During the past 45 years, the cesarean delivery (CD) rate in the United States has increased from 5.5% in 1970 to 33% from 2009 to 2013, followed by a small decrease to 32% in 2014 and 2015.¹ Many clinical problems cause clinicians and patients to decide that CD is an optimal birth route, including: abnormal labor progress, abnormal or indeterminate fetal heart rate pattern, breech presentation, multiple gestation, macrosomia, placental and cord abnormalities, preeclampsia, prior uterine surgery, and prior CD.² Recent secular trends that contribute to the current rate of CD include an adversarial liability environment,^3,4 increasing rates of maternal obesity,⁵ and widespread use of continuous fetal-heart monitoring during labor.⁶

Wide variation in CD rate has been reported among countries, states, and hospitals. The variation is due, in part, to different perspectives about balancing the harms and benefits of vaginal delivery versus CD. In Europe, in 2010 the CD rates in Sweden and Italy were 17.1% and 38%, respectively.⁷ In 2010, among the states, Alaska had the lowest rate of CD at 22% and Kentucky had the highest rate at 40%.⁸ In 2015, the highest rate was 38%, in Mississippi (FIGURE).⁹ In 2014, among Massachusetts hospitals with more than 2,500 births, the CD rate ranged from a low of 22% to a high of 37%.¹⁰

Clinicians, patients, policy experts, and the media are perplexed and troubled by the “high” US CD rate and the major variation in rate among countries, states, and hospitals. Labor management practices likely influence the rate of CD and diverse approaches to labor management likely account for the wide variation in CD rates.

A nationwide effort to standardize and continuously improve labor management might result in a decrease in the CD rate. Building on this opportunity, the American College of Obstetricians and Gynecologists (ACOG) and the Society of Maternal-Fetal Medicine (SMFM) have jointly recommended new labor management guidelines that may reduce the primary CD rate.⁸

The ACOG/SMFM guidelines encourage obstetricians to extend the time for labor progress in both the 1st and 2nd stages prior to recommending a CD.⁸ These new guidelines emphasize that for a modern obstetrician, patience is a virtue. There are 2 important caveats to this statement: to safely extend the length of time of labor requires both (1) a reassuring fetal heart rate tracing and (2) stable maternal health. If the fetus demonstrates a persistent worrisome Category II or a Category IIIheart-rate tracing, decisive intervention is necessary and permitting an extended labor would not be optimal. Similarly, if the mother has rapidly worsening preeclampsia it may not be wise to extend an induction of labor (IOL) over many days.

There are risks with extending the length of labor. An extended duration of the 1st stage of labor is associated with an increased rate of maternal chorioamnionitis and shoulder dystocia at birth.¹¹ An extended duration of the 2nd stage of labor is associated with an increase in the rate of maternal chorioamnionitis, anal sphincter injury, uterine atony, and neonatal admission to an intensive care unit.¹² Clinicians who adopt practices that permit an extended length of labor must weigh the benefits of avoiding a CD against these maternal and fetal complications.

Active phase redefined

Central to the ACOG/SMFM guidelines is a new definition of the active phase of labor. The research of Dr. Emmanuel Friedman indicated that at approximately 4 cm of cervical dilation many women in labor transition from the latent phase, a time of slow change in cervical dilation, to the active phase, a time of more rapid change in cervical dilation.^13,14 However, more recent research indicates that the transition between the latent and active phase is difficult to precisely define, but more often occurs at about 6 cm of cervical dilation and not 4 cm of dilation.¹⁵ Adopting these new norms means that laboring women will spend much more time in the latent phase, a phase of labor in which patience is a virtue.

The ACOG/SMFM guidelines

Main takeaways from the ACOG/SMFM guidelines are summarized below. Interventions that address common obstetric issues and labor abnormalities are outlined below.

Do not perform CD for a prolonged latent phase of labor, defined as regular contractions of >20 hours duration in nulliparous women and >14 hours duration in multiparous women. Patience with a prolonged latent phase will be rewarded by the majority of women entering the active phase of labor. Alternatively, if appropriate, cervical ripening followed by oxytocin IOL and amniotomy will help the patient with a prolonged latent phase to enter the active phase of labor.¹⁶

For women with an unfavorable cervix as assessed by the Bishop score, cervical ripening should be performed prior to IOL. Use of cervical ripening prior to IOL increases the chance of achieving vaginal delivery within 24 hours and may result in a modest decrease in the rate of CD.^17,18

Related article:
Should oxytocin and a Foley catheter be used concurrently for cervical ripening in induction of labor?
 

Failed IOL in the latent phase should only be diagnosed following 12 to 18 hours of both ruptured membranes and adequate contractions stimulated with oxytocin. The key ingredients for the successful management of the latent phase of labor are patience, oxytocin, and amniotomy.¹⁶

CD for the indication of active phase arrest requires cervical dilation ≥6 cm with ruptured membranes and no change in cervical dilation for ≥4 hours of adequate uterine activity. In the past, most obstetricians defined active phase arrest, a potential indication for CD, as the absence of cervical change for 2 or more hours in the presence of adequate uterine contractions and cervical dilation of at least 4 cm. Given the new definition of active phase arrest, slow but progressive progress in the 1st stage of labor is not an indication for CD.^11,19

“A specific absolute maximum length of time spent in the 2nd stage beyond which all women should be offered an operative delivery has not been identified.”⁸ Diagnosis of arrest of labor in the 2nd stage may be considered after at least 2 hours of pushing in multiparous women and 3 hours of pushing in nulliparous women, especially if no fetal descent is occurring. The guidelines also state “longer durations may be appropriate on an individualized basis (eg, with use of epidural analgesia or with fetal malposition)” as long as fetal descent is observed.

Patience is a virtue, especially in the management of the 2nd stage of labor. Extending the 2nd stage up to 4 hours appears to be reasonably safe if the fetal status is reassuring and the mother is physiologically stable. In a study from San Francisco of 42,268 births with normal newborn outcomes, the 95th percentile for the length of the 2nd stage of labor for nulliparous women was 3.3 hours without an epidural and 5.6 hours with an epidural.²⁰

In a study of 53,285 births, longer duration of pushing was associated with a small increase in the rate of neonatal adverse outcomes. In nulliparous women the rate of adverse neonatal outcomes increased from 1.3% with less than 60 minutes of pushing to 2.4% with greater than 240 minutes of pushing. Remarkably, even after 4 hours of pushing, 78% of nulliparous women who continued to push had a vaginal delivery.²¹ In this study, among nulliparous women the rate of anal sphincter injury increased from 5% with less than 60 minutes of pushing to 16% with greater than 240 minutes of pushing, and the rate of postpartum hemorrhage increased from 1% with less than 60 minutes of pushing to 3.3% with greater than 240 minutes of pushing.

I am not enthusiastic about patiently watching a labor extend into the 5th hour of the 2nd stage, especially if the fetus is at +2 station or lower. In a nulliparous woman, after 4 hours of managing the 2nd stage of labor, my patience is exhausted and I am inclined to identify a clear plan for delivery, either by enhanced labor coaching, operative vaginal delivery, or CD.

Operative vaginal delivery in the 2nd stage of labor is an acceptable alternative to CD. The rate of operative vaginal delivery in the United States has declined over the past 2 decades (TABLE). In Sweden in 2010 the operative vaginal delivery rate was 7.6% with a CD rate of 17.1%.⁷ In the United States in 2010 the operative delivery rate was 3.6%, and the CD rate was 33%.¹ A renewed focus on operative vaginal delivery with ongoing training and team simulation for the procedure would increase our use of operative delivery and decrease the overall rate of CD.

Related article:
STOP using instruments to assist with delivery of the head at cesarean
 

Encourage the detection of persistent fetal occiput posterior position by physical examination and/or ultrasound and consider manual rotation of the fetal occiput from the posterior to anterior position in the 2nd stage. Persistent occiput posterior is the most common fetal malposition.²² This malposition is associated with an increased rate of CD.²³ There are few randomized trials of manual rotation of the fetal occiput from posterior to anterior position in the 2nd stage of labor, and the evidence is insufficient to determine the efficacy of manual rotation.²⁴ Small nonrandomized studies report that manual rotation of the occiput from posterior to anterior position may reduce the CD rate.^25–27

For persistent 2nd stage fetal occiput posterior position in a woman with an adequate pelvis, where manual rotation was not successful and the fetus is at +2 station or below, operative vaginal delivery is an option. “Vacuum or forceps?” and “If forceps, to rotate or not to rotate?” those are the clinical questions. Forceps delivery is more likely to be successfulthan vacuum delivery.²⁸ Direct forceps delivery of the occiput posterior fetus is associated with more anal sphincter injuries than forceps delivery after successful rotation, but few clinicians regularly perform rotational forceps.²⁹ In a study of 2,351 women in the 2nd stage of labor with the fetus at +2 station or below, compared with either forceps or vacuum delivery, CD was associated with more maternal infections and fewer perineal lacerations. Neonatal composite morbidity was not significantly different among the 3 routes of operative delivery.³⁰

Amnioinfusion for repetitive variable decelerations of the fetal heart rate may reduce the risk of CD for an indeterminate fetal heart-rate pattern.³¹

IOL in a well-dated pregnancy at 41 weeks will reduce the risk of CD. In a large clinical trial, 3,407 women at 41 weeks of gestation were randomly assigned to IOL or expectant management. The rate of CD was significantly lower in the women assigned to IOL compared with expectant management (21% vs 25%, respectively; P = .03).³² The rate of neonatal morbidity was similar in the 2 groups.

Women with twin gestations and the first twin in a cephalic presentation may elect vaginal delivery. In a large clinical trial, 1,398 women with a twin gestation and the first twin in a cephalic presentation were randomly assigned to planned vaginal delivery (with cesarean only if necessary) or planned CD.³³ The rate of CD was 44% and 91% for the women in the planned-vaginal and planned-cesarean groups, respectively. There was no significant difference in composite fetal or neonatal death or serious morbidity. The authors concluded that, for twin pregnancy with the presenting twin in the cephalic presentation, there were no demonstrated benefits of planned CD.

Develop maternity care systems that encourage the use of trial of labor after cesarean (TOLAC). The ACOG/SMFM guidelines focus on interventions to reduce the rate of primary CD and do not address the role of TOLAC in reducing CD rates. There are little data from clinical trials to assess the benefits and harms from TOLAC versus scheduled repeat CD.³⁴ However, our experience with TOLAC in the 1990s strongly suggests that encouraging TOLAC will decrease the rate of CD. In 1996 the US rate of vaginal birth after cesarean (VBAC) peaked at 28%, and the rate of CD achieved a recent historic nadir of 21%. Growing concerns that TOLAC occasionally results in fetal harm was followed by a decrease in the VBAC rate to 12% in 2015.¹ A recent study of obstetric practices in countries with high and low VBAC rates concluded that patient and clinician commitment and comfort with prioritizing TOLAC over scheduled repeat CD greatly influenced the VBAC rate.³⁵

Related article:
Should lower uterine segment thickness measurement be included in the TOLAC decision-making process?

Labor management is an art

During labor obstetricians must balance the unique needs of mother and fetus, which requires great clinical skill and patience. Evolving concepts of normal labor progress necessitate that we change our expectations concerning the acceptable rate of progress in the 1st and 2nd stage of labor. Consistent application of these new labor guidelines may help to reduce the rate of CD.

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

During the past 45 years, the cesarean delivery (CD) rate in the United States has increased from 5.5% in 1970 to 33% from 2009 to 2013, followed by a small decrease to 32% in 2014 and 2015.¹ Many clinical problems cause clinicians and patients to decide that CD is an optimal birth route, including: abnormal labor progress, abnormal or indeterminate fetal heart rate pattern, breech presentation, multiple gestation, macrosomia, placental and cord abnormalities, preeclampsia, prior uterine surgery, and prior CD.² Recent secular trends that contribute to the current rate of CD include an adversarial liability environment,^3,4 increasing rates of maternal obesity,⁵ and widespread use of continuous fetal-heart monitoring during labor.⁶

Wide variation in CD rate has been reported among countries, states, and hospitals. The variation is due, in part, to different perspectives about balancing the harms and benefits of vaginal delivery versus CD. In Europe, in 2010 the CD rates in Sweden and Italy were 17.1% and 38%, respectively.⁷ In 2010, among the states, Alaska had the lowest rate of CD at 22% and Kentucky had the highest rate at 40%.⁸ In 2015, the highest rate was 38%, in Mississippi (FIGURE).⁹ In 2014, among Massachusetts hospitals with more than 2,500 births, the CD rate ranged from a low of 22% to a high of 37%.¹⁰

Clinicians, patients, policy experts, and the media are perplexed and troubled by the “high” US CD rate and the major variation in rate among countries, states, and hospitals. Labor management practices likely influence the rate of CD and diverse approaches to labor management likely account for the wide variation in CD rates.

A nationwide effort to standardize and continuously improve labor management might result in a decrease in the CD rate. Building on this opportunity, the American College of Obstetricians and Gynecologists (ACOG) and the Society of Maternal-Fetal Medicine (SMFM) have jointly recommended new labor management guidelines that may reduce the primary CD rate.⁸

The ACOG/SMFM guidelines encourage obstetricians to extend the time for labor progress in both the 1st and 2nd stages prior to recommending a CD.⁸ These new guidelines emphasize that for a modern obstetrician, patience is a virtue. There are 2 important caveats to this statement: to safely extend the length of time of labor requires both (1) a reassuring fetal heart rate tracing and (2) stable maternal health. If the fetus demonstrates a persistent worrisome Category II or a Category IIIheart-rate tracing, decisive intervention is necessary and permitting an extended labor would not be optimal. Similarly, if the mother has rapidly worsening preeclampsia it may not be wise to extend an induction of labor (IOL) over many days.

There are risks with extending the length of labor. An extended duration of the 1st stage of labor is associated with an increased rate of maternal chorioamnionitis and shoulder dystocia at birth.¹¹ An extended duration of the 2nd stage of labor is associated with an increase in the rate of maternal chorioamnionitis, anal sphincter injury, uterine atony, and neonatal admission to an intensive care unit.¹² Clinicians who adopt practices that permit an extended length of labor must weigh the benefits of avoiding a CD against these maternal and fetal complications.

Active phase redefined

Central to the ACOG/SMFM guidelines is a new definition of the active phase of labor. The research of Dr. Emmanuel Friedman indicated that at approximately 4 cm of cervical dilation many women in labor transition from the latent phase, a time of slow change in cervical dilation, to the active phase, a time of more rapid change in cervical dilation.^13,14 However, more recent research indicates that the transition between the latent and active phase is difficult to precisely define, but more often occurs at about 6 cm of cervical dilation and not 4 cm of dilation.¹⁵ Adopting these new norms means that laboring women will spend much more time in the latent phase, a phase of labor in which patience is a virtue.

The ACOG/SMFM guidelines

Main takeaways from the ACOG/SMFM guidelines are summarized below. Interventions that address common obstetric issues and labor abnormalities are outlined below.

Do not perform CD for a prolonged latent phase of labor, defined as regular contractions of >20 hours duration in nulliparous women and >14 hours duration in multiparous women. Patience with a prolonged latent phase will be rewarded by the majority of women entering the active phase of labor. Alternatively, if appropriate, cervical ripening followed by oxytocin IOL and amniotomy will help the patient with a prolonged latent phase to enter the active phase of labor.¹⁶

For women with an unfavorable cervix as assessed by the Bishop score, cervical ripening should be performed prior to IOL. Use of cervical ripening prior to IOL increases the chance of achieving vaginal delivery within 24 hours and may result in a modest decrease in the rate of CD.^17,18

Related article:
Should oxytocin and a Foley catheter be used concurrently for cervical ripening in induction of labor?
 

Failed IOL in the latent phase should only be diagnosed following 12 to 18 hours of both ruptured membranes and adequate contractions stimulated with oxytocin. The key ingredients for the successful management of the latent phase of labor are patience, oxytocin, and amniotomy.¹⁶

CD for the indication of active phase arrest requires cervical dilation ≥6 cm with ruptured membranes and no change in cervical dilation for ≥4 hours of adequate uterine activity. In the past, most obstetricians defined active phase arrest, a potential indication for CD, as the absence of cervical change for 2 or more hours in the presence of adequate uterine contractions and cervical dilation of at least 4 cm. Given the new definition of active phase arrest, slow but progressive progress in the 1st stage of labor is not an indication for CD.^11,19

“A specific absolute maximum length of time spent in the 2nd stage beyond which all women should be offered an operative delivery has not been identified.”⁸ Diagnosis of arrest of labor in the 2nd stage may be considered after at least 2 hours of pushing in multiparous women and 3 hours of pushing in nulliparous women, especially if no fetal descent is occurring. The guidelines also state “longer durations may be appropriate on an individualized basis (eg, with use of epidural analgesia or with fetal malposition)” as long as fetal descent is observed.

Patience is a virtue, especially in the management of the 2nd stage of labor. Extending the 2nd stage up to 4 hours appears to be reasonably safe if the fetal status is reassuring and the mother is physiologically stable. In a study from San Francisco of 42,268 births with normal newborn outcomes, the 95th percentile for the length of the 2nd stage of labor for nulliparous women was 3.3 hours without an epidural and 5.6 hours with an epidural.²⁰

In a study of 53,285 births, longer duration of pushing was associated with a small increase in the rate of neonatal adverse outcomes. In nulliparous women the rate of adverse neonatal outcomes increased from 1.3% with less than 60 minutes of pushing to 2.4% with greater than 240 minutes of pushing. Remarkably, even after 4 hours of pushing, 78% of nulliparous women who continued to push had a vaginal delivery.²¹ In this study, among nulliparous women the rate of anal sphincter injury increased from 5% with less than 60 minutes of pushing to 16% with greater than 240 minutes of pushing, and the rate of postpartum hemorrhage increased from 1% with less than 60 minutes of pushing to 3.3% with greater than 240 minutes of pushing.

I am not enthusiastic about patiently watching a labor extend into the 5th hour of the 2nd stage, especially if the fetus is at +2 station or lower. In a nulliparous woman, after 4 hours of managing the 2nd stage of labor, my patience is exhausted and I am inclined to identify a clear plan for delivery, either by enhanced labor coaching, operative vaginal delivery, or CD.

Operative vaginal delivery in the 2nd stage of labor is an acceptable alternative to CD. The rate of operative vaginal delivery in the United States has declined over the past 2 decades (TABLE). In Sweden in 2010 the operative vaginal delivery rate was 7.6% with a CD rate of 17.1%.⁷ In the United States in 2010 the operative delivery rate was 3.6%, and the CD rate was 33%.¹ A renewed focus on operative vaginal delivery with ongoing training and team simulation for the procedure would increase our use of operative delivery and decrease the overall rate of CD.

Related article:
STOP using instruments to assist with delivery of the head at cesarean
 

Encourage the detection of persistent fetal occiput posterior position by physical examination and/or ultrasound and consider manual rotation of the fetal occiput from the posterior to anterior position in the 2nd stage. Persistent occiput posterior is the most common fetal malposition.²² This malposition is associated with an increased rate of CD.²³ There are few randomized trials of manual rotation of the fetal occiput from posterior to anterior position in the 2nd stage of labor, and the evidence is insufficient to determine the efficacy of manual rotation.²⁴ Small nonrandomized studies report that manual rotation of the occiput from posterior to anterior position may reduce the CD rate.^25–27

For persistent 2nd stage fetal occiput posterior position in a woman with an adequate pelvis, where manual rotation was not successful and the fetus is at +2 station or below, operative vaginal delivery is an option. “Vacuum or forceps?” and “If forceps, to rotate or not to rotate?” those are the clinical questions. Forceps delivery is more likely to be successfulthan vacuum delivery.²⁸ Direct forceps delivery of the occiput posterior fetus is associated with more anal sphincter injuries than forceps delivery after successful rotation, but few clinicians regularly perform rotational forceps.²⁹ In a study of 2,351 women in the 2nd stage of labor with the fetus at +2 station or below, compared with either forceps or vacuum delivery, CD was associated with more maternal infections and fewer perineal lacerations. Neonatal composite morbidity was not significantly different among the 3 routes of operative delivery.³⁰

Amnioinfusion for repetitive variable decelerations of the fetal heart rate may reduce the risk of CD for an indeterminate fetal heart-rate pattern.³¹

IOL in a well-dated pregnancy at 41 weeks will reduce the risk of CD. In a large clinical trial, 3,407 women at 41 weeks of gestation were randomly assigned to IOL or expectant management. The rate of CD was significantly lower in the women assigned to IOL compared with expectant management (21% vs 25%, respectively; P = .03).³² The rate of neonatal morbidity was similar in the 2 groups.

Women with twin gestations and the first twin in a cephalic presentation may elect vaginal delivery. In a large clinical trial, 1,398 women with a twin gestation and the first twin in a cephalic presentation were randomly assigned to planned vaginal delivery (with cesarean only if necessary) or planned CD.³³ The rate of CD was 44% and 91% for the women in the planned-vaginal and planned-cesarean groups, respectively. There was no significant difference in composite fetal or neonatal death or serious morbidity. The authors concluded that, for twin pregnancy with the presenting twin in the cephalic presentation, there were no demonstrated benefits of planned CD.

Develop maternity care systems that encourage the use of trial of labor after cesarean (TOLAC). The ACOG/SMFM guidelines focus on interventions to reduce the rate of primary CD and do not address the role of TOLAC in reducing CD rates. There are little data from clinical trials to assess the benefits and harms from TOLAC versus scheduled repeat CD.³⁴ However, our experience with TOLAC in the 1990s strongly suggests that encouraging TOLAC will decrease the rate of CD. In 1996 the US rate of vaginal birth after cesarean (VBAC) peaked at 28%, and the rate of CD achieved a recent historic nadir of 21%. Growing concerns that TOLAC occasionally results in fetal harm was followed by a decrease in the VBAC rate to 12% in 2015.¹ A recent study of obstetric practices in countries with high and low VBAC rates concluded that patient and clinician commitment and comfort with prioritizing TOLAC over scheduled repeat CD greatly influenced the VBAC rate.³⁵

Related article:
Should lower uterine segment thickness measurement be included in the TOLAC decision-making process?

Labor management is an art

During labor obstetricians must balance the unique needs of mother and fetus, which requires great clinical skill and patience. Evolving concepts of normal labor progress necessitate that we change our expectations concerning the acceptable rate of progress in the 1st and 2nd stage of labor. Consistent application of these new labor guidelines may help to reduce the rate of CD.

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

During the past 45 years, the cesarean delivery (CD) rate in the United States has increased from 5.5% in 1970 to 33% from 2009 to 2013, followed by a small decrease to 32% in 2014 and 2015.¹ Many clinical problems cause clinicians and patients to decide that CD is an optimal birth route, including: abnormal labor progress, abnormal or indeterminate fetal heart rate pattern, breech presentation, multiple gestation, macrosomia, placental and cord abnormalities, preeclampsia, prior uterine surgery, and prior CD.² Recent secular trends that contribute to the current rate of CD include an adversarial liability environment,^3,4 increasing rates of maternal obesity,⁵ and widespread use of continuous fetal-heart monitoring during labor.⁶

Wide variation in CD rate has been reported among countries, states, and hospitals. The variation is due, in part, to different perspectives about balancing the harms and benefits of vaginal delivery versus CD. In Europe, in 2010 the CD rates in Sweden and Italy were 17.1% and 38%, respectively.⁷ In 2010, among the states, Alaska had the lowest rate of CD at 22% and Kentucky had the highest rate at 40%.⁸ In 2015, the highest rate was 38%, in Mississippi (FIGURE).⁹ In 2014, among Massachusetts hospitals with more than 2,500 births, the CD rate ranged from a low of 22% to a high of 37%.¹⁰

Clinicians, patients, policy experts, and the media are perplexed and troubled by the “high” US CD rate and the major variation in rate among countries, states, and hospitals. Labor management practices likely influence the rate of CD and diverse approaches to labor management likely account for the wide variation in CD rates.

A nationwide effort to standardize and continuously improve labor management might result in a decrease in the CD rate. Building on this opportunity, the American College of Obstetricians and Gynecologists (ACOG) and the Society of Maternal-Fetal Medicine (SMFM) have jointly recommended new labor management guidelines that may reduce the primary CD rate.⁸

The ACOG/SMFM guidelines encourage obstetricians to extend the time for labor progress in both the 1st and 2nd stages prior to recommending a CD.⁸ These new guidelines emphasize that for a modern obstetrician, patience is a virtue. There are 2 important caveats to this statement: to safely extend the length of time of labor requires both (1) a reassuring fetal heart rate tracing and (2) stable maternal health. If the fetus demonstrates a persistent worrisome Category II or a Category IIIheart-rate tracing, decisive intervention is necessary and permitting an extended labor would not be optimal. Similarly, if the mother has rapidly worsening preeclampsia it may not be wise to extend an induction of labor (IOL) over many days.

There are risks with extending the length of labor. An extended duration of the 1st stage of labor is associated with an increased rate of maternal chorioamnionitis and shoulder dystocia at birth.¹¹ An extended duration of the 2nd stage of labor is associated with an increase in the rate of maternal chorioamnionitis, anal sphincter injury, uterine atony, and neonatal admission to an intensive care unit.¹² Clinicians who adopt practices that permit an extended length of labor must weigh the benefits of avoiding a CD against these maternal and fetal complications.

Active phase redefined

Central to the ACOG/SMFM guidelines is a new definition of the active phase of labor. The research of Dr. Emmanuel Friedman indicated that at approximately 4 cm of cervical dilation many women in labor transition from the latent phase, a time of slow change in cervical dilation, to the active phase, a time of more rapid change in cervical dilation.^13,14 However, more recent research indicates that the transition between the latent and active phase is difficult to precisely define, but more often occurs at about 6 cm of cervical dilation and not 4 cm of dilation.¹⁵ Adopting these new norms means that laboring women will spend much more time in the latent phase, a phase of labor in which patience is a virtue.

The ACOG/SMFM guidelines

Main takeaways from the ACOG/SMFM guidelines are summarized below. Interventions that address common obstetric issues and labor abnormalities are outlined below.

Do not perform CD for a prolonged latent phase of labor, defined as regular contractions of >20 hours duration in nulliparous women and >14 hours duration in multiparous women. Patience with a prolonged latent phase will be rewarded by the majority of women entering the active phase of labor. Alternatively, if appropriate, cervical ripening followed by oxytocin IOL and amniotomy will help the patient with a prolonged latent phase to enter the active phase of labor.¹⁶

For women with an unfavorable cervix as assessed by the Bishop score, cervical ripening should be performed prior to IOL. Use of cervical ripening prior to IOL increases the chance of achieving vaginal delivery within 24 hours and may result in a modest decrease in the rate of CD.^17,18

Related article:
Should oxytocin and a Foley catheter be used concurrently for cervical ripening in induction of labor?
 

Failed IOL in the latent phase should only be diagnosed following 12 to 18 hours of both ruptured membranes and adequate contractions stimulated with oxytocin. The key ingredients for the successful management of the latent phase of labor are patience, oxytocin, and amniotomy.¹⁶

CD for the indication of active phase arrest requires cervical dilation ≥6 cm with ruptured membranes and no change in cervical dilation for ≥4 hours of adequate uterine activity. In the past, most obstetricians defined active phase arrest, a potential indication for CD, as the absence of cervical change for 2 or more hours in the presence of adequate uterine contractions and cervical dilation of at least 4 cm. Given the new definition of active phase arrest, slow but progressive progress in the 1st stage of labor is not an indication for CD.^11,19

“A specific absolute maximum length of time spent in the 2nd stage beyond which all women should be offered an operative delivery has not been identified.”⁸ Diagnosis of arrest of labor in the 2nd stage may be considered after at least 2 hours of pushing in multiparous women and 3 hours of pushing in nulliparous women, especially if no fetal descent is occurring. The guidelines also state “longer durations may be appropriate on an individualized basis (eg, with use of epidural analgesia or with fetal malposition)” as long as fetal descent is observed.

Patience is a virtue, especially in the management of the 2nd stage of labor. Extending the 2nd stage up to 4 hours appears to be reasonably safe if the fetal status is reassuring and the mother is physiologically stable. In a study from San Francisco of 42,268 births with normal newborn outcomes, the 95th percentile for the length of the 2nd stage of labor for nulliparous women was 3.3 hours without an epidural and 5.6 hours with an epidural.²⁰

In a study of 53,285 births, longer duration of pushing was associated with a small increase in the rate of neonatal adverse outcomes. In nulliparous women the rate of adverse neonatal outcomes increased from 1.3% with less than 60 minutes of pushing to 2.4% with greater than 240 minutes of pushing. Remarkably, even after 4 hours of pushing, 78% of nulliparous women who continued to push had a vaginal delivery.²¹ In this study, among nulliparous women the rate of anal sphincter injury increased from 5% with less than 60 minutes of pushing to 16% with greater than 240 minutes of pushing, and the rate of postpartum hemorrhage increased from 1% with less than 60 minutes of pushing to 3.3% with greater than 240 minutes of pushing.

I am not enthusiastic about patiently watching a labor extend into the 5th hour of the 2nd stage, especially if the fetus is at +2 station or lower. In a nulliparous woman, after 4 hours of managing the 2nd stage of labor, my patience is exhausted and I am inclined to identify a clear plan for delivery, either by enhanced labor coaching, operative vaginal delivery, or CD.

Operative vaginal delivery in the 2nd stage of labor is an acceptable alternative to CD. The rate of operative vaginal delivery in the United States has declined over the past 2 decades (TABLE). In Sweden in 2010 the operative vaginal delivery rate was 7.6% with a CD rate of 17.1%.⁷ In the United States in 2010 the operative delivery rate was 3.6%, and the CD rate was 33%.¹ A renewed focus on operative vaginal delivery with ongoing training and team simulation for the procedure would increase our use of operative delivery and decrease the overall rate of CD.

Related article:
STOP using instruments to assist with delivery of the head at cesarean
 

Encourage the detection of persistent fetal occiput posterior position by physical examination and/or ultrasound and consider manual rotation of the fetal occiput from the posterior to anterior position in the 2nd stage. Persistent occiput posterior is the most common fetal malposition.²² This malposition is associated with an increased rate of CD.²³ There are few randomized trials of manual rotation of the fetal occiput from posterior to anterior position in the 2nd stage of labor, and the evidence is insufficient to determine the efficacy of manual rotation.²⁴ Small nonrandomized studies report that manual rotation of the occiput from posterior to anterior position may reduce the CD rate.^25–27

For persistent 2nd stage fetal occiput posterior position in a woman with an adequate pelvis, where manual rotation was not successful and the fetus is at +2 station or below, operative vaginal delivery is an option. “Vacuum or forceps?” and “If forceps, to rotate or not to rotate?” those are the clinical questions. Forceps delivery is more likely to be successfulthan vacuum delivery.²⁸ Direct forceps delivery of the occiput posterior fetus is associated with more anal sphincter injuries than forceps delivery after successful rotation, but few clinicians regularly perform rotational forceps.²⁹ In a study of 2,351 women in the 2nd stage of labor with the fetus at +2 station or below, compared with either forceps or vacuum delivery, CD was associated with more maternal infections and fewer perineal lacerations. Neonatal composite morbidity was not significantly different among the 3 routes of operative delivery.³⁰

Amnioinfusion for repetitive variable decelerations of the fetal heart rate may reduce the risk of CD for an indeterminate fetal heart-rate pattern.³¹

IOL in a well-dated pregnancy at 41 weeks will reduce the risk of CD. In a large clinical trial, 3,407 women at 41 weeks of gestation were randomly assigned to IOL or expectant management. The rate of CD was significantly lower in the women assigned to IOL compared with expectant management (21% vs 25%, respectively; P = .03).³² The rate of neonatal morbidity was similar in the 2 groups.

Women with twin gestations and the first twin in a cephalic presentation may elect vaginal delivery. In a large clinical trial, 1,398 women with a twin gestation and the first twin in a cephalic presentation were randomly assigned to planned vaginal delivery (with cesarean only if necessary) or planned CD.³³ The rate of CD was 44% and 91% for the women in the planned-vaginal and planned-cesarean groups, respectively. There was no significant difference in composite fetal or neonatal death or serious morbidity. The authors concluded that, for twin pregnancy with the presenting twin in the cephalic presentation, there were no demonstrated benefits of planned CD.

Develop maternity care systems that encourage the use of trial of labor after cesarean (TOLAC). The ACOG/SMFM guidelines focus on interventions to reduce the rate of primary CD and do not address the role of TOLAC in reducing CD rates. There are little data from clinical trials to assess the benefits and harms from TOLAC versus scheduled repeat CD.³⁴ However, our experience with TOLAC in the 1990s strongly suggests that encouraging TOLAC will decrease the rate of CD. In 1996 the US rate of vaginal birth after cesarean (VBAC) peaked at 28%, and the rate of CD achieved a recent historic nadir of 21%. Growing concerns that TOLAC occasionally results in fetal harm was followed by a decrease in the VBAC rate to 12% in 2015.¹ A recent study of obstetric practices in countries with high and low VBAC rates concluded that patient and clinician commitment and comfort with prioritizing TOLAC over scheduled repeat CD greatly influenced the VBAC rate.³⁵

Related article:
Should lower uterine segment thickness measurement be included in the TOLAC decision-making process?

Labor management is an art

During labor obstetricians must balance the unique needs of mother and fetus, which requires great clinical skill and patience. Evolving concepts of normal labor progress necessitate that we change our expectations concerning the acceptable rate of progress in the 1st and 2nd stage of labor. Consistent application of these new labor guidelines may help to reduce the rate of CD.

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

Free water in the posterior substantia nigra brain region increased as clinical Parkinson’s disease progressed in a 4-year longitudinal study of participants in the Parkinson’s Progression Markers Initiative.

Free water in this brain region is measurable via diffusion MRI, and this study – the first to look at free water in Parkinson’s patients across this time frame – suggests it to be a viable biomarker of disease progression that could be used in clinical trials evaluating Parkinson’s therapies.

Image courtesy of David Vaillancourt, PhD, University of Florida

Free water in the posterior substantia nigra brain region increased as clinical Parkinson’s disease progressed in a 4-year longitudinal study of participants in the Parkinson’s Progression Markers Initiative.

Free water in this brain region is measurable via diffusion MRI, and this study – the first to look at free water in Parkinson’s patients across this time frame – suggests it to be a viable biomarker of disease progression that could be used in clinical trials evaluating Parkinson’s therapies.

Image courtesy of David Vaillancourt, PhD, University of Florida

Free water in the posterior substantia nigra brain region increased as clinical Parkinson’s disease progressed in a 4-year longitudinal study of participants in the Parkinson’s Progression Markers Initiative.

Free water in this brain region is measurable via diffusion MRI, and this study – the first to look at free water in Parkinson’s patients across this time frame – suggests it to be a viable biomarker of disease progression that could be used in clinical trials evaluating Parkinson’s therapies.

Image courtesy of David Vaillancourt, PhD, University of Florida

BOSTON – Many selected patients with low- or intermediate-risk differentiated thyroid cancer who have had excellent or good responses to their treatment may be able to safely transition to follow-up monitoring at longer intervals, Bryan R. Haugen, MD, suggested in a keynote lecture during the World Congress on Thyroid Cancer.

Traditionally, thyroid cancer specialists have monitored these patients for persistent or recurrent disease as often as every 6 or 12 months. “But what we’ve realized with recent assessments of response to treatment is that some patients do well without a recurrence over many years; so, the concept of doing less monitoring and less imaging, especially in patients with an excellent response [to their initial treatment], is being studied,” Dr. Haugen said in a video interview following his talk.

He estimated that perhaps two-thirds or as many as three-quarters of patients with differentiated thyroid cancer fall into the category of having low- or intermediate-risk disease with an excellent or good response to treatment, and hence they are potential candidates for eventually transitioning to less frequent follow-up.

During his talk, Dr. Haugen suggested that after several years with no sign of disease recurrence, lower-risk patients with an excellent treatment response may be able to stop undergoing regular monitoring, and those with a good treatment response may be able to safely have their monitoring intervals extended.

According to the most recent (2015) guidelines for differentiated thyroid cancer management from the American Thyroid Association, lower-risk patients with an excellent treatment response should have their serum thyroglobulin measured every 12-24 months and undergo an ultrasound examination every 3-5 years, while patients with a good response are targeted for serum thyroglobulin measurement annually with an ultrasound every 1-3 years (Thyroid. 2016 Jan;26[1]:1-133). Dr. Haugen chaired the expert panel that wrote these guidelines.

In another provocative suggestion, Dr. Haugen proposed that once well-responsive, lower-risk patients have remained disease free for several years, their less frequent follow-up monitoring could be continued by a primary care physician or another less specialized clinician.

At some time in the future, “a patient’s primary care physician could follow a simple tumor marker, thyroglobulin, maybe once every 5 years,” said Dr. Haugen, professor of medicine and head of the division of endocrinology, metabolism, and diabetes at the University of Colorado in Aurora. “At the University of Colorado, we use advanced-practice providers to do long-term follow-up” for lower-risk, treatment-responsive patients, he said.

BOSTON – Many selected patients with low- or intermediate-risk differentiated thyroid cancer who have had excellent or good responses to their treatment may be able to safely transition to follow-up monitoring at longer intervals, Bryan R. Haugen, MD, suggested in a keynote lecture during the World Congress on Thyroid Cancer.

Traditionally, thyroid cancer specialists have monitored these patients for persistent or recurrent disease as often as every 6 or 12 months. “But what we’ve realized with recent assessments of response to treatment is that some patients do well without a recurrence over many years; so, the concept of doing less monitoring and less imaging, especially in patients with an excellent response [to their initial treatment], is being studied,” Dr. Haugen said in a video interview following his talk.

He estimated that perhaps two-thirds or as many as three-quarters of patients with differentiated thyroid cancer fall into the category of having low- or intermediate-risk disease with an excellent or good response to treatment, and hence they are potential candidates for eventually transitioning to less frequent follow-up.

During his talk, Dr. Haugen suggested that after several years with no sign of disease recurrence, lower-risk patients with an excellent treatment response may be able to stop undergoing regular monitoring, and those with a good treatment response may be able to safely have their monitoring intervals extended.

According to the most recent (2015) guidelines for differentiated thyroid cancer management from the American Thyroid Association, lower-risk patients with an excellent treatment response should have their serum thyroglobulin measured every 12-24 months and undergo an ultrasound examination every 3-5 years, while patients with a good response are targeted for serum thyroglobulin measurement annually with an ultrasound every 1-3 years (Thyroid. 2016 Jan;26[1]:1-133). Dr. Haugen chaired the expert panel that wrote these guidelines.

In another provocative suggestion, Dr. Haugen proposed that once well-responsive, lower-risk patients have remained disease free for several years, their less frequent follow-up monitoring could be continued by a primary care physician or another less specialized clinician.

At some time in the future, “a patient’s primary care physician could follow a simple tumor marker, thyroglobulin, maybe once every 5 years,” said Dr. Haugen, professor of medicine and head of the division of endocrinology, metabolism, and diabetes at the University of Colorado in Aurora. “At the University of Colorado, we use advanced-practice providers to do long-term follow-up” for lower-risk, treatment-responsive patients, he said.

BOSTON – Many selected patients with low- or intermediate-risk differentiated thyroid cancer who have had excellent or good responses to their treatment may be able to safely transition to follow-up monitoring at longer intervals, Bryan R. Haugen, MD, suggested in a keynote lecture during the World Congress on Thyroid Cancer.

Traditionally, thyroid cancer specialists have monitored these patients for persistent or recurrent disease as often as every 6 or 12 months. “But what we’ve realized with recent assessments of response to treatment is that some patients do well without a recurrence over many years; so, the concept of doing less monitoring and less imaging, especially in patients with an excellent response [to their initial treatment], is being studied,” Dr. Haugen said in a video interview following his talk.

He estimated that perhaps two-thirds or as many as three-quarters of patients with differentiated thyroid cancer fall into the category of having low- or intermediate-risk disease with an excellent or good response to treatment, and hence they are potential candidates for eventually transitioning to less frequent follow-up.

During his talk, Dr. Haugen suggested that after several years with no sign of disease recurrence, lower-risk patients with an excellent treatment response may be able to stop undergoing regular monitoring, and those with a good treatment response may be able to safely have their monitoring intervals extended.

According to the most recent (2015) guidelines for differentiated thyroid cancer management from the American Thyroid Association, lower-risk patients with an excellent treatment response should have their serum thyroglobulin measured every 12-24 months and undergo an ultrasound examination every 3-5 years, while patients with a good response are targeted for serum thyroglobulin measurement annually with an ultrasound every 1-3 years (Thyroid. 2016 Jan;26[1]:1-133). Dr. Haugen chaired the expert panel that wrote these guidelines.

In another provocative suggestion, Dr. Haugen proposed that once well-responsive, lower-risk patients have remained disease free for several years, their less frequent follow-up monitoring could be continued by a primary care physician or another less specialized clinician.

At some time in the future, “a patient’s primary care physician could follow a simple tumor marker, thyroglobulin, maybe once every 5 years,” said Dr. Haugen, professor of medicine and head of the division of endocrinology, metabolism, and diabetes at the University of Colorado in Aurora. “At the University of Colorado, we use advanced-practice providers to do long-term follow-up” for lower-risk, treatment-responsive patients, he said.

The Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee approved licensure for Heplisav-B, a new two-dose recombinant hepatitis B vaccination, after voting that presented data proved the vaccine to be safe for adults 18 and over.

At an advisory meeting, after hearing testimony from government researchers and representatives of Dynavax Technologies Corporation, the manufacturer of Heplisav-B, 11 members voted to approve the drug, 1 member voted no, and 3 abstained.

There are more than 20,000 new infections each year, with a reported increase of 21% between 2014 and 2015, according to research presented by William Schaffner, MD, professor of preventative medicine and infectious diseases at Vanderbilt University, Nashville, Tenn.

There are two approved immunizations for hepatitis B: Engerix-B, manufactured by GlaxoSmithKline, and Recombivax HB, by Merck. Both are three-dose, recombinant vaccines produced from yeast cells.

Like the current vaccines, Heplisav-B is a recombinant hepatitis B surface antigen that is derived from yeast; however, this vaccine would be administered in two doses over 1 month, as opposed to three doses over 6 months as is the schedule for currently approved vaccines. Both manufacturing representatives and approving members of the committee stressed this as an important factor due to vaccination dropout rates.

“We have a problem with hepatitis B infections in this country as well as problems with the current vaccines,“ said John Ward, MD, director of the division of viral hepatitis at the Centers for Disease Control and Prevention, “and they happen in these populations where, in terms of data, both of those audiences have problems about going for the second and third dose.”

Patients that drop out before the third dose are at high risk of infection, as only 20%-50% of adults have the appropriate seroprotection after two doses. However, only 54% of patients in a vaccine safety Datalink study reported completing the vaccination series, with 81% reporting having received two doses, according to Dr. Schaffner.

While the committee did approve the safety research as sufficient to approve use of Heplisav-B in adults 18 years and older, members of the committee had an issue with the drug’s correlation with myocardial infarction.

In one of the studies presented, Heplisav-B’s acute myocardial infarction (AMI) events (14 patients) greatly outnumbered those of Engerix-B (1 patient), presenting an AMI relative risk of 6.97.

Dynavax representatives, in response to this concern, presented intention to conduct a postmarketing analysis of the risk of MI in patients who have been administered Heplisav-B, which committee members considered to be a crucial contingency for approval.

“I would like to say I am for the approval of this vaccine, I just think as a statistician that the safety was inconclusive,” said Mei-Ling Ting Lee, PhD, director of the Biostatistics and Risk Assessment Center at the University of Maryland. “But I think for the pharmacological vigilance plan, I think that it will be good to have specific analysis for the myocardial infarction and other risks.”

Courtesy Wikimedia Commons/FitzColinGerald/Creative Commons License

[email protected]

On Twitter @eaztweets

The Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee approved licensure for Heplisav-B, a new two-dose recombinant hepatitis B vaccination, after voting that presented data proved the vaccine to be safe for adults 18 and over.

At an advisory meeting, after hearing testimony from government researchers and representatives of Dynavax Technologies Corporation, the manufacturer of Heplisav-B, 11 members voted to approve the drug, 1 member voted no, and 3 abstained.

There are more than 20,000 new infections each year, with a reported increase of 21% between 2014 and 2015, according to research presented by William Schaffner, MD, professor of preventative medicine and infectious diseases at Vanderbilt University, Nashville, Tenn.

There are two approved immunizations for hepatitis B: Engerix-B, manufactured by GlaxoSmithKline, and Recombivax HB, by Merck. Both are three-dose, recombinant vaccines produced from yeast cells.

Like the current vaccines, Heplisav-B is a recombinant hepatitis B surface antigen that is derived from yeast; however, this vaccine would be administered in two doses over 1 month, as opposed to three doses over 6 months as is the schedule for currently approved vaccines. Both manufacturing representatives and approving members of the committee stressed this as an important factor due to vaccination dropout rates.

“We have a problem with hepatitis B infections in this country as well as problems with the current vaccines,“ said John Ward, MD, director of the division of viral hepatitis at the Centers for Disease Control and Prevention, “and they happen in these populations where, in terms of data, both of those audiences have problems about going for the second and third dose.”

Patients that drop out before the third dose are at high risk of infection, as only 20%-50% of adults have the appropriate seroprotection after two doses. However, only 54% of patients in a vaccine safety Datalink study reported completing the vaccination series, with 81% reporting having received two doses, according to Dr. Schaffner.

While the committee did approve the safety research as sufficient to approve use of Heplisav-B in adults 18 years and older, members of the committee had an issue with the drug’s correlation with myocardial infarction.

In one of the studies presented, Heplisav-B’s acute myocardial infarction (AMI) events (14 patients) greatly outnumbered those of Engerix-B (1 patient), presenting an AMI relative risk of 6.97.

Dynavax representatives, in response to this concern, presented intention to conduct a postmarketing analysis of the risk of MI in patients who have been administered Heplisav-B, which committee members considered to be a crucial contingency for approval.

“I would like to say I am for the approval of this vaccine, I just think as a statistician that the safety was inconclusive,” said Mei-Ling Ting Lee, PhD, director of the Biostatistics and Risk Assessment Center at the University of Maryland. “But I think for the pharmacological vigilance plan, I think that it will be good to have specific analysis for the myocardial infarction and other risks.”

Courtesy Wikimedia Commons/FitzColinGerald/Creative Commons License

[email protected]

On Twitter @eaztweets

The Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee approved licensure for Heplisav-B, a new two-dose recombinant hepatitis B vaccination, after voting that presented data proved the vaccine to be safe for adults 18 and over.

At an advisory meeting, after hearing testimony from government researchers and representatives of Dynavax Technologies Corporation, the manufacturer of Heplisav-B, 11 members voted to approve the drug, 1 member voted no, and 3 abstained.

There are more than 20,000 new infections each year, with a reported increase of 21% between 2014 and 2015, according to research presented by William Schaffner, MD, professor of preventative medicine and infectious diseases at Vanderbilt University, Nashville, Tenn.

There are two approved immunizations for hepatitis B: Engerix-B, manufactured by GlaxoSmithKline, and Recombivax HB, by Merck. Both are three-dose, recombinant vaccines produced from yeast cells.

Like the current vaccines, Heplisav-B is a recombinant hepatitis B surface antigen that is derived from yeast; however, this vaccine would be administered in two doses over 1 month, as opposed to three doses over 6 months as is the schedule for currently approved vaccines. Both manufacturing representatives and approving members of the committee stressed this as an important factor due to vaccination dropout rates.

“We have a problem with hepatitis B infections in this country as well as problems with the current vaccines,“ said John Ward, MD, director of the division of viral hepatitis at the Centers for Disease Control and Prevention, “and they happen in these populations where, in terms of data, both of those audiences have problems about going for the second and third dose.”

Patients that drop out before the third dose are at high risk of infection, as only 20%-50% of adults have the appropriate seroprotection after two doses. However, only 54% of patients in a vaccine safety Datalink study reported completing the vaccination series, with 81% reporting having received two doses, according to Dr. Schaffner.

While the committee did approve the safety research as sufficient to approve use of Heplisav-B in adults 18 years and older, members of the committee had an issue with the drug’s correlation with myocardial infarction.

In one of the studies presented, Heplisav-B’s acute myocardial infarction (AMI) events (14 patients) greatly outnumbered those of Engerix-B (1 patient), presenting an AMI relative risk of 6.97.

Dynavax representatives, in response to this concern, presented intention to conduct a postmarketing analysis of the risk of MI in patients who have been administered Heplisav-B, which committee members considered to be a crucial contingency for approval.

“I would like to say I am for the approval of this vaccine, I just think as a statistician that the safety was inconclusive,” said Mei-Ling Ting Lee, PhD, director of the Biostatistics and Risk Assessment Center at the University of Maryland. “But I think for the pharmacological vigilance plan, I think that it will be good to have specific analysis for the myocardial infarction and other risks.”

Courtesy Wikimedia Commons/FitzColinGerald/Creative Commons License

[email protected]

On Twitter @eaztweets

Prompt, symptomatic, multidisciplinary treatment is the best way to curtail the symptoms of pediatric acute-onset neuropsychiatric syndrome (PANS) and pediatric autoimmune neuropsychiatric syndrome associated with streptococcal infection (PANDAS), according to new guidelines.

Clinicians should tailor treatment to symptoms, wrote Margo Thienemann, MD, of Stanford (Calif.) University and her coauthors in the clinical management section of the guidelines. For example, children with mild psychiatric symptoms might only need cognitive-behavioral therapy (CBT), while more severe symptoms can merit a slow up-titration of psychoactive medications.

Prompt, symptomatic, multidisciplinary treatment is the best way to curtail the symptoms of pediatric acute-onset neuropsychiatric syndrome (PANS) and pediatric autoimmune neuropsychiatric syndrome associated with streptococcal infection (PANDAS), according to new guidelines.

Clinicians should tailor treatment to symptoms, wrote Margo Thienemann, MD, of Stanford (Calif.) University and her coauthors in the clinical management section of the guidelines. For example, children with mild psychiatric symptoms might only need cognitive-behavioral therapy (CBT), while more severe symptoms can merit a slow up-titration of psychoactive medications.

Prompt, symptomatic, multidisciplinary treatment is the best way to curtail the symptoms of pediatric acute-onset neuropsychiatric syndrome (PANS) and pediatric autoimmune neuropsychiatric syndrome associated with streptococcal infection (PANDAS), according to new guidelines.

Clinicians should tailor treatment to symptoms, wrote Margo Thienemann, MD, of Stanford (Calif.) University and her coauthors in the clinical management section of the guidelines. For example, children with mild psychiatric symptoms might only need cognitive-behavioral therapy (CBT), while more severe symptoms can merit a slow up-titration of psychoactive medications.

There is growing recognition that patients and family members have critical insights into healthcare experiences. As consumers of healthcare, patient experience is the definitive gauge of whether healthcare is patient centered. In addition, patients may know things about their healthcare that the care team does not. Several studies have demonstrated that patients have knowledge of adverse events and medical errors that are not detected by other methods.^1-5 For these reasons, systems designed to elicit patient perspectives of care and detect patient-perceived breakdowns in care could be used to improve healthcare safety and quality, including the patient experience.

Historically, hospitals have relied on patient-initiated reporting via complaints or legal action as the main source of information regarding patient-perceived breakdowns in care. However, many patients are hesitant to speak up about problems or uncertain about how to report concerns.^6-8 As a result, healthcare systems often only learn of the most severe breakdowns in care from a subset of activated patients, thus underestimating how widespread patient-perceived breakdowns are.

To overcome these limitations of patient-initiated reporting, hospitals could conduct outreach to patients to actively identify and learn about patient-perceived breakdowns in care. Potential benefits of outreach to patients include more reliable detection of patient-perceived breakdowns in care, identification of a broader range of types of breakdowns commonly experienced by patients, and recognition of problems in real-time when there is more opportunity for redress. Indeed, some hospitals have adopted active outreach programs such as structured nurse manager rounding or postdischarge phone calls.⁹

It is possible that outreach will not overcome patients’ reluctance to speak up, or patients may not share serious or actionable breakdowns. The manner in which outreach is conducted is likely to influence the information patients are willing to share. Prior studies examining patient perspectives of healthcare have primarily taken a structured approach with close-ended questions or a focus on specific aspects of care.^1,10,11 Limited data collected using an open-ended approach suggest patient-perceived breakdowns in care may be very common.^2,12,13 However, the impact of such breakdowns on patients has not been well characterized.

In order to design systems that can optimally detect patient-perceived breakdowns in care, additional information is needed to understand whether patients will report breakdowns in response to outreach programs, what types of problems they will report, and how these problems impact them. Understanding such issues will allow healthcare systems to respond to calls by federal health agencies to develop mechanisms for patients to report concerns about breakdowns in care, thereby providing truly patient-centered care.¹⁴ Therefore, we undertook this study with the overall goal of describing what may be learned from an open-ended outreach approach that directly asks patients about problems they have encountered during hospitalization. Specifically, we aim to (1) describe the types of problems reported by patients in response to this outreach approach and (2) characterize patients’ perceptions of the impact of these events.

Setting

We conducted this study in 2 hospitals between June 2014 and February 2015. One participating hospital is a large, urban, tertiary care medical center serving a predominantly white (78%) patient population in Baltimore, Maryland. The second hospital is a large, inner city, tertiary care medical center serving a predominantly African-American (71%) patient population in Washington, DC.

Three medical-surgical units (MSUs) at each hospital participated. We selected MSUs because MSU patients interact with a variety of clinicians, often have long stays, and are at risk for adverse events. Hospitalists were part of the clinical care team in each of the participating units, serving either as the attending of record or by comanaging patients.

Patient Eligibility

Patients were potentially eligible if they were at least 18 years old, able to speak English or Spanish, and admitted to the hospital for more than 24 hours. Ineligibility criteria included the following: imminent discharge, observation (noninpatient) status, on hospice, on infection precautions (for inpatient interviews only), psychiatric or violence concerns, prisoner status, significant confusion, or inability to provide informed consent.

Eligible patients in each unit were randomized. Interviewers consecutively approached patients according to their random assignment. If a patient was not available, the interviewer proceeded to the next room. Interviewers returned to rooms of missed patients when possible. Recruitment in the unit ended when the recruitment target for that unit was achieved.

Interviewers

Five interviewers conducted interviews. One author (KS) provided interviewer training that included didactic instruction, observation, feedback, and modeling. Interviewers participated in weekly debriefing sessions. One interviewer speaks Spanish fluently and was able to conduct interviews in Spanish. Translator services were available for the other interviewers.

Interview Process

Interviews were conducted in person while the patients were hospitalized or via telephone 7 - 30 days postdischarge. A patient who had completed an interview while hospitalized was not eligible for a postdischarge telephone interview. Family members or friends present at the time of the interviews could also participate in addition to or in lieu of the patients with the patients’ assent. Interviewers obtained verbal, informed consent at the start of each interview.

The interview domains and sample questions were developed specifically for the current study and are listed in Table 1. The goal of the interview was to elicit the patient’s (or family member’s) perception of their care experiences and their perceptions of the consequences of any problems with their care. The interviewer sought to obtain sufficient detail to understand the patient’s concerns and to determine what, if any, action might be needed to remediate problems reported by patients. Interviewers captured patient responses by taking detailed notes on a case report form or by directly entering patient responses using a computer or iPad at the time of interview at the discretion of the interviewer.

We defined a patient-perceived breakdown as something that went wrong during the hospitalization according to the patient. If a patient-perceived breakdown in care was identified, the interviewer attempted to resolve the concern. Some breakdowns had occurred in the past, making further resolution impossible (eg, a long wait in the emergency department). Other breakdowns were active and addressable, such as the patient having clinical questions that had not been answered. In such cases, the interviewer attempted to address the patient’s concerns, typically by working with unit nursing staff. For patients interviewed postdischarge, the interviewer worked to resolve ongoing patient concerns with the assistance of the patient safety, quality, and compliance teams as needed. The interviewer provided a brief narrative summary of all interviews to unit nursing leadership within 24 hours. Positive comments were sent to leadership but not captured systematically for research purposes. Further details of the process of responding to patients’ concerns will be reported elsewhere. All data were entered into REDCap to facilitate data management and reporting.¹⁵

The MedStar Health Research Institute Institutional Review Board reviewed and approved this study.

Categorizing Patients’ Responses: The Patient Experience Coding Tool

Using directed content analysis,¹⁶ we deductively created the Patient Experience Coding Tool (PECT) in order to summarize the narrative information captured during the interviews and categorize patient-perceived breakdowns in care. First, we referred to our prior interviews of patients’ views on breakdowns in cancer care⁶ and surrogate decision-makers’ views on breakdowns in intensive care units¹³ to create the initial categories. We then applied the resultant framework to the interviews in the present study and refined the categories. This involved applying the categorization to an initial set of interviews to check the sufficiency of the coding categories. We clarified the scope of each category (ie, what types of events fit under each category) and created additional categories (eg, medication-related problems) to capture patient experiences that were not included in the initial framework.

We then coded each interview using the PECT. A minimum of 2 readers reviewed the narrative notes for each interview. The first reader provided an initial categorization; the second reader reviewed the narrative and confirmed or questioned the initial categorization to improve coding accuracy. If a reader was uncertain about the correct categorization, it was discussed by three readers until an agreement was achieved. Because facilities-related problems (eg, food or parking) fall outside the realm of provider-based hospital care, such comments were not the focus of the outreach efforts and were not consistently recorded. Therefore, they were not included in the PECT and are not reported here.

Analyses

We computed simple, descriptive statistics including the number and percentage of patients identifying at least one breakdown, as well as the number and percent reporting each type of breakdown. We also computed the number and percentage of patients reporting any harm and each type of harm. We computed the percentage of patients reporting at least 1 breakdown by hospital, type of interview (postdischarge vs inpatient), selected patient demographic characteristics (eg, gender, age, education, race), and interviewee (patient vs someone other than the patient interviewed or present during the interview) using the chi-square statistic to test the statistical significance of the resulting differences. All statistical analyses were performed using SPSS version 22.

A total of 979 outreach interviews were conducted. Of these, 349 were conducted via telephone postdischarge, and 630 were conducted in person during hospitalization. The average interview duration was 8.5 minutes for telephone interviews and 12.2 minutes for in-person interviews. Of the patients approached to participate, 67% completed an interview (61% in person, 83% via telephone). Patient characteristics are summarized in Table 2.

Overall, 386 of 979 interviewees (39.4%) believed they had experienced at least one breakdown in care. The types of patient-perceived breakdowns reported were categorized using the PECT and are summarized in Table 3 and the Figure. The most common concern involved information exchange. Approximately 1 in 10 patients (n = 105, 10.7%) felt that they had not received the information they needed when they needed it. Medication-related concerns were reported by 12.3% (n = 120) of interviewees and predominantly included concerns about what medications were being administered (5.7%) and inadequately treated pain (5.6%). Many of the patients expressing concerns about what medications were administered questioned why they were not receiving their outpatient medications or did not understand why a different medication was being administered, suggesting that many of these instances were related to breakdowns in communication as well. Other relatively common concerns were delays in the admissions process (reported by 9.2% of interviewees), poor team communication (reported by 6.6% of interviewees), healthcare providers with a rude or uncaring manner (reported by 6.3% of interviewees), and problems related to discharge (reported by 5.7% of interviewees).

Through interviews with nearly 1000 patients, we have found that approximately 4 in 10 hospitalized patients believed they experienced a breakdown in care. Not only are patient-perceived breakdowns in care distressingly common, more than one-third of these events resulted in harm according to the patient. Patients reported a diverse range of breakdowns, including problems related to patient experience, as well as breakdowns in technical aspects of medical care. Collectively, these findings illustrate a striking need to identify and address these frequent and potentially harmful breakdowns.

Our findings are consistent with prior studies in which 20% to 50% of patients identified a problem during hospitalization. For example, Weingart et al^. interviewed patients in a single general medical unit and found that 20% experienced an adverse event, near miss, or medical error, while nearly 40% experienced what was defined as a service quality incident.^2,12 Of note, both our study and the study by Weingart et al. systematically elicited patients’ perspectives of breakdowns in care with explicit questions about problems or breakdowns in care.^2,12 Because patients are often reluctant to speak up about problems in care,without such efforts to actively identify problems, providers and leaders are likely to be unaware of the majority of these concerns.^6-8 These findings suggest that hospital-based providers should at least consider routinely asking patients about breakdowns in care to identify and respond to patients’ concerns.

Not only are patient-perceived breakdowns common, more than one-third of patients who experienced a breakdown considered it to be harmful. This suggests that our outreach approach identified predominantly nontrivial concerns. We adopted a broad definition of harm that includes emotional distress, damage to the relationship with providers, and life disruption. This differs from other studies examining patient reports of breakdowns in care, in which harm was restricted to physical injury.^1,2 We consider this inclusive definition of harm to be a strength of the present study as it provides the most complete picture of the impact of such events on patients. This approach is supported by other studies demonstrating that patients place great emphasis on the psychological consequences of adverse events.^17-19 Thus, it is clear from our work and other studies that nonphysical harm is important and warrants concerted efforts to address.

Patients in our study reported a variety of breakdowns, including breakdowns related to patient experience (eg, communication, relationship with providers) and technical aspects of healthcare delivery (eg, diagnosis, treatment). This is consistent with other studies examining patient perspectives of breakdowns in care. Weingart et al.found that hospitalized patients reported a broad range of problems, including adverse events, medical errors, communication breakdowns, and problems with food.^2,12 This variety of events suggests a need for integration between the various hospital groups that handle patient-perceived breakdowns, including bedside providers, risk management, patient relations, patient advocates, and quality and safety groups, in order to provide a coordinated and effective response to the full spectrum of patient-perceived breakdowns in care.

Patients in our study were more likely to report breakdowns related to communication and relationships with providers than those related to technical aspects of care. Similarly, Kuzel et al.found that the most common problems cited by patients in the primary care setting were breakdowns in the clinician-patient relationship and access-related problems.¹⁷This is not surprising, as patients are likely to have more direct knowledge about communication and interpersonal relationships than about technical aspects of care.

We identified several factors associated with the likelihood of reporting a breakdown in care. Most strikingly, involving a friend or family member in the interview was strongly associated with reporting a breakdown. Other work has also suggested that patients’ friends and family members are an important source of information about safety concerns.^20,21 In addition, several patient characteristics were associated with an increased likelihood of reporting a breakdown, including being younger and better educated. These findings highlight the importance of engaging patients’ friends and families in efforts to elicit patient concerns about healthcare, and they confirm recommendations for patients to bring a friend or family member to healthcare encounters.²² In addition, they illustrate the need to better understand how patient characteristics affect perceptions of breakdowns in care and their willingness to speak up, as this could inform efforts to target outreach to especially vulnerable patients.

A strength of this study is the number of interviews completed (almost 1000), which provides a diverse range of patient views and experiences, as evidenced by the demographic characteristics of participants. Interviews were conducted at two hospitals that differ substantially with regard to populations served, further enhancing the generalizability of our findings. Despite the large number of interviews and diverse patient characteristics, patients were drawn from only 3 units at 2 hospitals, which may limit generalizability.

We did not conduct medical record reviews to validate patients’ reports of problems, which may be viewed as a limitation. While such a comparison would be informative, the intent of the current study was to elicit patients’ perceptions of care, including aspects of care that are not typically captured in the medical record, such as communication. Other studies have demonstrated that patients’ reports of medical errors and adverse events tend to differ from providers’ reports of the same subjects.^19,23 Therefore, we considered the patients’ perceptions of care to be a useful endpoint in and of itself. We did not determine the extent to which providers were already aware of patients’ concerns or whether they considered patients’ concerns valid. A related limitation is our inability to determine whether the differences we identified in the rates of breakdown reporting based on patient characteristics reflect differences in willingness to report or differences in experiences. Because we included patients in an MSU, it is possible that breakdowns were related to medical care, surgical care, or both. We did not follow patients longitudinally and therefore only captured harm perceived by a patient at the time of the interview. It is possible that patients may have experienced harm later in their hospitalization or following discharge that was not measured. Lastly, we did not measure interrater reliability of the interview coding and therefore do not present the PECT as a validated instrument. These important questions should be targeted for future study.

When directly asked about their experiences, almost 4 out of 10 hospitalized patients reported a breakdown in their care, many of which were perceived to be harmful. Not all hospitals will have the resources to implement the intensive approach used in this study to elicit patient-perceived breakdowns. Therefore, further work is needed to develop sustainable methods to overcome patients’ reluctance to report breakdowns in care. Engaging patients’ families and friends may be a particularly fruitful strategy. We offer the PECT as a tool that hospitals could use to summarize a variety of sources of patient feedback such as complaints, responses to surveys, and consumer reviews. Hospitals that effectively encourage patients and their family members to speak up about perceived breakdowns will identify many opportunities to address patient concerns, potentially leading to improved patient safety and experience.

There is growing recognition that patients and family members have critical insights into healthcare experiences. As consumers of healthcare, patient experience is the definitive gauge of whether healthcare is patient centered. In addition, patients may know things about their healthcare that the care team does not. Several studies have demonstrated that patients have knowledge of adverse events and medical errors that are not detected by other methods.^1-5 For these reasons, systems designed to elicit patient perspectives of care and detect patient-perceived breakdowns in care could be used to improve healthcare safety and quality, including the patient experience.

Historically, hospitals have relied on patient-initiated reporting via complaints or legal action as the main source of information regarding patient-perceived breakdowns in care. However, many patients are hesitant to speak up about problems or uncertain about how to report concerns.^6-8 As a result, healthcare systems often only learn of the most severe breakdowns in care from a subset of activated patients, thus underestimating how widespread patient-perceived breakdowns are.

To overcome these limitations of patient-initiated reporting, hospitals could conduct outreach to patients to actively identify and learn about patient-perceived breakdowns in care. Potential benefits of outreach to patients include more reliable detection of patient-perceived breakdowns in care, identification of a broader range of types of breakdowns commonly experienced by patients, and recognition of problems in real-time when there is more opportunity for redress. Indeed, some hospitals have adopted active outreach programs such as structured nurse manager rounding or postdischarge phone calls.⁹

It is possible that outreach will not overcome patients’ reluctance to speak up, or patients may not share serious or actionable breakdowns. The manner in which outreach is conducted is likely to influence the information patients are willing to share. Prior studies examining patient perspectives of healthcare have primarily taken a structured approach with close-ended questions or a focus on specific aspects of care.^1,10,11 Limited data collected using an open-ended approach suggest patient-perceived breakdowns in care may be very common.^2,12,13 However, the impact of such breakdowns on patients has not been well characterized.

In order to design systems that can optimally detect patient-perceived breakdowns in care, additional information is needed to understand whether patients will report breakdowns in response to outreach programs, what types of problems they will report, and how these problems impact them. Understanding such issues will allow healthcare systems to respond to calls by federal health agencies to develop mechanisms for patients to report concerns about breakdowns in care, thereby providing truly patient-centered care.¹⁴ Therefore, we undertook this study with the overall goal of describing what may be learned from an open-ended outreach approach that directly asks patients about problems they have encountered during hospitalization. Specifically, we aim to (1) describe the types of problems reported by patients in response to this outreach approach and (2) characterize patients’ perceptions of the impact of these events.

Setting

We conducted this study in 2 hospitals between June 2014 and February 2015. One participating hospital is a large, urban, tertiary care medical center serving a predominantly white (78%) patient population in Baltimore, Maryland. The second hospital is a large, inner city, tertiary care medical center serving a predominantly African-American (71%) patient population in Washington, DC.

Three medical-surgical units (MSUs) at each hospital participated. We selected MSUs because MSU patients interact with a variety of clinicians, often have long stays, and are at risk for adverse events. Hospitalists were part of the clinical care team in each of the participating units, serving either as the attending of record or by comanaging patients.

Patient Eligibility

Patients were potentially eligible if they were at least 18 years old, able to speak English or Spanish, and admitted to the hospital for more than 24 hours. Ineligibility criteria included the following: imminent discharge, observation (noninpatient) status, on hospice, on infection precautions (for inpatient interviews only), psychiatric or violence concerns, prisoner status, significant confusion, or inability to provide informed consent.

Eligible patients in each unit were randomized. Interviewers consecutively approached patients according to their random assignment. If a patient was not available, the interviewer proceeded to the next room. Interviewers returned to rooms of missed patients when possible. Recruitment in the unit ended when the recruitment target for that unit was achieved.

Interviewers

Five interviewers conducted interviews. One author (KS) provided interviewer training that included didactic instruction, observation, feedback, and modeling. Interviewers participated in weekly debriefing sessions. One interviewer speaks Spanish fluently and was able to conduct interviews in Spanish. Translator services were available for the other interviewers.

Interview Process

Interviews were conducted in person while the patients were hospitalized or via telephone 7 - 30 days postdischarge. A patient who had completed an interview while hospitalized was not eligible for a postdischarge telephone interview. Family members or friends present at the time of the interviews could also participate in addition to or in lieu of the patients with the patients’ assent. Interviewers obtained verbal, informed consent at the start of each interview.

The interview domains and sample questions were developed specifically for the current study and are listed in Table 1. The goal of the interview was to elicit the patient’s (or family member’s) perception of their care experiences and their perceptions of the consequences of any problems with their care. The interviewer sought to obtain sufficient detail to understand the patient’s concerns and to determine what, if any, action might be needed to remediate problems reported by patients. Interviewers captured patient responses by taking detailed notes on a case report form or by directly entering patient responses using a computer or iPad at the time of interview at the discretion of the interviewer.

We defined a patient-perceived breakdown as something that went wrong during the hospitalization according to the patient. If a patient-perceived breakdown in care was identified, the interviewer attempted to resolve the concern. Some breakdowns had occurred in the past, making further resolution impossible (eg, a long wait in the emergency department). Other breakdowns were active and addressable, such as the patient having clinical questions that had not been answered. In such cases, the interviewer attempted to address the patient’s concerns, typically by working with unit nursing staff. For patients interviewed postdischarge, the interviewer worked to resolve ongoing patient concerns with the assistance of the patient safety, quality, and compliance teams as needed. The interviewer provided a brief narrative summary of all interviews to unit nursing leadership within 24 hours. Positive comments were sent to leadership but not captured systematically for research purposes. Further details of the process of responding to patients’ concerns will be reported elsewhere. All data were entered into REDCap to facilitate data management and reporting.¹⁵

The MedStar Health Research Institute Institutional Review Board reviewed and approved this study.

Categorizing Patients’ Responses: The Patient Experience Coding Tool

Using directed content analysis,¹⁶ we deductively created the Patient Experience Coding Tool (PECT) in order to summarize the narrative information captured during the interviews and categorize patient-perceived breakdowns in care. First, we referred to our prior interviews of patients’ views on breakdowns in cancer care⁶ and surrogate decision-makers’ views on breakdowns in intensive care units¹³ to create the initial categories. We then applied the resultant framework to the interviews in the present study and refined the categories. This involved applying the categorization to an initial set of interviews to check the sufficiency of the coding categories. We clarified the scope of each category (ie, what types of events fit under each category) and created additional categories (eg, medication-related problems) to capture patient experiences that were not included in the initial framework.

We then coded each interview using the PECT. A minimum of 2 readers reviewed the narrative notes for each interview. The first reader provided an initial categorization; the second reader reviewed the narrative and confirmed or questioned the initial categorization to improve coding accuracy. If a reader was uncertain about the correct categorization, it was discussed by three readers until an agreement was achieved. Because facilities-related problems (eg, food or parking) fall outside the realm of provider-based hospital care, such comments were not the focus of the outreach efforts and were not consistently recorded. Therefore, they were not included in the PECT and are not reported here.

Analyses

We computed simple, descriptive statistics including the number and percentage of patients identifying at least one breakdown, as well as the number and percent reporting each type of breakdown. We also computed the number and percentage of patients reporting any harm and each type of harm. We computed the percentage of patients reporting at least 1 breakdown by hospital, type of interview (postdischarge vs inpatient), selected patient demographic characteristics (eg, gender, age, education, race), and interviewee (patient vs someone other than the patient interviewed or present during the interview) using the chi-square statistic to test the statistical significance of the resulting differences. All statistical analyses were performed using SPSS version 22.

A total of 979 outreach interviews were conducted. Of these, 349 were conducted via telephone postdischarge, and 630 were conducted in person during hospitalization. The average interview duration was 8.5 minutes for telephone interviews and 12.2 minutes for in-person interviews. Of the patients approached to participate, 67% completed an interview (61% in person, 83% via telephone). Patient characteristics are summarized in Table 2.

Overall, 386 of 979 interviewees (39.4%) believed they had experienced at least one breakdown in care. The types of patient-perceived breakdowns reported were categorized using the PECT and are summarized in Table 3 and the Figure. The most common concern involved information exchange. Approximately 1 in 10 patients (n = 105, 10.7%) felt that they had not received the information they needed when they needed it. Medication-related concerns were reported by 12.3% (n = 120) of interviewees and predominantly included concerns about what medications were being administered (5.7%) and inadequately treated pain (5.6%). Many of the patients expressing concerns about what medications were administered questioned why they were not receiving their outpatient medications or did not understand why a different medication was being administered, suggesting that many of these instances were related to breakdowns in communication as well. Other relatively common concerns were delays in the admissions process (reported by 9.2% of interviewees), poor team communication (reported by 6.6% of interviewees), healthcare providers with a rude or uncaring manner (reported by 6.3% of interviewees), and problems related to discharge (reported by 5.7% of interviewees).

Through interviews with nearly 1000 patients, we have found that approximately 4 in 10 hospitalized patients believed they experienced a breakdown in care. Not only are patient-perceived breakdowns in care distressingly common, more than one-third of these events resulted in harm according to the patient. Patients reported a diverse range of breakdowns, including problems related to patient experience, as well as breakdowns in technical aspects of medical care. Collectively, these findings illustrate a striking need to identify and address these frequent and potentially harmful breakdowns.

Our findings are consistent with prior studies in which 20% to 50% of patients identified a problem during hospitalization. For example, Weingart et al^. interviewed patients in a single general medical unit and found that 20% experienced an adverse event, near miss, or medical error, while nearly 40% experienced what was defined as a service quality incident.^2,12 Of note, both our study and the study by Weingart et al. systematically elicited patients’ perspectives of breakdowns in care with explicit questions about problems or breakdowns in care.^2,12 Because patients are often reluctant to speak up about problems in care,without such efforts to actively identify problems, providers and leaders are likely to be unaware of the majority of these concerns.^6-8 These findings suggest that hospital-based providers should at least consider routinely asking patients about breakdowns in care to identify and respond to patients’ concerns.

Not only are patient-perceived breakdowns common, more than one-third of patients who experienced a breakdown considered it to be harmful. This suggests that our outreach approach identified predominantly nontrivial concerns. We adopted a broad definition of harm that includes emotional distress, damage to the relationship with providers, and life disruption. This differs from other studies examining patient reports of breakdowns in care, in which harm was restricted to physical injury.^1,2 We consider this inclusive definition of harm to be a strength of the present study as it provides the most complete picture of the impact of such events on patients. This approach is supported by other studies demonstrating that patients place great emphasis on the psychological consequences of adverse events.^17-19 Thus, it is clear from our work and other studies that nonphysical harm is important and warrants concerted efforts to address.

Patients in our study reported a variety of breakdowns, including breakdowns related to patient experience (eg, communication, relationship with providers) and technical aspects of healthcare delivery (eg, diagnosis, treatment). This is consistent with other studies examining patient perspectives of breakdowns in care. Weingart et al.found that hospitalized patients reported a broad range of problems, including adverse events, medical errors, communication breakdowns, and problems with food.^2,12 This variety of events suggests a need for integration between the various hospital groups that handle patient-perceived breakdowns, including bedside providers, risk management, patient relations, patient advocates, and quality and safety groups, in order to provide a coordinated and effective response to the full spectrum of patient-perceived breakdowns in care.

Patients in our study were more likely to report breakdowns related to communication and relationships with providers than those related to technical aspects of care. Similarly, Kuzel et al.found that the most common problems cited by patients in the primary care setting were breakdowns in the clinician-patient relationship and access-related problems.¹⁷This is not surprising, as patients are likely to have more direct knowledge about communication and interpersonal relationships than about technical aspects of care.

We identified several factors associated with the likelihood of reporting a breakdown in care. Most strikingly, involving a friend or family member in the interview was strongly associated with reporting a breakdown. Other work has also suggested that patients’ friends and family members are an important source of information about safety concerns.^20,21 In addition, several patient characteristics were associated with an increased likelihood of reporting a breakdown, including being younger and better educated. These findings highlight the importance of engaging patients’ friends and families in efforts to elicit patient concerns about healthcare, and they confirm recommendations for patients to bring a friend or family member to healthcare encounters.²² In addition, they illustrate the need to better understand how patient characteristics affect perceptions of breakdowns in care and their willingness to speak up, as this could inform efforts to target outreach to especially vulnerable patients.

A strength of this study is the number of interviews completed (almost 1000), which provides a diverse range of patient views and experiences, as evidenced by the demographic characteristics of participants. Interviews were conducted at two hospitals that differ substantially with regard to populations served, further enhancing the generalizability of our findings. Despite the large number of interviews and diverse patient characteristics, patients were drawn from only 3 units at 2 hospitals, which may limit generalizability.

We did not conduct medical record reviews to validate patients’ reports of problems, which may be viewed as a limitation. While such a comparison would be informative, the intent of the current study was to elicit patients’ perceptions of care, including aspects of care that are not typically captured in the medical record, such as communication. Other studies have demonstrated that patients’ reports of medical errors and adverse events tend to differ from providers’ reports of the same subjects.^19,23 Therefore, we considered the patients’ perceptions of care to be a useful endpoint in and of itself. We did not determine the extent to which providers were already aware of patients’ concerns or whether they considered patients’ concerns valid. A related limitation is our inability to determine whether the differences we identified in the rates of breakdown reporting based on patient characteristics reflect differences in willingness to report or differences in experiences. Because we included patients in an MSU, it is possible that breakdowns were related to medical care, surgical care, or both. We did not follow patients longitudinally and therefore only captured harm perceived by a patient at the time of the interview. It is possible that patients may have experienced harm later in their hospitalization or following discharge that was not measured. Lastly, we did not measure interrater reliability of the interview coding and therefore do not present the PECT as a validated instrument. These important questions should be targeted for future study.

When directly asked about their experiences, almost 4 out of 10 hospitalized patients reported a breakdown in their care, many of which were perceived to be harmful. Not all hospitals will have the resources to implement the intensive approach used in this study to elicit patient-perceived breakdowns. Therefore, further work is needed to develop sustainable methods to overcome patients’ reluctance to report breakdowns in care. Engaging patients’ families and friends may be a particularly fruitful strategy. We offer the PECT as a tool that hospitals could use to summarize a variety of sources of patient feedback such as complaints, responses to surveys, and consumer reviews. Hospitals that effectively encourage patients and their family members to speak up about perceived breakdowns will identify many opportunities to address patient concerns, potentially leading to improved patient safety and experience.

There is growing recognition that patients and family members have critical insights into healthcare experiences. As consumers of healthcare, patient experience is the definitive gauge of whether healthcare is patient centered. In addition, patients may know things about their healthcare that the care team does not. Several studies have demonstrated that patients have knowledge of adverse events and medical errors that are not detected by other methods.^1-5 For these reasons, systems designed to elicit patient perspectives of care and detect patient-perceived breakdowns in care could be used to improve healthcare safety and quality, including the patient experience.

Historically, hospitals have relied on patient-initiated reporting via complaints or legal action as the main source of information regarding patient-perceived breakdowns in care. However, many patients are hesitant to speak up about problems or uncertain about how to report concerns.^6-8 As a result, healthcare systems often only learn of the most severe breakdowns in care from a subset of activated patients, thus underestimating how widespread patient-perceived breakdowns are.

To overcome these limitations of patient-initiated reporting, hospitals could conduct outreach to patients to actively identify and learn about patient-perceived breakdowns in care. Potential benefits of outreach to patients include more reliable detection of patient-perceived breakdowns in care, identification of a broader range of types of breakdowns commonly experienced by patients, and recognition of problems in real-time when there is more opportunity for redress. Indeed, some hospitals have adopted active outreach programs such as structured nurse manager rounding or postdischarge phone calls.⁹

It is possible that outreach will not overcome patients’ reluctance to speak up, or patients may not share serious or actionable breakdowns. The manner in which outreach is conducted is likely to influence the information patients are willing to share. Prior studies examining patient perspectives of healthcare have primarily taken a structured approach with close-ended questions or a focus on specific aspects of care.^1,10,11 Limited data collected using an open-ended approach suggest patient-perceived breakdowns in care may be very common.^2,12,13 However, the impact of such breakdowns on patients has not been well characterized.

In order to design systems that can optimally detect patient-perceived breakdowns in care, additional information is needed to understand whether patients will report breakdowns in response to outreach programs, what types of problems they will report, and how these problems impact them. Understanding such issues will allow healthcare systems to respond to calls by federal health agencies to develop mechanisms for patients to report concerns about breakdowns in care, thereby providing truly patient-centered care.¹⁴ Therefore, we undertook this study with the overall goal of describing what may be learned from an open-ended outreach approach that directly asks patients about problems they have encountered during hospitalization. Specifically, we aim to (1) describe the types of problems reported by patients in response to this outreach approach and (2) characterize patients’ perceptions of the impact of these events.

Setting

We conducted this study in 2 hospitals between June 2014 and February 2015. One participating hospital is a large, urban, tertiary care medical center serving a predominantly white (78%) patient population in Baltimore, Maryland. The second hospital is a large, inner city, tertiary care medical center serving a predominantly African-American (71%) patient population in Washington, DC.

Three medical-surgical units (MSUs) at each hospital participated. We selected MSUs because MSU patients interact with a variety of clinicians, often have long stays, and are at risk for adverse events. Hospitalists were part of the clinical care team in each of the participating units, serving either as the attending of record or by comanaging patients.

Patient Eligibility

Patients were potentially eligible if they were at least 18 years old, able to speak English or Spanish, and admitted to the hospital for more than 24 hours. Ineligibility criteria included the following: imminent discharge, observation (noninpatient) status, on hospice, on infection precautions (for inpatient interviews only), psychiatric or violence concerns, prisoner status, significant confusion, or inability to provide informed consent.

Eligible patients in each unit were randomized. Interviewers consecutively approached patients according to their random assignment. If a patient was not available, the interviewer proceeded to the next room. Interviewers returned to rooms of missed patients when possible. Recruitment in the unit ended when the recruitment target for that unit was achieved.

Interviewers

Five interviewers conducted interviews. One author (KS) provided interviewer training that included didactic instruction, observation, feedback, and modeling. Interviewers participated in weekly debriefing sessions. One interviewer speaks Spanish fluently and was able to conduct interviews in Spanish. Translator services were available for the other interviewers.

Interview Process

Interviews were conducted in person while the patients were hospitalized or via telephone 7 - 30 days postdischarge. A patient who had completed an interview while hospitalized was not eligible for a postdischarge telephone interview. Family members or friends present at the time of the interviews could also participate in addition to or in lieu of the patients with the patients’ assent. Interviewers obtained verbal, informed consent at the start of each interview.

The interview domains and sample questions were developed specifically for the current study and are listed in Table 1. The goal of the interview was to elicit the patient’s (or family member’s) perception of their care experiences and their perceptions of the consequences of any problems with their care. The interviewer sought to obtain sufficient detail to understand the patient’s concerns and to determine what, if any, action might be needed to remediate problems reported by patients. Interviewers captured patient responses by taking detailed notes on a case report form or by directly entering patient responses using a computer or iPad at the time of interview at the discretion of the interviewer.

We defined a patient-perceived breakdown as something that went wrong during the hospitalization according to the patient. If a patient-perceived breakdown in care was identified, the interviewer attempted to resolve the concern. Some breakdowns had occurred in the past, making further resolution impossible (eg, a long wait in the emergency department). Other breakdowns were active and addressable, such as the patient having clinical questions that had not been answered. In such cases, the interviewer attempted to address the patient’s concerns, typically by working with unit nursing staff. For patients interviewed postdischarge, the interviewer worked to resolve ongoing patient concerns with the assistance of the patient safety, quality, and compliance teams as needed. The interviewer provided a brief narrative summary of all interviews to unit nursing leadership within 24 hours. Positive comments were sent to leadership but not captured systematically for research purposes. Further details of the process of responding to patients’ concerns will be reported elsewhere. All data were entered into REDCap to facilitate data management and reporting.¹⁵

The MedStar Health Research Institute Institutional Review Board reviewed and approved this study.

Categorizing Patients’ Responses: The Patient Experience Coding Tool

Using directed content analysis,¹⁶ we deductively created the Patient Experience Coding Tool (PECT) in order to summarize the narrative information captured during the interviews and categorize patient-perceived breakdowns in care. First, we referred to our prior interviews of patients’ views on breakdowns in cancer care⁶ and surrogate decision-makers’ views on breakdowns in intensive care units¹³ to create the initial categories. We then applied the resultant framework to the interviews in the present study and refined the categories. This involved applying the categorization to an initial set of interviews to check the sufficiency of the coding categories. We clarified the scope of each category (ie, what types of events fit under each category) and created additional categories (eg, medication-related problems) to capture patient experiences that were not included in the initial framework.

We then coded each interview using the PECT. A minimum of 2 readers reviewed the narrative notes for each interview. The first reader provided an initial categorization; the second reader reviewed the narrative and confirmed or questioned the initial categorization to improve coding accuracy. If a reader was uncertain about the correct categorization, it was discussed by three readers until an agreement was achieved. Because facilities-related problems (eg, food or parking) fall outside the realm of provider-based hospital care, such comments were not the focus of the outreach efforts and were not consistently recorded. Therefore, they were not included in the PECT and are not reported here.

Analyses

We computed simple, descriptive statistics including the number and percentage of patients identifying at least one breakdown, as well as the number and percent reporting each type of breakdown. We also computed the number and percentage of patients reporting any harm and each type of harm. We computed the percentage of patients reporting at least 1 breakdown by hospital, type of interview (postdischarge vs inpatient), selected patient demographic characteristics (eg, gender, age, education, race), and interviewee (patient vs someone other than the patient interviewed or present during the interview) using the chi-square statistic to test the statistical significance of the resulting differences. All statistical analyses were performed using SPSS version 22.

A total of 979 outreach interviews were conducted. Of these, 349 were conducted via telephone postdischarge, and 630 were conducted in person during hospitalization. The average interview duration was 8.5 minutes for telephone interviews and 12.2 minutes for in-person interviews. Of the patients approached to participate, 67% completed an interview (61% in person, 83% via telephone). Patient characteristics are summarized in Table 2.

Overall, 386 of 979 interviewees (39.4%) believed they had experienced at least one breakdown in care. The types of patient-perceived breakdowns reported were categorized using the PECT and are summarized in Table 3 and the Figure. The most common concern involved information exchange. Approximately 1 in 10 patients (n = 105, 10.7%) felt that they had not received the information they needed when they needed it. Medication-related concerns were reported by 12.3% (n = 120) of interviewees and predominantly included concerns about what medications were being administered (5.7%) and inadequately treated pain (5.6%). Many of the patients expressing concerns about what medications were administered questioned why they were not receiving their outpatient medications or did not understand why a different medication was being administered, suggesting that many of these instances were related to breakdowns in communication as well. Other relatively common concerns were delays in the admissions process (reported by 9.2% of interviewees), poor team communication (reported by 6.6% of interviewees), healthcare providers with a rude or uncaring manner (reported by 6.3% of interviewees), and problems related to discharge (reported by 5.7% of interviewees).

Through interviews with nearly 1000 patients, we have found that approximately 4 in 10 hospitalized patients believed they experienced a breakdown in care. Not only are patient-perceived breakdowns in care distressingly common, more than one-third of these events resulted in harm according to the patient. Patients reported a diverse range of breakdowns, including problems related to patient experience, as well as breakdowns in technical aspects of medical care. Collectively, these findings illustrate a striking need to identify and address these frequent and potentially harmful breakdowns.

Our findings are consistent with prior studies in which 20% to 50% of patients identified a problem during hospitalization. For example, Weingart et al^. interviewed patients in a single general medical unit and found that 20% experienced an adverse event, near miss, or medical error, while nearly 40% experienced what was defined as a service quality incident.^2,12 Of note, both our study and the study by Weingart et al. systematically elicited patients’ perspectives of breakdowns in care with explicit questions about problems or breakdowns in care.^2,12 Because patients are often reluctant to speak up about problems in care,without such efforts to actively identify problems, providers and leaders are likely to be unaware of the majority of these concerns.^6-8 These findings suggest that hospital-based providers should at least consider routinely asking patients about breakdowns in care to identify and respond to patients’ concerns.

Not only are patient-perceived breakdowns common, more than one-third of patients who experienced a breakdown considered it to be harmful. This suggests that our outreach approach identified predominantly nontrivial concerns. We adopted a broad definition of harm that includes emotional distress, damage to the relationship with providers, and life disruption. This differs from other studies examining patient reports of breakdowns in care, in which harm was restricted to physical injury.^1,2 We consider this inclusive definition of harm to be a strength of the present study as it provides the most complete picture of the impact of such events on patients. This approach is supported by other studies demonstrating that patients place great emphasis on the psychological consequences of adverse events.^17-19 Thus, it is clear from our work and other studies that nonphysical harm is important and warrants concerted efforts to address.

Patients in our study reported a variety of breakdowns, including breakdowns related to patient experience (eg, communication, relationship with providers) and technical aspects of healthcare delivery (eg, diagnosis, treatment). This is consistent with other studies examining patient perspectives of breakdowns in care. Weingart et al.found that hospitalized patients reported a broad range of problems, including adverse events, medical errors, communication breakdowns, and problems with food.^2,12 This variety of events suggests a need for integration between the various hospital groups that handle patient-perceived breakdowns, including bedside providers, risk management, patient relations, patient advocates, and quality and safety groups, in order to provide a coordinated and effective response to the full spectrum of patient-perceived breakdowns in care.

Patients in our study were more likely to report breakdowns related to communication and relationships with providers than those related to technical aspects of care. Similarly, Kuzel et al.found that the most common problems cited by patients in the primary care setting were breakdowns in the clinician-patient relationship and access-related problems.¹⁷This is not surprising, as patients are likely to have more direct knowledge about communication and interpersonal relationships than about technical aspects of care.

We identified several factors associated with the likelihood of reporting a breakdown in care. Most strikingly, involving a friend or family member in the interview was strongly associated with reporting a breakdown. Other work has also suggested that patients’ friends and family members are an important source of information about safety concerns.^20,21 In addition, several patient characteristics were associated with an increased likelihood of reporting a breakdown, including being younger and better educated. These findings highlight the importance of engaging patients’ friends and families in efforts to elicit patient concerns about healthcare, and they confirm recommendations for patients to bring a friend or family member to healthcare encounters.²² In addition, they illustrate the need to better understand how patient characteristics affect perceptions of breakdowns in care and their willingness to speak up, as this could inform efforts to target outreach to especially vulnerable patients.

A strength of this study is the number of interviews completed (almost 1000), which provides a diverse range of patient views and experiences, as evidenced by the demographic characteristics of participants. Interviews were conducted at two hospitals that differ substantially with regard to populations served, further enhancing the generalizability of our findings. Despite the large number of interviews and diverse patient characteristics, patients were drawn from only 3 units at 2 hospitals, which may limit generalizability.

We did not conduct medical record reviews to validate patients’ reports of problems, which may be viewed as a limitation. While such a comparison would be informative, the intent of the current study was to elicit patients’ perceptions of care, including aspects of care that are not typically captured in the medical record, such as communication. Other studies have demonstrated that patients’ reports of medical errors and adverse events tend to differ from providers’ reports of the same subjects.^19,23 Therefore, we considered the patients’ perceptions of care to be a useful endpoint in and of itself. We did not determine the extent to which providers were already aware of patients’ concerns or whether they considered patients’ concerns valid. A related limitation is our inability to determine whether the differences we identified in the rates of breakdown reporting based on patient characteristics reflect differences in willingness to report or differences in experiences. Because we included patients in an MSU, it is possible that breakdowns were related to medical care, surgical care, or both. We did not follow patients longitudinally and therefore only captured harm perceived by a patient at the time of the interview. It is possible that patients may have experienced harm later in their hospitalization or following discharge that was not measured. Lastly, we did not measure interrater reliability of the interview coding and therefore do not present the PECT as a validated instrument. These important questions should be targeted for future study.

When directly asked about their experiences, almost 4 out of 10 hospitalized patients reported a breakdown in their care, many of which were perceived to be harmful. Not all hospitals will have the resources to implement the intensive approach used in this study to elicit patient-perceived breakdowns. Therefore, further work is needed to develop sustainable methods to overcome patients’ reluctance to report breakdowns in care. Engaging patients’ families and friends may be a particularly fruitful strategy. We offer the PECT as a tool that hospitals could use to summarize a variety of sources of patient feedback such as complaints, responses to surveys, and consumer reviews. Hospitals that effectively encourage patients and their family members to speak up about perceived breakdowns will identify many opportunities to address patient concerns, potentially leading to improved patient safety and experience.

The VOLTAIRE-X study of a biosimilar candidate for adalimumab (Humira) for chronic plaque psoriasis has enrolled its first patient, announced Boehringer Ingelheim, the biosimilar’s developer, on July 27.

This is the first study in the United States to investigate whether a biosimilar candidate should be granted an interchangeability designation with adalimumab. The candidate, BI 695501, is up against adalimumab’s 40-mg injection.

In VOLTAIRE-X, some patients will alternate between adalimumab and BI 695501, and others will take adalimumab continuously. The study will compare the pharmacokinetics, clinical outcomes, safety, immunogenicity, and efficacy between the two groups of patients. The estimated enrollment of adult patients with moderate to severe chronic plaque psoriasis is 240, and the study is expected to conclude in July 2019.

A phase 3 study of BI 695501’s performance for rheumatoid arthritis patients, completed in 2016, demonstrated similar efficacy, safety, and immunogenicity.

[email protected]

The VOLTAIRE-X study of a biosimilar candidate for adalimumab (Humira) for chronic plaque psoriasis has enrolled its first patient, announced Boehringer Ingelheim, the biosimilar’s developer, on July 27.

This is the first study in the United States to investigate whether a biosimilar candidate should be granted an interchangeability designation with adalimumab. The candidate, BI 695501, is up against adalimumab’s 40-mg injection.

In VOLTAIRE-X, some patients will alternate between adalimumab and BI 695501, and others will take adalimumab continuously. The study will compare the pharmacokinetics, clinical outcomes, safety, immunogenicity, and efficacy between the two groups of patients. The estimated enrollment of adult patients with moderate to severe chronic plaque psoriasis is 240, and the study is expected to conclude in July 2019.

A phase 3 study of BI 695501’s performance for rheumatoid arthritis patients, completed in 2016, demonstrated similar efficacy, safety, and immunogenicity.

[email protected]

The VOLTAIRE-X study of a biosimilar candidate for adalimumab (Humira) for chronic plaque psoriasis has enrolled its first patient, announced Boehringer Ingelheim, the biosimilar’s developer, on July 27.

This is the first study in the United States to investigate whether a biosimilar candidate should be granted an interchangeability designation with adalimumab. The candidate, BI 695501, is up against adalimumab’s 40-mg injection.

In VOLTAIRE-X, some patients will alternate between adalimumab and BI 695501, and others will take adalimumab continuously. The study will compare the pharmacokinetics, clinical outcomes, safety, immunogenicity, and efficacy between the two groups of patients. The estimated enrollment of adult patients with moderate to severe chronic plaque psoriasis is 240, and the study is expected to conclude in July 2019.

A phase 3 study of BI 695501’s performance for rheumatoid arthritis patients, completed in 2016, demonstrated similar efficacy, safety, and immunogenicity.

[email protected]

ESTES PARK, COLO. – Before ordering any tests at all, an astute clinician can have a pretty good idea as to whether a palpable thyroid nodule is at higher or lower risk for being malignant based upon the patient’s history and physical examination, Michael T. McDermott, MD, said at a conference on internal medicine sponsored by the University of Colorado.

“The possibility of cancer is what scares people, and that’s what people want to know,” observed Dr. McDermott, professor of medicine and director of endocrinology and diabetes practice at University of Colorado Hospital.

This is a common clinical problem.

“If you felt the neck of every patient that you saw, 4%-7% would have a palpable thyroid nodule,” the endocrinologist said.

[email protected]

ESTES PARK, COLO. – Before ordering any tests at all, an astute clinician can have a pretty good idea as to whether a palpable thyroid nodule is at higher or lower risk for being malignant based upon the patient’s history and physical examination, Michael T. McDermott, MD, said at a conference on internal medicine sponsored by the University of Colorado.

“The possibility of cancer is what scares people, and that’s what people want to know,” observed Dr. McDermott, professor of medicine and director of endocrinology and diabetes practice at University of Colorado Hospital.

This is a common clinical problem.

“If you felt the neck of every patient that you saw, 4%-7% would have a palpable thyroid nodule,” the endocrinologist said.

[email protected]

ESTES PARK, COLO. – Before ordering any tests at all, an astute clinician can have a pretty good idea as to whether a palpable thyroid nodule is at higher or lower risk for being malignant based upon the patient’s history and physical examination, Michael T. McDermott, MD, said at a conference on internal medicine sponsored by the University of Colorado.

“The possibility of cancer is what scares people, and that’s what people want to know,” observed Dr. McDermott, professor of medicine and director of endocrinology and diabetes practice at University of Colorado Hospital.

This is a common clinical problem.

“If you felt the neck of every patient that you saw, 4%-7% would have a palpable thyroid nodule,” the endocrinologist said.

[email protected]

DIAGNOSE HERPES SIMPLEX VIRUS

According to the CDC, infections with HSV-2 affect more than 24 million Americans. Patients with HSV-2 strain are at increased risk for contracting and transmitting HIV. Pregnant women infected with HSV-2 are at risk of transmitting the virus to their babies, with increased risk for neurologic complications in the child. 

FOR MORE INFORMATION, VISIT: http://www.hologic.com/search/site/aptima%20hsv

PRECISELY TARGET TISSUE DURING LUMPECTOMY OR BIOPSY

Cianna Medical reported recent data showing that, when compared with wire localization, the SCOUT reduces breast surgery operating room (OR) delay times by 72.5%, resulted in an average 29- minute reduction in OR waiting time, and significantly improved workflow efficiency.

FOR MORE INFORMATION, VISIT: https://www.ciannamedical.com/savi-scout/

PLASMA HYSTEROSCOPIC RESECTION

During gynecologic procedures, the Olympus 8.5-mm hystero-resectoscope uses a combination of radio frequency, energy, and saline to create plasma, an electrically conductive gas cloud of vapor and charged particles. Due to its conductivity, plasma allows energy to cross into targeted tissue at lower energy levels than with more traditional approaches. This effect leads to lower operating temperatures and therefore less thermal spread.

FOR MORE INFORMATION, VISIT:  http://olympusmedical.com.sg

APP-BASED HANDHELD ULTRASOUND

High-resolution images can be saved, reviewed, and managed on the secure Clarius Cloud. Built with a durable magnesium shell, each device has an IPX7 immersion rating so it can be sterilized. Power is obtained from a rechargeable battery that will last for more than 45 minutes of scanning; 2 batteries come with each Clarius device.

FOR MORE INFORMATION, VISIT: https://www.clarius.me/

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

DIAGNOSE HERPES SIMPLEX VIRUS

According to the CDC, infections with HSV-2 affect more than 24 million Americans. Patients with HSV-2 strain are at increased risk for contracting and transmitting HIV. Pregnant women infected with HSV-2 are at risk of transmitting the virus to their babies, with increased risk for neurologic complications in the child. 

FOR MORE INFORMATION, VISIT: http://www.hologic.com/search/site/aptima%20hsv

PRECISELY TARGET TISSUE DURING LUMPECTOMY OR BIOPSY

Cianna Medical reported recent data showing that, when compared with wire localization, the SCOUT reduces breast surgery operating room (OR) delay times by 72.5%, resulted in an average 29- minute reduction in OR waiting time, and significantly improved workflow efficiency.

FOR MORE INFORMATION, VISIT: https://www.ciannamedical.com/savi-scout/

PLASMA HYSTEROSCOPIC RESECTION

During gynecologic procedures, the Olympus 8.5-mm hystero-resectoscope uses a combination of radio frequency, energy, and saline to create plasma, an electrically conductive gas cloud of vapor and charged particles. Due to its conductivity, plasma allows energy to cross into targeted tissue at lower energy levels than with more traditional approaches. This effect leads to lower operating temperatures and therefore less thermal spread.

FOR MORE INFORMATION, VISIT:  http://olympusmedical.com.sg

APP-BASED HANDHELD ULTRASOUND

High-resolution images can be saved, reviewed, and managed on the secure Clarius Cloud. Built with a durable magnesium shell, each device has an IPX7 immersion rating so it can be sterilized. Power is obtained from a rechargeable battery that will last for more than 45 minutes of scanning; 2 batteries come with each Clarius device.

FOR MORE INFORMATION, VISIT: https://www.clarius.me/

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

DIAGNOSE HERPES SIMPLEX VIRUS

According to the CDC, infections with HSV-2 affect more than 24 million Americans. Patients with HSV-2 strain are at increased risk for contracting and transmitting HIV. Pregnant women infected with HSV-2 are at risk of transmitting the virus to their babies, with increased risk for neurologic complications in the child. 

FOR MORE INFORMATION, VISIT: http://www.hologic.com/search/site/aptima%20hsv

PRECISELY TARGET TISSUE DURING LUMPECTOMY OR BIOPSY

Cianna Medical reported recent data showing that, when compared with wire localization, the SCOUT reduces breast surgery operating room (OR) delay times by 72.5%, resulted in an average 29- minute reduction in OR waiting time, and significantly improved workflow efficiency.

FOR MORE INFORMATION, VISIT: https://www.ciannamedical.com/savi-scout/

PLASMA HYSTEROSCOPIC RESECTION

During gynecologic procedures, the Olympus 8.5-mm hystero-resectoscope uses a combination of radio frequency, energy, and saline to create plasma, an electrically conductive gas cloud of vapor and charged particles. Due to its conductivity, plasma allows energy to cross into targeted tissue at lower energy levels than with more traditional approaches. This effect leads to lower operating temperatures and therefore less thermal spread.

FOR MORE INFORMATION, VISIT:  http://olympusmedical.com.sg

APP-BASED HANDHELD ULTRASOUND

High-resolution images can be saved, reviewed, and managed on the secure Clarius Cloud. Built with a durable magnesium shell, each device has an IPX7 immersion rating so it can be sterilized. Power is obtained from a rechargeable battery that will last for more than 45 minutes of scanning; 2 batteries come with each Clarius device.

FOR MORE INFORMATION, VISIT: https://www.clarius.me/

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

As healthcare system use and costs continue to rise, increased importance has been placed on identifying the small subgroup of patients that drive this trend.¹ It is estimated that 5% of healthcare users account for over 60% of healthcare spending.^2-6 Furthermore, care for these “high users” is expensive due to an over-reliance on inpatient services. Approximately 40% of all health spending is for inpatient care, the largest single category of health spending, which is similarly skewed toward high users.^1,3,5 Improving our understanding of this population may provide an opportunity to direct improvement efforts to a select group of patients with a potentially high benefit, as well as move care away from the costly inpatient setting.

However, the development of effective interventions to improve patient experience and outcomes while decreasing costs (referred to as the “Triple Aim” by the Institute for Health Improvement) for high users of inpatient services hinges on the methodology used to identify this high-risk population.⁷ There is substantial variability in definitions of high users; the most common definitions are based on the number of hospital encounters, days spent in the hospital, and hospital costs.^8-15 Definitions have intrinsic differences in their implications around appropriateness, efficiency, and financial sustainability of inpatient resource use. Though the constructs underlying these definitions are highly variable, direct comparisons of differences in patient capture are limited.

A recent study from a single US center explored the clinical characteristics of hospital patients based on definitions of use vs cost and observed important differences in patients’ profiles and outcomes.¹² While this suggests that the choice of definition may have major implications for whom to target (and the efficacy of any proposed interventions), this concept has not been explored at the population level. Therefore, we used population-based administrative data from a single-payer healthcare system to compare 3 common definitions of high inpatient service use and their influence on patient capture, health outcomes, and inpatient system burden.

Data Sources and Study Population

We conducted a retrospective population-based study using administrative and clinical data for the province of Alberta, including the discharge abstracts database, physician claims, ambulatory care records, population health registry file, and aggregated data from the Canadian census.¹⁶ We identified all adults who had 1 or more hospitalizations with a discharge date between April 1, 2012, and March 31, 2013, though the admission date could be prior to April 1, 2012.

Definition of High-Inpatient Use

High-inpatient use was defined using 3 metrics: number of inpatient episodes, length of stay, and cost. As in prior studies, for each definition, individuals in the upper5th percentile of the relevant distribution were designated “high users,”^2,15 while patients in the lower 95th percentile were considered “nonhigh users.” Patients could be defined as a high user in more than 1 definition.

Patients with 3 or more hospital episodes were defined as high users for the “number of inpatient episodes” definition. A hospital episode of care was defined as an event that resulted in discharge (or death) from an inpatient facility. If an individual was admitted to a hospital and transferred to another facility within 1 day of discharge, the hospitalizations were considered part of the same episode of care.

The “length of stay” definition refers to the cumulative number of days spent in an inpatient facility for all eligible episodes of care. Patients with 56 or more days in hospital during the study period were considered high users. Day of admission and discharge were considered full inpatient days, regardless of the time of admission and discharge.

The “cost” definition considered the cumulative estimated cost of every eligible episode of care. We estimated costs for each hospitalization using resource intensity weights (RIW). This is a relative weighted value for the average inpatient case after taking factors such as age, comorbidity, and procedures into account. The RIW for each episode was multiplied by the national average inpatient cost.¹⁷ Based on this definition, patients with a cumulative hospital cost of ≥ $63,597 were deemed high users. All costs were calculated in Canadian Dollars (CAD, $) and adjusted to 2013 dollars based on Statistics Canada’s Consumer Price Index.¹⁸

Demographic, Clinical, and Encounter Characteristics

Individual characteristics were measured using a combination of provincial administrative data sources. All measures were recorded as of the admission date of the first eligible hospitalization. Demographic characteristics included age, sex, First Nations status, urban/rural status (based on the individual’s residential postal code), and median neighborhood income quintile. Clinical characteristics included 28 comorbid conditions defined based on separate validated International Statistical Classification of Disease and Health Related Problems, Tenth Revision, Canada (ICD-10-CA) coding algorithms reported individually and cumulatively (categorized as 0, 1, 2–3, and 4+).¹⁹ Primary care attachment was defined as the percentage of all outpatient primary care visits made to a single practitioner in the 2-year period prior to their first hospitalization (among those with ≥3 visits). Attachment was categorized as 75%-100% (good attachment), 50%-74% (moderate attachment), or <50% (low attachment).^20,21

We also identified hospital encounter-level characteristics. These included the most responsible diagnosis, admission category (elective or urgent/emergent), and discharge disposition for each hospital episode. Reported health outcomes included the proportion of patients with in-hospital mortality and those with at least one 30-day, all-cause readmission to hospital.

Analysis

Patient characteristics were described using proportions and means (standard deviation) as appropriate for high users and nonhigh users within and across each definition. Encounter characteristics were also described and stratified by age category (18-64 or 65+ years). Comparison of patient capture was then analyzed among patients who were high use by at least 1 definition. The overlap and agreement of the 3 definitions were compared using a Venn diagram and kappa statistic. The 10 most responsible diagnoses (based on frequency) were also compared across definitions and stratified by age.

Finally, the percentage of system burden accounted for by each measure was calculated as the amount used by high users divided by the total amount used by the entire study population (x 100). To assess the potential modifying effect of age, results were stratified by age category for each definition.

All analyses were conducted using Stata 11.2 (StataCorp LP, College Station, TX).²² The Conjoint Health Research Ethics Board of the University of Calgary approved this study and granted waiver of patient consent. This manuscript is written in accordance with reporting guidelines for studies conducted using observational routinely collected health data (RECORD statement).²³

Comparison of Patient and Encounter-level Characterist

ics

A total of 219,106 adults had 283,204 inpatient episodes of care within the study timeframe. There were 12,707 (5.8%), 11,095 (5.1%), and 10,956 (5.0%) patients defined as high users based on number of inpatient episodes, length of stay, and cost, respectively (supplementary Figure 1). Regardless of definition, when compared to their non–high use counterparts, patients classified as high use were more likely to be male, older, in a lower median neighborhood income quintile, and have a higher level of comorbidity. Comparing across definitions of high use, those defined by number of inpatient episodes were more likely to be younger, live in rural areas, have better primary care attachment, and have fewer comorbidities, compared to the other definitions. High users by length of stay were more likely to be older and had a higher proportion of mental health–related comorbidities, including dementia and depression, as compared with the other definitions. Results were largely similar for those defined by cost (Table 1).

Encounter-level analyses

Comparison of Patient Capture and Inpatient Burden

Of the 22,691 individuals who were defined as high use by at least 1 definition, 2,331 (10.3%) were consistently high use across all 3 definitions (kappa = 0.38; Figure 1). Of the 13,682 individuals classified as high use by at least 1 of length of stay or cost, 8369 (61.2%) were defined as high use by both definitions (kappa = 0.75). However, of the 12,707 defined as high use by the number of inpatient episodes, only 3698 (29.1%) were also defined as high use by another definition. Exploration of the most responsible diagnoses across definitions showed that congestive heart failure (2.8%-3.5%), chronic obstructive pulmonary disease (1.6%-3.2%), and dementia (0.6%-2.2%) were the most frequent. Acute medical conditions (eg, pneumonia [1.8%] or gastroenteritis [0.7%]) that may result in multiple shorter hospitalizations were observed at higher frequencies among high users defined by inpatient episodes, while conditions commonly requiring rehabilitation (eg, fracture [1.8%] and stroke [1.7%]) were more common among high users defined by length of stay and cost (supplementary Table 2). Stratification by age showed marked differences in the diagnoses across high-use definitions. Among hi

When assessing inpatient system burden, high users by number of inpatient episodes accounted for 47,044 (16.6%) of the 283,204 episodes. High users defined by length of stay accounted for 1,286,539 (46.4%) days of 2,773,561 total days, while high users defined by cost accumulated $1.4 billion (38.9%) of the estimated $3.7 billion in inpatient expenditures. High users defined by cost and length of stay each accounted for comparatively few episode

Using a large population-based cohort of all adults with at least 1 hospitalization in the province of Alberta, Canada, within a 12-month period, we compared 3 commonly used definitions of high inpatient use. The choice of definition had a substantial influence on the types of patients categorized as high use, as well as the proportion of total inpatient utilization that was associated with high users. The definition based on number of inpatient episodes captured a distinct population of high users, while the populations identified using cumulative length of stay or cost were similar.

Differences within and between definitions were especially apparent in age-stratified analyses: Greater length of stay or higher cost among patients aged 18-64 years identifies a large proportion of psychological conditions, while a greater number of inpatient episodes identifies acute conditions and childbirth or labor-related complications. Conversely, definitions based on length of stay and cost in the elderly (65+) identified groups with chronic conditions that result in progressive functional decline (often requiring increasing supportive services upon discharge) or conditions that require significant rehabilitation prior to discharge. Regarding inpatient system burden, high users defined by number of inpatient episodes accounted for a small proportion of total inpatient episodes, while high users defined by length of stay and cost accounted for nearly half of the accumulated hospital days and cost for each. These findings highlight the need for careful consideration of how high use is defined when studying high-user populations and implications for targeting subpopulations for intervention.

Our results add to those from previous studies. A US-based, single-center study of 2566 individuals compared definitions of high inpatient use based on cost and frequency of admission and found that patients defined by cost were predominantly hospitalized for surgical conditions, while those fulfilling the episode-based definition were often hospitalized for medical conditions.¹² The most responsible diagnoses for patient hospitalizations in our study reflect this. We extended this comparison to consider the impact of age on outcomes and inpatient system burden and found that older age was also linked to poorer outcomes and increased burden. We also considered a third definition (cumulative length of stay), which provided another opportunity for comparison. The presence of chronic conditions requiring rehabilitation and possible alternate level of care days within our cohort highlights the utility of this length of stay-based approach when considering definitions. Although there were similarities between patients defined by length of stay and cost, partly due to cost being largely a function of length of stay, there were also important differences in their patient profiles. Those defined by cost tended to have conditions requiring surgical procedures not requiring extended in-hospital rehabilitation. Furthermore, the higher proportion of in-hospital mortality among those defined by cost may also reflect the fact that patients tend to accrue the majority of their healthcare expenditures during the final 120 days of life.²⁴

Each definition of high use identified complex patients; however, the differences between the various types of high users identified by these definitions suggest that they are not interchangeable. Arguably, selection of the most appropriate definition should depend on the objective of measuring high users, particularly if an intervention is planned. Interventions for high users are complex, requiring both medical and nonmedical components. The current literature in this area has often focused on case management programs, collaboration with community-based social support programs, and improving coordination and transitions of care.^25-27 While many of these approaches require considerable involvement outside of the inpatient setting, these interventions can be informed by defining who high users of inpatient services are. Our findings show several possible subgroups of high users, which could be targeted for intervention. For example, an inpatient episode-based definition, which identifies patients with frequent encounters for acute conditions (eg, pneumonia and urinary tract infections), would be informative if an intervention targeted reductions in inpatient use and readmission rates. Alternatively, an intervention designed to improve community-based mental health programs would best be informed by a definition based on length of stay in which high users with underlying mental health conditions were prevalent. Such interventions are rarely mutually exclusive and require multiple perspectives to inform their objectives. A well-designed intervention will not only address the medical characteristics of high users but also the social determinants of health that place patients at risk of high inpatient use.

Our study should be interpreted in light of its limitations. First, measures of disease severity were not available to further characterize similarities and differences across high-use groups. Furthermore, we were unable to account for other social determinants of health that may be relevant to inpatient system usage. Second, direct cost of hospitalizations was estimated based on RIW and is thus reflective of expected rather than actual costs. However, this will have minimal impact on capture, as patients defined by this metric require substantial costs to be included in the top fifth percentile, and thus deviations in individual hospitalization costs will have minimal influence on the cumulative cost. Finally, while inpatient spending makes up a large proportion of healthcare spending, there is likely a number of different high-use profiles found outside of the acute care setting. Despite these limitations, our study includes several key strengths. The use of population-level data allows for analysis that is robust and more generalizable than studies from single centers. Additionally, the comparison of 3 independent definitions allows for a greater comparison of the nuances of each definition. Our study also considers the important impact of age as an effect modifier of inpatient use in the general population and identifies distinct patient profiles that exist across each definition.

Definitions of high use of inpatient services based on number of inpatient episodes, days spent in hospital, and total hospital costs identify patient populations with different characteristics and differ substantially in their impact on health outcomes and inpatient burden. These results highlight the need for careful consideration of the context of the study or intervention and the implications of selecting a specific definition of high inpatient use at study conception. Ultimately, the performance of an intervention in high-use populations is likely to be conditional on the fit of the patient population generated by the chosen definition of high inpatient use to the objectives of a study.

Acknowledgments

This study is based in part on data provided by Alberta Health and Alberta Health Services. The interpretation and conclusions are those of the researchers and do not represent the views of the Government of Alberta. Neither the Government of Alberta nor Alberta Health express any opinion in relation to this study.

Disclosure

Dr. Hemmelgarn is supported by the Roy and Vi Baay Chair in Kidney Research. Dr. Manns is supported by the Svare Professorship in Health Economics and by a Health Scholar Award by Alberta Innovates Health Solutions (AIHS). Dr. Tonelli is supported by the David Freeze chair in Health Services Research. The Interdisciplinary Chronic Disease Collaboration is funded by AIHS—Collaborative Research and Innovation Opportunity (CRIO) Team Grants Program.

As healthcare system use and costs continue to rise, increased importance has been placed on identifying the small subgroup of patients that drive this trend.¹ It is estimated that 5% of healthcare users account for over 60% of healthcare spending.^2-6 Furthermore, care for these “high users” is expensive due to an over-reliance on inpatient services. Approximately 40% of all health spending is for inpatient care, the largest single category of health spending, which is similarly skewed toward high users.^1,3,5 Improving our understanding of this population may provide an opportunity to direct improvement efforts to a select group of patients with a potentially high benefit, as well as move care away from the costly inpatient setting.

However, the development of effective interventions to improve patient experience and outcomes while decreasing costs (referred to as the “Triple Aim” by the Institute for Health Improvement) for high users of inpatient services hinges on the methodology used to identify this high-risk population.⁷ There is substantial variability in definitions of high users; the most common definitions are based on the number of hospital encounters, days spent in the hospital, and hospital costs.^8-15 Definitions have intrinsic differences in their implications around appropriateness, efficiency, and financial sustainability of inpatient resource use. Though the constructs underlying these definitions are highly variable, direct comparisons of differences in patient capture are limited.

A recent study from a single US center explored the clinical characteristics of hospital patients based on definitions of use vs cost and observed important differences in patients’ profiles and outcomes.¹² While this suggests that the choice of definition may have major implications for whom to target (and the efficacy of any proposed interventions), this concept has not been explored at the population level. Therefore, we used population-based administrative data from a single-payer healthcare system to compare 3 common definitions of high inpatient service use and their influence on patient capture, health outcomes, and inpatient system burden.

Data Sources and Study Population

We conducted a retrospective population-based study using administrative and clinical data for the province of Alberta, including the discharge abstracts database, physician claims, ambulatory care records, population health registry file, and aggregated data from the Canadian census.¹⁶ We identified all adults who had 1 or more hospitalizations with a discharge date between April 1, 2012, and March 31, 2013, though the admission date could be prior to April 1, 2012.

Definition of High-Inpatient Use

High-inpatient use was defined using 3 metrics: number of inpatient episodes, length of stay, and cost. As in prior studies, for each definition, individuals in the upper5th percentile of the relevant distribution were designated “high users,”^2,15 while patients in the lower 95th percentile were considered “nonhigh users.” Patients could be defined as a high user in more than 1 definition.

Patients with 3 or more hospital episodes were defined as high users for the “number of inpatient episodes” definition. A hospital episode of care was defined as an event that resulted in discharge (or death) from an inpatient facility. If an individual was admitted to a hospital and transferred to another facility within 1 day of discharge, the hospitalizations were considered part of the same episode of care.

The “length of stay” definition refers to the cumulative number of days spent in an inpatient facility for all eligible episodes of care. Patients with 56 or more days in hospital during the study period were considered high users. Day of admission and discharge were considered full inpatient days, regardless of the time of admission and discharge.

The “cost” definition considered the cumulative estimated cost of every eligible episode of care. We estimated costs for each hospitalization using resource intensity weights (RIW). This is a relative weighted value for the average inpatient case after taking factors such as age, comorbidity, and procedures into account. The RIW for each episode was multiplied by the national average inpatient cost.¹⁷ Based on this definition, patients with a cumulative hospital cost of ≥ $63,597 were deemed high users. All costs were calculated in Canadian Dollars (CAD, $) and adjusted to 2013 dollars based on Statistics Canada’s Consumer Price Index.¹⁸

Demographic, Clinical, and Encounter Characteristics

Individual characteristics were measured using a combination of provincial administrative data sources. All measures were recorded as of the admission date of the first eligible hospitalization. Demographic characteristics included age, sex, First Nations status, urban/rural status (based on the individual’s residential postal code), and median neighborhood income quintile. Clinical characteristics included 28 comorbid conditions defined based on separate validated International Statistical Classification of Disease and Health Related Problems, Tenth Revision, Canada (ICD-10-CA) coding algorithms reported individually and cumulatively (categorized as 0, 1, 2–3, and 4+).¹⁹ Primary care attachment was defined as the percentage of all outpatient primary care visits made to a single practitioner in the 2-year period prior to their first hospitalization (among those with ≥3 visits). Attachment was categorized as 75%-100% (good attachment), 50%-74% (moderate attachment), or <50% (low attachment).^20,21

We also identified hospital encounter-level characteristics. These included the most responsible diagnosis, admission category (elective or urgent/emergent), and discharge disposition for each hospital episode. Reported health outcomes included the proportion of patients with in-hospital mortality and those with at least one 30-day, all-cause readmission to hospital.

Analysis

Patient characteristics were described using proportions and means (standard deviation) as appropriate for high users and nonhigh users within and across each definition. Encounter characteristics were also described and stratified by age category (18-64 or 65+ years). Comparison of patient capture was then analyzed among patients who were high use by at least 1 definition. The overlap and agreement of the 3 definitions were compared using a Venn diagram and kappa statistic. The 10 most responsible diagnoses (based on frequency) were also compared across definitions and stratified by age.

Finally, the percentage of system burden accounted for by each measure was calculated as the amount used by high users divided by the total amount used by the entire study population (x 100). To assess the potential modifying effect of age, results were stratified by age category for each definition.

All analyses were conducted using Stata 11.2 (StataCorp LP, College Station, TX).²² The Conjoint Health Research Ethics Board of the University of Calgary approved this study and granted waiver of patient consent. This manuscript is written in accordance with reporting guidelines for studies conducted using observational routinely collected health data (RECORD statement).²³

Comparison of Patient and Encounter-level Characterist

ics

A total of 219,106 adults had 283,204 inpatient episodes of care within the study timeframe. There were 12,707 (5.8%), 11,095 (5.1%), and 10,956 (5.0%) patients defined as high users based on number of inpatient episodes, length of stay, and cost, respectively (supplementary Figure 1). Regardless of definition, when compared to their non–high use counterparts, patients classified as high use were more likely to be male, older, in a lower median neighborhood income quintile, and have a higher level of comorbidity. Comparing across definitions of high use, those defined by number of inpatient episodes were more likely to be younger, live in rural areas, have better primary care attachment, and have fewer comorbidities, compared to the other definitions. High users by length of stay were more likely to be older and had a higher proportion of mental health–related comorbidities, including dementia and depression, as compared with the other definitions. Results were largely similar for those defined by cost (Table 1).

Encounter-level analyses

Comparison of Patient Capture and Inpatient Burden

Of the 22,691 individuals who were defined as high use by at least 1 definition, 2,331 (10.3%) were consistently high use across all 3 definitions (kappa = 0.38; Figure 1). Of the 13,682 individuals classified as high use by at least 1 of length of stay or cost, 8369 (61.2%) were defined as high use by both definitions (kappa = 0.75). However, of the 12,707 defined as high use by the number of inpatient episodes, only 3698 (29.1%) were also defined as high use by another definition. Exploration of the most responsible diagnoses across definitions showed that congestive heart failure (2.8%-3.5%), chronic obstructive pulmonary disease (1.6%-3.2%), and dementia (0.6%-2.2%) were the most frequent. Acute medical conditions (eg, pneumonia [1.8%] or gastroenteritis [0.7%]) that may result in multiple shorter hospitalizations were observed at higher frequencies among high users defined by inpatient episodes, while conditions commonly requiring rehabilitation (eg, fracture [1.8%] and stroke [1.7%]) were more common among high users defined by length of stay and cost (supplementary Table 2). Stratification by age showed marked differences in the diagnoses across high-use definitions. Among hi

When assessing inpatient system burden, high users by number of inpatient episodes accounted for 47,044 (16.6%) of the 283,204 episodes. High users defined by length of stay accounted for 1,286,539 (46.4%) days of 2,773,561 total days, while high users defined by cost accumulated $1.4 billion (38.9%) of the estimated $3.7 billion in inpatient expenditures. High users defined by cost and length of stay each accounted for comparatively few episode

Using a large population-based cohort of all adults with at least 1 hospitalization in the province of Alberta, Canada, within a 12-month period, we compared 3 commonly used definitions of high inpatient use. The choice of definition had a substantial influence on the types of patients categorized as high use, as well as the proportion of total inpatient utilization that was associated with high users. The definition based on number of inpatient episodes captured a distinct population of high users, while the populations identified using cumulative length of stay or cost were similar.

Differences within and between definitions were especially apparent in age-stratified analyses: Greater length of stay or higher cost among patients aged 18-64 years identifies a large proportion of psychological conditions, while a greater number of inpatient episodes identifies acute conditions and childbirth or labor-related complications. Conversely, definitions based on length of stay and cost in the elderly (65+) identified groups with chronic conditions that result in progressive functional decline (often requiring increasing supportive services upon discharge) or conditions that require significant rehabilitation prior to discharge. Regarding inpatient system burden, high users defined by number of inpatient episodes accounted for a small proportion of total inpatient episodes, while high users defined by length of stay and cost accounted for nearly half of the accumulated hospital days and cost for each. These findings highlight the need for careful consideration of how high use is defined when studying high-user populations and implications for targeting subpopulations for intervention.

Our results add to those from previous studies. A US-based, single-center study of 2566 individuals compared definitions of high inpatient use based on cost and frequency of admission and found that patients defined by cost were predominantly hospitalized for surgical conditions, while those fulfilling the episode-based definition were often hospitalized for medical conditions.¹² The most responsible diagnoses for patient hospitalizations in our study reflect this. We extended this comparison to consider the impact of age on outcomes and inpatient system burden and found that older age was also linked to poorer outcomes and increased burden. We also considered a third definition (cumulative length of stay), which provided another opportunity for comparison. The presence of chronic conditions requiring rehabilitation and possible alternate level of care days within our cohort highlights the utility of this length of stay-based approach when considering definitions. Although there were similarities between patients defined by length of stay and cost, partly due to cost being largely a function of length of stay, there were also important differences in their patient profiles. Those defined by cost tended to have conditions requiring surgical procedures not requiring extended in-hospital rehabilitation. Furthermore, the higher proportion of in-hospital mortality among those defined by cost may also reflect the fact that patients tend to accrue the majority of their healthcare expenditures during the final 120 days of life.²⁴

Each definition of high use identified complex patients; however, the differences between the various types of high users identified by these definitions suggest that they are not interchangeable. Arguably, selection of the most appropriate definition should depend on the objective of measuring high users, particularly if an intervention is planned. Interventions for high users are complex, requiring both medical and nonmedical components. The current literature in this area has often focused on case management programs, collaboration with community-based social support programs, and improving coordination and transitions of care.^25-27 While many of these approaches require considerable involvement outside of the inpatient setting, these interventions can be informed by defining who high users of inpatient services are. Our findings show several possible subgroups of high users, which could be targeted for intervention. For example, an inpatient episode-based definition, which identifies patients with frequent encounters for acute conditions (eg, pneumonia and urinary tract infections), would be informative if an intervention targeted reductions in inpatient use and readmission rates. Alternatively, an intervention designed to improve community-based mental health programs would best be informed by a definition based on length of stay in which high users with underlying mental health conditions were prevalent. Such interventions are rarely mutually exclusive and require multiple perspectives to inform their objectives. A well-designed intervention will not only address the medical characteristics of high users but also the social determinants of health that place patients at risk of high inpatient use.

Our study should be interpreted in light of its limitations. First, measures of disease severity were not available to further characterize similarities and differences across high-use groups. Furthermore, we were unable to account for other social determinants of health that may be relevant to inpatient system usage. Second, direct cost of hospitalizations was estimated based on RIW and is thus reflective of expected rather than actual costs. However, this will have minimal impact on capture, as patients defined by this metric require substantial costs to be included in the top fifth percentile, and thus deviations in individual hospitalization costs will have minimal influence on the cumulative cost. Finally, while inpatient spending makes up a large proportion of healthcare spending, there is likely a number of different high-use profiles found outside of the acute care setting. Despite these limitations, our study includes several key strengths. The use of population-level data allows for analysis that is robust and more generalizable than studies from single centers. Additionally, the comparison of 3 independent definitions allows for a greater comparison of the nuances of each definition. Our study also considers the important impact of age as an effect modifier of inpatient use in the general population and identifies distinct patient profiles that exist across each definition.

Definitions of high use of inpatient services based on number of inpatient episodes, days spent in hospital, and total hospital costs identify patient populations with different characteristics and differ substantially in their impact on health outcomes and inpatient burden. These results highlight the need for careful consideration of the context of the study or intervention and the implications of selecting a specific definition of high inpatient use at study conception. Ultimately, the performance of an intervention in high-use populations is likely to be conditional on the fit of the patient population generated by the chosen definition of high inpatient use to the objectives of a study.

Acknowledgments

This study is based in part on data provided by Alberta Health and Alberta Health Services. The interpretation and conclusions are those of the researchers and do not represent the views of the Government of Alberta. Neither the Government of Alberta nor Alberta Health express any opinion in relation to this study.

Disclosure

Dr. Hemmelgarn is supported by the Roy and Vi Baay Chair in Kidney Research. Dr. Manns is supported by the Svare Professorship in Health Economics and by a Health Scholar Award by Alberta Innovates Health Solutions (AIHS). Dr. Tonelli is supported by the David Freeze chair in Health Services Research. The Interdisciplinary Chronic Disease Collaboration is funded by AIHS—Collaborative Research and Innovation Opportunity (CRIO) Team Grants Program.

As healthcare system use and costs continue to rise, increased importance has been placed on identifying the small subgroup of patients that drive this trend.¹ It is estimated that 5% of healthcare users account for over 60% of healthcare spending.^2-6 Furthermore, care for these “high users” is expensive due to an over-reliance on inpatient services. Approximately 40% of all health spending is for inpatient care, the largest single category of health spending, which is similarly skewed toward high users.^1,3,5 Improving our understanding of this population may provide an opportunity to direct improvement efforts to a select group of patients with a potentially high benefit, as well as move care away from the costly inpatient setting.

However, the development of effective interventions to improve patient experience and outcomes while decreasing costs (referred to as the “Triple Aim” by the Institute for Health Improvement) for high users of inpatient services hinges on the methodology used to identify this high-risk population.⁷ There is substantial variability in definitions of high users; the most common definitions are based on the number of hospital encounters, days spent in the hospital, and hospital costs.^8-15 Definitions have intrinsic differences in their implications around appropriateness, efficiency, and financial sustainability of inpatient resource use. Though the constructs underlying these definitions are highly variable, direct comparisons of differences in patient capture are limited.

A recent study from a single US center explored the clinical characteristics of hospital patients based on definitions of use vs cost and observed important differences in patients’ profiles and outcomes.¹² While this suggests that the choice of definition may have major implications for whom to target (and the efficacy of any proposed interventions), this concept has not been explored at the population level. Therefore, we used population-based administrative data from a single-payer healthcare system to compare 3 common definitions of high inpatient service use and their influence on patient capture, health outcomes, and inpatient system burden.

Data Sources and Study Population

We conducted a retrospective population-based study using administrative and clinical data for the province of Alberta, including the discharge abstracts database, physician claims, ambulatory care records, population health registry file, and aggregated data from the Canadian census.¹⁶ We identified all adults who had 1 or more hospitalizations with a discharge date between April 1, 2012, and March 31, 2013, though the admission date could be prior to April 1, 2012.

Definition of High-Inpatient Use

High-inpatient use was defined using 3 metrics: number of inpatient episodes, length of stay, and cost. As in prior studies, for each definition, individuals in the upper5th percentile of the relevant distribution were designated “high users,”^2,15 while patients in the lower 95th percentile were considered “nonhigh users.” Patients could be defined as a high user in more than 1 definition.

Patients with 3 or more hospital episodes were defined as high users for the “number of inpatient episodes” definition. A hospital episode of care was defined as an event that resulted in discharge (or death) from an inpatient facility. If an individual was admitted to a hospital and transferred to another facility within 1 day of discharge, the hospitalizations were considered part of the same episode of care.

The “length of stay” definition refers to the cumulative number of days spent in an inpatient facility for all eligible episodes of care. Patients with 56 or more days in hospital during the study period were considered high users. Day of admission and discharge were considered full inpatient days, regardless of the time of admission and discharge.

The “cost” definition considered the cumulative estimated cost of every eligible episode of care. We estimated costs for each hospitalization using resource intensity weights (RIW). This is a relative weighted value for the average inpatient case after taking factors such as age, comorbidity, and procedures into account. The RIW for each episode was multiplied by the national average inpatient cost.¹⁷ Based on this definition, patients with a cumulative hospital cost of ≥ $63,597 were deemed high users. All costs were calculated in Canadian Dollars (CAD, $) and adjusted to 2013 dollars based on Statistics Canada’s Consumer Price Index.¹⁸

Demographic, Clinical, and Encounter Characteristics

Individual characteristics were measured using a combination of provincial administrative data sources. All measures were recorded as of the admission date of the first eligible hospitalization. Demographic characteristics included age, sex, First Nations status, urban/rural status (based on the individual’s residential postal code), and median neighborhood income quintile. Clinical characteristics included 28 comorbid conditions defined based on separate validated International Statistical Classification of Disease and Health Related Problems, Tenth Revision, Canada (ICD-10-CA) coding algorithms reported individually and cumulatively (categorized as 0, 1, 2–3, and 4+).¹⁹ Primary care attachment was defined as the percentage of all outpatient primary care visits made to a single practitioner in the 2-year period prior to their first hospitalization (among those with ≥3 visits). Attachment was categorized as 75%-100% (good attachment), 50%-74% (moderate attachment), or <50% (low attachment).^20,21

We also identified hospital encounter-level characteristics. These included the most responsible diagnosis, admission category (elective or urgent/emergent), and discharge disposition for each hospital episode. Reported health outcomes included the proportion of patients with in-hospital mortality and those with at least one 30-day, all-cause readmission to hospital.

Analysis

Patient characteristics were described using proportions and means (standard deviation) as appropriate for high users and nonhigh users within and across each definition. Encounter characteristics were also described and stratified by age category (18-64 or 65+ years). Comparison of patient capture was then analyzed among patients who were high use by at least 1 definition. The overlap and agreement of the 3 definitions were compared using a Venn diagram and kappa statistic. The 10 most responsible diagnoses (based on frequency) were also compared across definitions and stratified by age.

Finally, the percentage of system burden accounted for by each measure was calculated as the amount used by high users divided by the total amount used by the entire study population (x 100). To assess the potential modifying effect of age, results were stratified by age category for each definition.

All analyses were conducted using Stata 11.2 (StataCorp LP, College Station, TX).²² The Conjoint Health Research Ethics Board of the University of Calgary approved this study and granted waiver of patient consent. This manuscript is written in accordance with reporting guidelines for studies conducted using observational routinely collected health data (RECORD statement).²³

Comparison of Patient and Encounter-level Characterist

ics

A total of 219,106 adults had 283,204 inpatient episodes of care within the study timeframe. There were 12,707 (5.8%), 11,095 (5.1%), and 10,956 (5.0%) patients defined as high users based on number of inpatient episodes, length of stay, and cost, respectively (supplementary Figure 1). Regardless of definition, when compared to their non–high use counterparts, patients classified as high use were more likely to be male, older, in a lower median neighborhood income quintile, and have a higher level of comorbidity. Comparing across definitions of high use, those defined by number of inpatient episodes were more likely to be younger, live in rural areas, have better primary care attachment, and have fewer comorbidities, compared to the other definitions. High users by length of stay were more likely to be older and had a higher proportion of mental health–related comorbidities, including dementia and depression, as compared with the other definitions. Results were largely similar for those defined by cost (Table 1).

Encounter-level analyses

Comparison of Patient Capture and Inpatient Burden

Of the 22,691 individuals who were defined as high use by at least 1 definition, 2,331 (10.3%) were consistently high use across all 3 definitions (kappa = 0.38; Figure 1). Of the 13,682 individuals classified as high use by at least 1 of length of stay or cost, 8369 (61.2%) were defined as high use by both definitions (kappa = 0.75). However, of the 12,707 defined as high use by the number of inpatient episodes, only 3698 (29.1%) were also defined as high use by another definition. Exploration of the most responsible diagnoses across definitions showed that congestive heart failure (2.8%-3.5%), chronic obstructive pulmonary disease (1.6%-3.2%), and dementia (0.6%-2.2%) were the most frequent. Acute medical conditions (eg, pneumonia [1.8%] or gastroenteritis [0.7%]) that may result in multiple shorter hospitalizations were observed at higher frequencies among high users defined by inpatient episodes, while conditions commonly requiring rehabilitation (eg, fracture [1.8%] and stroke [1.7%]) were more common among high users defined by length of stay and cost (supplementary Table 2). Stratification by age showed marked differences in the diagnoses across high-use definitions. Among hi

When assessing inpatient system burden, high users by number of inpatient episodes accounted for 47,044 (16.6%) of the 283,204 episodes. High users defined by length of stay accounted for 1,286,539 (46.4%) days of 2,773,561 total days, while high users defined by cost accumulated $1.4 billion (38.9%) of the estimated $3.7 billion in inpatient expenditures. High users defined by cost and length of stay each accounted for comparatively few episode

Using a large population-based cohort of all adults with at least 1 hospitalization in the province of Alberta, Canada, within a 12-month period, we compared 3 commonly used definitions of high inpatient use. The choice of definition had a substantial influence on the types of patients categorized as high use, as well as the proportion of total inpatient utilization that was associated with high users. The definition based on number of inpatient episodes captured a distinct population of high users, while the populations identified using cumulative length of stay or cost were similar.

Differences within and between definitions were especially apparent in age-stratified analyses: Greater length of stay or higher cost among patients aged 18-64 years identifies a large proportion of psychological conditions, while a greater number of inpatient episodes identifies acute conditions and childbirth or labor-related complications. Conversely, definitions based on length of stay and cost in the elderly (65+) identified groups with chronic conditions that result in progressive functional decline (often requiring increasing supportive services upon discharge) or conditions that require significant rehabilitation prior to discharge. Regarding inpatient system burden, high users defined by number of inpatient episodes accounted for a small proportion of total inpatient episodes, while high users defined by length of stay and cost accounted for nearly half of the accumulated hospital days and cost for each. These findings highlight the need for careful consideration of how high use is defined when studying high-user populations and implications for targeting subpopulations for intervention.

Our results add to those from previous studies. A US-based, single-center study of 2566 individuals compared definitions of high inpatient use based on cost and frequency of admission and found that patients defined by cost were predominantly hospitalized for surgical conditions, while those fulfilling the episode-based definition were often hospitalized for medical conditions.¹² The most responsible diagnoses for patient hospitalizations in our study reflect this. We extended this comparison to consider the impact of age on outcomes and inpatient system burden and found that older age was also linked to poorer outcomes and increased burden. We also considered a third definition (cumulative length of stay), which provided another opportunity for comparison. The presence of chronic conditions requiring rehabilitation and possible alternate level of care days within our cohort highlights the utility of this length of stay-based approach when considering definitions. Although there were similarities between patients defined by length of stay and cost, partly due to cost being largely a function of length of stay, there were also important differences in their patient profiles. Those defined by cost tended to have conditions requiring surgical procedures not requiring extended in-hospital rehabilitation. Furthermore, the higher proportion of in-hospital mortality among those defined by cost may also reflect the fact that patients tend to accrue the majority of their healthcare expenditures during the final 120 days of life.²⁴

Each definition of high use identified complex patients; however, the differences between the various types of high users identified by these definitions suggest that they are not interchangeable. Arguably, selection of the most appropriate definition should depend on the objective of measuring high users, particularly if an intervention is planned. Interventions for high users are complex, requiring both medical and nonmedical components. The current literature in this area has often focused on case management programs, collaboration with community-based social support programs, and improving coordination and transitions of care.^25-27 While many of these approaches require considerable involvement outside of the inpatient setting, these interventions can be informed by defining who high users of inpatient services are. Our findings show several possible subgroups of high users, which could be targeted for intervention. For example, an inpatient episode-based definition, which identifies patients with frequent encounters for acute conditions (eg, pneumonia and urinary tract infections), would be informative if an intervention targeted reductions in inpatient use and readmission rates. Alternatively, an intervention designed to improve community-based mental health programs would best be informed by a definition based on length of stay in which high users with underlying mental health conditions were prevalent. Such interventions are rarely mutually exclusive and require multiple perspectives to inform their objectives. A well-designed intervention will not only address the medical characteristics of high users but also the social determinants of health that place patients at risk of high inpatient use.

Our study should be interpreted in light of its limitations. First, measures of disease severity were not available to further characterize similarities and differences across high-use groups. Furthermore, we were unable to account for other social determinants of health that may be relevant to inpatient system usage. Second, direct cost of hospitalizations was estimated based on RIW and is thus reflective of expected rather than actual costs. However, this will have minimal impact on capture, as patients defined by this metric require substantial costs to be included in the top fifth percentile, and thus deviations in individual hospitalization costs will have minimal influence on the cumulative cost. Finally, while inpatient spending makes up a large proportion of healthcare spending, there is likely a number of different high-use profiles found outside of the acute care setting. Despite these limitations, our study includes several key strengths. The use of population-level data allows for analysis that is robust and more generalizable than studies from single centers. Additionally, the comparison of 3 independent definitions allows for a greater comparison of the nuances of each definition. Our study also considers the important impact of age as an effect modifier of inpatient use in the general population and identifies distinct patient profiles that exist across each definition.

Definitions of high use of inpatient services based on number of inpatient episodes, days spent in hospital, and total hospital costs identify patient populations with different characteristics and differ substantially in their impact on health outcomes and inpatient burden. These results highlight the need for careful consideration of the context of the study or intervention and the implications of selecting a specific definition of high inpatient use at study conception. Ultimately, the performance of an intervention in high-use populations is likely to be conditional on the fit of the patient population generated by the chosen definition of high inpatient use to the objectives of a study.

Acknowledgments

This study is based in part on data provided by Alberta Health and Alberta Health Services. The interpretation and conclusions are those of the researchers and do not represent the views of the Government of Alberta. Neither the Government of Alberta nor Alberta Health express any opinion in relation to this study.

Disclosure

Dr. Hemmelgarn is supported by the Roy and Vi Baay Chair in Kidney Research. Dr. Manns is supported by the Svare Professorship in Health Economics and by a Health Scholar Award by Alberta Innovates Health Solutions (AIHS). Dr. Tonelli is supported by the David Freeze chair in Health Services Research. The Interdisciplinary Chronic Disease Collaboration is funded by AIHS—Collaborative Research and Innovation Opportunity (CRIO) Team Grants Program.