hospital noise has focused on the intensive care unit (ICU), where beeping machines and busy staff often push peak nighttime noise levels over 80 dB (ie, a kitchen blender).⁴ When evaluated during sleep, noise in the ICU causes frequent arousals and awakenings. When noise is combined with other factors, such as bright light and patient care interactions, poor sleep quality invariably results.⁴

While it has been known for years that critically ill patients experience markedly fragmented and nonrestorative sleep,⁵ poor sleep has recently gained attention due to its potential role as a modifiable risk factor for delirium and its associated consequences, including prolonged length of stay and long-lasting neuropsychological and physical impairments.⁶ Due to this interest, numerous interventions have been attempted,⁷ including multicomponent bundles to promote sleep,⁸ which have been shown to reduce delirium in the ICU.^9-12 Therefore, efforts to promote sleep in the ICU, including interventions to minimize nighttime noise, are recommended in Society of Critical Care Medicine clinical practice guidelines¹³ and are listed as a top 5 research priority by an expert panel of ICU delirium researchers.¹⁴

In contrast to the ICU, there has been little attention paid to noise in other patient care areas. Existing studies in non-ICU ward settings suggest that excessive noise is common,³ similar to the ICU, and that patients experience poor sleep, with noise being a significant disruptor of sleep.^5,15,16 Such poor sleep is thought to contribute to uncontrolled pain, labile blood pressure, and dissatisfaction with care.^16,17

In this issue of the Journal of Hospital Medicine, Jaiswal and colleagues¹⁸ report on an important study evaluating sound and light levels in both non-ICU and ICU settings within a busy tertiary-care hospital. In 8 general ward, 8 telemetry, and 8 ICU patient rooms, the investigators used meters to record sound and light levels for 24 to 72 hours. In each of these locations, they detected average hourly sound levels ranging from 45 to 54 dB, 47 to 55 dB, and 56 to 60 dB, respectively, with ICUs consistently registering the highest hourly sound levels. Notably, all locations exceeded WHO noise limits at all hours of the day. As a novel measure, the investigators evaluated sound level changes (SLCs), or the difference between peak and background sound levels, based on research suggesting that dramatic SLCs (≥17.5 dB) are more disruptive than constant loud noise.¹⁹ The authors observed that SLCs ≥17.5 dB occur predominantly during daytime hours and, interestingly, at a similar rate in the wards versus the ICU.

Importantly, the authors do not link their findings with patient sleep or other patient outcomes but instead focus on employing rigorous methods to gather continuous recordings. By measuring light levels, the authors bring attention to an issue often considered less disruptive to sleep than noise.^6,10,20 Similar to prior research,²¹ Jaiswal and colleagues demonstrate low levels of light at night, with no substantial difference between non-ICU and ICU settings. As a key finding, the authors bring attention to low levels of light during daytime hours, particularly in the morning, when levels range from 22 to 101 lux in the wards and 16 to 39 lux in the ICU. While the optimal timing and brightness of light exposure remains unknown, it is well established that ambient light is the most potent cue for circadian rhythms, with levels >100 lux necessary to suppress melatonin, the key hormone involved in circadian entrainment. Hence, the levels of morning light observed in this study were likely insufficient to maintain healthy circadian rhythms. When exposed to abnormal light levels and factors such as noise, stress, and medications, hospitalized patients are at risk for circadian rhythm misalignment, which can disrupt sleep and trigger a complex molecular cascade, leading to end-organ dysfunction including depressed immunity, glucose dysregulation, arrhythmias, and delirium.^22-24

What are the major takeaway messages from this study? First, it confirms that sound levels are not only high in the ICU but also in non-ICU wards. As hospital ratings and reimbursements now rely on favorable patient ratings, future noise-reduction efforts will surely expand more vigorously across patient care areas.²⁵ Second, SLCs and daytime recordings must be included in efforts to understand and improve sleep and circadian rhythms in hospitalized patients. Finally, this study provides a sobering reminder of the challenge of meeting WHO guidelines and facilitating an optimal healing environment for patients. Sadly, hospital sound levels continue to rise, and quiet-time interventions consistently fail to lower noise to levels anywhere near WHO limits.²⁶ Hence, to make any progress, hospitals of the future must entertain novel design modifications (eg, sound-absorbing walls and alternative room layouts), fix common sources of noise pollution (eg, ventilation systems and alarms), and critically evaluate and update interventions aimed at improving sleep and aligning circadian rhythms for hospitalized patients.²⁷

Acknowledgments

B.B.K. is currently supported by a grant through the University of California, Los Angeles Clinical Translational Research Institute and the National Institutes of Health’s National Center for Advancing Translational Sciences (UL1TR000124).

Disclosure

The authors have nothing to disclose.

“Unnecessary noise is the most cruel abuse of care which can be inflicted on either the sick or the well.”

–Florence Nightingale¹

Motivated by the “unsustainable” rise in noise pollution and its “direct, as well as cumulative, adverse health effects,” an expert World Health Organization (WHO) task force composed the Guidelines for Community Noise, outlining specific noise recommendations for public settings, including hospitals.² In ward settings, these guidelines mandate that background noise (which is defined as unwanted sound) levels average <35 decibels (dB; ie, a typical library) during the day, average <30 dB at night, and peak no higher than 40 dB (ie, a normal conversation), a level sufficient to awaken someone from sleep.

Since the publication of these guidelines in 1999, substantial new research has added to our understanding of hospital noise levels. Recent research has demonstrated that few, if any, hospitals comply with WHO noise recommendations.³ Moreover, since 1960, hospital sound levels have risen ~4 dB per decade; based on the logarithmic decibel scale, if this trend continues, this translates to a 528% increase in loudness by 2020.³

The overwhelming majority of research on hospital noise has focused on the intensive care unit (ICU), where beeping machines and busy staff often push peak nighttime noise levels over 80 dB (ie, a kitchen blender).⁴ When evaluated during sleep, noise in the ICU causes frequent arousals and awakenings. When noise is combined with other factors, such as bright light and patient care interactions, poor sleep quality invariably results.⁴

While it has been known for years that critically ill patients experience markedly fragmented and nonrestorative sleep,⁵ poor sleep has recently gained attention due to its potential role as a modifiable risk factor for delirium and its associated consequences, including prolonged length of stay and long-lasting neuropsychological and physical impairments.⁶ Due to this interest, numerous interventions have been attempted,⁷ including multicomponent bundles to promote sleep,⁸ which have been shown to reduce delirium in the ICU.^9-12 Therefore, efforts to promote sleep in the ICU, including interventions to minimize nighttime noise, are recommended in Society of Critical Care Medicine clinical practice guidelines¹³ and are listed as a top 5 research priority by an expert panel of ICU delirium researchers.¹⁴

In contrast to the ICU, there has been little attention paid to noise in other patient care areas. Existing studies in non-ICU ward settings suggest that excessive noise is common,³ similar to the ICU, and that patients experience poor sleep, with noise being a significant disruptor of sleep.^5,15,16 Such poor sleep is thought to contribute to uncontrolled pain, labile blood pressure, and dissatisfaction with care.^16,17

In this issue of the Journal of Hospital Medicine, Jaiswal and colleagues¹⁸ report on an important study evaluating sound and light levels in both non-ICU and ICU settings within a busy tertiary-care hospital. In 8 general ward, 8 telemetry, and 8 ICU patient rooms, the investigators used meters to record sound and light levels for 24 to 72 hours. In each of these locations, they detected average hourly sound levels ranging from 45 to 54 dB, 47 to 55 dB, and 56 to 60 dB, respectively, with ICUs consistently registering the highest hourly sound levels. Notably, all locations exceeded WHO noise limits at all hours of the day. As a novel measure, the investigators evaluated sound level changes (SLCs), or the difference between peak and background sound levels, based on research suggesting that dramatic SLCs (≥17.5 dB) are more disruptive than constant loud noise.¹⁹ The authors observed that SLCs ≥17.5 dB occur predominantly during daytime hours and, interestingly, at a similar rate in the wards versus the ICU.

Importantly, the authors do not link their findings with patient sleep or other patient outcomes but instead focus on employing rigorous methods to gather continuous recordings. By measuring light levels, the authors bring attention to an issue often considered less disruptive to sleep than noise.^6,10,20 Similar to prior research,²¹ Jaiswal and colleagues demonstrate low levels of light at night, with no substantial difference between non-ICU and ICU settings. As a key finding, the authors bring attention to low levels of light during daytime hours, particularly in the morning, when levels range from 22 to 101 lux in the wards and 16 to 39 lux in the ICU. While the optimal timing and brightness of light exposure remains unknown, it is well established that ambient light is the most potent cue for circadian rhythms, with levels >100 lux necessary to suppress melatonin, the key hormone involved in circadian entrainment. Hence, the levels of morning light observed in this study were likely insufficient to maintain healthy circadian rhythms. When exposed to abnormal light levels and factors such as noise, stress, and medications, hospitalized patients are at risk for circadian rhythm misalignment, which can disrupt sleep and trigger a complex molecular cascade, leading to end-organ dysfunction including depressed immunity, glucose dysregulation, arrhythmias, and delirium.^22-24

What are the major takeaway messages from this study? First, it confirms that sound levels are not only high in the ICU but also in non-ICU wards. As hospital ratings and reimbursements now rely on favorable patient ratings, future noise-reduction efforts will surely expand more vigorously across patient care areas.²⁵ Second, SLCs and daytime recordings must be included in efforts to understand and improve sleep and circadian rhythms in hospitalized patients. Finally, this study provides a sobering reminder of the challenge of meeting WHO guidelines and facilitating an optimal healing environment for patients. Sadly, hospital sound levels continue to rise, and quiet-time interventions consistently fail to lower noise to levels anywhere near WHO limits.²⁶ Hence, to make any progress, hospitals of the future must entertain novel design modifications (eg, sound-absorbing walls and alternative room layouts), fix common sources of noise pollution (eg, ventilation systems and alarms), and critically evaluate and update interventions aimed at improving sleep and aligning circadian rhythms for hospitalized patients.²⁷

Acknowledgments

B.B.K. is currently supported by a grant through the University of California, Los Angeles Clinical Translational Research Institute and the National Institutes of Health’s National Center for Advancing Translational Sciences (UL1TR000124).

Disclosure

The authors have nothing to disclose.

Peripheral intravenous catheters (PIVCs) are the most frequently used vascular access devices (VADs) in all patient populations and practice settings. Because of its invasive nature and the fact that PIVCs are placed and medications are administered directly into the bloodstream, vascular access is risky. There are multiple factors to consider when placing a PIVC, the least of which is determining the most appropriate device for the patient based on the prescribed therapy.

VAD planning and assessment needs to occur at the first patient encounter so that the most appropriate device is selected and it aligns with the duration of the treatment, minimizes the number of unnecessary VADs placed, and preserves veins for any future needs. The level of the clinician’s expertise, coupled with challenging environments of care, add to the complexity of what most perceive to be a “simple” procedure—placing a PIVC. For these reasons, it’s imperative that clinicians are competent in the use and placement of VADs to ensure safe patient care.

Carr and colleagues¹ performed a notable scoping review to determine the existence of tools, clinical prediction rules, and algorithms (TRAs) that would support decision-making for the use of PIVCs and promote first-time insertion success (FTIS). They refined their search strategy to studies that described the use or development of any TRA regarding PIVC insertion in hospitalized adult patients.

The team identified 36 references for screening and based on their inclusion and exclusion criteria, were left with 13 studies in the final review. Inclusion criteria included TRAs for PIVC insertion in hospitalized adult patients using a traditional insertion approach, which was defined as “an assessment and/or insertion with touch and feel, therefore, without vessel locating technology such as ultrasound and/or near infrared technology.” ¹ Of note is that some of the exclusion criteria included pediatric studies, TRAs focused on postinsertion assessment, studies that examined VADs other than PIVCs, and studies in which vascular visualization techniques were used.

In general, the authors were unable to find reported evidence that the study recommendations were adopted in clinical practice or to what degree any TRA had on the success of a PIVC insertion. As a result, they were unable to determine what, if any, clinical value the TRAs had.

The review of the studies, however, identified 3 variables that had an impact on PIVC insertion success: patient, clinician, and product characteristics. Vein characteristics, such as the number, size, and location of veins, and patients’ clinical conditions, such as diabetes, sickle cell anemia, and intravenous drug abuse, were noted as predictors of PIVC insertion success. In 7 papers, the primary focus was on patients with a history of difficult intravenous access (DIVA). The definition of DIVA varied from time to insertion of the PIVC to the number of failed attempts, ranging from 1 to 3 or more attempts.

Clinician variables, such as specialty nurse certification, years of experience, and self-reporting skill level, were associated with successful insertions, and clinicians who predicted FTIS were likely to have FTIS. Product variables included PIVC gauge size and the number of vein options and the relationship with successful first attempts.

Limitations noted by the researchers were a lack of sufficient published evidence for TRAs for PIVC insertion and standardized definitions for DIVA and expert inserters. The number of variables and the dearth of standardized terms may also influence the ability to adopt any TRAs.

While the purpose of the research was to identify TRAs that could guide clinical practice for the use of PIVCs and successful insertions, the authors make an important point that dwell time was not considered. While a TRA may lead to a successful insertion, it may not transcend the intended life of the PIVC or the duration of the therapy. Therefore, TRAs should embed steps that ensure the appropriate device is selected at the start of the patient’s treatment.

The authors identified a need for undertaking and providing research in a critical area of patient care and safety. This article increases awareness of issues related to PIVCs and the impact they have on patient care. FTIS rates vary and the implications of their use are many. Patient satisfaction, no delay in treatment, vein preservation, a decreased risk of complications, and the cost of labor and products are factors to consider. Tools to improve patient outcomes related to device insertion, care, and management need to be developed and validated. The authors also note that future TRAs should integrate the use of ultrasound and vascular visualization technologies.

In a complex, challenging healthcare environment, tools and guidance that enhance practice do not only help clinicians; they have a positive impact on patient care. The need for research, so that gaps in knowledge and science can be bridged, is clear. Gaps must be identified, research conducted, and TRAs developed and adopted to enhance patient outcomes.

Disclosure

The author reports no conflicts of interest.

Peripheral intravenous catheters (PIVCs) are the most frequently used vascular access devices (VADs) in all patient populations and practice settings. Because of its invasive nature and the fact that PIVCs are placed and medications are administered directly into the bloodstream, vascular access is risky. There are multiple factors to consider when placing a PIVC, the least of which is determining the most appropriate device for the patient based on the prescribed therapy.

VAD planning and assessment needs to occur at the first patient encounter so that the most appropriate device is selected and it aligns with the duration of the treatment, minimizes the number of unnecessary VADs placed, and preserves veins for any future needs. The level of the clinician’s expertise, coupled with challenging environments of care, add to the complexity of what most perceive to be a “simple” procedure—placing a PIVC. For these reasons, it’s imperative that clinicians are competent in the use and placement of VADs to ensure safe patient care.

Carr and colleagues¹ performed a notable scoping review to determine the existence of tools, clinical prediction rules, and algorithms (TRAs) that would support decision-making for the use of PIVCs and promote first-time insertion success (FTIS). They refined their search strategy to studies that described the use or development of any TRA regarding PIVC insertion in hospitalized adult patients.

The team identified 36 references for screening and based on their inclusion and exclusion criteria, were left with 13 studies in the final review. Inclusion criteria included TRAs for PIVC insertion in hospitalized adult patients using a traditional insertion approach, which was defined as “an assessment and/or insertion with touch and feel, therefore, without vessel locating technology such as ultrasound and/or near infrared technology.” ¹ Of note is that some of the exclusion criteria included pediatric studies, TRAs focused on postinsertion assessment, studies that examined VADs other than PIVCs, and studies in which vascular visualization techniques were used.

In general, the authors were unable to find reported evidence that the study recommendations were adopted in clinical practice or to what degree any TRA had on the success of a PIVC insertion. As a result, they were unable to determine what, if any, clinical value the TRAs had.

The review of the studies, however, identified 3 variables that had an impact on PIVC insertion success: patient, clinician, and product characteristics. Vein characteristics, such as the number, size, and location of veins, and patients’ clinical conditions, such as diabetes, sickle cell anemia, and intravenous drug abuse, were noted as predictors of PIVC insertion success. In 7 papers, the primary focus was on patients with a history of difficult intravenous access (DIVA). The definition of DIVA varied from time to insertion of the PIVC to the number of failed attempts, ranging from 1 to 3 or more attempts.

Clinician variables, such as specialty nurse certification, years of experience, and self-reporting skill level, were associated with successful insertions, and clinicians who predicted FTIS were likely to have FTIS. Product variables included PIVC gauge size and the number of vein options and the relationship with successful first attempts.

Limitations noted by the researchers were a lack of sufficient published evidence for TRAs for PIVC insertion and standardized definitions for DIVA and expert inserters. The number of variables and the dearth of standardized terms may also influence the ability to adopt any TRAs.

While the purpose of the research was to identify TRAs that could guide clinical practice for the use of PIVCs and successful insertions, the authors make an important point that dwell time was not considered. While a TRA may lead to a successful insertion, it may not transcend the intended life of the PIVC or the duration of the therapy. Therefore, TRAs should embed steps that ensure the appropriate device is selected at the start of the patient’s treatment.

The authors identified a need for undertaking and providing research in a critical area of patient care and safety. This article increases awareness of issues related to PIVCs and the impact they have on patient care. FTIS rates vary and the implications of their use are many. Patient satisfaction, no delay in treatment, vein preservation, a decreased risk of complications, and the cost of labor and products are factors to consider. Tools to improve patient outcomes related to device insertion, care, and management need to be developed and validated. The authors also note that future TRAs should integrate the use of ultrasound and vascular visualization technologies.

In a complex, challenging healthcare environment, tools and guidance that enhance practice do not only help clinicians; they have a positive impact on patient care. The need for research, so that gaps in knowledge and science can be bridged, is clear. Gaps must be identified, research conducted, and TRAs developed and adopted to enhance patient outcomes.

Disclosure

The author reports no conflicts of interest.

Peripheral intravenous catheters (PIVCs) are the most frequently used vascular access devices (VADs) in all patient populations and practice settings. Because of its invasive nature and the fact that PIVCs are placed and medications are administered directly into the bloodstream, vascular access is risky. There are multiple factors to consider when placing a PIVC, the least of which is determining the most appropriate device for the patient based on the prescribed therapy.

VAD planning and assessment needs to occur at the first patient encounter so that the most appropriate device is selected and it aligns with the duration of the treatment, minimizes the number of unnecessary VADs placed, and preserves veins for any future needs. The level of the clinician’s expertise, coupled with challenging environments of care, add to the complexity of what most perceive to be a “simple” procedure—placing a PIVC. For these reasons, it’s imperative that clinicians are competent in the use and placement of VADs to ensure safe patient care.

Carr and colleagues¹ performed a notable scoping review to determine the existence of tools, clinical prediction rules, and algorithms (TRAs) that would support decision-making for the use of PIVCs and promote first-time insertion success (FTIS). They refined their search strategy to studies that described the use or development of any TRA regarding PIVC insertion in hospitalized adult patients.

The team identified 36 references for screening and based on their inclusion and exclusion criteria, were left with 13 studies in the final review. Inclusion criteria included TRAs for PIVC insertion in hospitalized adult patients using a traditional insertion approach, which was defined as “an assessment and/or insertion with touch and feel, therefore, without vessel locating technology such as ultrasound and/or near infrared technology.” ¹ Of note is that some of the exclusion criteria included pediatric studies, TRAs focused on postinsertion assessment, studies that examined VADs other than PIVCs, and studies in which vascular visualization techniques were used.

In general, the authors were unable to find reported evidence that the study recommendations were adopted in clinical practice or to what degree any TRA had on the success of a PIVC insertion. As a result, they were unable to determine what, if any, clinical value the TRAs had.

The review of the studies, however, identified 3 variables that had an impact on PIVC insertion success: patient, clinician, and product characteristics. Vein characteristics, such as the number, size, and location of veins, and patients’ clinical conditions, such as diabetes, sickle cell anemia, and intravenous drug abuse, were noted as predictors of PIVC insertion success. In 7 papers, the primary focus was on patients with a history of difficult intravenous access (DIVA). The definition of DIVA varied from time to insertion of the PIVC to the number of failed attempts, ranging from 1 to 3 or more attempts.

Clinician variables, such as specialty nurse certification, years of experience, and self-reporting skill level, were associated with successful insertions, and clinicians who predicted FTIS were likely to have FTIS. Product variables included PIVC gauge size and the number of vein options and the relationship with successful first attempts.

Limitations noted by the researchers were a lack of sufficient published evidence for TRAs for PIVC insertion and standardized definitions for DIVA and expert inserters. The number of variables and the dearth of standardized terms may also influence the ability to adopt any TRAs.

While the purpose of the research was to identify TRAs that could guide clinical practice for the use of PIVCs and successful insertions, the authors make an important point that dwell time was not considered. While a TRA may lead to a successful insertion, it may not transcend the intended life of the PIVC or the duration of the therapy. Therefore, TRAs should embed steps that ensure the appropriate device is selected at the start of the patient’s treatment.

The authors identified a need for undertaking and providing research in a critical area of patient care and safety. This article increases awareness of issues related to PIVCs and the impact they have on patient care. FTIS rates vary and the implications of their use are many. Patient satisfaction, no delay in treatment, vein preservation, a decreased risk of complications, and the cost of labor and products are factors to consider. Tools to improve patient outcomes related to device insertion, care, and management need to be developed and validated. The authors also note that future TRAs should integrate the use of ultrasound and vascular visualization technologies.

In a complex, challenging healthcare environment, tools and guidance that enhance practice do not only help clinicians; they have a positive impact on patient care. The need for research, so that gaps in knowledge and science can be bridged, is clear. Gaps must be identified, research conducted, and TRAs developed and adopted to enhance patient outcomes.

Disclosure

The author reports no conflicts of interest.

Up to a billion peripheral intravenous catheters (PIVCs) are inserted annually; therefore, the importance of this invasive device in modern medicine cannot be argued.¹ The insertion of a PIVC is a clinical procedure undertaken by a range of clinical staff and in a variety of patient populations and settings. In many clinical environments (for example, the emergency department [ED]), PIVCs are the predominant first-choice vascular access device (VAD).^2,3 Researchers in one study estimated over 25 million PIVCs are used in French EDs each year,³ and intravenous therapy is the leading ED treatment in the United States.⁴

First-time insertion success (FTIS) for PIVCs has been reported at 18% to 98% in adult populations.^5,6 The variability of FTIS likely reflects not just a variety of clinician groups and patient populations but also the absence of uniform approaches to PIVC insertion. Terms frequently used to describe or formalize a pattern of care or a clinical procedure include the following: diagnostic and prognostic tools and/or plans, frameworks, predictive assessment tools, prediction models, rules, decision-making rules, scores, scales, risk factors, risk algorithms, and algorithms.^7-12 In this paper, we use the terms tools, clinical prediction rules, and algorithms (TRAs) to review such frameworks that have been reported in the context of promoting FTIS for PIVCs.

The purpose of this systematic scoping review was to investigate what PIVC decision-making approaches exist to facilitate FTIS of PIVCs in adult hospitalized patients. Our intention was to systematically synthesize the research on TRAs, to review significant associations identified with these TRAs, and to critique TRA validity and reliability.

Scoping Review

We selected a scoping review method that, by definition, maps the evidence to identify gaps,^13,14 set research agendas, and identify implications for decision making. This allowed a targeted approach to answering our 3 research questions:

• What published clinical TRAs exist to facilitate PIVC insertion in adults?
• What clinical, patient and/or product variables have been identified using TRAs as having significant associations with FTIS for PIVCs in adult patients?
• What is the reported reliability, validity, responsiveness, clinical feasibility, and utility of existing TRAs for PIVC insertion in adults?

Our aim was to identify the amount, variety and essential qualities of TRA literature rather than to critically appraise and evaluate the effectiveness of TRAs, a process reserved for systematic review and meta-analysis of interventional studies.^13,14 We followed scoping review guidelines published by members and collaborators of the Joanna Briggs Institute, an internationally recognized leader in research synthesis, evidence use, and implementation. The guidance is based on 5 steps: (i) scoping review objective and question, (ii) background of the topic to support scoping review, (iii) study selection, (iv) charting the results, and (v) collating and summarizing results.¹⁵ Clinicometric assessment of a TRA or any clinical prediction rule requires 4 specific phases: (i) development (identification of predictors from data), (ii) validation (testing the rule in a separate population for reliability), (iii) impact analysis or responsiveness (How clinically useful is the rule in the clinical setting? Is it resource heavy or light? Is it cost effective?), and (iv) implementation and adoption (uptake into clinical practice).¹⁶

Search Strategy

We included studies that described the use or development of any TRA regarding PIVC insertion in the adult hospitalized population.

Inclusion Criteria

Studies were included if they were published in the English Language, included TRAs for PIVC insertion in adult hospital patients, and prospectively assessed a clinical category of patient for PIVC insertion using a traditional approach. We defined a traditional PIVC insertion approach as an assessment and/or insertion with touch and feel, therefore, without vessel-locating technology such as ultrasound and/or near infrared technology.

Exclusion Criteria

Exclusion criteria included pediatric studies, authors’ personal (nonresearch) experience of tools, TRAs focused on postinsertion assessment of the cannula (such as phlebitis, infiltration, and/or dressing failure), and papers with a focus on VADs other than PIVCs. We excluded studies using PIVC ultrasound and/or near infrared technology because these are not standard in all insertions and greatly change the information available for pre-insertion assessment as well as the likelihood of insertion success.

In June 2016, a systematic search of the Cochrane library, Ovid Medline® In-process & Other Non-Indexed Citations and Ovid MEDLINE(R) <1946 to Present>, EBSCO CINAHL databases, and Google Scholar with specific keywords to identify publications that identified or defined TRAs was undertaken. Medical subject headings were created with assistance from a research librarian using tailored functions within individual databases. With key search terms, we limited studies to those related to our inclusion criteria. See Appendix 1 for our search strategy for Medline and CINAHL.

We used Covidence, a web-based application specifically designed for systematic reviews to screen and evaluate eligible publications.¹⁷ Two authors (PJC and NSH) screened the initial retrieved searches based upon the predetermined inclusion and exclusion criteria.

Data Extraction

A paper template was developed and used by 2 reviewers (P.J.C. and N.S.H.). Data included the following: study sample, aim(s), design, setting and country in which the study took place, clinical and patient variables, and how the TRAs were developed and tested. Studies were categorized by TRA type. We also sought to identify if clinical trial registration (where appropriate) was evidenced, in addition to evidence of protocol publication and what standardized reporting guidelines were used (such as those outlined by the EQUATOR Network).¹⁸

Data Synthesis

Formal meta-analysis was beyond the scope and intention of this review. However, we provide the FTIS rate and the ranges of odds ratios (ORs) with 95% confidence intervals (CIs) for certain independent predictors.

Thirty-six references were imported for screening against title and abstract content, with 11 studies excluded and 25 studies assessed for full-text eligibility (see Figure, PRISMA Flowchart). We then excluded a further 12 studies (6 did not meet inclusion criteria, 2 were focused on the prehospital setting, 2 were personal correspondence and focused on another type of VAD, 1 was a protocol to establish a TRA, and 1 was a framework for all device types), leaving 13 studies included in the final review (see Figure). These studies presented data on 4 tools,^19-22 4 predictive models^3,23-25 (of which 3 present receiver operating characteristic/area under the curve scores),^3,23,24 2 framed as risk factor studies,^26,27 and 1 of each of the following: a scale,²⁸ a score,²⁹ and an estimation of the incidence report rate (Table 1).³⁰ Seven studies had “difficult” or “difficulty” in their title as a term to use to describe insertion failure.^{3,19,24-27,30} One study was titled exclusively for the nursing profession,²⁰ 5 studies were reported in medical journals,^{3,24,26,29,30} and 6 were reported in nursing journals,^19-22,25,27 with the remainder published in a vascular access journal.^23,28

General Characteristics of Included Studies

One TRA which was registered as a clinical trial²⁴ involved a standardized reporting tool as is recommended by the EQUATOR Network.¹⁸

Nine of the 13 papers reported that TRA components were chosen based on identified predictors of successful insertion from observational data^{3,19,23-28,30}, with 5 papers using multivariate logistic regression to identify independent predictors.^3,23,24,26,2 At least 4330 insertion attempts on patients were reported. Seven papers reported FTIS, which ranged from 61%-90%.^3,23-27,30

Two clinical settings accounted for 10 of the 13 included studies. We identified 5 papers from the ED setting^{3,23,26,29,30} and 5 studies specific to cancer settings.^19-22,28 Two ED papers identified clinical predictors of insertion difficulty, with 1 identifying an existing medical diagnosis (such as sickle cell disease, diabetes, or intravenous drug abuse) and the other reporting a pragmatic patient self-report of difficulty.^26,30 Three studies focused on patient-exclusive variables (such as vein characteristics)^19,21,28 and some with a combined clinician and patient focus.^{3,23-25,27,30}Relatively few studies reported interobserver measurements to describe the reliability of clinical assessments made.^3,19,21,28 Webster et al. in Australia assessed interrater reliability of a vein assessment tool (VAT) and found high agreement (kappa 0.83 for medical imaging nurses and 0.93 for oncology nurses).²¹ Wells compared reliability with Altman’s K scores obtained from a different VAT when compared with the Deciding on Intravenous Access tool and found good agreement.²² Vein deterioration was proposed as a variable for inclusion when developing an assessment tool within an oncological context.³¹ In Spain, de la Torre and colleagues²⁸ demonstrated good interrater agreement (with kappa, 0.77) for the Venous International Assessment (VIA) tool. The VIA offers a grading system scale to predict the patient’s declining vessel size while undergoing chemotherapy via peripheral veins with PIVCs. Grade I suggests little or no insertion failure, whereas a Grade V should predict insertion failure.

Patient Variables

Vein characteristics were significant independent factors associated with insertion success in a number of studies.^{3,19,23,24,27,28} These included the number of veins, descriptive quality (eg, small, medium, large), size, location, visible veins, and palpable veins. Other factors appear to be patient specific (such as chronic conditions), including diabetes (OR, 2.1 [adjusted to identify demographic risk factors]; 95% CI, 1.3-3.4), sickle cell disease (OR, 3.5; 95% CI, 1.4-4.8), and intravenous drug abuse (OR, 2.4; 95% CI, 1.1-5.3).²⁶ It is unclear if a consistent relationship between weight classification and insertion outcomes exists. Despite a finding that BMI was not independently associated with insertion difficulty,²⁶ one study reports that BMI was independently associated with insertion failure (BMI <18.5 [OR, 2.24; 95% CI, 1.07-4.67], BMI >30 [OR, 1.98; 95% CI, 1.9-3.60])³ and another reports emaciated patients were associated with greater failure when compared to normal weight patients (OR, 0.07; 95% CI, 0.02-0.34).²³ Consequently, extremes of BMI appear to be associated with insertion outcomes despite 1 study reporting no significant association with BMI as an independent factor of insertion failure.²⁶ A history of difficult intravenous access (DIVA) was reported in 1 study and independently associated with insertion failure (OR, 3.86; 95% CI, 2.39-6.25; see Table 2). DIVA appears to be the motivating factor in the title of 7 studies. When defined, the definitions of DIVA are heterogeneous and varied and include the following: >1 minute to insert a PIVC and requiring >1 attempt²⁷; 2 failed attempts³⁰; 3 or more PIVC attempts.²⁶ In the remaining 4 studies, variables associated with difficulty are identified and, therefore, TRAs to target those in future with predicted difficulty prior to any attempts are proposed.^3,19,24,25

Clinician Variables

Specialist nurse certification, years of experience, and self-report skill level (P < 0.001) appear to be significantly associated with successful insertions.²⁵ This is in part validated in another study reporting greater procedural inserting PIVCs as an independent predictor of success (OR, 4.404; 95% CI, 1.61-12-06; see Table 2).²³ Two studies involved simple pragmatic percentage cut offs for PIVCs: likelihood of use²⁹ and likelihood of insertion success.²³ One paper using a cross-sectional design that surveyed ED clinicians suggested if the clinician’s predicted likelihood of the patient needing a PIVC was >80%, this was a reasonable trigger for PIVC insertion.²⁹ The other, in a self-report cohort study, reported that a clinician’s likelihood estimation of PIVC FTIS prior to insertion is independently associated with FTIS (OR, 1.06; 95% CI, 1.04-1.07).²³

Product Variables

In this review, higher failure rates were identified in smaller sizes (22-24 g).²⁶ One study revealed gauge size was significantly associated with a failed first attempt in a univariate analysis (OR, 0.44; 95% CI, 0.34-0.58), but this was not retained in a multivariate model.²⁴ Matching the PIVC size with vein assessment is considered in the VIA tool.²⁸ It suggests a large PIVC (18 g) can be considered in patients with at least 6 vein options; smaller PIVCs of 22 to 24 g are recommended when 3 or fewer veins are found.²⁸ One paper describes a greater proportion of success between PIVC brands.²⁵

The published evidence for TRAs for PIVCs is limited, with few studies using 2 or more reliability, validity, responsiveness, clinical feasibility, or utility measurements in their development. There is a clear need to assess the clinical utility and clinical feasibility of these approaches so they can be externally validated prior to clinical adoption.¹⁶ For this reason, a validated TRA is likely required but must be appropriate for the capability of the healthcare services to use it. We suggest the consistent absence of all of these phases is owing to the variety of healthcare practitioners who are responsible for the insertion, the care and surveillance of peripheral cannulae, and the fragmentation of clinical approaches that exist.³²

Previously, a comprehensive systematic review on the subject of PIVCs found that the presence of a visible and/or palpable vein is usually associated with FTIS.³³ This current review found evidence of simple scores or cutoff percentage estimates in 2 TRA reports to predict either appropriate PIVC insertion or FTIS.^23,29 If such methods are supported by future experimental trials, then such simple approaches could initiate huge clinical return, particularly given that idle or unused PIVCs are of substantial clinical concern.^34-36 PIVCs transcend a variety of clinical environments with excessive use identified in the ED, where it may be performed for blood sampling alone and, hence, are labeled as “just in case” PIVCs and contribute to the term “idle PIVC.”^23,34 Therefore, a clinical indication to perform PIVC insertion in the first instance must be embedded into any TRA; for example, clinical deterioration is likely and the risks are outweighed by benefit, intravenous fluids and/or medicines are required, and/or diagnostic or clinical procedures are requested (such as contrast scans or procedural sedation).

In the majority of papers reviewed, researchers described how to categorize patients into levels of anticipated and predicted difficulty, but none offered corresponding detailed recommendations for strategies to increase insertion success, such as insertion with ultrasound or vascular access expert. Hypothetically, adopting a TRA may assist with the early identification of difficult to cannulate patients who may require a more expert vascular access clinician. However, in this review, we identify that a uniform definition for DIVA is lacking. Both Webster et al.²¹ and Wells²² suggest that an expert inserter is required if difficult access is identified by their tools, but there is no clear description of the qualities of an expert inserter in the literature.³⁷ Recently, consensus recommendations for the definition of vascular access specialist add to discussions about defining vascular access as an interdisciplinary specialist role.³⁸ This is supported by other publications that highlight the association between PIVC procedural experience and increased insertion success.^6,23,39-41With regards to products, PIVC gauge size may or may not be significantly associated with insertion success. For identifying a relationship of PIVC gauge with vein quality, both the vein diameter and description will help with the clinical interpretation of results. For example, it may be the case that bigger veins are easier to insert a PIVC and, thus, larger PIVCs are inserted. The opposite can occur when the veins are small and poorly visualized; hence, one may select a small gauge catheter. This argument is supported by Prottengeier et al.⁴² in a prehospital study that excluded PIVC size in a multivariate analysis because of confounding. However, gauge size is very likely to influence postinsertion complications. Prospective studies are contradictory and suggest 16 to 18 g PIVCs are more likely to contribute to superficial thrombus,⁴³ phlebitis, and, thus, device failure, in contrast to others reporting more frequent dislodgement with smaller 22 g PIVCs.^6,44Finally, the studies included did not assess survival times of the inserted PIVCs, given postinsertion failure in the hospitalized patient is prevalent⁴⁵ and, importantly, modifiable.⁴⁶ A TRA may yield initial insertion success, but if postinsertion the PIVC fails because of a modifiable reason that the TRA has not acknowledged, then it may be of negligible overall benefit. Therefore, TRAs for PIVC insertion need calibration, further development, and ongoing refinement prior to external validation testing.²⁴ Future research should also examine the role of TRAs in settings where ultrasound or other insertion technology is routinely used.

This review identifies a clinically significant gap in vascular access science. The findings of this review support recent work on vessel health and preservation^47-49 and appropriate device insertion.⁵⁰ It also points to the need for further research on the development and testing of an appropriate clinical TRA to improve vascular access outcomes in clinical practice.

Acknowledgments

The authors thank Ms. Kylie Black and Mr. Simon Lewis, who are medical research librarians at The University of Western Australia.

Disclosure

 Mr. Carr has received “speakers bureau” payment form CareFusion in 2013 and Becton Dickinson (BD) in 2014 for lectures on the subject of vascular access. He received a grant from CareFusion (facilitated by his institution at the time) to attend a scientific meeting on vascular access in the USA in 2012. Griffith University has received unrestricted investigator initiated research or educational grants on Marie Cooke’s behalf from product manufacturers: Baxter; Becton, Dickinson and Company; Centurion Medical Products and Entrotech Lifesciences. Griffith University has received unrestricted investigator initiated research or educational grants on Claire M. Rickard’s behalf from product manufacturers: 3M; Adhezion Biomedical, AngioDynamics; Bard, Baxter; B.Braun; Becton, Dickinson and Company; Centurion Medical Products; Cook Medical; Entrotech, Flomedical; ICU Medical; Medtronic; Smiths Medical, Teleflex. Griffith University has received consultancy payments on Claire M. Rickard’s behalf from product manufacturers: 3M, Bard; BBraun, BD, ResQDevices, Smiths Medical. Dr. Higgins and Dr. Rippey have nothing to disclose. All of the aforementioned have not biased or influenced this review.

All authors have made substantial contributions with this review. Each author has contributed to drafting and editing the manuscript and approves the final version for publishing.

Up to a billion peripheral intravenous catheters (PIVCs) are inserted annually; therefore, the importance of this invasive device in modern medicine cannot be argued.¹ The insertion of a PIVC is a clinical procedure undertaken by a range of clinical staff and in a variety of patient populations and settings. In many clinical environments (for example, the emergency department [ED]), PIVCs are the predominant first-choice vascular access device (VAD).^2,3 Researchers in one study estimated over 25 million PIVCs are used in French EDs each year,³ and intravenous therapy is the leading ED treatment in the United States.⁴

First-time insertion success (FTIS) for PIVCs has been reported at 18% to 98% in adult populations.^5,6 The variability of FTIS likely reflects not just a variety of clinician groups and patient populations but also the absence of uniform approaches to PIVC insertion. Terms frequently used to describe or formalize a pattern of care or a clinical procedure include the following: diagnostic and prognostic tools and/or plans, frameworks, predictive assessment tools, prediction models, rules, decision-making rules, scores, scales, risk factors, risk algorithms, and algorithms.^7-12 In this paper, we use the terms tools, clinical prediction rules, and algorithms (TRAs) to review such frameworks that have been reported in the context of promoting FTIS for PIVCs.

The purpose of this systematic scoping review was to investigate what PIVC decision-making approaches exist to facilitate FTIS of PIVCs in adult hospitalized patients. Our intention was to systematically synthesize the research on TRAs, to review significant associations identified with these TRAs, and to critique TRA validity and reliability.

Scoping Review

We selected a scoping review method that, by definition, maps the evidence to identify gaps,^13,14 set research agendas, and identify implications for decision making. This allowed a targeted approach to answering our 3 research questions:

• What published clinical TRAs exist to facilitate PIVC insertion in adults?
• What clinical, patient and/or product variables have been identified using TRAs as having significant associations with FTIS for PIVCs in adult patients?
• What is the reported reliability, validity, responsiveness, clinical feasibility, and utility of existing TRAs for PIVC insertion in adults?

Our aim was to identify the amount, variety and essential qualities of TRA literature rather than to critically appraise and evaluate the effectiveness of TRAs, a process reserved for systematic review and meta-analysis of interventional studies.^13,14 We followed scoping review guidelines published by members and collaborators of the Joanna Briggs Institute, an internationally recognized leader in research synthesis, evidence use, and implementation. The guidance is based on 5 steps: (i) scoping review objective and question, (ii) background of the topic to support scoping review, (iii) study selection, (iv) charting the results, and (v) collating and summarizing results.¹⁵ Clinicometric assessment of a TRA or any clinical prediction rule requires 4 specific phases: (i) development (identification of predictors from data), (ii) validation (testing the rule in a separate population for reliability), (iii) impact analysis or responsiveness (How clinically useful is the rule in the clinical setting? Is it resource heavy or light? Is it cost effective?), and (iv) implementation and adoption (uptake into clinical practice).¹⁶

Search Strategy

We included studies that described the use or development of any TRA regarding PIVC insertion in the adult hospitalized population.

Inclusion Criteria

Studies were included if they were published in the English Language, included TRAs for PIVC insertion in adult hospital patients, and prospectively assessed a clinical category of patient for PIVC insertion using a traditional approach. We defined a traditional PIVC insertion approach as an assessment and/or insertion with touch and feel, therefore, without vessel-locating technology such as ultrasound and/or near infrared technology.

Exclusion Criteria

Exclusion criteria included pediatric studies, authors’ personal (nonresearch) experience of tools, TRAs focused on postinsertion assessment of the cannula (such as phlebitis, infiltration, and/or dressing failure), and papers with a focus on VADs other than PIVCs. We excluded studies using PIVC ultrasound and/or near infrared technology because these are not standard in all insertions and greatly change the information available for pre-insertion assessment as well as the likelihood of insertion success.

In June 2016, a systematic search of the Cochrane library, Ovid Medline® In-process & Other Non-Indexed Citations and Ovid MEDLINE(R) <1946 to Present>, EBSCO CINAHL databases, and Google Scholar with specific keywords to identify publications that identified or defined TRAs was undertaken. Medical subject headings were created with assistance from a research librarian using tailored functions within individual databases. With key search terms, we limited studies to those related to our inclusion criteria. See Appendix 1 for our search strategy for Medline and CINAHL.

We used Covidence, a web-based application specifically designed for systematic reviews to screen and evaluate eligible publications.¹⁷ Two authors (PJC and NSH) screened the initial retrieved searches based upon the predetermined inclusion and exclusion criteria.

Data Extraction

A paper template was developed and used by 2 reviewers (P.J.C. and N.S.H.). Data included the following: study sample, aim(s), design, setting and country in which the study took place, clinical and patient variables, and how the TRAs were developed and tested. Studies were categorized by TRA type. We also sought to identify if clinical trial registration (where appropriate) was evidenced, in addition to evidence of protocol publication and what standardized reporting guidelines were used (such as those outlined by the EQUATOR Network).¹⁸

Data Synthesis

Formal meta-analysis was beyond the scope and intention of this review. However, we provide the FTIS rate and the ranges of odds ratios (ORs) with 95% confidence intervals (CIs) for certain independent predictors.

Thirty-six references were imported for screening against title and abstract content, with 11 studies excluded and 25 studies assessed for full-text eligibility (see Figure, PRISMA Flowchart). We then excluded a further 12 studies (6 did not meet inclusion criteria, 2 were focused on the prehospital setting, 2 were personal correspondence and focused on another type of VAD, 1 was a protocol to establish a TRA, and 1 was a framework for all device types), leaving 13 studies included in the final review (see Figure). These studies presented data on 4 tools,^19-22 4 predictive models^3,23-25 (of which 3 present receiver operating characteristic/area under the curve scores),^3,23,24 2 framed as risk factor studies,^26,27 and 1 of each of the following: a scale,²⁸ a score,²⁹ and an estimation of the incidence report rate (Table 1).³⁰ Seven studies had “difficult” or “difficulty” in their title as a term to use to describe insertion failure.^{3,19,24-27,30} One study was titled exclusively for the nursing profession,²⁰ 5 studies were reported in medical journals,^{3,24,26,29,30} and 6 were reported in nursing journals,^19-22,25,27 with the remainder published in a vascular access journal.^23,28

General Characteristics of Included Studies

One TRA which was registered as a clinical trial²⁴ involved a standardized reporting tool as is recommended by the EQUATOR Network.¹⁸

Nine of the 13 papers reported that TRA components were chosen based on identified predictors of successful insertion from observational data^{3,19,23-28,30}, with 5 papers using multivariate logistic regression to identify independent predictors.^3,23,24,26,2 At least 4330 insertion attempts on patients were reported. Seven papers reported FTIS, which ranged from 61%-90%.^3,23-27,30

Two clinical settings accounted for 10 of the 13 included studies. We identified 5 papers from the ED setting^{3,23,26,29,30} and 5 studies specific to cancer settings.^19-22,28 Two ED papers identified clinical predictors of insertion difficulty, with 1 identifying an existing medical diagnosis (such as sickle cell disease, diabetes, or intravenous drug abuse) and the other reporting a pragmatic patient self-report of difficulty.^26,30 Three studies focused on patient-exclusive variables (such as vein characteristics)^19,21,28 and some with a combined clinician and patient focus.^{3,23-25,27,30}Relatively few studies reported interobserver measurements to describe the reliability of clinical assessments made.^3,19,21,28 Webster et al. in Australia assessed interrater reliability of a vein assessment tool (VAT) and found high agreement (kappa 0.83 for medical imaging nurses and 0.93 for oncology nurses).²¹ Wells compared reliability with Altman’s K scores obtained from a different VAT when compared with the Deciding on Intravenous Access tool and found good agreement.²² Vein deterioration was proposed as a variable for inclusion when developing an assessment tool within an oncological context.³¹ In Spain, de la Torre and colleagues²⁸ demonstrated good interrater agreement (with kappa, 0.77) for the Venous International Assessment (VIA) tool. The VIA offers a grading system scale to predict the patient’s declining vessel size while undergoing chemotherapy via peripheral veins with PIVCs. Grade I suggests little or no insertion failure, whereas a Grade V should predict insertion failure.

Patient Variables

Vein characteristics were significant independent factors associated with insertion success in a number of studies.^{3,19,23,24,27,28} These included the number of veins, descriptive quality (eg, small, medium, large), size, location, visible veins, and palpable veins. Other factors appear to be patient specific (such as chronic conditions), including diabetes (OR, 2.1 [adjusted to identify demographic risk factors]; 95% CI, 1.3-3.4), sickle cell disease (OR, 3.5; 95% CI, 1.4-4.8), and intravenous drug abuse (OR, 2.4; 95% CI, 1.1-5.3).²⁶ It is unclear if a consistent relationship between weight classification and insertion outcomes exists. Despite a finding that BMI was not independently associated with insertion difficulty,²⁶ one study reports that BMI was independently associated with insertion failure (BMI <18.5 [OR, 2.24; 95% CI, 1.07-4.67], BMI >30 [OR, 1.98; 95% CI, 1.9-3.60])³ and another reports emaciated patients were associated with greater failure when compared to normal weight patients (OR, 0.07; 95% CI, 0.02-0.34).²³ Consequently, extremes of BMI appear to be associated with insertion outcomes despite 1 study reporting no significant association with BMI as an independent factor of insertion failure.²⁶ A history of difficult intravenous access (DIVA) was reported in 1 study and independently associated with insertion failure (OR, 3.86; 95% CI, 2.39-6.25; see Table 2). DIVA appears to be the motivating factor in the title of 7 studies. When defined, the definitions of DIVA are heterogeneous and varied and include the following: >1 minute to insert a PIVC and requiring >1 attempt²⁷; 2 failed attempts³⁰; 3 or more PIVC attempts.²⁶ In the remaining 4 studies, variables associated with difficulty are identified and, therefore, TRAs to target those in future with predicted difficulty prior to any attempts are proposed.^3,19,24,25

Clinician Variables

Specialist nurse certification, years of experience, and self-report skill level (P < 0.001) appear to be significantly associated with successful insertions.²⁵ This is in part validated in another study reporting greater procedural inserting PIVCs as an independent predictor of success (OR, 4.404; 95% CI, 1.61-12-06; see Table 2).²³ Two studies involved simple pragmatic percentage cut offs for PIVCs: likelihood of use²⁹ and likelihood of insertion success.²³ One paper using a cross-sectional design that surveyed ED clinicians suggested if the clinician’s predicted likelihood of the patient needing a PIVC was >80%, this was a reasonable trigger for PIVC insertion.²⁹ The other, in a self-report cohort study, reported that a clinician’s likelihood estimation of PIVC FTIS prior to insertion is independently associated with FTIS (OR, 1.06; 95% CI, 1.04-1.07).²³

Product Variables

In this review, higher failure rates were identified in smaller sizes (22-24 g).²⁶ One study revealed gauge size was significantly associated with a failed first attempt in a univariate analysis (OR, 0.44; 95% CI, 0.34-0.58), but this was not retained in a multivariate model.²⁴ Matching the PIVC size with vein assessment is considered in the VIA tool.²⁸ It suggests a large PIVC (18 g) can be considered in patients with at least 6 vein options; smaller PIVCs of 22 to 24 g are recommended when 3 or fewer veins are found.²⁸ One paper describes a greater proportion of success between PIVC brands.²⁵

The published evidence for TRAs for PIVCs is limited, with few studies using 2 or more reliability, validity, responsiveness, clinical feasibility, or utility measurements in their development. There is a clear need to assess the clinical utility and clinical feasibility of these approaches so they can be externally validated prior to clinical adoption.¹⁶ For this reason, a validated TRA is likely required but must be appropriate for the capability of the healthcare services to use it. We suggest the consistent absence of all of these phases is owing to the variety of healthcare practitioners who are responsible for the insertion, the care and surveillance of peripheral cannulae, and the fragmentation of clinical approaches that exist.³²

Previously, a comprehensive systematic review on the subject of PIVCs found that the presence of a visible and/or palpable vein is usually associated with FTIS.³³ This current review found evidence of simple scores or cutoff percentage estimates in 2 TRA reports to predict either appropriate PIVC insertion or FTIS.^23,29 If such methods are supported by future experimental trials, then such simple approaches could initiate huge clinical return, particularly given that idle or unused PIVCs are of substantial clinical concern.^34-36 PIVCs transcend a variety of clinical environments with excessive use identified in the ED, where it may be performed for blood sampling alone and, hence, are labeled as “just in case” PIVCs and contribute to the term “idle PIVC.”^23,34 Therefore, a clinical indication to perform PIVC insertion in the first instance must be embedded into any TRA; for example, clinical deterioration is likely and the risks are outweighed by benefit, intravenous fluids and/or medicines are required, and/or diagnostic or clinical procedures are requested (such as contrast scans or procedural sedation).

In the majority of papers reviewed, researchers described how to categorize patients into levels of anticipated and predicted difficulty, but none offered corresponding detailed recommendations for strategies to increase insertion success, such as insertion with ultrasound or vascular access expert. Hypothetically, adopting a TRA may assist with the early identification of difficult to cannulate patients who may require a more expert vascular access clinician. However, in this review, we identify that a uniform definition for DIVA is lacking. Both Webster et al.²¹ and Wells²² suggest that an expert inserter is required if difficult access is identified by their tools, but there is no clear description of the qualities of an expert inserter in the literature.³⁷ Recently, consensus recommendations for the definition of vascular access specialist add to discussions about defining vascular access as an interdisciplinary specialist role.³⁸ This is supported by other publications that highlight the association between PIVC procedural experience and increased insertion success.^6,23,39-41With regards to products, PIVC gauge size may or may not be significantly associated with insertion success. For identifying a relationship of PIVC gauge with vein quality, both the vein diameter and description will help with the clinical interpretation of results. For example, it may be the case that bigger veins are easier to insert a PIVC and, thus, larger PIVCs are inserted. The opposite can occur when the veins are small and poorly visualized; hence, one may select a small gauge catheter. This argument is supported by Prottengeier et al.⁴² in a prehospital study that excluded PIVC size in a multivariate analysis because of confounding. However, gauge size is very likely to influence postinsertion complications. Prospective studies are contradictory and suggest 16 to 18 g PIVCs are more likely to contribute to superficial thrombus,⁴³ phlebitis, and, thus, device failure, in contrast to others reporting more frequent dislodgement with smaller 22 g PIVCs.^6,44Finally, the studies included did not assess survival times of the inserted PIVCs, given postinsertion failure in the hospitalized patient is prevalent⁴⁵ and, importantly, modifiable.⁴⁶ A TRA may yield initial insertion success, but if postinsertion the PIVC fails because of a modifiable reason that the TRA has not acknowledged, then it may be of negligible overall benefit. Therefore, TRAs for PIVC insertion need calibration, further development, and ongoing refinement prior to external validation testing.²⁴ Future research should also examine the role of TRAs in settings where ultrasound or other insertion technology is routinely used.

This review identifies a clinically significant gap in vascular access science. The findings of this review support recent work on vessel health and preservation^47-49 and appropriate device insertion.⁵⁰ It also points to the need for further research on the development and testing of an appropriate clinical TRA to improve vascular access outcomes in clinical practice.

Acknowledgments

The authors thank Ms. Kylie Black and Mr. Simon Lewis, who are medical research librarians at The University of Western Australia.

Disclosure

 Mr. Carr has received “speakers bureau” payment form CareFusion in 2013 and Becton Dickinson (BD) in 2014 for lectures on the subject of vascular access. He received a grant from CareFusion (facilitated by his institution at the time) to attend a scientific meeting on vascular access in the USA in 2012. Griffith University has received unrestricted investigator initiated research or educational grants on Marie Cooke’s behalf from product manufacturers: Baxter; Becton, Dickinson and Company; Centurion Medical Products and Entrotech Lifesciences. Griffith University has received unrestricted investigator initiated research or educational grants on Claire M. Rickard’s behalf from product manufacturers: 3M; Adhezion Biomedical, AngioDynamics; Bard, Baxter; B.Braun; Becton, Dickinson and Company; Centurion Medical Products; Cook Medical; Entrotech, Flomedical; ICU Medical; Medtronic; Smiths Medical, Teleflex. Griffith University has received consultancy payments on Claire M. Rickard’s behalf from product manufacturers: 3M, Bard; BBraun, BD, ResQDevices, Smiths Medical. Dr. Higgins and Dr. Rippey have nothing to disclose. All of the aforementioned have not biased or influenced this review.

All authors have made substantial contributions with this review. Each author has contributed to drafting and editing the manuscript and approves the final version for publishing.

Up to a billion peripheral intravenous catheters (PIVCs) are inserted annually; therefore, the importance of this invasive device in modern medicine cannot be argued.¹ The insertion of a PIVC is a clinical procedure undertaken by a range of clinical staff and in a variety of patient populations and settings. In many clinical environments (for example, the emergency department [ED]), PIVCs are the predominant first-choice vascular access device (VAD).^2,3 Researchers in one study estimated over 25 million PIVCs are used in French EDs each year,³ and intravenous therapy is the leading ED treatment in the United States.⁴

First-time insertion success (FTIS) for PIVCs has been reported at 18% to 98% in adult populations.^5,6 The variability of FTIS likely reflects not just a variety of clinician groups and patient populations but also the absence of uniform approaches to PIVC insertion. Terms frequently used to describe or formalize a pattern of care or a clinical procedure include the following: diagnostic and prognostic tools and/or plans, frameworks, predictive assessment tools, prediction models, rules, decision-making rules, scores, scales, risk factors, risk algorithms, and algorithms.^7-12 In this paper, we use the terms tools, clinical prediction rules, and algorithms (TRAs) to review such frameworks that have been reported in the context of promoting FTIS for PIVCs.

The purpose of this systematic scoping review was to investigate what PIVC decision-making approaches exist to facilitate FTIS of PIVCs in adult hospitalized patients. Our intention was to systematically synthesize the research on TRAs, to review significant associations identified with these TRAs, and to critique TRA validity and reliability.

Scoping Review

We selected a scoping review method that, by definition, maps the evidence to identify gaps,^13,14 set research agendas, and identify implications for decision making. This allowed a targeted approach to answering our 3 research questions:

• What published clinical TRAs exist to facilitate PIVC insertion in adults?
• What clinical, patient and/or product variables have been identified using TRAs as having significant associations with FTIS for PIVCs in adult patients?
• What is the reported reliability, validity, responsiveness, clinical feasibility, and utility of existing TRAs for PIVC insertion in adults?

Our aim was to identify the amount, variety and essential qualities of TRA literature rather than to critically appraise and evaluate the effectiveness of TRAs, a process reserved for systematic review and meta-analysis of interventional studies.^13,14 We followed scoping review guidelines published by members and collaborators of the Joanna Briggs Institute, an internationally recognized leader in research synthesis, evidence use, and implementation. The guidance is based on 5 steps: (i) scoping review objective and question, (ii) background of the topic to support scoping review, (iii) study selection, (iv) charting the results, and (v) collating and summarizing results.¹⁵ Clinicometric assessment of a TRA or any clinical prediction rule requires 4 specific phases: (i) development (identification of predictors from data), (ii) validation (testing the rule in a separate population for reliability), (iii) impact analysis or responsiveness (How clinically useful is the rule in the clinical setting? Is it resource heavy or light? Is it cost effective?), and (iv) implementation and adoption (uptake into clinical practice).¹⁶

Search Strategy

We included studies that described the use or development of any TRA regarding PIVC insertion in the adult hospitalized population.

Inclusion Criteria

Studies were included if they were published in the English Language, included TRAs for PIVC insertion in adult hospital patients, and prospectively assessed a clinical category of patient for PIVC insertion using a traditional approach. We defined a traditional PIVC insertion approach as an assessment and/or insertion with touch and feel, therefore, without vessel-locating technology such as ultrasound and/or near infrared technology.

Exclusion Criteria

Exclusion criteria included pediatric studies, authors’ personal (nonresearch) experience of tools, TRAs focused on postinsertion assessment of the cannula (such as phlebitis, infiltration, and/or dressing failure), and papers with a focus on VADs other than PIVCs. We excluded studies using PIVC ultrasound and/or near infrared technology because these are not standard in all insertions and greatly change the information available for pre-insertion assessment as well as the likelihood of insertion success.

In June 2016, a systematic search of the Cochrane library, Ovid Medline® In-process & Other Non-Indexed Citations and Ovid MEDLINE(R) <1946 to Present>, EBSCO CINAHL databases, and Google Scholar with specific keywords to identify publications that identified or defined TRAs was undertaken. Medical subject headings were created with assistance from a research librarian using tailored functions within individual databases. With key search terms, we limited studies to those related to our inclusion criteria. See Appendix 1 for our search strategy for Medline and CINAHL.

We used Covidence, a web-based application specifically designed for systematic reviews to screen and evaluate eligible publications.¹⁷ Two authors (PJC and NSH) screened the initial retrieved searches based upon the predetermined inclusion and exclusion criteria.

Data Extraction

A paper template was developed and used by 2 reviewers (P.J.C. and N.S.H.). Data included the following: study sample, aim(s), design, setting and country in which the study took place, clinical and patient variables, and how the TRAs were developed and tested. Studies were categorized by TRA type. We also sought to identify if clinical trial registration (where appropriate) was evidenced, in addition to evidence of protocol publication and what standardized reporting guidelines were used (such as those outlined by the EQUATOR Network).¹⁸

Data Synthesis

Formal meta-analysis was beyond the scope and intention of this review. However, we provide the FTIS rate and the ranges of odds ratios (ORs) with 95% confidence intervals (CIs) for certain independent predictors.

Thirty-six references were imported for screening against title and abstract content, with 11 studies excluded and 25 studies assessed for full-text eligibility (see Figure, PRISMA Flowchart). We then excluded a further 12 studies (6 did not meet inclusion criteria, 2 were focused on the prehospital setting, 2 were personal correspondence and focused on another type of VAD, 1 was a protocol to establish a TRA, and 1 was a framework for all device types), leaving 13 studies included in the final review (see Figure). These studies presented data on 4 tools,^19-22 4 predictive models^3,23-25 (of which 3 present receiver operating characteristic/area under the curve scores),^3,23,24 2 framed as risk factor studies,^26,27 and 1 of each of the following: a scale,²⁸ a score,²⁹ and an estimation of the incidence report rate (Table 1).³⁰ Seven studies had “difficult” or “difficulty” in their title as a term to use to describe insertion failure.^{3,19,24-27,30} One study was titled exclusively for the nursing profession,²⁰ 5 studies were reported in medical journals,^{3,24,26,29,30} and 6 were reported in nursing journals,^19-22,25,27 with the remainder published in a vascular access journal.^23,28

General Characteristics of Included Studies

One TRA which was registered as a clinical trial²⁴ involved a standardized reporting tool as is recommended by the EQUATOR Network.¹⁸

Nine of the 13 papers reported that TRA components were chosen based on identified predictors of successful insertion from observational data^{3,19,23-28,30}, with 5 papers using multivariate logistic regression to identify independent predictors.^3,23,24,26,2 At least 4330 insertion attempts on patients were reported. Seven papers reported FTIS, which ranged from 61%-90%.^3,23-27,30

Two clinical settings accounted for 10 of the 13 included studies. We identified 5 papers from the ED setting^{3,23,26,29,30} and 5 studies specific to cancer settings.^19-22,28 Two ED papers identified clinical predictors of insertion difficulty, with 1 identifying an existing medical diagnosis (such as sickle cell disease, diabetes, or intravenous drug abuse) and the other reporting a pragmatic patient self-report of difficulty.^26,30 Three studies focused on patient-exclusive variables (such as vein characteristics)^19,21,28 and some with a combined clinician and patient focus.^{3,23-25,27,30}Relatively few studies reported interobserver measurements to describe the reliability of clinical assessments made.^3,19,21,28 Webster et al. in Australia assessed interrater reliability of a vein assessment tool (VAT) and found high agreement (kappa 0.83 for medical imaging nurses and 0.93 for oncology nurses).²¹ Wells compared reliability with Altman’s K scores obtained from a different VAT when compared with the Deciding on Intravenous Access tool and found good agreement.²² Vein deterioration was proposed as a variable for inclusion when developing an assessment tool within an oncological context.³¹ In Spain, de la Torre and colleagues²⁸ demonstrated good interrater agreement (with kappa, 0.77) for the Venous International Assessment (VIA) tool. The VIA offers a grading system scale to predict the patient’s declining vessel size while undergoing chemotherapy via peripheral veins with PIVCs. Grade I suggests little or no insertion failure, whereas a Grade V should predict insertion failure.

Patient Variables

Vein characteristics were significant independent factors associated with insertion success in a number of studies.^{3,19,23,24,27,28} These included the number of veins, descriptive quality (eg, small, medium, large), size, location, visible veins, and palpable veins. Other factors appear to be patient specific (such as chronic conditions), including diabetes (OR, 2.1 [adjusted to identify demographic risk factors]; 95% CI, 1.3-3.4), sickle cell disease (OR, 3.5; 95% CI, 1.4-4.8), and intravenous drug abuse (OR, 2.4; 95% CI, 1.1-5.3).²⁶ It is unclear if a consistent relationship between weight classification and insertion outcomes exists. Despite a finding that BMI was not independently associated with insertion difficulty,²⁶ one study reports that BMI was independently associated with insertion failure (BMI <18.5 [OR, 2.24; 95% CI, 1.07-4.67], BMI >30 [OR, 1.98; 95% CI, 1.9-3.60])³ and another reports emaciated patients were associated with greater failure when compared to normal weight patients (OR, 0.07; 95% CI, 0.02-0.34).²³ Consequently, extremes of BMI appear to be associated with insertion outcomes despite 1 study reporting no significant association with BMI as an independent factor of insertion failure.²⁶ A history of difficult intravenous access (DIVA) was reported in 1 study and independently associated with insertion failure (OR, 3.86; 95% CI, 2.39-6.25; see Table 2). DIVA appears to be the motivating factor in the title of 7 studies. When defined, the definitions of DIVA are heterogeneous and varied and include the following: >1 minute to insert a PIVC and requiring >1 attempt²⁷; 2 failed attempts³⁰; 3 or more PIVC attempts.²⁶ In the remaining 4 studies, variables associated with difficulty are identified and, therefore, TRAs to target those in future with predicted difficulty prior to any attempts are proposed.^3,19,24,25

Clinician Variables

Specialist nurse certification, years of experience, and self-report skill level (P < 0.001) appear to be significantly associated with successful insertions.²⁵ This is in part validated in another study reporting greater procedural inserting PIVCs as an independent predictor of success (OR, 4.404; 95% CI, 1.61-12-06; see Table 2).²³ Two studies involved simple pragmatic percentage cut offs for PIVCs: likelihood of use²⁹ and likelihood of insertion success.²³ One paper using a cross-sectional design that surveyed ED clinicians suggested if the clinician’s predicted likelihood of the patient needing a PIVC was >80%, this was a reasonable trigger for PIVC insertion.²⁹ The other, in a self-report cohort study, reported that a clinician’s likelihood estimation of PIVC FTIS prior to insertion is independently associated with FTIS (OR, 1.06; 95% CI, 1.04-1.07).²³

Product Variables

In this review, higher failure rates were identified in smaller sizes (22-24 g).²⁶ One study revealed gauge size was significantly associated with a failed first attempt in a univariate analysis (OR, 0.44; 95% CI, 0.34-0.58), but this was not retained in a multivariate model.²⁴ Matching the PIVC size with vein assessment is considered in the VIA tool.²⁸ It suggests a large PIVC (18 g) can be considered in patients with at least 6 vein options; smaller PIVCs of 22 to 24 g are recommended when 3 or fewer veins are found.²⁸ One paper describes a greater proportion of success between PIVC brands.²⁵

The published evidence for TRAs for PIVCs is limited, with few studies using 2 or more reliability, validity, responsiveness, clinical feasibility, or utility measurements in their development. There is a clear need to assess the clinical utility and clinical feasibility of these approaches so they can be externally validated prior to clinical adoption.¹⁶ For this reason, a validated TRA is likely required but must be appropriate for the capability of the healthcare services to use it. We suggest the consistent absence of all of these phases is owing to the variety of healthcare practitioners who are responsible for the insertion, the care and surveillance of peripheral cannulae, and the fragmentation of clinical approaches that exist.³²

Previously, a comprehensive systematic review on the subject of PIVCs found that the presence of a visible and/or palpable vein is usually associated with FTIS.³³ This current review found evidence of simple scores or cutoff percentage estimates in 2 TRA reports to predict either appropriate PIVC insertion or FTIS.^23,29 If such methods are supported by future experimental trials, then such simple approaches could initiate huge clinical return, particularly given that idle or unused PIVCs are of substantial clinical concern.^34-36 PIVCs transcend a variety of clinical environments with excessive use identified in the ED, where it may be performed for blood sampling alone and, hence, are labeled as “just in case” PIVCs and contribute to the term “idle PIVC.”^23,34 Therefore, a clinical indication to perform PIVC insertion in the first instance must be embedded into any TRA; for example, clinical deterioration is likely and the risks are outweighed by benefit, intravenous fluids and/or medicines are required, and/or diagnostic or clinical procedures are requested (such as contrast scans or procedural sedation).

In the majority of papers reviewed, researchers described how to categorize patients into levels of anticipated and predicted difficulty, but none offered corresponding detailed recommendations for strategies to increase insertion success, such as insertion with ultrasound or vascular access expert. Hypothetically, adopting a TRA may assist with the early identification of difficult to cannulate patients who may require a more expert vascular access clinician. However, in this review, we identify that a uniform definition for DIVA is lacking. Both Webster et al.²¹ and Wells²² suggest that an expert inserter is required if difficult access is identified by their tools, but there is no clear description of the qualities of an expert inserter in the literature.³⁷ Recently, consensus recommendations for the definition of vascular access specialist add to discussions about defining vascular access as an interdisciplinary specialist role.³⁸ This is supported by other publications that highlight the association between PIVC procedural experience and increased insertion success.^6,23,39-41With regards to products, PIVC gauge size may or may not be significantly associated with insertion success. For identifying a relationship of PIVC gauge with vein quality, both the vein diameter and description will help with the clinical interpretation of results. For example, it may be the case that bigger veins are easier to insert a PIVC and, thus, larger PIVCs are inserted. The opposite can occur when the veins are small and poorly visualized; hence, one may select a small gauge catheter. This argument is supported by Prottengeier et al.⁴² in a prehospital study that excluded PIVC size in a multivariate analysis because of confounding. However, gauge size is very likely to influence postinsertion complications. Prospective studies are contradictory and suggest 16 to 18 g PIVCs are more likely to contribute to superficial thrombus,⁴³ phlebitis, and, thus, device failure, in contrast to others reporting more frequent dislodgement with smaller 22 g PIVCs.^6,44Finally, the studies included did not assess survival times of the inserted PIVCs, given postinsertion failure in the hospitalized patient is prevalent⁴⁵ and, importantly, modifiable.⁴⁶ A TRA may yield initial insertion success, but if postinsertion the PIVC fails because of a modifiable reason that the TRA has not acknowledged, then it may be of negligible overall benefit. Therefore, TRAs for PIVC insertion need calibration, further development, and ongoing refinement prior to external validation testing.²⁴ Future research should also examine the role of TRAs in settings where ultrasound or other insertion technology is routinely used.

This review identifies a clinically significant gap in vascular access science. The findings of this review support recent work on vessel health and preservation^47-49 and appropriate device insertion.⁵⁰ It also points to the need for further research on the development and testing of an appropriate clinical TRA to improve vascular access outcomes in clinical practice.

Acknowledgments

The authors thank Ms. Kylie Black and Mr. Simon Lewis, who are medical research librarians at The University of Western Australia.

Disclosure

 Mr. Carr has received “speakers bureau” payment form CareFusion in 2013 and Becton Dickinson (BD) in 2014 for lectures on the subject of vascular access. He received a grant from CareFusion (facilitated by his institution at the time) to attend a scientific meeting on vascular access in the USA in 2012. Griffith University has received unrestricted investigator initiated research or educational grants on Marie Cooke’s behalf from product manufacturers: Baxter; Becton, Dickinson and Company; Centurion Medical Products and Entrotech Lifesciences. Griffith University has received unrestricted investigator initiated research or educational grants on Claire M. Rickard’s behalf from product manufacturers: 3M; Adhezion Biomedical, AngioDynamics; Bard, Baxter; B.Braun; Becton, Dickinson and Company; Centurion Medical Products; Cook Medical; Entrotech, Flomedical; ICU Medical; Medtronic; Smiths Medical, Teleflex. Griffith University has received consultancy payments on Claire M. Rickard’s behalf from product manufacturers: 3M, Bard; BBraun, BD, ResQDevices, Smiths Medical. Dr. Higgins and Dr. Rippey have nothing to disclose. All of the aforementioned have not biased or influenced this review.

All authors have made substantial contributions with this review. Each author has contributed to drafting and editing the manuscript and approves the final version for publishing.

A 52-year-old woman presented with a 4-day history of progressive dyspnea, nonproductive cough, pleuritic chest pain, and subjective fevers. She described dyspnea at rest, which worsened with exertion. She reported no chills, night sweats, weight change, wheezing, hemoptysis, orthopnea, lower extremity edema, or nasal congestion. She also denied myalgia, arthralgia, or joint swelling. She reported no rash, itching, or peripheral lymphadenopathy. She had no seasonal allergies. She was treated for presumed bronchitis with azithromycin by her primary care provider 4 days prior to presentation but experienced progressive dyspnea.

The constellation of dry cough, fever, and dyspnea is often infectious in origin, with the nonproductive, dry cough more suggestive of a viral than bacterial syndrome. Atypical organisms such as Mycoplasma pneumoniae, Legionella pneumophila, and Chlamydia pneumoniae may also present with these symptoms. Noninfectious etiologies should also be considered, including pulmonary embolism, systemic lupus erythematosus, asbestosis, hypersensitivity pneumonitis, sarcoidosis, and lung cancer. The dyspnea at rest stands out as a worrisome feature, as it implies hypoxia; therefore, an oxygen saturation is necessary to quickly determine her peripheral oxygen saturation.

Her past medical history was notable for lung adenocarcinoma, for which she had undergone right upper lobectomy, without chemotherapy or radiation, 13 years ago without recurrence. She had no history of chronic obstructive pulmonary disease, asthma, or pneumonia, nor a family history of chronic obstructive pulmonary disease, asthma, pneumonia, or lung cancer. Her only medication was azithromycin. She drank alcohol on occasion and denied illicit drug use. Three weeks prior to admission, she began smoking 4 to 5 cigarettes per day after 13 years of abstinence. Her smoking history prior to abstinence was 1 pack per day for 20 years. She worked as a department store remodeler; she had no exposure to asbestos, mold, or water-damaged wood. She reported no recent travel, sick contacts, or exposure to animals.

A primary lung neoplasm with a pleural effusion could cause her shortness of breath and pleuritic chest pain. Her history of lung cancer at age 39 raises the possibility of recurrence. For cigarette smokers, a second lung cancer may occur many years after the first diagnosis and treatment, even if they have quit smoking. A review of her original cancer records is essential to confirm the diagnosis of pulmonary adenocarcinoma. What is now being described as pulmonary adenocarcinoma may have been a metastatic lesion arising from outside the lung. Although unlikely, a primary adenocarcinoma may remain active.

Infectious etiologies continue to merit consideration. A parapneumonic effusion from a pneumonia or an empyema are consistent with her symptoms. Systemic lupus erythematosus can cause lung disease with pleural effusions. She does exhibit dyspnea and pleurisy, which are consistent with autoimmune disease, but does not exhibit some of the more typical autoimmune symptoms such as arthralgias, joint swelling, and rash. Pneumothorax could also produce her symptoms; however, pneumothorax usually occurs spontaneously in younger patients or after trauma or a procedure. Remote right upper lobectomy would not be a cause of pneumothorax now. Her reported history makes lung disease or pneumoconiosis due to occupational exposure to mold or aspergillosis a possibility. Legionellosis, histoplasmosis, or coccidioidomycosis should be considered if she lives in or has visited a high-risk area. Pulmonary embolism remains a concern for all patients with new-onset shortness of breath. Decision support tools, such as the Wells criteria, are valuable, but the gestalt of the physician does not lag far behind in accuracy.

Cardiac disease is also in the differential. Bibasilar crackles, third heart sound gallop, and jugular vein distension would suggest heart failure. A pericardial friction rub would be highly suggestive of pericarditis. A paradoxical pulse would raise concern for pericardial tamponade. Pleurisy may be associated with a pericardial effusion, making viral pericarditis and myocarditis possibilities.

She was in moderate distress with tachypnea and increased work of breathing. Her temperature was 36.7°C, heart rate 104 beats per minute, respiratory rate 24 breaths per minute, oxygen saturation was 88% on room air, 94% on 3 liters of oxygen, and blood pressure was 147/61 mmHg. Auscultation of the lungs revealed bibasilar crackles and decreased breath sounds at the bases. She was tachycardic, with a regular rhythm and no appreciable murmurs, rubs, or gallops. There was no jugular venous distention or lower extremity edema. Her thyroid was palpable, without appreciation of nodules. Skin and musculoskeletal examinations were normal.

Unless she is immunocompromised, infection has become lower in the differential, as she is afebrile. Decreased breath sounds at the bases and bibasilar crackles may be due to pleural effusions. Congestive heart failure is a possibility, especially given her dyspnea and bibasilar crackles. Volume overload from renal failure is possible, but she does not have other signs of volume overload such as lower extremity edema or jugular venous distension. It is important to note that crackles may be due to other etiologies, including atelectasis, fibrosis, or pneumonia. Pulmonary embolism may cause hypoxia, tachycardia, and pleural effusions. Additional diseases may present similarly, including human immunodeficiency virus with Pneumocystis jirovecii, causing dyspnea, tachypnea, and tachycardia; hematologic malignancy with anemia, causing dyspnea and tachycardia; and thyrotoxic states with thyromegaly, causing dyspnea and tachycardia. Thyroid storm patients appear in distress, are tachycardic, and may have thyromegaly.

Moderate distress, increased work of breathing, tachycardia, tachypnea, and hypoxia are all worrisome signs. Her temperature is subnormal, although this may not be accurate, as oral temperatures may register lower in patients with increased respiratory rates because of increased air flow across the thermometer. Bibasilar crackles with decreased bibasilar sounds require further investigation. A complete blood count, complete metabolic profile, troponin, arterial blood gas (ABG), electrocardiogram (ECG), and chest radiograph are warranted.

Laboratory studies revealed a white blood cell count of 8600 per mm³ with 11% bands and 7.3% eosinophils, and a hemoglobin count of 15 gm/dL. Basic metabolic panel, liver function tests, coagulation panel, and urinalysis were within normal limits, including serum creatinine 0.7 mg/dL, sodium 143 mmoL/L, chloride 104 mmoL/L, bicarbonate 30 mEq/L, anion gap 9 mmoL/L, and blood urea nitrogen 12 mg/dL. Chest radiograph disclosed diffusely increased interstitial markings and a small left pleural effusion (Figure 1).

Eosinophilia may be seen in drug reactions, allergies, pulmonary emboli, pleural effusions, and occasionally in malignancy. Eosinophilic pneumonia typically has the “reverse pulmonary edema” picture, with infiltrates in the periphery and not centrally, as in congestive heart failure.

A serum bicarbonate of 30 mEq/L suggests a metabolic compensation for a chronic respiratory acidosis as renal compensation, and rise in bicarbonate generally takes 3 days. She may have been hypoxic longer than her symptoms suggest.

An ABG should be ordered to determine the degree of hypoxia and whether a higher level of care is indicated. The abnormal chest radiograph, along with her hypoxia, merits a closer look at her lung parenchyma with chest computed tomography (CT). A D-dimer would be beneficial to rule out pulmonary embolism. If the D-dimer is positive, chest CT with contrast is indicated to determine if a pulmonary embolism is present. A brain natriuretic peptide would assist in the diagnosis of congestive heart failure. A sputum culture and Gram stain and respiratory viral panel may establish a pathogen for pneumonia. An ECG and troponin to rule out myocardial infarction should be performed as well.

Eosinophilic infiltration may lead to fibrosis, as was found on the lung biopsy. She should be counseled to avoid “fine dust exposure” in the future. Follow-up lung imaging and pulmonary function tests (PFTs) should be performed once her acute illness resolves. She should be strongly urged not to smoke tobacco. Interestingly, there are reports that ex-smokers who restart smoking have an increased risk of eosinophilic pneumonia, but in this case dust exposure is the more likely etiology.

She was diagnosed with acute eosinophilic pneumonia (AEP). Antibiotics were discontinued, and oral prednisone was initiated at 40 mg daily, with a brisk response and resolution of her dyspnea. She was discharged with a 6-week prednisone taper. She had no cough, dyspnea, chest pain, or fevers at her follow-up 14 days after discharge. On a 6-week, postdischarge phone call, she continued to report no symptoms, and she maintained abstinence from cigarette smoking.

This case highlights that the very best test in any medical situation is a thorough, detailed history and physical examination. A comprehensive history with physical examination is noninvasive, safe, and cheap. Had the history of fine-dust exposure been known, it is likely that a great deal of testing and money would have been saved. The patient would have been diagnosed and treated earlier, and suffered less.

First described in 1989,^1,2 AEP is an uncommon cause of acute respiratory failure. Cases have been reported throughout the world, including in the United States, Belgium, Japan, and Iraq.^2,3 AEP is an acute febrile illness with cough, chest pain, and dyspnea for fewer than 7 days, diffuse pulmonary infiltrates on chest radiograph, hypoxemia, no history of asthma or atopic disease, no infection, and greater than 25% eosinophils on a BAL.^1,3 Physical examination typically reveals fever, tachypnea, and crackles on auscultation.¹ Peripheral blood eosinophilia is inconsistently seen at presentation but generally observed as the disease progresses.¹ Peripheral eosinophilia at presentation is positively correlated with a milder course of AEP, including higher oxygen saturation and fewer intensive care admissions.⁴ Acute respiratory failure in AEP progresses rapidly, often within hours.¹ Delayed recognition of AEP may lead to respiratory failure, requiring intubation, and even to death.¹

Reticular markings with Kerley-B lines, mixed reticular and alveolar infiltrates, and pleural effusions are usually found on chest radiography.¹ Bilateral areas of ground-glass attenuation, interlobular septal thickening, bronchovascular bundle thickening, and pleural effusions are seen on chest CT.⁵ Marked eosinophilic infiltration of the interstitium and alveolar spaces, as well as diffuse alveolar damage with hyaline membrane fibroblast proliferation and inflammatory cells, are present on lung biopsy.¹ Restriction with impaired diffusion capacity is found on PFTs. However, PFTs return to normal after recovery.¹

AEP is distinguished from other pulmonary diseases by BAL, lung biopsy, symptoms, symptom course, and/or radiographically. AEP is often misdiagnosed as severe community-acquired pneumonia and/or acute respiratory distress syndrome, as AEP tends to occur in previously healthy individuals who have diffuse infiltrates on chest radiograph, fevers, and acute, often severe, respiratory symptoms.^1-3 Other eosinophilic lung diseases to rule out include simple pulmonary eosinophilia, chronic eosinophilic pneumonia, eosinophilic granulomatosis with polyangitis (Churg-Strauss), idiopathic hypereosinophilic syndrome, infection, and drug reactions.^1,3,5 Simple eosinophilic pneumonia is characterized by no symptoms or very mild pulmonary symptoms and transient patchy infiltrates on radiography.^3,5 Patients with simple pulmonary eosinophilia do not have interlobular septal thickening, thickening of the bronchovascular bundles, or pleural effusions radiographically, as seen with AEP.⁵ Chronic eosinophilic pneumonia is subacute, with respiratory symptoms of more than 3 months in duration, in contrast with the 7 days of respiratory symptoms for AEP, and is also not associated with interlobular septal thickening, thickening of the bronchovascular bundles, or pleural effusions on radiography.^3,5 Unlike AEP, chronic eosinophilic pneumonia often recurs after the course of steroids has ended.³ In contrast with AEP, eosinophilic granulomatosis with polyangitis is associated with concomitant asthma and the involvement of nonpulmonary organs.³ Idiopathic hypereosinophilic syndrome is characterized by extremely high peripheral eosinophilia and by eosinophilic involvement of multiple organs, and it requires chronic steroid use.³ Patients with allergic bronchopulmonary aspergillosis (ABPA), in contrast with AEP, typically have steroid-dependent asthma and chronic respiratory symptoms.³ ABPA also differs from AEP in that radiographic infiltrates are localized and transient, and the syndrome may relapse after steroid treatment.³ Other infectious etiologies that may present similarly to AEP include invasive pulmonary aspergillosis, pulmonary coccidiodomycosis, Pneumocystis jioveri pneumonia, pulmonary toxocariasis, pulmonary filariasis, paragonimiasis, and Loeffler syndrome (pneumonia due to Strongyloides, Ascaris, or hookworms), highlighting the importance of a thorough travel and exposure history.^1,3 Several drugs may cause eosinophilic lung disease, including nitrofurantoin, tetracyclines, phenytoin, L-tryptophan, acetaminophen, ampicillin, heroin, and cocaine, which necessitates a thorough review of medication and illegal drug use.³

Steroids and supportive care are the treatment of choice for AEP, although spontaneous resolution has been seen.^1,3 Significant clinical improvement occurs within 24 to 48 hours of steroid initiation.^1,3 Optimal dose and duration of therapy have not been determined; however, methylprednisolone 125 mg intravenously every 6 hours until improvement is an often-used option.¹ Tapers vary from 2 to 12 weeks with no difference in outcome.^1-3 AEP does not recur after appropriate treatment with steroids.^1,3

Little is known about the etiology of AEP. It usually occurs in young, healthy individuals and is presumed to be an unusual, acute hypersensitivity reaction to an inhaled allergen.¹ A report of 18 US soldiers deployed in or near Iraq proposed dust exposure and cigarette or cigar smoking as a cause of AEP.² Similar to our patient’s fine-dust exposure and recent onset of cigarette smoking, the soldiers were exposed to the dusty, arid environment for at least 1 day and had been smoking for at least 1 month.² The authors proposed that small dust particles irritate alveoli, stimulating eosinophils, which are exacerbated by the onset of smoking. Alternatively, cigarette smoke may prime the lung such that dust triggers an inflammatory cascade, resulting in AEP.² Because of the potential for the rapid progression of respiratory failure, it is critical that clinicians recognize that AEP may be caused by relatively new cigarette smoking and dust in the wind.

• With the potential for the rapid progression of respiratory failure, it is imperative that the diagnosis of AEP be considered for a patient with diffuse infiltrates on a chest radiograph and acute respiratory failure of unknown cause.
• A thorough history of exposure is key to including AEP in the differential of acute pulmonary disease, with recent-onset cigarette smoking and dust exposure.
• The rapid initiation of steroids leads to a full recovery without recurrence and may be life-saving in AEP.

Disclosure 

The authors report no conflicts of interest.

A 52-year-old woman presented with a 4-day history of progressive dyspnea, nonproductive cough, pleuritic chest pain, and subjective fevers. She described dyspnea at rest, which worsened with exertion. She reported no chills, night sweats, weight change, wheezing, hemoptysis, orthopnea, lower extremity edema, or nasal congestion. She also denied myalgia, arthralgia, or joint swelling. She reported no rash, itching, or peripheral lymphadenopathy. She had no seasonal allergies. She was treated for presumed bronchitis with azithromycin by her primary care provider 4 days prior to presentation but experienced progressive dyspnea.

The constellation of dry cough, fever, and dyspnea is often infectious in origin, with the nonproductive, dry cough more suggestive of a viral than bacterial syndrome. Atypical organisms such as Mycoplasma pneumoniae, Legionella pneumophila, and Chlamydia pneumoniae may also present with these symptoms. Noninfectious etiologies should also be considered, including pulmonary embolism, systemic lupus erythematosus, asbestosis, hypersensitivity pneumonitis, sarcoidosis, and lung cancer. The dyspnea at rest stands out as a worrisome feature, as it implies hypoxia; therefore, an oxygen saturation is necessary to quickly determine her peripheral oxygen saturation.

Her past medical history was notable for lung adenocarcinoma, for which she had undergone right upper lobectomy, without chemotherapy or radiation, 13 years ago without recurrence. She had no history of chronic obstructive pulmonary disease, asthma, or pneumonia, nor a family history of chronic obstructive pulmonary disease, asthma, pneumonia, or lung cancer. Her only medication was azithromycin. She drank alcohol on occasion and denied illicit drug use. Three weeks prior to admission, she began smoking 4 to 5 cigarettes per day after 13 years of abstinence. Her smoking history prior to abstinence was 1 pack per day for 20 years. She worked as a department store remodeler; she had no exposure to asbestos, mold, or water-damaged wood. She reported no recent travel, sick contacts, or exposure to animals.

A primary lung neoplasm with a pleural effusion could cause her shortness of breath and pleuritic chest pain. Her history of lung cancer at age 39 raises the possibility of recurrence. For cigarette smokers, a second lung cancer may occur many years after the first diagnosis and treatment, even if they have quit smoking. A review of her original cancer records is essential to confirm the diagnosis of pulmonary adenocarcinoma. What is now being described as pulmonary adenocarcinoma may have been a metastatic lesion arising from outside the lung. Although unlikely, a primary adenocarcinoma may remain active.

Infectious etiologies continue to merit consideration. A parapneumonic effusion from a pneumonia or an empyema are consistent with her symptoms. Systemic lupus erythematosus can cause lung disease with pleural effusions. She does exhibit dyspnea and pleurisy, which are consistent with autoimmune disease, but does not exhibit some of the more typical autoimmune symptoms such as arthralgias, joint swelling, and rash. Pneumothorax could also produce her symptoms; however, pneumothorax usually occurs spontaneously in younger patients or after trauma or a procedure. Remote right upper lobectomy would not be a cause of pneumothorax now. Her reported history makes lung disease or pneumoconiosis due to occupational exposure to mold or aspergillosis a possibility. Legionellosis, histoplasmosis, or coccidioidomycosis should be considered if she lives in or has visited a high-risk area. Pulmonary embolism remains a concern for all patients with new-onset shortness of breath. Decision support tools, such as the Wells criteria, are valuable, but the gestalt of the physician does not lag far behind in accuracy.

Cardiac disease is also in the differential. Bibasilar crackles, third heart sound gallop, and jugular vein distension would suggest heart failure. A pericardial friction rub would be highly suggestive of pericarditis. A paradoxical pulse would raise concern for pericardial tamponade. Pleurisy may be associated with a pericardial effusion, making viral pericarditis and myocarditis possibilities.

She was in moderate distress with tachypnea and increased work of breathing. Her temperature was 36.7°C, heart rate 104 beats per minute, respiratory rate 24 breaths per minute, oxygen saturation was 88% on room air, 94% on 3 liters of oxygen, and blood pressure was 147/61 mmHg. Auscultation of the lungs revealed bibasilar crackles and decreased breath sounds at the bases. She was tachycardic, with a regular rhythm and no appreciable murmurs, rubs, or gallops. There was no jugular venous distention or lower extremity edema. Her thyroid was palpable, without appreciation of nodules. Skin and musculoskeletal examinations were normal.

Unless she is immunocompromised, infection has become lower in the differential, as she is afebrile. Decreased breath sounds at the bases and bibasilar crackles may be due to pleural effusions. Congestive heart failure is a possibility, especially given her dyspnea and bibasilar crackles. Volume overload from renal failure is possible, but she does not have other signs of volume overload such as lower extremity edema or jugular venous distension. It is important to note that crackles may be due to other etiologies, including atelectasis, fibrosis, or pneumonia. Pulmonary embolism may cause hypoxia, tachycardia, and pleural effusions. Additional diseases may present similarly, including human immunodeficiency virus with Pneumocystis jirovecii, causing dyspnea, tachypnea, and tachycardia; hematologic malignancy with anemia, causing dyspnea and tachycardia; and thyrotoxic states with thyromegaly, causing dyspnea and tachycardia. Thyroid storm patients appear in distress, are tachycardic, and may have thyromegaly.

Moderate distress, increased work of breathing, tachycardia, tachypnea, and hypoxia are all worrisome signs. Her temperature is subnormal, although this may not be accurate, as oral temperatures may register lower in patients with increased respiratory rates because of increased air flow across the thermometer. Bibasilar crackles with decreased bibasilar sounds require further investigation. A complete blood count, complete metabolic profile, troponin, arterial blood gas (ABG), electrocardiogram (ECG), and chest radiograph are warranted.

Laboratory studies revealed a white blood cell count of 8600 per mm³ with 11% bands and 7.3% eosinophils, and a hemoglobin count of 15 gm/dL. Basic metabolic panel, liver function tests, coagulation panel, and urinalysis were within normal limits, including serum creatinine 0.7 mg/dL, sodium 143 mmoL/L, chloride 104 mmoL/L, bicarbonate 30 mEq/L, anion gap 9 mmoL/L, and blood urea nitrogen 12 mg/dL. Chest radiograph disclosed diffusely increased interstitial markings and a small left pleural effusion (Figure 1).

Eosinophilia may be seen in drug reactions, allergies, pulmonary emboli, pleural effusions, and occasionally in malignancy. Eosinophilic pneumonia typically has the “reverse pulmonary edema” picture, with infiltrates in the periphery and not centrally, as in congestive heart failure.

A serum bicarbonate of 30 mEq/L suggests a metabolic compensation for a chronic respiratory acidosis as renal compensation, and rise in bicarbonate generally takes 3 days. She may have been hypoxic longer than her symptoms suggest.

An ABG should be ordered to determine the degree of hypoxia and whether a higher level of care is indicated. The abnormal chest radiograph, along with her hypoxia, merits a closer look at her lung parenchyma with chest computed tomography (CT). A D-dimer would be beneficial to rule out pulmonary embolism. If the D-dimer is positive, chest CT with contrast is indicated to determine if a pulmonary embolism is present. A brain natriuretic peptide would assist in the diagnosis of congestive heart failure. A sputum culture and Gram stain and respiratory viral panel may establish a pathogen for pneumonia. An ECG and troponin to rule out myocardial infarction should be performed as well.

Eosinophilic infiltration may lead to fibrosis, as was found on the lung biopsy. She should be counseled to avoid “fine dust exposure” in the future. Follow-up lung imaging and pulmonary function tests (PFTs) should be performed once her acute illness resolves. She should be strongly urged not to smoke tobacco. Interestingly, there are reports that ex-smokers who restart smoking have an increased risk of eosinophilic pneumonia, but in this case dust exposure is the more likely etiology.

She was diagnosed with acute eosinophilic pneumonia (AEP). Antibiotics were discontinued, and oral prednisone was initiated at 40 mg daily, with a brisk response and resolution of her dyspnea. She was discharged with a 6-week prednisone taper. She had no cough, dyspnea, chest pain, or fevers at her follow-up 14 days after discharge. On a 6-week, postdischarge phone call, she continued to report no symptoms, and she maintained abstinence from cigarette smoking.

This case highlights that the very best test in any medical situation is a thorough, detailed history and physical examination. A comprehensive history with physical examination is noninvasive, safe, and cheap. Had the history of fine-dust exposure been known, it is likely that a great deal of testing and money would have been saved. The patient would have been diagnosed and treated earlier, and suffered less.

First described in 1989,^1,2 AEP is an uncommon cause of acute respiratory failure. Cases have been reported throughout the world, including in the United States, Belgium, Japan, and Iraq.^2,3 AEP is an acute febrile illness with cough, chest pain, and dyspnea for fewer than 7 days, diffuse pulmonary infiltrates on chest radiograph, hypoxemia, no history of asthma or atopic disease, no infection, and greater than 25% eosinophils on a BAL.^1,3 Physical examination typically reveals fever, tachypnea, and crackles on auscultation.¹ Peripheral blood eosinophilia is inconsistently seen at presentation but generally observed as the disease progresses.¹ Peripheral eosinophilia at presentation is positively correlated with a milder course of AEP, including higher oxygen saturation and fewer intensive care admissions.⁴ Acute respiratory failure in AEP progresses rapidly, often within hours.¹ Delayed recognition of AEP may lead to respiratory failure, requiring intubation, and even to death.¹

Reticular markings with Kerley-B lines, mixed reticular and alveolar infiltrates, and pleural effusions are usually found on chest radiography.¹ Bilateral areas of ground-glass attenuation, interlobular septal thickening, bronchovascular bundle thickening, and pleural effusions are seen on chest CT.⁵ Marked eosinophilic infiltration of the interstitium and alveolar spaces, as well as diffuse alveolar damage with hyaline membrane fibroblast proliferation and inflammatory cells, are present on lung biopsy.¹ Restriction with impaired diffusion capacity is found on PFTs. However, PFTs return to normal after recovery.¹

AEP is distinguished from other pulmonary diseases by BAL, lung biopsy, symptoms, symptom course, and/or radiographically. AEP is often misdiagnosed as severe community-acquired pneumonia and/or acute respiratory distress syndrome, as AEP tends to occur in previously healthy individuals who have diffuse infiltrates on chest radiograph, fevers, and acute, often severe, respiratory symptoms.^1-3 Other eosinophilic lung diseases to rule out include simple pulmonary eosinophilia, chronic eosinophilic pneumonia, eosinophilic granulomatosis with polyangitis (Churg-Strauss), idiopathic hypereosinophilic syndrome, infection, and drug reactions.^1,3,5 Simple eosinophilic pneumonia is characterized by no symptoms or very mild pulmonary symptoms and transient patchy infiltrates on radiography.^3,5 Patients with simple pulmonary eosinophilia do not have interlobular septal thickening, thickening of the bronchovascular bundles, or pleural effusions radiographically, as seen with AEP.⁵ Chronic eosinophilic pneumonia is subacute, with respiratory symptoms of more than 3 months in duration, in contrast with the 7 days of respiratory symptoms for AEP, and is also not associated with interlobular septal thickening, thickening of the bronchovascular bundles, or pleural effusions on radiography.^3,5 Unlike AEP, chronic eosinophilic pneumonia often recurs after the course of steroids has ended.³ In contrast with AEP, eosinophilic granulomatosis with polyangitis is associated with concomitant asthma and the involvement of nonpulmonary organs.³ Idiopathic hypereosinophilic syndrome is characterized by extremely high peripheral eosinophilia and by eosinophilic involvement of multiple organs, and it requires chronic steroid use.³ Patients with allergic bronchopulmonary aspergillosis (ABPA), in contrast with AEP, typically have steroid-dependent asthma and chronic respiratory symptoms.³ ABPA also differs from AEP in that radiographic infiltrates are localized and transient, and the syndrome may relapse after steroid treatment.³ Other infectious etiologies that may present similarly to AEP include invasive pulmonary aspergillosis, pulmonary coccidiodomycosis, Pneumocystis jioveri pneumonia, pulmonary toxocariasis, pulmonary filariasis, paragonimiasis, and Loeffler syndrome (pneumonia due to Strongyloides, Ascaris, or hookworms), highlighting the importance of a thorough travel and exposure history.^1,3 Several drugs may cause eosinophilic lung disease, including nitrofurantoin, tetracyclines, phenytoin, L-tryptophan, acetaminophen, ampicillin, heroin, and cocaine, which necessitates a thorough review of medication and illegal drug use.³

Steroids and supportive care are the treatment of choice for AEP, although spontaneous resolution has been seen.^1,3 Significant clinical improvement occurs within 24 to 48 hours of steroid initiation.^1,3 Optimal dose and duration of therapy have not been determined; however, methylprednisolone 125 mg intravenously every 6 hours until improvement is an often-used option.¹ Tapers vary from 2 to 12 weeks with no difference in outcome.^1-3 AEP does not recur after appropriate treatment with steroids.^1,3

Little is known about the etiology of AEP. It usually occurs in young, healthy individuals and is presumed to be an unusual, acute hypersensitivity reaction to an inhaled allergen.¹ A report of 18 US soldiers deployed in or near Iraq proposed dust exposure and cigarette or cigar smoking as a cause of AEP.² Similar to our patient’s fine-dust exposure and recent onset of cigarette smoking, the soldiers were exposed to the dusty, arid environment for at least 1 day and had been smoking for at least 1 month.² The authors proposed that small dust particles irritate alveoli, stimulating eosinophils, which are exacerbated by the onset of smoking. Alternatively, cigarette smoke may prime the lung such that dust triggers an inflammatory cascade, resulting in AEP.² Because of the potential for the rapid progression of respiratory failure, it is critical that clinicians recognize that AEP may be caused by relatively new cigarette smoking and dust in the wind.

• With the potential for the rapid progression of respiratory failure, it is imperative that the diagnosis of AEP be considered for a patient with diffuse infiltrates on a chest radiograph and acute respiratory failure of unknown cause.
• A thorough history of exposure is key to including AEP in the differential of acute pulmonary disease, with recent-onset cigarette smoking and dust exposure.
• The rapid initiation of steroids leads to a full recovery without recurrence and may be life-saving in AEP.

Disclosure 

The authors report no conflicts of interest.

A 52-year-old woman presented with a 4-day history of progressive dyspnea, nonproductive cough, pleuritic chest pain, and subjective fevers. She described dyspnea at rest, which worsened with exertion. She reported no chills, night sweats, weight change, wheezing, hemoptysis, orthopnea, lower extremity edema, or nasal congestion. She also denied myalgia, arthralgia, or joint swelling. She reported no rash, itching, or peripheral lymphadenopathy. She had no seasonal allergies. She was treated for presumed bronchitis with azithromycin by her primary care provider 4 days prior to presentation but experienced progressive dyspnea.

The constellation of dry cough, fever, and dyspnea is often infectious in origin, with the nonproductive, dry cough more suggestive of a viral than bacterial syndrome. Atypical organisms such as Mycoplasma pneumoniae, Legionella pneumophila, and Chlamydia pneumoniae may also present with these symptoms. Noninfectious etiologies should also be considered, including pulmonary embolism, systemic lupus erythematosus, asbestosis, hypersensitivity pneumonitis, sarcoidosis, and lung cancer. The dyspnea at rest stands out as a worrisome feature, as it implies hypoxia; therefore, an oxygen saturation is necessary to quickly determine her peripheral oxygen saturation.

Her past medical history was notable for lung adenocarcinoma, for which she had undergone right upper lobectomy, without chemotherapy or radiation, 13 years ago without recurrence. She had no history of chronic obstructive pulmonary disease, asthma, or pneumonia, nor a family history of chronic obstructive pulmonary disease, asthma, pneumonia, or lung cancer. Her only medication was azithromycin. She drank alcohol on occasion and denied illicit drug use. Three weeks prior to admission, she began smoking 4 to 5 cigarettes per day after 13 years of abstinence. Her smoking history prior to abstinence was 1 pack per day for 20 years. She worked as a department store remodeler; she had no exposure to asbestos, mold, or water-damaged wood. She reported no recent travel, sick contacts, or exposure to animals.

A primary lung neoplasm with a pleural effusion could cause her shortness of breath and pleuritic chest pain. Her history of lung cancer at age 39 raises the possibility of recurrence. For cigarette smokers, a second lung cancer may occur many years after the first diagnosis and treatment, even if they have quit smoking. A review of her original cancer records is essential to confirm the diagnosis of pulmonary adenocarcinoma. What is now being described as pulmonary adenocarcinoma may have been a metastatic lesion arising from outside the lung. Although unlikely, a primary adenocarcinoma may remain active.

Infectious etiologies continue to merit consideration. A parapneumonic effusion from a pneumonia or an empyema are consistent with her symptoms. Systemic lupus erythematosus can cause lung disease with pleural effusions. She does exhibit dyspnea and pleurisy, which are consistent with autoimmune disease, but does not exhibit some of the more typical autoimmune symptoms such as arthralgias, joint swelling, and rash. Pneumothorax could also produce her symptoms; however, pneumothorax usually occurs spontaneously in younger patients or after trauma or a procedure. Remote right upper lobectomy would not be a cause of pneumothorax now. Her reported history makes lung disease or pneumoconiosis due to occupational exposure to mold or aspergillosis a possibility. Legionellosis, histoplasmosis, or coccidioidomycosis should be considered if she lives in or has visited a high-risk area. Pulmonary embolism remains a concern for all patients with new-onset shortness of breath. Decision support tools, such as the Wells criteria, are valuable, but the gestalt of the physician does not lag far behind in accuracy.

Cardiac disease is also in the differential. Bibasilar crackles, third heart sound gallop, and jugular vein distension would suggest heart failure. A pericardial friction rub would be highly suggestive of pericarditis. A paradoxical pulse would raise concern for pericardial tamponade. Pleurisy may be associated with a pericardial effusion, making viral pericarditis and myocarditis possibilities.

She was in moderate distress with tachypnea and increased work of breathing. Her temperature was 36.7°C, heart rate 104 beats per minute, respiratory rate 24 breaths per minute, oxygen saturation was 88% on room air, 94% on 3 liters of oxygen, and blood pressure was 147/61 mmHg. Auscultation of the lungs revealed bibasilar crackles and decreased breath sounds at the bases. She was tachycardic, with a regular rhythm and no appreciable murmurs, rubs, or gallops. There was no jugular venous distention or lower extremity edema. Her thyroid was palpable, without appreciation of nodules. Skin and musculoskeletal examinations were normal.

Unless she is immunocompromised, infection has become lower in the differential, as she is afebrile. Decreased breath sounds at the bases and bibasilar crackles may be due to pleural effusions. Congestive heart failure is a possibility, especially given her dyspnea and bibasilar crackles. Volume overload from renal failure is possible, but she does not have other signs of volume overload such as lower extremity edema or jugular venous distension. It is important to note that crackles may be due to other etiologies, including atelectasis, fibrosis, or pneumonia. Pulmonary embolism may cause hypoxia, tachycardia, and pleural effusions. Additional diseases may present similarly, including human immunodeficiency virus with Pneumocystis jirovecii, causing dyspnea, tachypnea, and tachycardia; hematologic malignancy with anemia, causing dyspnea and tachycardia; and thyrotoxic states with thyromegaly, causing dyspnea and tachycardia. Thyroid storm patients appear in distress, are tachycardic, and may have thyromegaly.

Moderate distress, increased work of breathing, tachycardia, tachypnea, and hypoxia are all worrisome signs. Her temperature is subnormal, although this may not be accurate, as oral temperatures may register lower in patients with increased respiratory rates because of increased air flow across the thermometer. Bibasilar crackles with decreased bibasilar sounds require further investigation. A complete blood count, complete metabolic profile, troponin, arterial blood gas (ABG), electrocardiogram (ECG), and chest radiograph are warranted.

Laboratory studies revealed a white blood cell count of 8600 per mm³ with 11% bands and 7.3% eosinophils, and a hemoglobin count of 15 gm/dL. Basic metabolic panel, liver function tests, coagulation panel, and urinalysis were within normal limits, including serum creatinine 0.7 mg/dL, sodium 143 mmoL/L, chloride 104 mmoL/L, bicarbonate 30 mEq/L, anion gap 9 mmoL/L, and blood urea nitrogen 12 mg/dL. Chest radiograph disclosed diffusely increased interstitial markings and a small left pleural effusion (Figure 1).

Eosinophilia may be seen in drug reactions, allergies, pulmonary emboli, pleural effusions, and occasionally in malignancy. Eosinophilic pneumonia typically has the “reverse pulmonary edema” picture, with infiltrates in the periphery and not centrally, as in congestive heart failure.

A serum bicarbonate of 30 mEq/L suggests a metabolic compensation for a chronic respiratory acidosis as renal compensation, and rise in bicarbonate generally takes 3 days. She may have been hypoxic longer than her symptoms suggest.

An ABG should be ordered to determine the degree of hypoxia and whether a higher level of care is indicated. The abnormal chest radiograph, along with her hypoxia, merits a closer look at her lung parenchyma with chest computed tomography (CT). A D-dimer would be beneficial to rule out pulmonary embolism. If the D-dimer is positive, chest CT with contrast is indicated to determine if a pulmonary embolism is present. A brain natriuretic peptide would assist in the diagnosis of congestive heart failure. A sputum culture and Gram stain and respiratory viral panel may establish a pathogen for pneumonia. An ECG and troponin to rule out myocardial infarction should be performed as well.

Eosinophilic infiltration may lead to fibrosis, as was found on the lung biopsy. She should be counseled to avoid “fine dust exposure” in the future. Follow-up lung imaging and pulmonary function tests (PFTs) should be performed once her acute illness resolves. She should be strongly urged not to smoke tobacco. Interestingly, there are reports that ex-smokers who restart smoking have an increased risk of eosinophilic pneumonia, but in this case dust exposure is the more likely etiology.

She was diagnosed with acute eosinophilic pneumonia (AEP). Antibiotics were discontinued, and oral prednisone was initiated at 40 mg daily, with a brisk response and resolution of her dyspnea. She was discharged with a 6-week prednisone taper. She had no cough, dyspnea, chest pain, or fevers at her follow-up 14 days after discharge. On a 6-week, postdischarge phone call, she continued to report no symptoms, and she maintained abstinence from cigarette smoking.

This case highlights that the very best test in any medical situation is a thorough, detailed history and physical examination. A comprehensive history with physical examination is noninvasive, safe, and cheap. Had the history of fine-dust exposure been known, it is likely that a great deal of testing and money would have been saved. The patient would have been diagnosed and treated earlier, and suffered less.

First described in 1989,^1,2 AEP is an uncommon cause of acute respiratory failure. Cases have been reported throughout the world, including in the United States, Belgium, Japan, and Iraq.^2,3 AEP is an acute febrile illness with cough, chest pain, and dyspnea for fewer than 7 days, diffuse pulmonary infiltrates on chest radiograph, hypoxemia, no history of asthma or atopic disease, no infection, and greater than 25% eosinophils on a BAL.^1,3 Physical examination typically reveals fever, tachypnea, and crackles on auscultation.¹ Peripheral blood eosinophilia is inconsistently seen at presentation but generally observed as the disease progresses.¹ Peripheral eosinophilia at presentation is positively correlated with a milder course of AEP, including higher oxygen saturation and fewer intensive care admissions.⁴ Acute respiratory failure in AEP progresses rapidly, often within hours.¹ Delayed recognition of AEP may lead to respiratory failure, requiring intubation, and even to death.¹

Reticular markings with Kerley-B lines, mixed reticular and alveolar infiltrates, and pleural effusions are usually found on chest radiography.¹ Bilateral areas of ground-glass attenuation, interlobular septal thickening, bronchovascular bundle thickening, and pleural effusions are seen on chest CT.⁵ Marked eosinophilic infiltration of the interstitium and alveolar spaces, as well as diffuse alveolar damage with hyaline membrane fibroblast proliferation and inflammatory cells, are present on lung biopsy.¹ Restriction with impaired diffusion capacity is found on PFTs. However, PFTs return to normal after recovery.¹

AEP is distinguished from other pulmonary diseases by BAL, lung biopsy, symptoms, symptom course, and/or radiographically. AEP is often misdiagnosed as severe community-acquired pneumonia and/or acute respiratory distress syndrome, as AEP tends to occur in previously healthy individuals who have diffuse infiltrates on chest radiograph, fevers, and acute, often severe, respiratory symptoms.^1-3 Other eosinophilic lung diseases to rule out include simple pulmonary eosinophilia, chronic eosinophilic pneumonia, eosinophilic granulomatosis with polyangitis (Churg-Strauss), idiopathic hypereosinophilic syndrome, infection, and drug reactions.^1,3,5 Simple eosinophilic pneumonia is characterized by no symptoms or very mild pulmonary symptoms and transient patchy infiltrates on radiography.^3,5 Patients with simple pulmonary eosinophilia do not have interlobular septal thickening, thickening of the bronchovascular bundles, or pleural effusions radiographically, as seen with AEP.⁵ Chronic eosinophilic pneumonia is subacute, with respiratory symptoms of more than 3 months in duration, in contrast with the 7 days of respiratory symptoms for AEP, and is also not associated with interlobular septal thickening, thickening of the bronchovascular bundles, or pleural effusions on radiography.^3,5 Unlike AEP, chronic eosinophilic pneumonia often recurs after the course of steroids has ended.³ In contrast with AEP, eosinophilic granulomatosis with polyangitis is associated with concomitant asthma and the involvement of nonpulmonary organs.³ Idiopathic hypereosinophilic syndrome is characterized by extremely high peripheral eosinophilia and by eosinophilic involvement of multiple organs, and it requires chronic steroid use.³ Patients with allergic bronchopulmonary aspergillosis (ABPA), in contrast with AEP, typically have steroid-dependent asthma and chronic respiratory symptoms.³ ABPA also differs from AEP in that radiographic infiltrates are localized and transient, and the syndrome may relapse after steroid treatment.³ Other infectious etiologies that may present similarly to AEP include invasive pulmonary aspergillosis, pulmonary coccidiodomycosis, Pneumocystis jioveri pneumonia, pulmonary toxocariasis, pulmonary filariasis, paragonimiasis, and Loeffler syndrome (pneumonia due to Strongyloides, Ascaris, or hookworms), highlighting the importance of a thorough travel and exposure history.^1,3 Several drugs may cause eosinophilic lung disease, including nitrofurantoin, tetracyclines, phenytoin, L-tryptophan, acetaminophen, ampicillin, heroin, and cocaine, which necessitates a thorough review of medication and illegal drug use.³

Steroids and supportive care are the treatment of choice for AEP, although spontaneous resolution has been seen.^1,3 Significant clinical improvement occurs within 24 to 48 hours of steroid initiation.^1,3 Optimal dose and duration of therapy have not been determined; however, methylprednisolone 125 mg intravenously every 6 hours until improvement is an often-used option.¹ Tapers vary from 2 to 12 weeks with no difference in outcome.^1-3 AEP does not recur after appropriate treatment with steroids.^1,3

Little is known about the etiology of AEP. It usually occurs in young, healthy individuals and is presumed to be an unusual, acute hypersensitivity reaction to an inhaled allergen.¹ A report of 18 US soldiers deployed in or near Iraq proposed dust exposure and cigarette or cigar smoking as a cause of AEP.² Similar to our patient’s fine-dust exposure and recent onset of cigarette smoking, the soldiers were exposed to the dusty, arid environment for at least 1 day and had been smoking for at least 1 month.² The authors proposed that small dust particles irritate alveoli, stimulating eosinophils, which are exacerbated by the onset of smoking. Alternatively, cigarette smoke may prime the lung such that dust triggers an inflammatory cascade, resulting in AEP.² Because of the potential for the rapid progression of respiratory failure, it is critical that clinicians recognize that AEP may be caused by relatively new cigarette smoking and dust in the wind.

• With the potential for the rapid progression of respiratory failure, it is imperative that the diagnosis of AEP be considered for a patient with diffuse infiltrates on a chest radiograph and acute respiratory failure of unknown cause.
• A thorough history of exposure is key to including AEP in the differential of acute pulmonary disease, with recent-onset cigarette smoking and dust exposure.
• The rapid initiation of steroids leads to a full recovery without recurrence and may be life-saving in AEP.

Disclosure 

The authors report no conflicts of interest.

The “Things We Do for No Reason” (TWDFNR) series reviews practices which have become common parts of hospital care but which may provide little value to our patients. Practices reviewed in the TWDFNR series do not represent “black and white” conclusions or clinical practice standards, but are meant as a starting place for research and active discussions among hospitalists and patients. We invite you to be part of that discussion. https://www.choosingwisely.org/

Against medical advice (AMA) discharges, which account for up to 2% of all inpatient discharges, are associated with worse health and health services outcomes and disproportionately affect vulnerable patient populations. This paper will review the background data on AMA discharges as well as the reasons physicians may choose to discharge patients AMA. From a healthcare quality perspective, the designation of a discharge as AMA is low-value care in that it is a routine hospital practice without demonstrated benefit and is not supported by a strong evidence base. We argue that designating discharges as AMA has never been shown to advance patient care and that it has the potential to harm patients by reducing access to care and promoting stigma. We believe that greater attention to both shared decision-making as well as harm reduction principles in discharge planning can serve as effective, patient-centered alternatives when patients choose not to follow a healthcare professional’s recommended advice.

A 54-year-old man with active intravenous (IV) drug use and hepatitis C was admitted with lower extremity cellulitis. On hospital day 2, the patient insisted that he wanted to go home. The treatment team informed the patient that an additional 2-3 days of IV antibiotics would produce a more reliable cure and reduce the risk of readmission. Should the team inform the patient that he will be discharged against medical advice (AMA) if he chooses to leave the hospital prematurely?

In the United States, patients are discharged AMA approximately 500,000 times per year (1%-2% of all discharges).¹ These discharges represent a wide array of clinical scenarios that all culminate in the formal recognition and documentation of a competent patient’s choice to decline further inpatient medical care and leave the hospital prior to a recommended clinical endpoint. Compared with standard discharges, AMA discharges are associated with an increased adjusted relative risk of 30-day mortality as high as 10% and 30-day readmission rates that are 20%-40% higher than readmission rates following standard discharges.² AMA discharges are more likely among patients with substance use disorders, psychiatric illness, and HIV.³

Although there are little empirical data to inform how and why physicians choose to designate a discharge as AMA when patients decline recommended care, the existing evidence suggests that fears of legal liability are strongly driving the practice.⁴ Physicians may believe that they must discharge patients AMA in order to fulfill their legal and ethical responsibilities, or to demonstrate in writing the physician’s concern and the significant risk of leaving.^5,6 Clinicians may have been acculturated during training to believe that an AMA discharge may also be seen as a way of formally distancing themselves from the patient’s request for a nonstandard or unsafe discharge plan, thus deflecting any potential blame for worse patient outcomes.

Finally, clinicians and administrators may also believe that an AMA discharge is the appropriate designation for a hospital stay that ended because the patient chose to prematurely discontinue the treatment relationship or to decline the postdischarge placement recommendations. This reasoning may explain why the hospital penalties authorized by Medicare’s Hospital Readmission Reduction Program generally exclude initial admissions ending in an AMA discharge⁷ and may provide the rationale (and perhaps a financial incentive) to discharge patients AMA in order to limit CMS readmission penalties.

The AMA discharge is a routine hospital practice without demonstrated patient benefit and which disproportionately affects vulnerable populations. There is also a growing literature that demonstrates that AMA discharges stigmatize patients, reduce their access to care, and can reduce the quality of informed consent discussions in discharge planning.^8-10 Although there are no conclusive data that AMA discharges are more likely among underrepresented racial minorities, the disproportionate burden of AMA discharges and their worse health outcomes are borne by the homeless, those with substance use disorders, and the uninsured.^3,11

Compared to patients discharged conventionally from an emergency department, 25% of patients discharged AMA reported not wanting to return for follow-up care.⁸ This reluctance to return for care is in part mediated by provider-generated stigma and blame^9,12 and may be exacerbated when patients believe that their decision to leave AMA was based upon extenuating circumstance or competing necessity (eg, limited care options for their dependents, poor quality hospital care, etc.).

To persuade patients to remain hospitalized, 85% of trainees and 67% of attending physicians in one study incorrectly informed their patients that insurance will not reimburse a hospitalization if they leave AMA.¹³ Because this study demonstrated that there is no empirical evidence that payment after AMA discharges is denied by private or government payers, physicians sharing this misinformation can breed distrust and coercively undermine patients’ ability to make a voluntary choice.

When clinicians assert they are bound by duty to discharge a patient AMA, they may be conflating a presumed legal obligation to formally designate the discharge as AMA in the medical record with their actual obligation to obtain the patient’s informed consent for the discharge. In other words, there is no identifiable medico-legal requirement to specifically designate a discharge as AMA.

Although clinicians may presume that the AMA designation provides protection from liability, the claim is not supported by the available literature.^14,15 In these studies, which reviewed relevant case law, defendants prevailed not because of the physician’s AMA designation, but because the plaintiff was not able to prove negligence. The proper execution of the discharge process, not the specific designation of AMA, is what conferred liability protection.⁵ Indeed, malpractice claims, which are associated with patient perceptions of feeling deserted or devalued,¹⁶ might be more likely with AMA discharges when they result from flawed and stigmatizing communication processes.¹⁷

Finally, there are no clinical, regulatory, or professional standards that specify the designation of an AMA discharge. Neither the Joint Commission nor any other professional organization specify under what conditions a clinician should discharge a patient AMA, thus promoting wide variability in its use and further limiting it as a valid and reliable healthcare metric.

Because all competent patients have the right to decline recommended inpatient treatment, the ethical and legal standard is that the physician obtain the patient’s informed consent to leave by communicating the risks, benefits, and alternatives to leaving and fully documenting the conversation in the medical record.² The additional steps of formalizing the discharge as AMA and providing AMA forms for the patient to sign have never been demonstrated to improve quality (and add needless clerical work). When declining any treatment, even life-sustaining treatment, the request for a patient signature to decline such treatment has not been demonstrated to improve risk communication and is not considered a best practice for informed consent.¹⁸ When the physician’s motives for this behavior are punitive or directed primarily at reducing liability, it may distract the physician from their fiduciary duty to put patients first.

The solution to improve quality is straightforward—avoid designating discharges as AMA. Instead, clinicians should maintain a single discharge process with clear, objective documentation including providing appropriate prescriptions and follow-up appointments regardless of whether the patient’s choice is consistent with a physician’s recommendation. In its place, the physician should use shared decision-making (SDM) and harm reduction principles to enhance the patient’s well-being within the identified constraints. SDM involves physicians and patients making healthcare decisions together by combining the patients’ values and preferences for care with the physicians’ expertise and knowledge of medical evidence. Harm reduction practices seek to reduce the adverse health consequences that may come from unhealthy behaviors while assuming that patients will likely continue such behaviors. Evidence-based and widely accepted examples of harm reduction strategies include nicotine replacement therapy and needle exchange programs.¹⁹

SDM in discharge planning provides a range of discharge and transitional care options that are within prevailing medical standards, not simply a single recommendation that prioritizes health promotion to the exclusion of other identified patient goals. Quality discharge planning should provide the “right care for the right patient at the right time”²⁰ that moves beyond the false choice of either remaining in the hospital under the conditions specified by the physician or leaving AMA. Although physicians are understandably concerned about patients making choices that do not prioritize their health, physicians can consider the evidence for harm reduction programs’ effectiveness in improving health outcomes²¹ and accommodate patients by providing harm-reducing discharge options that, while suboptimal, may not be substandard.²²

Physicians who wish to promote stronger patient-centered discharge practices may find that avoiding or limiting AMA discharges may conflict with their institution’s policy. In those cases, physicians should work closely with their leadership and legal counsel to ensure that any proposed practice changes are legally compliant but also improve SDM and reduce stigma for this population.

Although ending the clinical practice of designating discharges as AMA is unlikely to completely ameliorate the morbidity and costs associated with patients declining episodes of inpatient care, there is reasonable face validity to conclude that replacing the AMA practice with greater attention to harm reduction and SDM can reduce some of the preventable harms like stigmatization and reduced access to care. Together, these practices demonstrate the profession’s continued commitment to the public to practice patient-centered care.

• Treat all discharges similarly. Avoid designating an inpatient discharge as AMA.
• Ensure there is objective documentation of the patient’s informed choice to leave the hospital.
• When patients wish to leave the hospital prior to a physician-recommended clinical endpoint, engage in SDM with a focus on providing all medically reasonable treatment options that promote harm reduction.
• If you choose to designate a discharge as AMA, approach the discharge planning process consistently and with patient-centered principles by optimizing SDM and harm reduction.

The physician informed the patient of the risks, benefits, and alternatives to leaving the hospital prior to the completion of IV antibiotics and confirmed the patient’s decision-making capacity. Next, the physician elicited the patient’s preferences for care and identified competing priorities. The patient wanted treatment for his cellulitis, but he was experiencing pain and opioid withdrawal. The physician then expanded the range of potential treatment options, including evaluation for medication-assisted treatment for the patient’s opioid use disorder (OUD) and harm reduction measures such as safer injection practices, needle exchange, housing assistance, and overdose prevention and treatment education.²³ An alternative harm-reducing option included discharge with oral antibiotics and follow-up with his primary physician in 48-72 hours. After the patient indicated that he wanted to leave because he was not yet ready for OUD treatment, he was discharged with the standard discharge paperwork and antibiotics, and the physician documented the informed consent discussion.

Disclosure

The authors report no conflicts of interest, financial or otherwise. The views expressed in this article are those of the authors and do not necessarily reflect the position or policy of the US Department of Veterans Affairs, the VA National Center for Ethics in Health Care or the US Government.

Do you think this is a low-value practice? Is this truly a “Thing We Do for No Reason?” Share what you do in your practice and join in the conversation online by retweeting it on Twitter (#TWDFNR) and liking it on Facebook. We invite you to propose ideas for other “Things We Do for No Reason” topics by emailing [email protected] 

The “Things We Do for No Reason” (TWDFNR) series reviews practices which have become common parts of hospital care but which may provide little value to our patients. Practices reviewed in the TWDFNR series do not represent “black and white” conclusions or clinical practice standards, but are meant as a starting place for research and active discussions among hospitalists and patients. We invite you to be part of that discussion. https://www.choosingwisely.org/

Against medical advice (AMA) discharges, which account for up to 2% of all inpatient discharges, are associated with worse health and health services outcomes and disproportionately affect vulnerable patient populations. This paper will review the background data on AMA discharges as well as the reasons physicians may choose to discharge patients AMA. From a healthcare quality perspective, the designation of a discharge as AMA is low-value care in that it is a routine hospital practice without demonstrated benefit and is not supported by a strong evidence base. We argue that designating discharges as AMA has never been shown to advance patient care and that it has the potential to harm patients by reducing access to care and promoting stigma. We believe that greater attention to both shared decision-making as well as harm reduction principles in discharge planning can serve as effective, patient-centered alternatives when patients choose not to follow a healthcare professional’s recommended advice.

A 54-year-old man with active intravenous (IV) drug use and hepatitis C was admitted with lower extremity cellulitis. On hospital day 2, the patient insisted that he wanted to go home. The treatment team informed the patient that an additional 2-3 days of IV antibiotics would produce a more reliable cure and reduce the risk of readmission. Should the team inform the patient that he will be discharged against medical advice (AMA) if he chooses to leave the hospital prematurely?

In the United States, patients are discharged AMA approximately 500,000 times per year (1%-2% of all discharges).¹ These discharges represent a wide array of clinical scenarios that all culminate in the formal recognition and documentation of a competent patient’s choice to decline further inpatient medical care and leave the hospital prior to a recommended clinical endpoint. Compared with standard discharges, AMA discharges are associated with an increased adjusted relative risk of 30-day mortality as high as 10% and 30-day readmission rates that are 20%-40% higher than readmission rates following standard discharges.² AMA discharges are more likely among patients with substance use disorders, psychiatric illness, and HIV.³

Although there are little empirical data to inform how and why physicians choose to designate a discharge as AMA when patients decline recommended care, the existing evidence suggests that fears of legal liability are strongly driving the practice.⁴ Physicians may believe that they must discharge patients AMA in order to fulfill their legal and ethical responsibilities, or to demonstrate in writing the physician’s concern and the significant risk of leaving.^5,6 Clinicians may have been acculturated during training to believe that an AMA discharge may also be seen as a way of formally distancing themselves from the patient’s request for a nonstandard or unsafe discharge plan, thus deflecting any potential blame for worse patient outcomes.

Finally, clinicians and administrators may also believe that an AMA discharge is the appropriate designation for a hospital stay that ended because the patient chose to prematurely discontinue the treatment relationship or to decline the postdischarge placement recommendations. This reasoning may explain why the hospital penalties authorized by Medicare’s Hospital Readmission Reduction Program generally exclude initial admissions ending in an AMA discharge⁷ and may provide the rationale (and perhaps a financial incentive) to discharge patients AMA in order to limit CMS readmission penalties.

The AMA discharge is a routine hospital practice without demonstrated patient benefit and which disproportionately affects vulnerable populations. There is also a growing literature that demonstrates that AMA discharges stigmatize patients, reduce their access to care, and can reduce the quality of informed consent discussions in discharge planning.^8-10 Although there are no conclusive data that AMA discharges are more likely among underrepresented racial minorities, the disproportionate burden of AMA discharges and their worse health outcomes are borne by the homeless, those with substance use disorders, and the uninsured.^3,11

Compared to patients discharged conventionally from an emergency department, 25% of patients discharged AMA reported not wanting to return for follow-up care.⁸ This reluctance to return for care is in part mediated by provider-generated stigma and blame^9,12 and may be exacerbated when patients believe that their decision to leave AMA was based upon extenuating circumstance or competing necessity (eg, limited care options for their dependents, poor quality hospital care, etc.).

To persuade patients to remain hospitalized, 85% of trainees and 67% of attending physicians in one study incorrectly informed their patients that insurance will not reimburse a hospitalization if they leave AMA.¹³ Because this study demonstrated that there is no empirical evidence that payment after AMA discharges is denied by private or government payers, physicians sharing this misinformation can breed distrust and coercively undermine patients’ ability to make a voluntary choice.

When clinicians assert they are bound by duty to discharge a patient AMA, they may be conflating a presumed legal obligation to formally designate the discharge as AMA in the medical record with their actual obligation to obtain the patient’s informed consent for the discharge. In other words, there is no identifiable medico-legal requirement to specifically designate a discharge as AMA.

Although clinicians may presume that the AMA designation provides protection from liability, the claim is not supported by the available literature.^14,15 In these studies, which reviewed relevant case law, defendants prevailed not because of the physician’s AMA designation, but because the plaintiff was not able to prove negligence. The proper execution of the discharge process, not the specific designation of AMA, is what conferred liability protection.⁵ Indeed, malpractice claims, which are associated with patient perceptions of feeling deserted or devalued,¹⁶ might be more likely with AMA discharges when they result from flawed and stigmatizing communication processes.¹⁷

Finally, there are no clinical, regulatory, or professional standards that specify the designation of an AMA discharge. Neither the Joint Commission nor any other professional organization specify under what conditions a clinician should discharge a patient AMA, thus promoting wide variability in its use and further limiting it as a valid and reliable healthcare metric.

Because all competent patients have the right to decline recommended inpatient treatment, the ethical and legal standard is that the physician obtain the patient’s informed consent to leave by communicating the risks, benefits, and alternatives to leaving and fully documenting the conversation in the medical record.² The additional steps of formalizing the discharge as AMA and providing AMA forms for the patient to sign have never been demonstrated to improve quality (and add needless clerical work). When declining any treatment, even life-sustaining treatment, the request for a patient signature to decline such treatment has not been demonstrated to improve risk communication and is not considered a best practice for informed consent.¹⁸ When the physician’s motives for this behavior are punitive or directed primarily at reducing liability, it may distract the physician from their fiduciary duty to put patients first.

The solution to improve quality is straightforward—avoid designating discharges as AMA. Instead, clinicians should maintain a single discharge process with clear, objective documentation including providing appropriate prescriptions and follow-up appointments regardless of whether the patient’s choice is consistent with a physician’s recommendation. In its place, the physician should use shared decision-making (SDM) and harm reduction principles to enhance the patient’s well-being within the identified constraints. SDM involves physicians and patients making healthcare decisions together by combining the patients’ values and preferences for care with the physicians’ expertise and knowledge of medical evidence. Harm reduction practices seek to reduce the adverse health consequences that may come from unhealthy behaviors while assuming that patients will likely continue such behaviors. Evidence-based and widely accepted examples of harm reduction strategies include nicotine replacement therapy and needle exchange programs.¹⁹

SDM in discharge planning provides a range of discharge and transitional care options that are within prevailing medical standards, not simply a single recommendation that prioritizes health promotion to the exclusion of other identified patient goals. Quality discharge planning should provide the “right care for the right patient at the right time”²⁰ that moves beyond the false choice of either remaining in the hospital under the conditions specified by the physician or leaving AMA. Although physicians are understandably concerned about patients making choices that do not prioritize their health, physicians can consider the evidence for harm reduction programs’ effectiveness in improving health outcomes²¹ and accommodate patients by providing harm-reducing discharge options that, while suboptimal, may not be substandard.²²

Physicians who wish to promote stronger patient-centered discharge practices may find that avoiding or limiting AMA discharges may conflict with their institution’s policy. In those cases, physicians should work closely with their leadership and legal counsel to ensure that any proposed practice changes are legally compliant but also improve SDM and reduce stigma for this population.

Although ending the clinical practice of designating discharges as AMA is unlikely to completely ameliorate the morbidity and costs associated with patients declining episodes of inpatient care, there is reasonable face validity to conclude that replacing the AMA practice with greater attention to harm reduction and SDM can reduce some of the preventable harms like stigmatization and reduced access to care. Together, these practices demonstrate the profession’s continued commitment to the public to practice patient-centered care.

• Treat all discharges similarly. Avoid designating an inpatient discharge as AMA.
• Ensure there is objective documentation of the patient’s informed choice to leave the hospital.
• When patients wish to leave the hospital prior to a physician-recommended clinical endpoint, engage in SDM with a focus on providing all medically reasonable treatment options that promote harm reduction.
• If you choose to designate a discharge as AMA, approach the discharge planning process consistently and with patient-centered principles by optimizing SDM and harm reduction.

The physician informed the patient of the risks, benefits, and alternatives to leaving the hospital prior to the completion of IV antibiotics and confirmed the patient’s decision-making capacity. Next, the physician elicited the patient’s preferences for care and identified competing priorities. The patient wanted treatment for his cellulitis, but he was experiencing pain and opioid withdrawal. The physician then expanded the range of potential treatment options, including evaluation for medication-assisted treatment for the patient’s opioid use disorder (OUD) and harm reduction measures such as safer injection practices, needle exchange, housing assistance, and overdose prevention and treatment education.²³ An alternative harm-reducing option included discharge with oral antibiotics and follow-up with his primary physician in 48-72 hours. After the patient indicated that he wanted to leave because he was not yet ready for OUD treatment, he was discharged with the standard discharge paperwork and antibiotics, and the physician documented the informed consent discussion.

Disclosure

The authors report no conflicts of interest, financial or otherwise. The views expressed in this article are those of the authors and do not necessarily reflect the position or policy of the US Department of Veterans Affairs, the VA National Center for Ethics in Health Care or the US Government.

Do you think this is a low-value practice? Is this truly a “Thing We Do for No Reason?” Share what you do in your practice and join in the conversation online by retweeting it on Twitter (#TWDFNR) and liking it on Facebook. We invite you to propose ideas for other “Things We Do for No Reason” topics by emailing [email protected] 

The “Things We Do for No Reason” (TWDFNR) series reviews practices which have become common parts of hospital care but which may provide little value to our patients. Practices reviewed in the TWDFNR series do not represent “black and white” conclusions or clinical practice standards, but are meant as a starting place for research and active discussions among hospitalists and patients. We invite you to be part of that discussion. https://www.choosingwisely.org/

Against medical advice (AMA) discharges, which account for up to 2% of all inpatient discharges, are associated with worse health and health services outcomes and disproportionately affect vulnerable patient populations. This paper will review the background data on AMA discharges as well as the reasons physicians may choose to discharge patients AMA. From a healthcare quality perspective, the designation of a discharge as AMA is low-value care in that it is a routine hospital practice without demonstrated benefit and is not supported by a strong evidence base. We argue that designating discharges as AMA has never been shown to advance patient care and that it has the potential to harm patients by reducing access to care and promoting stigma. We believe that greater attention to both shared decision-making as well as harm reduction principles in discharge planning can serve as effective, patient-centered alternatives when patients choose not to follow a healthcare professional’s recommended advice.

A 54-year-old man with active intravenous (IV) drug use and hepatitis C was admitted with lower extremity cellulitis. On hospital day 2, the patient insisted that he wanted to go home. The treatment team informed the patient that an additional 2-3 days of IV antibiotics would produce a more reliable cure and reduce the risk of readmission. Should the team inform the patient that he will be discharged against medical advice (AMA) if he chooses to leave the hospital prematurely?

In the United States, patients are discharged AMA approximately 500,000 times per year (1%-2% of all discharges).¹ These discharges represent a wide array of clinical scenarios that all culminate in the formal recognition and documentation of a competent patient’s choice to decline further inpatient medical care and leave the hospital prior to a recommended clinical endpoint. Compared with standard discharges, AMA discharges are associated with an increased adjusted relative risk of 30-day mortality as high as 10% and 30-day readmission rates that are 20%-40% higher than readmission rates following standard discharges.² AMA discharges are more likely among patients with substance use disorders, psychiatric illness, and HIV.³

Although there are little empirical data to inform how and why physicians choose to designate a discharge as AMA when patients decline recommended care, the existing evidence suggests that fears of legal liability are strongly driving the practice.⁴ Physicians may believe that they must discharge patients AMA in order to fulfill their legal and ethical responsibilities, or to demonstrate in writing the physician’s concern and the significant risk of leaving.^5,6 Clinicians may have been acculturated during training to believe that an AMA discharge may also be seen as a way of formally distancing themselves from the patient’s request for a nonstandard or unsafe discharge plan, thus deflecting any potential blame for worse patient outcomes.

Finally, clinicians and administrators may also believe that an AMA discharge is the appropriate designation for a hospital stay that ended because the patient chose to prematurely discontinue the treatment relationship or to decline the postdischarge placement recommendations. This reasoning may explain why the hospital penalties authorized by Medicare’s Hospital Readmission Reduction Program generally exclude initial admissions ending in an AMA discharge⁷ and may provide the rationale (and perhaps a financial incentive) to discharge patients AMA in order to limit CMS readmission penalties.

The AMA discharge is a routine hospital practice without demonstrated patient benefit and which disproportionately affects vulnerable populations. There is also a growing literature that demonstrates that AMA discharges stigmatize patients, reduce their access to care, and can reduce the quality of informed consent discussions in discharge planning.^8-10 Although there are no conclusive data that AMA discharges are more likely among underrepresented racial minorities, the disproportionate burden of AMA discharges and their worse health outcomes are borne by the homeless, those with substance use disorders, and the uninsured.^3,11

Compared to patients discharged conventionally from an emergency department, 25% of patients discharged AMA reported not wanting to return for follow-up care.⁸ This reluctance to return for care is in part mediated by provider-generated stigma and blame^9,12 and may be exacerbated when patients believe that their decision to leave AMA was based upon extenuating circumstance or competing necessity (eg, limited care options for their dependents, poor quality hospital care, etc.).

To persuade patients to remain hospitalized, 85% of trainees and 67% of attending physicians in one study incorrectly informed their patients that insurance will not reimburse a hospitalization if they leave AMA.¹³ Because this study demonstrated that there is no empirical evidence that payment after AMA discharges is denied by private or government payers, physicians sharing this misinformation can breed distrust and coercively undermine patients’ ability to make a voluntary choice.

When clinicians assert they are bound by duty to discharge a patient AMA, they may be conflating a presumed legal obligation to formally designate the discharge as AMA in the medical record with their actual obligation to obtain the patient’s informed consent for the discharge. In other words, there is no identifiable medico-legal requirement to specifically designate a discharge as AMA.

Although clinicians may presume that the AMA designation provides protection from liability, the claim is not supported by the available literature.^14,15 In these studies, which reviewed relevant case law, defendants prevailed not because of the physician’s AMA designation, but because the plaintiff was not able to prove negligence. The proper execution of the discharge process, not the specific designation of AMA, is what conferred liability protection.⁵ Indeed, malpractice claims, which are associated with patient perceptions of feeling deserted or devalued,¹⁶ might be more likely with AMA discharges when they result from flawed and stigmatizing communication processes.¹⁷

Finally, there are no clinical, regulatory, or professional standards that specify the designation of an AMA discharge. Neither the Joint Commission nor any other professional organization specify under what conditions a clinician should discharge a patient AMA, thus promoting wide variability in its use and further limiting it as a valid and reliable healthcare metric.

Because all competent patients have the right to decline recommended inpatient treatment, the ethical and legal standard is that the physician obtain the patient’s informed consent to leave by communicating the risks, benefits, and alternatives to leaving and fully documenting the conversation in the medical record.² The additional steps of formalizing the discharge as AMA and providing AMA forms for the patient to sign have never been demonstrated to improve quality (and add needless clerical work). When declining any treatment, even life-sustaining treatment, the request for a patient signature to decline such treatment has not been demonstrated to improve risk communication and is not considered a best practice for informed consent.¹⁸ When the physician’s motives for this behavior are punitive or directed primarily at reducing liability, it may distract the physician from their fiduciary duty to put patients first.

The solution to improve quality is straightforward—avoid designating discharges as AMA. Instead, clinicians should maintain a single discharge process with clear, objective documentation including providing appropriate prescriptions and follow-up appointments regardless of whether the patient’s choice is consistent with a physician’s recommendation. In its place, the physician should use shared decision-making (SDM) and harm reduction principles to enhance the patient’s well-being within the identified constraints. SDM involves physicians and patients making healthcare decisions together by combining the patients’ values and preferences for care with the physicians’ expertise and knowledge of medical evidence. Harm reduction practices seek to reduce the adverse health consequences that may come from unhealthy behaviors while assuming that patients will likely continue such behaviors. Evidence-based and widely accepted examples of harm reduction strategies include nicotine replacement therapy and needle exchange programs.¹⁹

SDM in discharge planning provides a range of discharge and transitional care options that are within prevailing medical standards, not simply a single recommendation that prioritizes health promotion to the exclusion of other identified patient goals. Quality discharge planning should provide the “right care for the right patient at the right time”²⁰ that moves beyond the false choice of either remaining in the hospital under the conditions specified by the physician or leaving AMA. Although physicians are understandably concerned about patients making choices that do not prioritize their health, physicians can consider the evidence for harm reduction programs’ effectiveness in improving health outcomes²¹ and accommodate patients by providing harm-reducing discharge options that, while suboptimal, may not be substandard.²²

Physicians who wish to promote stronger patient-centered discharge practices may find that avoiding or limiting AMA discharges may conflict with their institution’s policy. In those cases, physicians should work closely with their leadership and legal counsel to ensure that any proposed practice changes are legally compliant but also improve SDM and reduce stigma for this population.

Although ending the clinical practice of designating discharges as AMA is unlikely to completely ameliorate the morbidity and costs associated with patients declining episodes of inpatient care, there is reasonable face validity to conclude that replacing the AMA practice with greater attention to harm reduction and SDM can reduce some of the preventable harms like stigmatization and reduced access to care. Together, these practices demonstrate the profession’s continued commitment to the public to practice patient-centered care.

• Treat all discharges similarly. Avoid designating an inpatient discharge as AMA.
• Ensure there is objective documentation of the patient’s informed choice to leave the hospital.
• When patients wish to leave the hospital prior to a physician-recommended clinical endpoint, engage in SDM with a focus on providing all medically reasonable treatment options that promote harm reduction.
• If you choose to designate a discharge as AMA, approach the discharge planning process consistently and with patient-centered principles by optimizing SDM and harm reduction.

The physician informed the patient of the risks, benefits, and alternatives to leaving the hospital prior to the completion of IV antibiotics and confirmed the patient’s decision-making capacity. Next, the physician elicited the patient’s preferences for care and identified competing priorities. The patient wanted treatment for his cellulitis, but he was experiencing pain and opioid withdrawal. The physician then expanded the range of potential treatment options, including evaluation for medication-assisted treatment for the patient’s opioid use disorder (OUD) and harm reduction measures such as safer injection practices, needle exchange, housing assistance, and overdose prevention and treatment education.²³ An alternative harm-reducing option included discharge with oral antibiotics and follow-up with his primary physician in 48-72 hours. After the patient indicated that he wanted to leave because he was not yet ready for OUD treatment, he was discharged with the standard discharge paperwork and antibiotics, and the physician documented the informed consent discussion.

Disclosure

The authors report no conflicts of interest, financial or otherwise. The views expressed in this article are those of the authors and do not necessarily reflect the position or policy of the US Department of Veterans Affairs, the VA National Center for Ethics in Health Care or the US Government.

Do you think this is a low-value practice? Is this truly a “Thing We Do for No Reason?” Share what you do in your practice and join in the conversation online by retweeting it on Twitter (#TWDFNR) and liking it on Facebook. We invite you to propose ideas for other “Things We Do for No Reason” topics by emailing [email protected] 

Readmissions result in $41.3 billion in annual healthcare expenses.¹ As a result of the Affordable Care Act, Centers for Medicare & Medicaid Services (CMS) implemented the Hospital Readmission Reduction Program (HRRP) to reduce expenditures and improve quality associated with hospital care.^2-5 The HRRP monitors readmission rates for pneumonia, congestive heart failure (CHF), acute myocardial infarction (AMI), chronic obstructive pulmonary disease (COPD), coronary artery bypass graft (CABG), and joint replacement. Hospitals are penalized for excess readmissions that occur following any of these index admissions. However, some readmissions within 30 days of an index admission are planned. For example, patients may have scheduled admissions for chemotherapy visits or may have prescheduled elective surgeries that happen to fall within a 30-day postdischarge window. Furthermore, even unplanned readmissions may not be a marker of suboptimal care.⁶ To prevent penalization for planned readmissions, CMS developed an algorithm to exclude planned readmissions from the HRRP.⁷

Few studies have investigated the planned readmissions in the HRRP since Horwitz and colleagues⁷ developed the algorithm with the assistance of a technical expert panel and validated it by reviewing charts in 2 healthcare systems comprising 7 hospitals. Most studies focus on unplanned readmissions.^8,9 We build on this work by studying readmissions for 131 hospitals and using administrative claims to determine whether the algorithm could be improved. Specifically, we examined planned readmissions after the conditions included in the HRRP and determine whether they occurred under elective, urgent, or emergent circumstances. The goal is to assess whether the algorithm may misclassify some readmissions as planned even though the readmission is unanticipated. We hypothesize that some readmissions considered planned by the HRRP will occur under emergent circumstances. Our findings will provide more nuanced insights regarding planned readmissions and potentially provide a mechanism to identify potentially misclassified readmissions without administrative burden.

We analyzed Medicare claims from 2011 to 2015 for beneficiaries in Michigan who had index admissions for pneumonia, CHF, AMI, COPD, CABG, and joint replacement. Exclusion criteria were as follows: patients who were not continuously enrolled in Medicare Part A and B, had health maintenance organization coverage, were transferred to another hospital during the index admission, or received Medicare because of end-stage renal disease or disability. Patients with hip fractures were excluded because the HRRP readmission algorithm only includes elective, unilateral, total hip arthroplasties. Transfer patients were excluded because these patients are excluded from the HRRP readmission algorithm. We also excluded patients who died within 90 days of their index admission because these patients are often outliers in regards to healthcare utilization. The institutional review board at our health system deemed this study exempt from review.

For each hospital and each condition, we calculated 30-day readmission rates by identifying inpatient claims that occurred following discharge from the index admission. For patients who had multiple readmissions, we only considered the first readmission, as this follows the HRRP method. All readmissions were credited to the hospital where the index admission occurred.

To calculate 30-day planned readmission rates, we examined all readmissions and identified those deemed planned by version 3.0 of the CMS readmissions algorithm.¹⁰ We characterized these planned readmissions by examining the admission type variable and the presence or absence of emergency department (ED) charges. Planned readmissions that had an admission type of “emergent” or “urgent” and/or ED charges may have been unplanned. Because we cannot unequivocally determine whether or not the readmissions were misclassified, we refer to these readmissions as “potentially misclassified” in this manuscript. We also calculated the potential misclassification rate by hospital type.

For 131 Michigan hospitals, we identified 143,054 index admissions, 16,116 (11.3%) 30-day readmissions, and 1252 (7.8%) planned readmissions (Table 1).

Of the unplanned readmissions, 97.0% had either an admission type that was “urgent” or “emergent” and/or ED charges, 96.2% were associated with an “emergent” or “urgent” admission type, and 84.3% had emergency room charges on the claim line.

In this study, we found that planned readmissions are generally infrequent. However, the majority are coded with an emergent or urgent admission type and many have ED charges reported on the claim. These findings suggest that the CMS readmission algorithm examined in this study may potentially misclassify many planned readmissions and that CMS should explore the use of admission type and presence of ED charges in the unplanned/planned readmission algorithm.

Our primary finding that planned readmissions are infrequent is supported by several observations.^7-9,11 In the initial article describing the CMS algorithm,⁷ 7.8% of readmissions were considered planned; upon review of the discharge medical records from the index admissions, 41.3% of these planned readmissions were found to be unplanned. These findings closely correlate with our own findings that 7.8% of readmissions were considered planned by the CMS criteria, and 57.8% of planned readmissions were urgent or emergent. From a clinical perspective, there are few circumstances where a patient undergoing an elective procedure will transit electively through the ED.

The CMS algorithm was intentionally designed to have a high specificity for unplanned readmissions to ensure that truly planned readmissions would not be characterized as unplanned.⁷ There is a potential tradeoff to increasing the sensitivity for unplanned readmissions, in that more planned readmissions might be inadvertently characterized as unplanned. Additional validation work (ie, medical chart review) will be required to explore potentially misclassified planned readmissions in greater detail.

Our study has several limitations. First, we rely solely on information in administrative claims to determine whether an admission is planned. The full clinical story is obviously limited by this method. However, the CMS readmission algorithm is only based on information from administrative claims,⁷ and our goal was to explore a method of improving the algorithm that could be applied by CMS in a pragmatic manner. Second, the validity of the admission type variable for the purpose of identifying “emergent” and “urgent” admissions is not entirely clear. However, based on personal communication with the Research Data Assistance Center, the variable is known to be reliable, although no specific validity testing has been performed. Third, it is possible that some truly planned readmissions began in the ED. This situation may arise at small hospitals. However, we found that most of the planned readmissions that started in the ED had secondary diagnosis codes associated with acute conditions. In addition, we did not find a disproportionate number of potentially misclassified planned readmissions at small hospitals. Fourth, the association between high readmission rates and poor quality of care has been called into question recently. However, the purpose of this study is not to assess the quality of healthcare provided by these hospitals; our intent is to explore opportunities to improve the HRRP planned readmission algorithm. Fifth, our analysis only included the state of Michigan. However, Michigan is 1 of the 10 largest states by population, and we do not expect significant differences between our data and the rest of the country. Sixth, we conducted this analysis with version 3.0 of the CMS readmission algorithm. The latest version (4.0) has made several substantial changes to reduce the number of potentially misclassified planned readmissions. However, neither admission type nor presence of ED charges are considered in the updated version. Therefore, our study provides another potential target for further improvement.

These limitations notwithstanding, these findings have important implications for key stakeholders. Relevant to policymakers, the finding that a large percentage of the planned readmissions had ED charges and/or emergent/urgent admission claim type suggests that CMS should explore the use of these variables in their readmission algorithm. Relevant to hospitals and physicians, the potential misclassification of some planned readmissions suggests that close evaluation of the sources and causes of readmission is imperative during the local development of readmission reduction initiatives.

Collectively, these findings suggest that although planned readmissions are infrequent, many of these planned readmissions may actually be nonelective or unplanned in nature. Furthermore, our findings suggest that the CMS readmission algorithm might improve its accuracy by considering the admission type and the presence of ED charges. Future research in this area should focus on validating the use of ED charges and admission type to identify unplanned readmissions through medical chart review. The aim of the HRRP is to identify signals of poor quality in a fair and equitable manner. Misclassification of readmissions will limit CMS’ ability to achieve this important goal.

Disclosure

None of the authors have any conflicts of interest to disclose.

Readmissions result in $41.3 billion in annual healthcare expenses.¹ As a result of the Affordable Care Act, Centers for Medicare & Medicaid Services (CMS) implemented the Hospital Readmission Reduction Program (HRRP) to reduce expenditures and improve quality associated with hospital care.^2-5 The HRRP monitors readmission rates for pneumonia, congestive heart failure (CHF), acute myocardial infarction (AMI), chronic obstructive pulmonary disease (COPD), coronary artery bypass graft (CABG), and joint replacement. Hospitals are penalized for excess readmissions that occur following any of these index admissions. However, some readmissions within 30 days of an index admission are planned. For example, patients may have scheduled admissions for chemotherapy visits or may have prescheduled elective surgeries that happen to fall within a 30-day postdischarge window. Furthermore, even unplanned readmissions may not be a marker of suboptimal care.⁶ To prevent penalization for planned readmissions, CMS developed an algorithm to exclude planned readmissions from the HRRP.⁷

Few studies have investigated the planned readmissions in the HRRP since Horwitz and colleagues⁷ developed the algorithm with the assistance of a technical expert panel and validated it by reviewing charts in 2 healthcare systems comprising 7 hospitals. Most studies focus on unplanned readmissions.^8,9 We build on this work by studying readmissions for 131 hospitals and using administrative claims to determine whether the algorithm could be improved. Specifically, we examined planned readmissions after the conditions included in the HRRP and determine whether they occurred under elective, urgent, or emergent circumstances. The goal is to assess whether the algorithm may misclassify some readmissions as planned even though the readmission is unanticipated. We hypothesize that some readmissions considered planned by the HRRP will occur under emergent circumstances. Our findings will provide more nuanced insights regarding planned readmissions and potentially provide a mechanism to identify potentially misclassified readmissions without administrative burden.

We analyzed Medicare claims from 2011 to 2015 for beneficiaries in Michigan who had index admissions for pneumonia, CHF, AMI, COPD, CABG, and joint replacement. Exclusion criteria were as follows: patients who were not continuously enrolled in Medicare Part A and B, had health maintenance organization coverage, were transferred to another hospital during the index admission, or received Medicare because of end-stage renal disease or disability. Patients with hip fractures were excluded because the HRRP readmission algorithm only includes elective, unilateral, total hip arthroplasties. Transfer patients were excluded because these patients are excluded from the HRRP readmission algorithm. We also excluded patients who died within 90 days of their index admission because these patients are often outliers in regards to healthcare utilization. The institutional review board at our health system deemed this study exempt from review.

For each hospital and each condition, we calculated 30-day readmission rates by identifying inpatient claims that occurred following discharge from the index admission. For patients who had multiple readmissions, we only considered the first readmission, as this follows the HRRP method. All readmissions were credited to the hospital where the index admission occurred.

To calculate 30-day planned readmission rates, we examined all readmissions and identified those deemed planned by version 3.0 of the CMS readmissions algorithm.¹⁰ We characterized these planned readmissions by examining the admission type variable and the presence or absence of emergency department (ED) charges. Planned readmissions that had an admission type of “emergent” or “urgent” and/or ED charges may have been unplanned. Because we cannot unequivocally determine whether or not the readmissions were misclassified, we refer to these readmissions as “potentially misclassified” in this manuscript. We also calculated the potential misclassification rate by hospital type.

For 131 Michigan hospitals, we identified 143,054 index admissions, 16,116 (11.3%) 30-day readmissions, and 1252 (7.8%) planned readmissions (Table 1).

Of the unplanned readmissions, 97.0% had either an admission type that was “urgent” or “emergent” and/or ED charges, 96.2% were associated with an “emergent” or “urgent” admission type, and 84.3% had emergency room charges on the claim line.

In this study, we found that planned readmissions are generally infrequent. However, the majority are coded with an emergent or urgent admission type and many have ED charges reported on the claim. These findings suggest that the CMS readmission algorithm examined in this study may potentially misclassify many planned readmissions and that CMS should explore the use of admission type and presence of ED charges in the unplanned/planned readmission algorithm.

Our primary finding that planned readmissions are infrequent is supported by several observations.^7-9,11 In the initial article describing the CMS algorithm,⁷ 7.8% of readmissions were considered planned; upon review of the discharge medical records from the index admissions, 41.3% of these planned readmissions were found to be unplanned. These findings closely correlate with our own findings that 7.8% of readmissions were considered planned by the CMS criteria, and 57.8% of planned readmissions were urgent or emergent. From a clinical perspective, there are few circumstances where a patient undergoing an elective procedure will transit electively through the ED.

The CMS algorithm was intentionally designed to have a high specificity for unplanned readmissions to ensure that truly planned readmissions would not be characterized as unplanned.⁷ There is a potential tradeoff to increasing the sensitivity for unplanned readmissions, in that more planned readmissions might be inadvertently characterized as unplanned. Additional validation work (ie, medical chart review) will be required to explore potentially misclassified planned readmissions in greater detail.

Our study has several limitations. First, we rely solely on information in administrative claims to determine whether an admission is planned. The full clinical story is obviously limited by this method. However, the CMS readmission algorithm is only based on information from administrative claims,⁷ and our goal was to explore a method of improving the algorithm that could be applied by CMS in a pragmatic manner. Second, the validity of the admission type variable for the purpose of identifying “emergent” and “urgent” admissions is not entirely clear. However, based on personal communication with the Research Data Assistance Center, the variable is known to be reliable, although no specific validity testing has been performed. Third, it is possible that some truly planned readmissions began in the ED. This situation may arise at small hospitals. However, we found that most of the planned readmissions that started in the ED had secondary diagnosis codes associated with acute conditions. In addition, we did not find a disproportionate number of potentially misclassified planned readmissions at small hospitals. Fourth, the association between high readmission rates and poor quality of care has been called into question recently. However, the purpose of this study is not to assess the quality of healthcare provided by these hospitals; our intent is to explore opportunities to improve the HRRP planned readmission algorithm. Fifth, our analysis only included the state of Michigan. However, Michigan is 1 of the 10 largest states by population, and we do not expect significant differences between our data and the rest of the country. Sixth, we conducted this analysis with version 3.0 of the CMS readmission algorithm. The latest version (4.0) has made several substantial changes to reduce the number of potentially misclassified planned readmissions. However, neither admission type nor presence of ED charges are considered in the updated version. Therefore, our study provides another potential target for further improvement.

These limitations notwithstanding, these findings have important implications for key stakeholders. Relevant to policymakers, the finding that a large percentage of the planned readmissions had ED charges and/or emergent/urgent admission claim type suggests that CMS should explore the use of these variables in their readmission algorithm. Relevant to hospitals and physicians, the potential misclassification of some planned readmissions suggests that close evaluation of the sources and causes of readmission is imperative during the local development of readmission reduction initiatives.

Collectively, these findings suggest that although planned readmissions are infrequent, many of these planned readmissions may actually be nonelective or unplanned in nature. Furthermore, our findings suggest that the CMS readmission algorithm might improve its accuracy by considering the admission type and the presence of ED charges. Future research in this area should focus on validating the use of ED charges and admission type to identify unplanned readmissions through medical chart review. The aim of the HRRP is to identify signals of poor quality in a fair and equitable manner. Misclassification of readmissions will limit CMS’ ability to achieve this important goal.

Disclosure

None of the authors have any conflicts of interest to disclose.

Readmissions result in $41.3 billion in annual healthcare expenses.¹ As a result of the Affordable Care Act, Centers for Medicare & Medicaid Services (CMS) implemented the Hospital Readmission Reduction Program (HRRP) to reduce expenditures and improve quality associated with hospital care.^2-5 The HRRP monitors readmission rates for pneumonia, congestive heart failure (CHF), acute myocardial infarction (AMI), chronic obstructive pulmonary disease (COPD), coronary artery bypass graft (CABG), and joint replacement. Hospitals are penalized for excess readmissions that occur following any of these index admissions. However, some readmissions within 30 days of an index admission are planned. For example, patients may have scheduled admissions for chemotherapy visits or may have prescheduled elective surgeries that happen to fall within a 30-day postdischarge window. Furthermore, even unplanned readmissions may not be a marker of suboptimal care.⁶ To prevent penalization for planned readmissions, CMS developed an algorithm to exclude planned readmissions from the HRRP.⁷

Few studies have investigated the planned readmissions in the HRRP since Horwitz and colleagues⁷ developed the algorithm with the assistance of a technical expert panel and validated it by reviewing charts in 2 healthcare systems comprising 7 hospitals. Most studies focus on unplanned readmissions.^8,9 We build on this work by studying readmissions for 131 hospitals and using administrative claims to determine whether the algorithm could be improved. Specifically, we examined planned readmissions after the conditions included in the HRRP and determine whether they occurred under elective, urgent, or emergent circumstances. The goal is to assess whether the algorithm may misclassify some readmissions as planned even though the readmission is unanticipated. We hypothesize that some readmissions considered planned by the HRRP will occur under emergent circumstances. Our findings will provide more nuanced insights regarding planned readmissions and potentially provide a mechanism to identify potentially misclassified readmissions without administrative burden.

We analyzed Medicare claims from 2011 to 2015 for beneficiaries in Michigan who had index admissions for pneumonia, CHF, AMI, COPD, CABG, and joint replacement. Exclusion criteria were as follows: patients who were not continuously enrolled in Medicare Part A and B, had health maintenance organization coverage, were transferred to another hospital during the index admission, or received Medicare because of end-stage renal disease or disability. Patients with hip fractures were excluded because the HRRP readmission algorithm only includes elective, unilateral, total hip arthroplasties. Transfer patients were excluded because these patients are excluded from the HRRP readmission algorithm. We also excluded patients who died within 90 days of their index admission because these patients are often outliers in regards to healthcare utilization. The institutional review board at our health system deemed this study exempt from review.

For each hospital and each condition, we calculated 30-day readmission rates by identifying inpatient claims that occurred following discharge from the index admission. For patients who had multiple readmissions, we only considered the first readmission, as this follows the HRRP method. All readmissions were credited to the hospital where the index admission occurred.

To calculate 30-day planned readmission rates, we examined all readmissions and identified those deemed planned by version 3.0 of the CMS readmissions algorithm.¹⁰ We characterized these planned readmissions by examining the admission type variable and the presence or absence of emergency department (ED) charges. Planned readmissions that had an admission type of “emergent” or “urgent” and/or ED charges may have been unplanned. Because we cannot unequivocally determine whether or not the readmissions were misclassified, we refer to these readmissions as “potentially misclassified” in this manuscript. We also calculated the potential misclassification rate by hospital type.

For 131 Michigan hospitals, we identified 143,054 index admissions, 16,116 (11.3%) 30-day readmissions, and 1252 (7.8%) planned readmissions (Table 1).

Of the unplanned readmissions, 97.0% had either an admission type that was “urgent” or “emergent” and/or ED charges, 96.2% were associated with an “emergent” or “urgent” admission type, and 84.3% had emergency room charges on the claim line.

In this study, we found that planned readmissions are generally infrequent. However, the majority are coded with an emergent or urgent admission type and many have ED charges reported on the claim. These findings suggest that the CMS readmission algorithm examined in this study may potentially misclassify many planned readmissions and that CMS should explore the use of admission type and presence of ED charges in the unplanned/planned readmission algorithm.

Our primary finding that planned readmissions are infrequent is supported by several observations.^7-9,11 In the initial article describing the CMS algorithm,⁷ 7.8% of readmissions were considered planned; upon review of the discharge medical records from the index admissions, 41.3% of these planned readmissions were found to be unplanned. These findings closely correlate with our own findings that 7.8% of readmissions were considered planned by the CMS criteria, and 57.8% of planned readmissions were urgent or emergent. From a clinical perspective, there are few circumstances where a patient undergoing an elective procedure will transit electively through the ED.

The CMS algorithm was intentionally designed to have a high specificity for unplanned readmissions to ensure that truly planned readmissions would not be characterized as unplanned.⁷ There is a potential tradeoff to increasing the sensitivity for unplanned readmissions, in that more planned readmissions might be inadvertently characterized as unplanned. Additional validation work (ie, medical chart review) will be required to explore potentially misclassified planned readmissions in greater detail.

Our study has several limitations. First, we rely solely on information in administrative claims to determine whether an admission is planned. The full clinical story is obviously limited by this method. However, the CMS readmission algorithm is only based on information from administrative claims,⁷ and our goal was to explore a method of improving the algorithm that could be applied by CMS in a pragmatic manner. Second, the validity of the admission type variable for the purpose of identifying “emergent” and “urgent” admissions is not entirely clear. However, based on personal communication with the Research Data Assistance Center, the variable is known to be reliable, although no specific validity testing has been performed. Third, it is possible that some truly planned readmissions began in the ED. This situation may arise at small hospitals. However, we found that most of the planned readmissions that started in the ED had secondary diagnosis codes associated with acute conditions. In addition, we did not find a disproportionate number of potentially misclassified planned readmissions at small hospitals. Fourth, the association between high readmission rates and poor quality of care has been called into question recently. However, the purpose of this study is not to assess the quality of healthcare provided by these hospitals; our intent is to explore opportunities to improve the HRRP planned readmission algorithm. Fifth, our analysis only included the state of Michigan. However, Michigan is 1 of the 10 largest states by population, and we do not expect significant differences between our data and the rest of the country. Sixth, we conducted this analysis with version 3.0 of the CMS readmission algorithm. The latest version (4.0) has made several substantial changes to reduce the number of potentially misclassified planned readmissions. However, neither admission type nor presence of ED charges are considered in the updated version. Therefore, our study provides another potential target for further improvement.

These limitations notwithstanding, these findings have important implications for key stakeholders. Relevant to policymakers, the finding that a large percentage of the planned readmissions had ED charges and/or emergent/urgent admission claim type suggests that CMS should explore the use of these variables in their readmission algorithm. Relevant to hospitals and physicians, the potential misclassification of some planned readmissions suggests that close evaluation of the sources and causes of readmission is imperative during the local development of readmission reduction initiatives.

Collectively, these findings suggest that although planned readmissions are infrequent, many of these planned readmissions may actually be nonelective or unplanned in nature. Furthermore, our findings suggest that the CMS readmission algorithm might improve its accuracy by considering the admission type and the presence of ED charges. Future research in this area should focus on validating the use of ED charges and admission type to identify unplanned readmissions through medical chart review. The aim of the HRRP is to identify signals of poor quality in a fair and equitable manner. Misclassification of readmissions will limit CMS’ ability to achieve this important goal.

Disclosure

None of the authors have any conflicts of interest to disclose.