TWDFNR Teaching Slides

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

Click here for the  Choosing Wisely website.

An 80-year-old woman with no significant past medical history presents with a mechanical fall. X-rays are notable for a right hip fracture. She is treated with morphine for analgesia and evaluated by orthopedic surgery for surgical repair. The hospitalist recognizes that this patient is at high risk for constipation and orders docusate for prevention of constipation.

Constipation is a highly prevalent problem in all practice settings, especially in the hospital, affecting two out of five hospitalized patients.¹ Multiple factors in the inpatient setting contribute to constipation, including decreased mobility, medical comorbidities, postsurgical ileus, anesthetics, and medications such as opioid analgesics. Furthermore, the inpatient population is aging in parallel with the general population and constipation is more common in the elderly, likely owing to a combination of decreased muscle mass and impaired function of autonomic nerves.² Consequently, inpatient providers frequently treat constipation or try to prevent it using stool softeners or laxatives.

One of the most commonly prescribed agents, regardless of medical specialty, is docusate, also known as dioctyl sulfosuccinate or by its brand name, Colace. A study from McGill University Health Centre in Montreal, Canada reported that docusate was the most frequently prescribed laxative, accounting for 64% of laxative medication doses, with associated costs approaching $60,000 per year.³ Direct drug costs accounted for a quarter of the expenses, and the remaining three quarters were estimated labor costs for administration. Medical and surgical admissions shared similar proportions of usage, with an average of 10 doses of docusate per admission across 17,064 admissions. Furthermore, half of the patients were prescribed docusate upon discharge. The authors extrapolated their data to suggest that total healthcare spending in North America on docusate products likely exceeds $100,000,000 yearly. A second study from Toronto found that 15% of all hospitalized patients are prescribed at least one dose of docusate, and that one-third of all new inpatient prescriptions are continued at discharge.⁴

Docusate is thought to act as a detergent to retain water in the stool, thereby acting as a stool softener to facilitate stool passage. Physicians have prescribed docusate for decades, and attendings have passed down the practice of prescribing docusate for constipation to medical trainees for generations. The initial docusate studies showed promise, as it softened the stool by increasing its water content and made it easier to pass through the intestines.⁵ One of the earliest human studies compared docusate to an unspecified placebo in 35 elderly patients with chronic atonic constipation and found a decreased need for enemas.⁶ Some other observational studies also reported a decreased need for manual disimpactions and enemas in elderly populations.^7,8 One randomized, controlled trial from 1968 showed an increased frequency of bowel movements compared to placebo, but it excluded half of the enrolled patients because they had a positive placebo response.⁹ Since those early studies from the 1950s and 1960s, docusate remains widely accepted as an effective stool softener with positive endorsements from hospital formularies and order sets and patient information sheets such as the JAMA Patient Page.¹⁰ Furthermore, the World Health Organization lists docusate as an “essential medicine,” reinforcing the notion that it is effective.¹¹

Despite common practice, the efficacy of docusate as a stool softener has not been borne out by rigorous scientific data. On the contrary, multiple randomized controlled trials have failed to show any significant efficacy of this drug over placebo (Table).

The initial trial in 1976 studied 34 elderly patients on a general medical ward for prophylaxis of constipation.¹² They randomized patients to 100 mg twice daily of docusate sodium versus a control group that did not receive any type of laxative. The number of bowel movements and their character served as the measured outcomes. The study demonstrated no statistically significant differences in the frequency and character of bowel movements between the docusate and placebo groups. Even at that time, the authors questioned whether docusate had any efficacy at all: “[w]hether the drug actually offers anything beyond a placebo effect in preventing constipation is in doubt.”

Another trial in 1978 studied 46 elderly, institutionalized patients with chronic functional constipation.¹³ All patients underwent a two-week placebo period followed by a three-week treatment period with three arms of randomization: docusate sodium 100 mg daily, docusate sodium 100 mg twice daily, or docusate calcium 240 mg daily. Patients received enemas or suppositories if required. All three arms showed an increase in the average number of natural bowel movements when compared to each patient’s own placebo period, but only the arm with docusate calcium reached statistical significance (P < .02). According to the authors, none of the therapies appeared to have a significant effect on stool consistency. The authors hypothesized that the higher dose given to the docusate calcium arm may have been the reason for the apparent efficacy in this cohort. As such, studies with higher doses of docusate calcium would be reasonable.

A third study in 1985 compared docusate sodium 100 mg three times daily versus placebo in six healthy patients with ileostomies and six healthy volunteers.¹⁴ Therapy with docusate “had no effect on stool weight, stool frequency, stool water, or mean transit time.”

Another study in 1991 evaluated 15 elderly nursing home residents with a randomized, double-blind crossover design.¹⁵ Subjects received 240 mg twice daily of docusate calcium versus placebo for three weeks and then crossed over to other arm after a two-week wash-out period. The investigators found no difference in the number of bowel movements per week or in the need for additional laxatives between the two study periods. There were also no differences in the patients’ subjective experience of constipation or discomfort with defecation.

Larger studies were subsequently initiated in more recent years. In 1998, a randomized controlled trial in 170 subjects with chronic idiopathic constipation compared psyllium 5.1 g twice daily and docusate sodium 100 mg twice daily with a corresponding placebo in each arm for a treatment duration of two weeks after a two-week placebo baseline period.¹⁶ Psyllium was found to increase stool water content and stool water weight over the baseline period, while docusate essentially had no effect on stool water content or water weight. Furthermore, by treatment week 2, psyllium demonstrated an increase in the frequency of bowel movements, whereas docusate did not. It should be noted that this study was funded by Procter & Gamble, which manufactures Metamucil, a popular brand of psyllium.

Lastly, the most recent randomized controlled trial was published in 2013. It included 74 hospice patients in Canada, comparing docusate 200 mg and sennosides twice daily versus placebo and sennosides for 10 days. The study found no difference in stool frequency, volume, or consistency between docusate and placebo.¹⁷

A number of systematic reviews have studied the literature on bowel regimens and have noted the paucity of high-quality data supporting the efficacy of docusate, despite its widespread use.^18-22 With these weak data, multiple authors have advocated for removing docusate from hospital formularies and using hospitalizations as an opportunity to deprescribe this medication to reduce polypharmacy. ^3,4,23

Although docusate is considered a benign therapy, there is certainly potential for harm to the patient and detrimental effects on the healthcare system. Patients commonly complain about the unpleasant taste and lingering aftertaste, which may lead to decreased oral intake and worsening nutritional status.²³ Furthermore, docusate may impact the absorption and effectiveness of other proven treatments.²³ Perhaps the most important harm is that providers needlessly wait for docusate to fail before prescribing effective therapies for constipation. This process negatively impacts patient satisfaction and potentially increases healthcare costs if hospital length of stay is increased. Another important consideration is that patients may refuse truly necessary medications due to the excessive pill burden.

Costs to the healthcare system are increased needlessly when medications that do not improve outcomes are prescribed. Although the individual pill cost is low, the widespread use and the associated pharmacy and nursing resources required for administration create an estimated cost for docusate over $100,000,000 per year for North America alone.³ The staff time required for administration may prevent healthcare personnel from engaging in other more valuable tasks. Additionally, every medication order creates an opportunity for medical error. Lastly, bacteria were recently found contaminating the liquid formulation, which carries its own obvious implications if patients develop iatrogenic infections.²⁴

Instead of using docusate, prescribe agents with established efficacy. In 2006, a systematic review published in the American Journal of Gastroenterology graded the evidence behind different therapies for chronic constipation.²¹ They found good evidence (Grade A) to support the use of polyethylene glycol (PEG), while psyllium and lactulose had moderate evidence (Grade B) to support their use. All other currently available agents that were reviewed had poor evidence to support their use. A more recent study in people prescribed opioids similarly found evidence to support the use of polyethylene glycol, lactulose, and sennosides.²⁵ Lastly, the 2016 guidelines from the American Society of Colon and Rectal Surgeons do not mention docusate, though they comment on the paucity of data on stool softeners. Their recommendations for laxative therapy are similar to those of the previously discussed reviews.²⁶ Ultimately, the choice of therapy, pharmacological and nonpharmacological, should be individualized for each patient based on the clinical context and cause of constipation. Nonpharmacologic treatments include dietary modification, mobilization, chewing gum, and biofeedback. If pharmacotherapy is required, use laxatives with the strongest evidence.

• In patients with constipation or at risk for constipation, use laxatives with proven efficacy (such as polyethylene glycol, lactulose, psyllium, or sennosides) for treatment or prophylaxis of constipation instead of using docusate.
• Discuss de-prescription for patients using docusate prior to admission.
• Remove docusate from your hospital formulary.

Docusate is commonly used for the treatment and prevention of constipation in hospitalized patients, with significant associated costs. This common practice continues despite little evidence supporting its efficacy and many trials failing to show benefits over placebo. Decreased utilization of ineffective therapies such as docusate is recommended. Returning to the case presentation, the hospitalist should start the patient on alternative therapies, instead of docusate, such as polyethylene glycol, lactulose, psyllium, or sennosides, which have better evidence supporting their use.

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

Disclosures

All authors deny any relevant conflict of interest with the attached manuscript.

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

Click here for the  Choosing Wisely website.

An 80-year-old woman with no significant past medical history presents with a mechanical fall. X-rays are notable for a right hip fracture. She is treated with morphine for analgesia and evaluated by orthopedic surgery for surgical repair. The hospitalist recognizes that this patient is at high risk for constipation and orders docusate for prevention of constipation.

Constipation is a highly prevalent problem in all practice settings, especially in the hospital, affecting two out of five hospitalized patients.¹ Multiple factors in the inpatient setting contribute to constipation, including decreased mobility, medical comorbidities, postsurgical ileus, anesthetics, and medications such as opioid analgesics. Furthermore, the inpatient population is aging in parallel with the general population and constipation is more common in the elderly, likely owing to a combination of decreased muscle mass and impaired function of autonomic nerves.² Consequently, inpatient providers frequently treat constipation or try to prevent it using stool softeners or laxatives.

One of the most commonly prescribed agents, regardless of medical specialty, is docusate, also known as dioctyl sulfosuccinate or by its brand name, Colace. A study from McGill University Health Centre in Montreal, Canada reported that docusate was the most frequently prescribed laxative, accounting for 64% of laxative medication doses, with associated costs approaching $60,000 per year.³ Direct drug costs accounted for a quarter of the expenses, and the remaining three quarters were estimated labor costs for administration. Medical and surgical admissions shared similar proportions of usage, with an average of 10 doses of docusate per admission across 17,064 admissions. Furthermore, half of the patients were prescribed docusate upon discharge. The authors extrapolated their data to suggest that total healthcare spending in North America on docusate products likely exceeds $100,000,000 yearly. A second study from Toronto found that 15% of all hospitalized patients are prescribed at least one dose of docusate, and that one-third of all new inpatient prescriptions are continued at discharge.⁴

Docusate is thought to act as a detergent to retain water in the stool, thereby acting as a stool softener to facilitate stool passage. Physicians have prescribed docusate for decades, and attendings have passed down the practice of prescribing docusate for constipation to medical trainees for generations. The initial docusate studies showed promise, as it softened the stool by increasing its water content and made it easier to pass through the intestines.⁵ One of the earliest human studies compared docusate to an unspecified placebo in 35 elderly patients with chronic atonic constipation and found a decreased need for enemas.⁶ Some other observational studies also reported a decreased need for manual disimpactions and enemas in elderly populations.^7,8 One randomized, controlled trial from 1968 showed an increased frequency of bowel movements compared to placebo, but it excluded half of the enrolled patients because they had a positive placebo response.⁹ Since those early studies from the 1950s and 1960s, docusate remains widely accepted as an effective stool softener with positive endorsements from hospital formularies and order sets and patient information sheets such as the JAMA Patient Page.¹⁰ Furthermore, the World Health Organization lists docusate as an “essential medicine,” reinforcing the notion that it is effective.¹¹

Despite common practice, the efficacy of docusate as a stool softener has not been borne out by rigorous scientific data. On the contrary, multiple randomized controlled trials have failed to show any significant efficacy of this drug over placebo (Table).

The initial trial in 1976 studied 34 elderly patients on a general medical ward for prophylaxis of constipation.¹² They randomized patients to 100 mg twice daily of docusate sodium versus a control group that did not receive any type of laxative. The number of bowel movements and their character served as the measured outcomes. The study demonstrated no statistically significant differences in the frequency and character of bowel movements between the docusate and placebo groups. Even at that time, the authors questioned whether docusate had any efficacy at all: “[w]hether the drug actually offers anything beyond a placebo effect in preventing constipation is in doubt.”

Another trial in 1978 studied 46 elderly, institutionalized patients with chronic functional constipation.¹³ All patients underwent a two-week placebo period followed by a three-week treatment period with three arms of randomization: docusate sodium 100 mg daily, docusate sodium 100 mg twice daily, or docusate calcium 240 mg daily. Patients received enemas or suppositories if required. All three arms showed an increase in the average number of natural bowel movements when compared to each patient’s own placebo period, but only the arm with docusate calcium reached statistical significance (P < .02). According to the authors, none of the therapies appeared to have a significant effect on stool consistency. The authors hypothesized that the higher dose given to the docusate calcium arm may have been the reason for the apparent efficacy in this cohort. As such, studies with higher doses of docusate calcium would be reasonable.

A third study in 1985 compared docusate sodium 100 mg three times daily versus placebo in six healthy patients with ileostomies and six healthy volunteers.¹⁴ Therapy with docusate “had no effect on stool weight, stool frequency, stool water, or mean transit time.”

Another study in 1991 evaluated 15 elderly nursing home residents with a randomized, double-blind crossover design.¹⁵ Subjects received 240 mg twice daily of docusate calcium versus placebo for three weeks and then crossed over to other arm after a two-week wash-out period. The investigators found no difference in the number of bowel movements per week or in the need for additional laxatives between the two study periods. There were also no differences in the patients’ subjective experience of constipation or discomfort with defecation.

Larger studies were subsequently initiated in more recent years. In 1998, a randomized controlled trial in 170 subjects with chronic idiopathic constipation compared psyllium 5.1 g twice daily and docusate sodium 100 mg twice daily with a corresponding placebo in each arm for a treatment duration of two weeks after a two-week placebo baseline period.¹⁶ Psyllium was found to increase stool water content and stool water weight over the baseline period, while docusate essentially had no effect on stool water content or water weight. Furthermore, by treatment week 2, psyllium demonstrated an increase in the frequency of bowel movements, whereas docusate did not. It should be noted that this study was funded by Procter & Gamble, which manufactures Metamucil, a popular brand of psyllium.

Lastly, the most recent randomized controlled trial was published in 2013. It included 74 hospice patients in Canada, comparing docusate 200 mg and sennosides twice daily versus placebo and sennosides for 10 days. The study found no difference in stool frequency, volume, or consistency between docusate and placebo.¹⁷

A number of systematic reviews have studied the literature on bowel regimens and have noted the paucity of high-quality data supporting the efficacy of docusate, despite its widespread use.^18-22 With these weak data, multiple authors have advocated for removing docusate from hospital formularies and using hospitalizations as an opportunity to deprescribe this medication to reduce polypharmacy. ^3,4,23

Although docusate is considered a benign therapy, there is certainly potential for harm to the patient and detrimental effects on the healthcare system. Patients commonly complain about the unpleasant taste and lingering aftertaste, which may lead to decreased oral intake and worsening nutritional status.²³ Furthermore, docusate may impact the absorption and effectiveness of other proven treatments.²³ Perhaps the most important harm is that providers needlessly wait for docusate to fail before prescribing effective therapies for constipation. This process negatively impacts patient satisfaction and potentially increases healthcare costs if hospital length of stay is increased. Another important consideration is that patients may refuse truly necessary medications due to the excessive pill burden.

Costs to the healthcare system are increased needlessly when medications that do not improve outcomes are prescribed. Although the individual pill cost is low, the widespread use and the associated pharmacy and nursing resources required for administration create an estimated cost for docusate over $100,000,000 per year for North America alone.³ The staff time required for administration may prevent healthcare personnel from engaging in other more valuable tasks. Additionally, every medication order creates an opportunity for medical error. Lastly, bacteria were recently found contaminating the liquid formulation, which carries its own obvious implications if patients develop iatrogenic infections.²⁴

Instead of using docusate, prescribe agents with established efficacy. In 2006, a systematic review published in the American Journal of Gastroenterology graded the evidence behind different therapies for chronic constipation.²¹ They found good evidence (Grade A) to support the use of polyethylene glycol (PEG), while psyllium and lactulose had moderate evidence (Grade B) to support their use. All other currently available agents that were reviewed had poor evidence to support their use. A more recent study in people prescribed opioids similarly found evidence to support the use of polyethylene glycol, lactulose, and sennosides.²⁵ Lastly, the 2016 guidelines from the American Society of Colon and Rectal Surgeons do not mention docusate, though they comment on the paucity of data on stool softeners. Their recommendations for laxative therapy are similar to those of the previously discussed reviews.²⁶ Ultimately, the choice of therapy, pharmacological and nonpharmacological, should be individualized for each patient based on the clinical context and cause of constipation. Nonpharmacologic treatments include dietary modification, mobilization, chewing gum, and biofeedback. If pharmacotherapy is required, use laxatives with the strongest evidence.

• In patients with constipation or at risk for constipation, use laxatives with proven efficacy (such as polyethylene glycol, lactulose, psyllium, or sennosides) for treatment or prophylaxis of constipation instead of using docusate.
• Discuss de-prescription for patients using docusate prior to admission.
• Remove docusate from your hospital formulary.

Docusate is commonly used for the treatment and prevention of constipation in hospitalized patients, with significant associated costs. This common practice continues despite little evidence supporting its efficacy and many trials failing to show benefits over placebo. Decreased utilization of ineffective therapies such as docusate is recommended. Returning to the case presentation, the hospitalist should start the patient on alternative therapies, instead of docusate, such as polyethylene glycol, lactulose, psyllium, or sennosides, which have better evidence supporting their use.

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

Disclosures

All authors deny any relevant conflict of interest with the attached manuscript.

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

Click here for the  Choosing Wisely website.

An 80-year-old woman with no significant past medical history presents with a mechanical fall. X-rays are notable for a right hip fracture. She is treated with morphine for analgesia and evaluated by orthopedic surgery for surgical repair. The hospitalist recognizes that this patient is at high risk for constipation and orders docusate for prevention of constipation.

Constipation is a highly prevalent problem in all practice settings, especially in the hospital, affecting two out of five hospitalized patients.¹ Multiple factors in the inpatient setting contribute to constipation, including decreased mobility, medical comorbidities, postsurgical ileus, anesthetics, and medications such as opioid analgesics. Furthermore, the inpatient population is aging in parallel with the general population and constipation is more common in the elderly, likely owing to a combination of decreased muscle mass and impaired function of autonomic nerves.² Consequently, inpatient providers frequently treat constipation or try to prevent it using stool softeners or laxatives.

One of the most commonly prescribed agents, regardless of medical specialty, is docusate, also known as dioctyl sulfosuccinate or by its brand name, Colace. A study from McGill University Health Centre in Montreal, Canada reported that docusate was the most frequently prescribed laxative, accounting for 64% of laxative medication doses, with associated costs approaching $60,000 per year.³ Direct drug costs accounted for a quarter of the expenses, and the remaining three quarters were estimated labor costs for administration. Medical and surgical admissions shared similar proportions of usage, with an average of 10 doses of docusate per admission across 17,064 admissions. Furthermore, half of the patients were prescribed docusate upon discharge. The authors extrapolated their data to suggest that total healthcare spending in North America on docusate products likely exceeds $100,000,000 yearly. A second study from Toronto found that 15% of all hospitalized patients are prescribed at least one dose of docusate, and that one-third of all new inpatient prescriptions are continued at discharge.⁴

Docusate is thought to act as a detergent to retain water in the stool, thereby acting as a stool softener to facilitate stool passage. Physicians have prescribed docusate for decades, and attendings have passed down the practice of prescribing docusate for constipation to medical trainees for generations. The initial docusate studies showed promise, as it softened the stool by increasing its water content and made it easier to pass through the intestines.⁵ One of the earliest human studies compared docusate to an unspecified placebo in 35 elderly patients with chronic atonic constipation and found a decreased need for enemas.⁶ Some other observational studies also reported a decreased need for manual disimpactions and enemas in elderly populations.^7,8 One randomized, controlled trial from 1968 showed an increased frequency of bowel movements compared to placebo, but it excluded half of the enrolled patients because they had a positive placebo response.⁹ Since those early studies from the 1950s and 1960s, docusate remains widely accepted as an effective stool softener with positive endorsements from hospital formularies and order sets and patient information sheets such as the JAMA Patient Page.¹⁰ Furthermore, the World Health Organization lists docusate as an “essential medicine,” reinforcing the notion that it is effective.¹¹

Despite common practice, the efficacy of docusate as a stool softener has not been borne out by rigorous scientific data. On the contrary, multiple randomized controlled trials have failed to show any significant efficacy of this drug over placebo (Table).

The initial trial in 1976 studied 34 elderly patients on a general medical ward for prophylaxis of constipation.¹² They randomized patients to 100 mg twice daily of docusate sodium versus a control group that did not receive any type of laxative. The number of bowel movements and their character served as the measured outcomes. The study demonstrated no statistically significant differences in the frequency and character of bowel movements between the docusate and placebo groups. Even at that time, the authors questioned whether docusate had any efficacy at all: “[w]hether the drug actually offers anything beyond a placebo effect in preventing constipation is in doubt.”

Another trial in 1978 studied 46 elderly, institutionalized patients with chronic functional constipation.¹³ All patients underwent a two-week placebo period followed by a three-week treatment period with three arms of randomization: docusate sodium 100 mg daily, docusate sodium 100 mg twice daily, or docusate calcium 240 mg daily. Patients received enemas or suppositories if required. All three arms showed an increase in the average number of natural bowel movements when compared to each patient’s own placebo period, but only the arm with docusate calcium reached statistical significance (P < .02). According to the authors, none of the therapies appeared to have a significant effect on stool consistency. The authors hypothesized that the higher dose given to the docusate calcium arm may have been the reason for the apparent efficacy in this cohort. As such, studies with higher doses of docusate calcium would be reasonable.

A third study in 1985 compared docusate sodium 100 mg three times daily versus placebo in six healthy patients with ileostomies and six healthy volunteers.¹⁴ Therapy with docusate “had no effect on stool weight, stool frequency, stool water, or mean transit time.”

Another study in 1991 evaluated 15 elderly nursing home residents with a randomized, double-blind crossover design.¹⁵ Subjects received 240 mg twice daily of docusate calcium versus placebo for three weeks and then crossed over to other arm after a two-week wash-out period. The investigators found no difference in the number of bowel movements per week or in the need for additional laxatives between the two study periods. There were also no differences in the patients’ subjective experience of constipation or discomfort with defecation.

Larger studies were subsequently initiated in more recent years. In 1998, a randomized controlled trial in 170 subjects with chronic idiopathic constipation compared psyllium 5.1 g twice daily and docusate sodium 100 mg twice daily with a corresponding placebo in each arm for a treatment duration of two weeks after a two-week placebo baseline period.¹⁶ Psyllium was found to increase stool water content and stool water weight over the baseline period, while docusate essentially had no effect on stool water content or water weight. Furthermore, by treatment week 2, psyllium demonstrated an increase in the frequency of bowel movements, whereas docusate did not. It should be noted that this study was funded by Procter & Gamble, which manufactures Metamucil, a popular brand of psyllium.

Lastly, the most recent randomized controlled trial was published in 2013. It included 74 hospice patients in Canada, comparing docusate 200 mg and sennosides twice daily versus placebo and sennosides for 10 days. The study found no difference in stool frequency, volume, or consistency between docusate and placebo.¹⁷

A number of systematic reviews have studied the literature on bowel regimens and have noted the paucity of high-quality data supporting the efficacy of docusate, despite its widespread use.^18-22 With these weak data, multiple authors have advocated for removing docusate from hospital formularies and using hospitalizations as an opportunity to deprescribe this medication to reduce polypharmacy. ^3,4,23

Although docusate is considered a benign therapy, there is certainly potential for harm to the patient and detrimental effects on the healthcare system. Patients commonly complain about the unpleasant taste and lingering aftertaste, which may lead to decreased oral intake and worsening nutritional status.²³ Furthermore, docusate may impact the absorption and effectiveness of other proven treatments.²³ Perhaps the most important harm is that providers needlessly wait for docusate to fail before prescribing effective therapies for constipation. This process negatively impacts patient satisfaction and potentially increases healthcare costs if hospital length of stay is increased. Another important consideration is that patients may refuse truly necessary medications due to the excessive pill burden.

Costs to the healthcare system are increased needlessly when medications that do not improve outcomes are prescribed. Although the individual pill cost is low, the widespread use and the associated pharmacy and nursing resources required for administration create an estimated cost for docusate over $100,000,000 per year for North America alone.³ The staff time required for administration may prevent healthcare personnel from engaging in other more valuable tasks. Additionally, every medication order creates an opportunity for medical error. Lastly, bacteria were recently found contaminating the liquid formulation, which carries its own obvious implications if patients develop iatrogenic infections.²⁴

Instead of using docusate, prescribe agents with established efficacy. In 2006, a systematic review published in the American Journal of Gastroenterology graded the evidence behind different therapies for chronic constipation.²¹ They found good evidence (Grade A) to support the use of polyethylene glycol (PEG), while psyllium and lactulose had moderate evidence (Grade B) to support their use. All other currently available agents that were reviewed had poor evidence to support their use. A more recent study in people prescribed opioids similarly found evidence to support the use of polyethylene glycol, lactulose, and sennosides.²⁵ Lastly, the 2016 guidelines from the American Society of Colon and Rectal Surgeons do not mention docusate, though they comment on the paucity of data on stool softeners. Their recommendations for laxative therapy are similar to those of the previously discussed reviews.²⁶ Ultimately, the choice of therapy, pharmacological and nonpharmacological, should be individualized for each patient based on the clinical context and cause of constipation. Nonpharmacologic treatments include dietary modification, mobilization, chewing gum, and biofeedback. If pharmacotherapy is required, use laxatives with the strongest evidence.

• In patients with constipation or at risk for constipation, use laxatives with proven efficacy (such as polyethylene glycol, lactulose, psyllium, or sennosides) for treatment or prophylaxis of constipation instead of using docusate.
• Discuss de-prescription for patients using docusate prior to admission.
• Remove docusate from your hospital formulary.

Docusate is commonly used for the treatment and prevention of constipation in hospitalized patients, with significant associated costs. This common practice continues despite little evidence supporting its efficacy and many trials failing to show benefits over placebo. Decreased utilization of ineffective therapies such as docusate is recommended. Returning to the case presentation, the hospitalist should start the patient on alternative therapies, instead of docusate, such as polyethylene glycol, lactulose, psyllium, or sennosides, which have better evidence supporting their use.

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

Disclosures

All authors deny any relevant conflict of interest with the attached manuscript.

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

A 60-year-old man with a past medical history of obesity and type 2 diabetes presented to the emergency department with one week of myalgias and fever up to 103.5°F (39.7°C). Other vital signs were normal. He had no localizing symptoms, and physical examination was unrevealing, except for a small scab from a tick bite sustained two weeks prior to symptom onset. Before admission, he had been managing his diabetes with metformin 1,000 mg twice a day, and on arrival, his blood sugar level was 275 mg/dL. The admitting provider decided to hold the patient’s metformin and replace it with insulin per a sliding scale. Is monotherapy with sliding-scale insulin the best inpatient management option for this patient’s type 2 diabetes?

The basic premise of sliding-scale insulin (SSI) is to correct hyperglycemia through the frequent administration of short-acting insulin dosed according to a patient’s blood glucose level with the help of a prespecified rubric. When blood glucose levels are low, patients receive little or no insulin, and when blood glucose levels are high, higher doses are given. This approach to inpatient blood glucose management was first popularized by Joslin in 1934,¹ and it remains a common strategy today. For example, a 2007 survey of 44 hospitals in the United States showed that approximately 43% of all noncritically ill patients with hyperglycemia were treated with SSI alone.² More recently, a single-center study showed that 30% of clinicians continued to use SSI as monotherapy even after the implementation of order sets designed to limit this practice.³

The rationale for SSI as monotherapy appears to have two components. First, guidelines suggest that certain patients should be screened periodically in the hospital for hyperglycemia (blood glucose persistently greater than 180 mg/dL) and that, if identified, hyperglycemia should be treated.⁴ By pairing finger-stick glucose monitoring with SSI, the diagnosis and treatment—although not the prevention—of hyperglycemia can be accomplished simultaneously. Second, inpatient providers do not want to cause harm in the form of hypoglycemia. SSI as monotherapy is sometimes viewed as a cautious approach in this regard as insulin is administered only if the blood sugar level is high.

Convenience is probably another key contributor to the enduring use of SSI as monotherapy. Several hospitals have ready-made order sets for SSI that are easier to prescribe than a patient-specific regimen including both short- and long-acting insulin. In at least one single-center survey, physicians and staff were found to favor convenience over perceived efficacy when asked about their attitudes toward inpatient glycemic control.⁵ Although efforts at individual hospitals to change practice patterns among residents have shown promise,⁶ reform on a broader scale remains elusive.

SSI administration does not attempt to replicate normal pancreatic physiology, which involves basal insulin secretion to impair hepatic gluconeogenesis and meal-associated insulin spikes to promote uptake into glucose-avid tissues. SSI is a reactive strategy, not a proactive one, and perhaps unsurprisingly, to our knowledge, it has never been shown to prevent hyperglycemia in hospitalized patients, an impression corroborated by a systematic review of the topic between 1964 and 2003.⁷ More recently, one multicenter trial analyzed the effect of adding SSI to oral antihyperglycemic medications in hospitalized diabetics and found no differences in rates of hyperglycemia.⁸ Another study found that 84% of administered SSI doses failed to correct hyperglycemia.⁹

However, does adding basal insulin to SSI raise a patient’s risk of hypoglycemia? When basal insulin is dosed carefully, the answer appears to be no. In a trial in which diabetic long-term care residents who were receiving SSI at baseline were randomized to either continued SSI or basal-bolus insulin, the investigators found that the basal-bolus group experienced significantly lower average blood glucose levels without an increase in adverse glycemic events.¹⁰ Perhaps the most significant milestone to date, however, was the RABBIT 2 multicenter trial, published in 2007, that randomized hospitalized, insulin-naïve diabetics to either a weight-based regimen of basal and prandial insulin or SSI only.¹¹ Rates of hypoglycemia and length of stay did not differ between the groups, and 66% of patients receiving basal-prandial insulin achieved their glycemic control target as opposed to just 38% of patients in the SSI-only group. The SSI group also required more total insulin. A weight-based, basal-bolus strategy was later proven to be similarly effective, without causing severe hypoglycemia, for patients undergoing surgery who could not maintain consistent oral alimentation.¹² Basal-bolus insulin was associated with fewer surgical complications, and it produced a cost savings of $751 per day as determined by a post hoc comparative effectiveness study.¹³

Prolonged use of SSI as monotherapy may be not only ineffective but also harmful. Clearly, the absence of basal insulin will harm type 1 diabetics, who need basal insulin to prevent diabetic ketoacidosis. However, even for type 2 diabetics and nondiabetics, hyperglycemia has been established as a marker for adverse outcomes among hospitalized patients,¹⁴ and SSI monotherapy has been associated with a three-fold higher risk of hyperglycemia compared with the use of a sliding scale plus other forms of insulin.¹⁵ At least one other study has also linked this practice with a significantly increased length of stay compared with patients who were receiving insulin proactively.¹⁶ We believe that the potential for harm is difficult to disregard, especially because safer alternatives are available. Ultimately, it can be stated that in hospitalized patients with persistent hyperglycemia who require insulin, SSI alone should not be the preferred treatment choice regardless of whether the patient carries a known diagnosis of diabetes mellitus or has used insulin previously.

As discussed above, there is no known clinical scenario in which SSI as monotherapy has been proven to be effective; however, the use of SSI as monotherapy as a short-term approach has not been well studied. Hospitalized patients who are at risk for adverse glycemic events should be monitored with periodic finger-stick blood glucose draws per guidelines, and in the first 24 hours, it may be reasonable to withhold basal insulin for insulin-naive patients, particularly if the medication reconciliation or other key components of the history are in doubt, or if there are risk factors for hypoglycemia such as a history of bariatric surgery. The amount of insulin received in the first 24 hours of such monitoring may inform subsequent insulin dosing, but this method of “dose finding” has not been validated in the literature.

Uncertain or interrupted alimentation status or stress hyperglycemia may complicate the assessment of a patient’s insulin needs. One of the insights from the RABBIT 2 surgery trial is that even with interrupted alimentation, patients on a weight-based, long-acting insulin regimen did not experience severe hypoglycemia. Nevertheless, if a patient without type 1 diabetes is felt to be at high risk for a severe hypoglycemic event, it may be prudent to withhold long-acting insulin. However, in that situation, adding SSI to finger-stick monitoring is unlikely to be beneficial. Cases of stress hyperglycemia in nondiabetics can also be challenging, as the persistence of hyperglycemia can be difficult to predict. Guidelines state that if hyperglycemia is persistent, then insulin therapy should be initiated and that this therapy is best accomplished in the form of a basal-prandial regimen.¹⁷

Current guidelines from the American Diabetes Association¹⁷ and the American Association of Clinical Endocrinologists¹⁸ for hospitalized patients with hyperglycemia who require insulin recommend against the prolonged use of SSI as monotherapy (category A recommendation) and support the use of basal plus correctional insulin with the addition of nutritional insulin for patients with consistent oral intake (category A recommendation). Although a complete discourse on the determination of the appropriate starting dose of insulin is outside of the scope of this cas presentation, the basic approach begins with calculating a weight-based total daily dose of insulin, approximately half of which can be given as basal insulin with the remainder given with meals along with correctional insulin as needed to account for premeal hyperglycemia.⁴ For example, the protocol used in the RABBIT 2 trial, which involved known type 2 diabetics, started insulin based on a total daily dose of 0.4 units/kg for patients presenting with blood sugar levels ≤200 mg/dL and 0.5 units/kg for those with higher initial glucose levels.⁷ Half of the total daily dose was given as basal insulin, and the other half was divided among meals. Caution with insulin dosing may be required in patients aged >70 years, in those with impaired renal function, and in situations in which steroid doses are fluctuating. The Society of Hospital Medicine has formulated an online subcutaneous insulin order implementation guideline, eQUIPS, that can be a helpful resource to centers that are interested in changing their practice patterns.¹⁹

• Instead of using SSI monotherapy for hospitalized patients who require insulin, add basal and prandial insulin, using a weight-based approach if necessary for insulin-naive patients.
• Engage with leadership at your center to learn how inpatient hyperglycemia protocols and blood sugar management teams can help provide evidence-based and individualized treatment plans for your patients.
• If no infrastructure exists at your center, the Society of Hospital Medicine offers training and guidance through its eQUIPS inpatient hyperglycemia management program.

In the case presentation, the hyperglycemic patient whose metformin was on hold should have been started on a combination of basal and prandial insulin as determined by his weight and current renal function as opposed to monotherapy with SSI. Using SSI as monotherapy for hyperglycemia is a common practice, and although well-intentioned, it is an ineffective and possibly dangerous approach. Continued efforts must be made to address the gap between guidelines and suboptimal practice patterns locally and nationally.

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

Acknowledgments

The authors would like to thank Dr. Asem Ali of the Division of Endocrinology at UMass Memorial Medical Center for his review of the manuscript.

Disclosures

The authors have nothing to disclose.

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

A 60-year-old man with a past medical history of obesity and type 2 diabetes presented to the emergency department with one week of myalgias and fever up to 103.5°F (39.7°C). Other vital signs were normal. He had no localizing symptoms, and physical examination was unrevealing, except for a small scab from a tick bite sustained two weeks prior to symptom onset. Before admission, he had been managing his diabetes with metformin 1,000 mg twice a day, and on arrival, his blood sugar level was 275 mg/dL. The admitting provider decided to hold the patient’s metformin and replace it with insulin per a sliding scale. Is monotherapy with sliding-scale insulin the best inpatient management option for this patient’s type 2 diabetes?

The basic premise of sliding-scale insulin (SSI) is to correct hyperglycemia through the frequent administration of short-acting insulin dosed according to a patient’s blood glucose level with the help of a prespecified rubric. When blood glucose levels are low, patients receive little or no insulin, and when blood glucose levels are high, higher doses are given. This approach to inpatient blood glucose management was first popularized by Joslin in 1934,¹ and it remains a common strategy today. For example, a 2007 survey of 44 hospitals in the United States showed that approximately 43% of all noncritically ill patients with hyperglycemia were treated with SSI alone.² More recently, a single-center study showed that 30% of clinicians continued to use SSI as monotherapy even after the implementation of order sets designed to limit this practice.³

The rationale for SSI as monotherapy appears to have two components. First, guidelines suggest that certain patients should be screened periodically in the hospital for hyperglycemia (blood glucose persistently greater than 180 mg/dL) and that, if identified, hyperglycemia should be treated.⁴ By pairing finger-stick glucose monitoring with SSI, the diagnosis and treatment—although not the prevention—of hyperglycemia can be accomplished simultaneously. Second, inpatient providers do not want to cause harm in the form of hypoglycemia. SSI as monotherapy is sometimes viewed as a cautious approach in this regard as insulin is administered only if the blood sugar level is high.

Convenience is probably another key contributor to the enduring use of SSI as monotherapy. Several hospitals have ready-made order sets for SSI that are easier to prescribe than a patient-specific regimen including both short- and long-acting insulin. In at least one single-center survey, physicians and staff were found to favor convenience over perceived efficacy when asked about their attitudes toward inpatient glycemic control.⁵ Although efforts at individual hospitals to change practice patterns among residents have shown promise,⁶ reform on a broader scale remains elusive.

SSI administration does not attempt to replicate normal pancreatic physiology, which involves basal insulin secretion to impair hepatic gluconeogenesis and meal-associated insulin spikes to promote uptake into glucose-avid tissues. SSI is a reactive strategy, not a proactive one, and perhaps unsurprisingly, to our knowledge, it has never been shown to prevent hyperglycemia in hospitalized patients, an impression corroborated by a systematic review of the topic between 1964 and 2003.⁷ More recently, one multicenter trial analyzed the effect of adding SSI to oral antihyperglycemic medications in hospitalized diabetics and found no differences in rates of hyperglycemia.⁸ Another study found that 84% of administered SSI doses failed to correct hyperglycemia.⁹

However, does adding basal insulin to SSI raise a patient’s risk of hypoglycemia? When basal insulin is dosed carefully, the answer appears to be no. In a trial in which diabetic long-term care residents who were receiving SSI at baseline were randomized to either continued SSI or basal-bolus insulin, the investigators found that the basal-bolus group experienced significantly lower average blood glucose levels without an increase in adverse glycemic events.¹⁰ Perhaps the most significant milestone to date, however, was the RABBIT 2 multicenter trial, published in 2007, that randomized hospitalized, insulin-naïve diabetics to either a weight-based regimen of basal and prandial insulin or SSI only.¹¹ Rates of hypoglycemia and length of stay did not differ between the groups, and 66% of patients receiving basal-prandial insulin achieved their glycemic control target as opposed to just 38% of patients in the SSI-only group. The SSI group also required more total insulin. A weight-based, basal-bolus strategy was later proven to be similarly effective, without causing severe hypoglycemia, for patients undergoing surgery who could not maintain consistent oral alimentation.¹² Basal-bolus insulin was associated with fewer surgical complications, and it produced a cost savings of $751 per day as determined by a post hoc comparative effectiveness study.¹³

Prolonged use of SSI as monotherapy may be not only ineffective but also harmful. Clearly, the absence of basal insulin will harm type 1 diabetics, who need basal insulin to prevent diabetic ketoacidosis. However, even for type 2 diabetics and nondiabetics, hyperglycemia has been established as a marker for adverse outcomes among hospitalized patients,¹⁴ and SSI monotherapy has been associated with a three-fold higher risk of hyperglycemia compared with the use of a sliding scale plus other forms of insulin.¹⁵ At least one other study has also linked this practice with a significantly increased length of stay compared with patients who were receiving insulin proactively.¹⁶ We believe that the potential for harm is difficult to disregard, especially because safer alternatives are available. Ultimately, it can be stated that in hospitalized patients with persistent hyperglycemia who require insulin, SSI alone should not be the preferred treatment choice regardless of whether the patient carries a known diagnosis of diabetes mellitus or has used insulin previously.

As discussed above, there is no known clinical scenario in which SSI as monotherapy has been proven to be effective; however, the use of SSI as monotherapy as a short-term approach has not been well studied. Hospitalized patients who are at risk for adverse glycemic events should be monitored with periodic finger-stick blood glucose draws per guidelines, and in the first 24 hours, it may be reasonable to withhold basal insulin for insulin-naive patients, particularly if the medication reconciliation or other key components of the history are in doubt, or if there are risk factors for hypoglycemia such as a history of bariatric surgery. The amount of insulin received in the first 24 hours of such monitoring may inform subsequent insulin dosing, but this method of “dose finding” has not been validated in the literature.

Uncertain or interrupted alimentation status or stress hyperglycemia may complicate the assessment of a patient’s insulin needs. One of the insights from the RABBIT 2 surgery trial is that even with interrupted alimentation, patients on a weight-based, long-acting insulin regimen did not experience severe hypoglycemia. Nevertheless, if a patient without type 1 diabetes is felt to be at high risk for a severe hypoglycemic event, it may be prudent to withhold long-acting insulin. However, in that situation, adding SSI to finger-stick monitoring is unlikely to be beneficial. Cases of stress hyperglycemia in nondiabetics can also be challenging, as the persistence of hyperglycemia can be difficult to predict. Guidelines state that if hyperglycemia is persistent, then insulin therapy should be initiated and that this therapy is best accomplished in the form of a basal-prandial regimen.¹⁷

Current guidelines from the American Diabetes Association¹⁷ and the American Association of Clinical Endocrinologists¹⁸ for hospitalized patients with hyperglycemia who require insulin recommend against the prolonged use of SSI as monotherapy (category A recommendation) and support the use of basal plus correctional insulin with the addition of nutritional insulin for patients with consistent oral intake (category A recommendation). Although a complete discourse on the determination of the appropriate starting dose of insulin is outside of the scope of this cas presentation, the basic approach begins with calculating a weight-based total daily dose of insulin, approximately half of which can be given as basal insulin with the remainder given with meals along with correctional insulin as needed to account for premeal hyperglycemia.⁴ For example, the protocol used in the RABBIT 2 trial, which involved known type 2 diabetics, started insulin based on a total daily dose of 0.4 units/kg for patients presenting with blood sugar levels ≤200 mg/dL and 0.5 units/kg for those with higher initial glucose levels.⁷ Half of the total daily dose was given as basal insulin, and the other half was divided among meals. Caution with insulin dosing may be required in patients aged >70 years, in those with impaired renal function, and in situations in which steroid doses are fluctuating. The Society of Hospital Medicine has formulated an online subcutaneous insulin order implementation guideline, eQUIPS, that can be a helpful resource to centers that are interested in changing their practice patterns.¹⁹

• Instead of using SSI monotherapy for hospitalized patients who require insulin, add basal and prandial insulin, using a weight-based approach if necessary for insulin-naive patients.
• Engage with leadership at your center to learn how inpatient hyperglycemia protocols and blood sugar management teams can help provide evidence-based and individualized treatment plans for your patients.
• If no infrastructure exists at your center, the Society of Hospital Medicine offers training and guidance through its eQUIPS inpatient hyperglycemia management program.

In the case presentation, the hyperglycemic patient whose metformin was on hold should have been started on a combination of basal and prandial insulin as determined by his weight and current renal function as opposed to monotherapy with SSI. Using SSI as monotherapy for hyperglycemia is a common practice, and although well-intentioned, it is an ineffective and possibly dangerous approach. Continued efforts must be made to address the gap between guidelines and suboptimal practice patterns locally and nationally.

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

Acknowledgments

The authors would like to thank Dr. Asem Ali of the Division of Endocrinology at UMass Memorial Medical Center for his review of the manuscript.

Disclosures

The authors have nothing to disclose.

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

A 60-year-old man with a past medical history of obesity and type 2 diabetes presented to the emergency department with one week of myalgias and fever up to 103.5°F (39.7°C). Other vital signs were normal. He had no localizing symptoms, and physical examination was unrevealing, except for a small scab from a tick bite sustained two weeks prior to symptom onset. Before admission, he had been managing his diabetes with metformin 1,000 mg twice a day, and on arrival, his blood sugar level was 275 mg/dL. The admitting provider decided to hold the patient’s metformin and replace it with insulin per a sliding scale. Is monotherapy with sliding-scale insulin the best inpatient management option for this patient’s type 2 diabetes?

The basic premise of sliding-scale insulin (SSI) is to correct hyperglycemia through the frequent administration of short-acting insulin dosed according to a patient’s blood glucose level with the help of a prespecified rubric. When blood glucose levels are low, patients receive little or no insulin, and when blood glucose levels are high, higher doses are given. This approach to inpatient blood glucose management was first popularized by Joslin in 1934,¹ and it remains a common strategy today. For example, a 2007 survey of 44 hospitals in the United States showed that approximately 43% of all noncritically ill patients with hyperglycemia were treated with SSI alone.² More recently, a single-center study showed that 30% of clinicians continued to use SSI as monotherapy even after the implementation of order sets designed to limit this practice.³

The rationale for SSI as monotherapy appears to have two components. First, guidelines suggest that certain patients should be screened periodically in the hospital for hyperglycemia (blood glucose persistently greater than 180 mg/dL) and that, if identified, hyperglycemia should be treated.⁴ By pairing finger-stick glucose monitoring with SSI, the diagnosis and treatment—although not the prevention—of hyperglycemia can be accomplished simultaneously. Second, inpatient providers do not want to cause harm in the form of hypoglycemia. SSI as monotherapy is sometimes viewed as a cautious approach in this regard as insulin is administered only if the blood sugar level is high.

Convenience is probably another key contributor to the enduring use of SSI as monotherapy. Several hospitals have ready-made order sets for SSI that are easier to prescribe than a patient-specific regimen including both short- and long-acting insulin. In at least one single-center survey, physicians and staff were found to favor convenience over perceived efficacy when asked about their attitudes toward inpatient glycemic control.⁵ Although efforts at individual hospitals to change practice patterns among residents have shown promise,⁶ reform on a broader scale remains elusive.

SSI administration does not attempt to replicate normal pancreatic physiology, which involves basal insulin secretion to impair hepatic gluconeogenesis and meal-associated insulin spikes to promote uptake into glucose-avid tissues. SSI is a reactive strategy, not a proactive one, and perhaps unsurprisingly, to our knowledge, it has never been shown to prevent hyperglycemia in hospitalized patients, an impression corroborated by a systematic review of the topic between 1964 and 2003.⁷ More recently, one multicenter trial analyzed the effect of adding SSI to oral antihyperglycemic medications in hospitalized diabetics and found no differences in rates of hyperglycemia.⁸ Another study found that 84% of administered SSI doses failed to correct hyperglycemia.⁹

However, does adding basal insulin to SSI raise a patient’s risk of hypoglycemia? When basal insulin is dosed carefully, the answer appears to be no. In a trial in which diabetic long-term care residents who were receiving SSI at baseline were randomized to either continued SSI or basal-bolus insulin, the investigators found that the basal-bolus group experienced significantly lower average blood glucose levels without an increase in adverse glycemic events.¹⁰ Perhaps the most significant milestone to date, however, was the RABBIT 2 multicenter trial, published in 2007, that randomized hospitalized, insulin-naïve diabetics to either a weight-based regimen of basal and prandial insulin or SSI only.¹¹ Rates of hypoglycemia and length of stay did not differ between the groups, and 66% of patients receiving basal-prandial insulin achieved their glycemic control target as opposed to just 38% of patients in the SSI-only group. The SSI group also required more total insulin. A weight-based, basal-bolus strategy was later proven to be similarly effective, without causing severe hypoglycemia, for patients undergoing surgery who could not maintain consistent oral alimentation.¹² Basal-bolus insulin was associated with fewer surgical complications, and it produced a cost savings of $751 per day as determined by a post hoc comparative effectiveness study.¹³

Prolonged use of SSI as monotherapy may be not only ineffective but also harmful. Clearly, the absence of basal insulin will harm type 1 diabetics, who need basal insulin to prevent diabetic ketoacidosis. However, even for type 2 diabetics and nondiabetics, hyperglycemia has been established as a marker for adverse outcomes among hospitalized patients,¹⁴ and SSI monotherapy has been associated with a three-fold higher risk of hyperglycemia compared with the use of a sliding scale plus other forms of insulin.¹⁵ At least one other study has also linked this practice with a significantly increased length of stay compared with patients who were receiving insulin proactively.¹⁶ We believe that the potential for harm is difficult to disregard, especially because safer alternatives are available. Ultimately, it can be stated that in hospitalized patients with persistent hyperglycemia who require insulin, SSI alone should not be the preferred treatment choice regardless of whether the patient carries a known diagnosis of diabetes mellitus or has used insulin previously.

As discussed above, there is no known clinical scenario in which SSI as monotherapy has been proven to be effective; however, the use of SSI as monotherapy as a short-term approach has not been well studied. Hospitalized patients who are at risk for adverse glycemic events should be monitored with periodic finger-stick blood glucose draws per guidelines, and in the first 24 hours, it may be reasonable to withhold basal insulin for insulin-naive patients, particularly if the medication reconciliation or other key components of the history are in doubt, or if there are risk factors for hypoglycemia such as a history of bariatric surgery. The amount of insulin received in the first 24 hours of such monitoring may inform subsequent insulin dosing, but this method of “dose finding” has not been validated in the literature.

Uncertain or interrupted alimentation status or stress hyperglycemia may complicate the assessment of a patient’s insulin needs. One of the insights from the RABBIT 2 surgery trial is that even with interrupted alimentation, patients on a weight-based, long-acting insulin regimen did not experience severe hypoglycemia. Nevertheless, if a patient without type 1 diabetes is felt to be at high risk for a severe hypoglycemic event, it may be prudent to withhold long-acting insulin. However, in that situation, adding SSI to finger-stick monitoring is unlikely to be beneficial. Cases of stress hyperglycemia in nondiabetics can also be challenging, as the persistence of hyperglycemia can be difficult to predict. Guidelines state that if hyperglycemia is persistent, then insulin therapy should be initiated and that this therapy is best accomplished in the form of a basal-prandial regimen.¹⁷

Current guidelines from the American Diabetes Association¹⁷ and the American Association of Clinical Endocrinologists¹⁸ for hospitalized patients with hyperglycemia who require insulin recommend against the prolonged use of SSI as monotherapy (category A recommendation) and support the use of basal plus correctional insulin with the addition of nutritional insulin for patients with consistent oral intake (category A recommendation). Although a complete discourse on the determination of the appropriate starting dose of insulin is outside of the scope of this cas presentation, the basic approach begins with calculating a weight-based total daily dose of insulin, approximately half of which can be given as basal insulin with the remainder given with meals along with correctional insulin as needed to account for premeal hyperglycemia.⁴ For example, the protocol used in the RABBIT 2 trial, which involved known type 2 diabetics, started insulin based on a total daily dose of 0.4 units/kg for patients presenting with blood sugar levels ≤200 mg/dL and 0.5 units/kg for those with higher initial glucose levels.⁷ Half of the total daily dose was given as basal insulin, and the other half was divided among meals. Caution with insulin dosing may be required in patients aged >70 years, in those with impaired renal function, and in situations in which steroid doses are fluctuating. The Society of Hospital Medicine has formulated an online subcutaneous insulin order implementation guideline, eQUIPS, that can be a helpful resource to centers that are interested in changing their practice patterns.¹⁹

• Instead of using SSI monotherapy for hospitalized patients who require insulin, add basal and prandial insulin, using a weight-based approach if necessary for insulin-naive patients.
• Engage with leadership at your center to learn how inpatient hyperglycemia protocols and blood sugar management teams can help provide evidence-based and individualized treatment plans for your patients.
• If no infrastructure exists at your center, the Society of Hospital Medicine offers training and guidance through its eQUIPS inpatient hyperglycemia management program.

In the case presentation, the hyperglycemic patient whose metformin was on hold should have been started on a combination of basal and prandial insulin as determined by his weight and current renal function as opposed to monotherapy with SSI. Using SSI as monotherapy for hyperglycemia is a common practice, and although well-intentioned, it is an ineffective and possibly dangerous approach. Continued efforts must be made to address the gap between guidelines and suboptimal practice patterns locally and nationally.

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

Acknowledgments

The authors would like to thank Dr. Asem Ali of the Division of Endocrinology at UMass Memorial Medical Center for his review of the manuscript.

Disclosures

The authors have nothing to disclose.

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

A 74-year-old man with a history of diabetes and gastrointestinal bleeding two months prior, presents with nausea/vomiting and diarrhea after eating unrefrigerated leftovers. Body mass index is 25. Labs are unremarkable except for a blood urea nitrogen of 37 mg/dL, serum creatinine of 1.6 mg/dL up from 1.3, and white blood cell count of 12 K/µL. He is afebrile with blood pressure of 100/60 mm Hg. He lives alone and is fully ambulatory at baseline. The Emergency Department physician requests observation admission for “dehydration/gastroenteritis.” The admitting hospitalist orders intermittent pneumatic compression (IPC) for venous thromboembolism (VTE) prophylaxis.

The American Public Health Association has called VTE prophylaxis a “public health crisis” due to the gap between existing evidence and implementation.¹ The incidence of symptomatic deep venous thrombosis (DVT) and pulmonary embolism (PE) in hospitalized medical patients managed without prophylaxis is 0.96% and 1.2%, respectively,² whereas that of asymptomatic DVT in hospitalized patients is approximately 1.8%.^2,3 IPC is widely used, and an international registry of 15,156 hospitalized acutely ill medical patients found that 22% of United States patients received IPC for VTE prophylaxis compared with 0.2% of patients in other countries.⁴

The main reason clinicians opt to use IPC for VTE prophylaxis is the wish to avoid the bleeding risk associated with heparin. The American College of Chest Physicians antithrombotic guideline 9th edition (ACCP-AT9) recommends mechanical prophylaxis for patients at increased risk for thrombosis who are either bleeding or at “high risk for major bleeding.”⁵ The guideline considered patients to have an excessive bleeding risk if they had an active gastroduodenal ulcer, bleeding within the past three months, a platelet count below 50,000/ml, or more than one of the following risk factors: age ≥ 85, hepatic failure with INR >1.5, severe renal failure with GFR <30 mL/min/m², ICU/CCU admission, central venous catheter, rheumatic disease, current cancer, or male gender.⁵ IPC also avoids the risk of heparin-induced thrombocytopenia, which is a rare but potentially devastating condition.

Prior studies have shown that IPC reduces VTE in high-risk groups such as orthopedic, surgical, trauma, and stroke patients. The largest systematic review on the topic found 70 studies of 16,164 high-risk patients and concluded that IPC reduced the rate of DVT from 16.7% to 7.3% and PE from 2.8% to 1.2%.⁶Since the publication of this systematic review, an additional large randomized trial of immobile patients with acute stroke was published, which found a reduction in the composite endpoint of proximal DVT on screening compression ultrasound or symptomatic proximal DVT from 12.1% to 8.5%.⁷ Another systematic review of 12 studies of high-risk ICU patients found that IPC conferred a relative risk of 0.5 (95% CI: 0.20-1.23) for DVT, although this result was not statistically significant.⁸ Finally, a Cochrane review of studies that compared IPC combined with pharmacologic prophylaxis with pharmacologic prophylaxis alone in high-risk trauma and surgical patients found reduced PE for the combination.⁹

IPC devices are frequently not worn or turned on. A study at two university-affiliated level one trauma centers found IPC to be functioning properly in only 19% of trauma patients.¹⁰ In another study of gynecologic oncology patients, 52% of IPCs were functioning improperly and 25% of patients experienced some discomfort, inconvenience, or problems with external pneumatic compression.¹¹ Redness, itching, or discomfort was cited by 26% of patients, and patients removed IPCs 11% of the time when nurses left the room.^11,12 In another study, skin breakdown occurred in 3% of IPC patients as compared with 1% in the control group.⁷

Concerns about a possible link between IPC and increased fall risk was raised by a 2005 report of 40 falls by the Pennsylvania Patient Safety Reporting System,¹³ and IPC accounted for 16 of 3,562 hospital falls according to Boelig and colleagues.¹⁴ Ritsema et al. found that the most important perceived barriers to IPC compliance according to patient surveys were that the devices “prevented walking or getting up” (47%), “were tethering or tangling” (25%), and “woke the patient from sleep” (15%).¹⁵

IPC devices are not created equally, differing in “anatomical location of the sleeve garment, number and location of air bladders, patterns for compression cycles and duration of inflation time and deflation time.”¹⁶ Comparative effectiveness may differ. A study comparing a rapid inflation asymmetrical compression device by Venaflow with a sequential circumferential compression device by Kendall in a high-risk post knee replacement population produced DVT rates of 6.9% versus 15%, respectively (P = .007).^16,17 Furthermore, the type of sleeve and device may affect comfort and compliance as some sleeves are considered “breathable.”

Perhaps most importantly, data supporting IPC efficacy in general medical ward patients are virtually nonexistent. Ho’s meta-analysis of IPC after excluding surgical patients found a relative risk (RR) of 0.53 (95% CI: 0.35-0.81, P < .01) for DVT in nine trials and a nonstatistically significant RR of 0.64 (95% CI: 0.29-1.42. P = .27) for PE in six trials.⁶ However, if high-risk populations such as trauma, critical care, and stroke are excluded, then the only remaining study is a letter to the editor published in 1982 that compared 20 patients with unstable angina treated with IPC with 23 controls and found a nonsignificant reduction in screened VTE.¹⁸ Given the near complete lack of data supporting IPC in medical patients, the ACCP-AT9 guideline rates the strength of evidence recommendation to use IPC only in medical patients who are currently bleeding or at high risk of major bleeding as “2C,” which is defined as “weak recommendation” based on “low-quality or very low-quality evidence.”¹⁹ Similarly, the latest American College of Physicians guidelines (2011) recommend pharmacologic prophylaxis for medical patients rather than IPC, except when bleeding risk outweighs the likely benefit of pharmacologic prophylaxis. The guidelines specifically recommend against graduated compression stockings given the lack of efficacy and increased risk of skin breakdown.²⁰

IPC is expensive. The cost for pneumatic compression boots is quoted in the literature at $120 with a range of $80-$250.²¹ Furthermore, patients averaged 2.5 pairs per hospitalization.²² An online search of retail prices revealed a pair of knee-length Covidien 5329 compression sleeves at $299.19 per pair²³ and knee-length Kendall 7325-2 compression sleeves at $433.76 per pair²⁴ with pumps costing $7,518.07 for Venodyne 610 Advantage,²⁵ $6,965.98 for VenaFlow Elite,²⁶ and $5,750.50 for Covidien 29525 700 series Kendall SCD.²⁷ However, using these prices would be overestimating costs given that hospitals do not pay retail prices. A prior surgical cost/benefit analysis used a prevalence of 6.9% and a 69% reduction of DVT.²⁸ However, recent data showed that VTE incidence in 31,219 medical patients was only 0.57% and RR for a large VTE prevention initiative was a nonsignificant 10% reduction.²⁹ Even if we use a VTE prevalence of 1% for the general medical floor and 0.5% RR reduction, 200 patients would need to be treated to prevent one symptomatic VTE and would cost about $24,000 for IPC sleeves alone (estimating $120 per patient) without factoring in additional costs of pump purchase or rental and six additional episodes of anticipated skin breakdown. In comparison, the cost for VTE treatment ranges from $7,712 to $16,644.³⁰

First, one should consider if VTE prophylaxis is needed based on risk assessment. According to the Agency for Healthcare Research and Quality (AHRQ), the most widely used risk stratification model is the University of California San Diego “3 bucket model” (Table 1) derived from tables in ACCP-AT8 guidelines.³¹The Caprini risk assessment model has been validated for surgical patients, but AHRQ offers caveats related to the complexity of the tool, the difficulty many sites have integrating it into order sets, and the negative experience of the Michigan Hospital Medicine Safety Consortium. The consortium enrolled 43 hospitals with the great majority using the Caprini risk assessment model, but it failed to reduce VTE in medical patients.³¹ Alternatively, the ACCP-AT9 guidelines recommend the Padua prediction score for risk assessment of medical patients (Table 2). VTE occurs in 0.3% of low-risk patients (Padua score <4) and 11.0% of high-risk patients (Padua score ≥4). If IPC is used in the low-risk populations with a predicted VTE rate of 0.3, then 666 patients would need to be treated to prevent one VTE. Treating 666 patients would cost $79,920 for IPC sleeves alone plus $5,500-$7,500 per pump and result in 20 additional episodes of skin breakdown. Therefore, IPC should be reserved for high-risk populations with contraindications to pharmacologic prophylaxis.

• The VTE risk of general medicine ward patients should be assessed, preferably with the “3 bucket” or Padua risk assessment models.
• For low-risk patients, no VTE prophylaxis is indicated. Ambulation ought to be encouraged for low-risk patients.
• If prophylaxis is indicated, then bleeding risk should be assessed to determine a contraindication to pharmacologic prophylaxis. If there is excessive bleeding risk, then treatment with IPC may be considered even though there are only data to support this in high-risk populations such as surgical, stroke, trauma, and critical care patients.
• If using IPC, then strategies that ensure compliance and consider patient comfort based on type and location of sleeves should be implemented.
• Combined IPC and pharmacologic prophylaxis should be used for high-risk trauma or surgical patients.

No current evidence supports IPC efficacy in general medical ward patients despite its widespread use; thus, prospective trials in this population are needed. Given costs, potential side effects, and uncertain efficacy in general medical ward patients, IPC should be reserved for surgical, trauma, critical care, or stroke patients. It may be considered for moderate to high-risk medical patients with excessive bleeding risk. Our clinical scenario patient bled within the past three months (odds ratio for bleeding 3.64; 95% CI, 2.21-5.99).³² On the basis of the increased risk, a dutiful hospitalist might be tempted to order IPC. However, given that our patient is ambulatory, is toileting frequently, and has an expected observation stay of less than 48 hours, he is considered low risk for VTE (Table 1). Additionally, his Padua score of two confirms his low risk status (Table 2). No VTE prophylaxis would be indicated.

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

Disclosures

The authors have nothing to disclose.

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

A 74-year-old man with a history of diabetes and gastrointestinal bleeding two months prior, presents with nausea/vomiting and diarrhea after eating unrefrigerated leftovers. Body mass index is 25. Labs are unremarkable except for a blood urea nitrogen of 37 mg/dL, serum creatinine of 1.6 mg/dL up from 1.3, and white blood cell count of 12 K/µL. He is afebrile with blood pressure of 100/60 mm Hg. He lives alone and is fully ambulatory at baseline. The Emergency Department physician requests observation admission for “dehydration/gastroenteritis.” The admitting hospitalist orders intermittent pneumatic compression (IPC) for venous thromboembolism (VTE) prophylaxis.

The American Public Health Association has called VTE prophylaxis a “public health crisis” due to the gap between existing evidence and implementation.¹ The incidence of symptomatic deep venous thrombosis (DVT) and pulmonary embolism (PE) in hospitalized medical patients managed without prophylaxis is 0.96% and 1.2%, respectively,² whereas that of asymptomatic DVT in hospitalized patients is approximately 1.8%.^2,3 IPC is widely used, and an international registry of 15,156 hospitalized acutely ill medical patients found that 22% of United States patients received IPC for VTE prophylaxis compared with 0.2% of patients in other countries.⁴

The main reason clinicians opt to use IPC for VTE prophylaxis is the wish to avoid the bleeding risk associated with heparin. The American College of Chest Physicians antithrombotic guideline 9th edition (ACCP-AT9) recommends mechanical prophylaxis for patients at increased risk for thrombosis who are either bleeding or at “high risk for major bleeding.”⁵ The guideline considered patients to have an excessive bleeding risk if they had an active gastroduodenal ulcer, bleeding within the past three months, a platelet count below 50,000/ml, or more than one of the following risk factors: age ≥ 85, hepatic failure with INR >1.5, severe renal failure with GFR <30 mL/min/m², ICU/CCU admission, central venous catheter, rheumatic disease, current cancer, or male gender.⁵ IPC also avoids the risk of heparin-induced thrombocytopenia, which is a rare but potentially devastating condition.

Prior studies have shown that IPC reduces VTE in high-risk groups such as orthopedic, surgical, trauma, and stroke patients. The largest systematic review on the topic found 70 studies of 16,164 high-risk patients and concluded that IPC reduced the rate of DVT from 16.7% to 7.3% and PE from 2.8% to 1.2%.⁶Since the publication of this systematic review, an additional large randomized trial of immobile patients with acute stroke was published, which found a reduction in the composite endpoint of proximal DVT on screening compression ultrasound or symptomatic proximal DVT from 12.1% to 8.5%.⁷ Another systematic review of 12 studies of high-risk ICU patients found that IPC conferred a relative risk of 0.5 (95% CI: 0.20-1.23) for DVT, although this result was not statistically significant.⁸ Finally, a Cochrane review of studies that compared IPC combined with pharmacologic prophylaxis with pharmacologic prophylaxis alone in high-risk trauma and surgical patients found reduced PE for the combination.⁹

IPC devices are frequently not worn or turned on. A study at two university-affiliated level one trauma centers found IPC to be functioning properly in only 19% of trauma patients.¹⁰ In another study of gynecologic oncology patients, 52% of IPCs were functioning improperly and 25% of patients experienced some discomfort, inconvenience, or problems with external pneumatic compression.¹¹ Redness, itching, or discomfort was cited by 26% of patients, and patients removed IPCs 11% of the time when nurses left the room.^11,12 In another study, skin breakdown occurred in 3% of IPC patients as compared with 1% in the control group.⁷

Concerns about a possible link between IPC and increased fall risk was raised by a 2005 report of 40 falls by the Pennsylvania Patient Safety Reporting System,¹³ and IPC accounted for 16 of 3,562 hospital falls according to Boelig and colleagues.¹⁴ Ritsema et al. found that the most important perceived barriers to IPC compliance according to patient surveys were that the devices “prevented walking or getting up” (47%), “were tethering or tangling” (25%), and “woke the patient from sleep” (15%).¹⁵

IPC devices are not created equally, differing in “anatomical location of the sleeve garment, number and location of air bladders, patterns for compression cycles and duration of inflation time and deflation time.”¹⁶ Comparative effectiveness may differ. A study comparing a rapid inflation asymmetrical compression device by Venaflow with a sequential circumferential compression device by Kendall in a high-risk post knee replacement population produced DVT rates of 6.9% versus 15%, respectively (P = .007).^16,17 Furthermore, the type of sleeve and device may affect comfort and compliance as some sleeves are considered “breathable.”

Perhaps most importantly, data supporting IPC efficacy in general medical ward patients are virtually nonexistent. Ho’s meta-analysis of IPC after excluding surgical patients found a relative risk (RR) of 0.53 (95% CI: 0.35-0.81, P < .01) for DVT in nine trials and a nonstatistically significant RR of 0.64 (95% CI: 0.29-1.42. P = .27) for PE in six trials.⁶ However, if high-risk populations such as trauma, critical care, and stroke are excluded, then the only remaining study is a letter to the editor published in 1982 that compared 20 patients with unstable angina treated with IPC with 23 controls and found a nonsignificant reduction in screened VTE.¹⁸ Given the near complete lack of data supporting IPC in medical patients, the ACCP-AT9 guideline rates the strength of evidence recommendation to use IPC only in medical patients who are currently bleeding or at high risk of major bleeding as “2C,” which is defined as “weak recommendation” based on “low-quality or very low-quality evidence.”¹⁹ Similarly, the latest American College of Physicians guidelines (2011) recommend pharmacologic prophylaxis for medical patients rather than IPC, except when bleeding risk outweighs the likely benefit of pharmacologic prophylaxis. The guidelines specifically recommend against graduated compression stockings given the lack of efficacy and increased risk of skin breakdown.²⁰

IPC is expensive. The cost for pneumatic compression boots is quoted in the literature at $120 with a range of $80-$250.²¹ Furthermore, patients averaged 2.5 pairs per hospitalization.²² An online search of retail prices revealed a pair of knee-length Covidien 5329 compression sleeves at $299.19 per pair²³ and knee-length Kendall 7325-2 compression sleeves at $433.76 per pair²⁴ with pumps costing $7,518.07 for Venodyne 610 Advantage,²⁵ $6,965.98 for VenaFlow Elite,²⁶ and $5,750.50 for Covidien 29525 700 series Kendall SCD.²⁷ However, using these prices would be overestimating costs given that hospitals do not pay retail prices. A prior surgical cost/benefit analysis used a prevalence of 6.9% and a 69% reduction of DVT.²⁸ However, recent data showed that VTE incidence in 31,219 medical patients was only 0.57% and RR for a large VTE prevention initiative was a nonsignificant 10% reduction.²⁹ Even if we use a VTE prevalence of 1% for the general medical floor and 0.5% RR reduction, 200 patients would need to be treated to prevent one symptomatic VTE and would cost about $24,000 for IPC sleeves alone (estimating $120 per patient) without factoring in additional costs of pump purchase or rental and six additional episodes of anticipated skin breakdown. In comparison, the cost for VTE treatment ranges from $7,712 to $16,644.³⁰

First, one should consider if VTE prophylaxis is needed based on risk assessment. According to the Agency for Healthcare Research and Quality (AHRQ), the most widely used risk stratification model is the University of California San Diego “3 bucket model” (Table 1) derived from tables in ACCP-AT8 guidelines.³¹The Caprini risk assessment model has been validated for surgical patients, but AHRQ offers caveats related to the complexity of the tool, the difficulty many sites have integrating it into order sets, and the negative experience of the Michigan Hospital Medicine Safety Consortium. The consortium enrolled 43 hospitals with the great majority using the Caprini risk assessment model, but it failed to reduce VTE in medical patients.³¹ Alternatively, the ACCP-AT9 guidelines recommend the Padua prediction score for risk assessment of medical patients (Table 2). VTE occurs in 0.3% of low-risk patients (Padua score <4) and 11.0% of high-risk patients (Padua score ≥4). If IPC is used in the low-risk populations with a predicted VTE rate of 0.3, then 666 patients would need to be treated to prevent one VTE. Treating 666 patients would cost $79,920 for IPC sleeves alone plus $5,500-$7,500 per pump and result in 20 additional episodes of skin breakdown. Therefore, IPC should be reserved for high-risk populations with contraindications to pharmacologic prophylaxis.

• The VTE risk of general medicine ward patients should be assessed, preferably with the “3 bucket” or Padua risk assessment models.
• For low-risk patients, no VTE prophylaxis is indicated. Ambulation ought to be encouraged for low-risk patients.
• If prophylaxis is indicated, then bleeding risk should be assessed to determine a contraindication to pharmacologic prophylaxis. If there is excessive bleeding risk, then treatment with IPC may be considered even though there are only data to support this in high-risk populations such as surgical, stroke, trauma, and critical care patients.
• If using IPC, then strategies that ensure compliance and consider patient comfort based on type and location of sleeves should be implemented.
• Combined IPC and pharmacologic prophylaxis should be used for high-risk trauma or surgical patients.

No current evidence supports IPC efficacy in general medical ward patients despite its widespread use; thus, prospective trials in this population are needed. Given costs, potential side effects, and uncertain efficacy in general medical ward patients, IPC should be reserved for surgical, trauma, critical care, or stroke patients. It may be considered for moderate to high-risk medical patients with excessive bleeding risk. Our clinical scenario patient bled within the past three months (odds ratio for bleeding 3.64; 95% CI, 2.21-5.99).³² On the basis of the increased risk, a dutiful hospitalist might be tempted to order IPC. However, given that our patient is ambulatory, is toileting frequently, and has an expected observation stay of less than 48 hours, he is considered low risk for VTE (Table 1). Additionally, his Padua score of two confirms his low risk status (Table 2). No VTE prophylaxis would be indicated.

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

Disclosures

The authors have nothing to disclose.

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

A 74-year-old man with a history of diabetes and gastrointestinal bleeding two months prior, presents with nausea/vomiting and diarrhea after eating unrefrigerated leftovers. Body mass index is 25. Labs are unremarkable except for a blood urea nitrogen of 37 mg/dL, serum creatinine of 1.6 mg/dL up from 1.3, and white blood cell count of 12 K/µL. He is afebrile with blood pressure of 100/60 mm Hg. He lives alone and is fully ambulatory at baseline. The Emergency Department physician requests observation admission for “dehydration/gastroenteritis.” The admitting hospitalist orders intermittent pneumatic compression (IPC) for venous thromboembolism (VTE) prophylaxis.

The American Public Health Association has called VTE prophylaxis a “public health crisis” due to the gap between existing evidence and implementation.¹ The incidence of symptomatic deep venous thrombosis (DVT) and pulmonary embolism (PE) in hospitalized medical patients managed without prophylaxis is 0.96% and 1.2%, respectively,² whereas that of asymptomatic DVT in hospitalized patients is approximately 1.8%.^2,3 IPC is widely used, and an international registry of 15,156 hospitalized acutely ill medical patients found that 22% of United States patients received IPC for VTE prophylaxis compared with 0.2% of patients in other countries.⁴

The main reason clinicians opt to use IPC for VTE prophylaxis is the wish to avoid the bleeding risk associated with heparin. The American College of Chest Physicians antithrombotic guideline 9th edition (ACCP-AT9) recommends mechanical prophylaxis for patients at increased risk for thrombosis who are either bleeding or at “high risk for major bleeding.”⁵ The guideline considered patients to have an excessive bleeding risk if they had an active gastroduodenal ulcer, bleeding within the past three months, a platelet count below 50,000/ml, or more than one of the following risk factors: age ≥ 85, hepatic failure with INR >1.5, severe renal failure with GFR <30 mL/min/m², ICU/CCU admission, central venous catheter, rheumatic disease, current cancer, or male gender.⁵ IPC also avoids the risk of heparin-induced thrombocytopenia, which is a rare but potentially devastating condition.

Prior studies have shown that IPC reduces VTE in high-risk groups such as orthopedic, surgical, trauma, and stroke patients. The largest systematic review on the topic found 70 studies of 16,164 high-risk patients and concluded that IPC reduced the rate of DVT from 16.7% to 7.3% and PE from 2.8% to 1.2%.⁶Since the publication of this systematic review, an additional large randomized trial of immobile patients with acute stroke was published, which found a reduction in the composite endpoint of proximal DVT on screening compression ultrasound or symptomatic proximal DVT from 12.1% to 8.5%.⁷ Another systematic review of 12 studies of high-risk ICU patients found that IPC conferred a relative risk of 0.5 (95% CI: 0.20-1.23) for DVT, although this result was not statistically significant.⁸ Finally, a Cochrane review of studies that compared IPC combined with pharmacologic prophylaxis with pharmacologic prophylaxis alone in high-risk trauma and surgical patients found reduced PE for the combination.⁹

IPC devices are frequently not worn or turned on. A study at two university-affiliated level one trauma centers found IPC to be functioning properly in only 19% of trauma patients.¹⁰ In another study of gynecologic oncology patients, 52% of IPCs were functioning improperly and 25% of patients experienced some discomfort, inconvenience, or problems with external pneumatic compression.¹¹ Redness, itching, or discomfort was cited by 26% of patients, and patients removed IPCs 11% of the time when nurses left the room.^11,12 In another study, skin breakdown occurred in 3% of IPC patients as compared with 1% in the control group.⁷

Concerns about a possible link between IPC and increased fall risk was raised by a 2005 report of 40 falls by the Pennsylvania Patient Safety Reporting System,¹³ and IPC accounted for 16 of 3,562 hospital falls according to Boelig and colleagues.¹⁴ Ritsema et al. found that the most important perceived barriers to IPC compliance according to patient surveys were that the devices “prevented walking or getting up” (47%), “were tethering or tangling” (25%), and “woke the patient from sleep” (15%).¹⁵

IPC devices are not created equally, differing in “anatomical location of the sleeve garment, number and location of air bladders, patterns for compression cycles and duration of inflation time and deflation time.”¹⁶ Comparative effectiveness may differ. A study comparing a rapid inflation asymmetrical compression device by Venaflow with a sequential circumferential compression device by Kendall in a high-risk post knee replacement population produced DVT rates of 6.9% versus 15%, respectively (P = .007).^16,17 Furthermore, the type of sleeve and device may affect comfort and compliance as some sleeves are considered “breathable.”

Perhaps most importantly, data supporting IPC efficacy in general medical ward patients are virtually nonexistent. Ho’s meta-analysis of IPC after excluding surgical patients found a relative risk (RR) of 0.53 (95% CI: 0.35-0.81, P < .01) for DVT in nine trials and a nonstatistically significant RR of 0.64 (95% CI: 0.29-1.42. P = .27) for PE in six trials.⁶ However, if high-risk populations such as trauma, critical care, and stroke are excluded, then the only remaining study is a letter to the editor published in 1982 that compared 20 patients with unstable angina treated with IPC with 23 controls and found a nonsignificant reduction in screened VTE.¹⁸ Given the near complete lack of data supporting IPC in medical patients, the ACCP-AT9 guideline rates the strength of evidence recommendation to use IPC only in medical patients who are currently bleeding or at high risk of major bleeding as “2C,” which is defined as “weak recommendation” based on “low-quality or very low-quality evidence.”¹⁹ Similarly, the latest American College of Physicians guidelines (2011) recommend pharmacologic prophylaxis for medical patients rather than IPC, except when bleeding risk outweighs the likely benefit of pharmacologic prophylaxis. The guidelines specifically recommend against graduated compression stockings given the lack of efficacy and increased risk of skin breakdown.²⁰

IPC is expensive. The cost for pneumatic compression boots is quoted in the literature at $120 with a range of $80-$250.²¹ Furthermore, patients averaged 2.5 pairs per hospitalization.²² An online search of retail prices revealed a pair of knee-length Covidien 5329 compression sleeves at $299.19 per pair²³ and knee-length Kendall 7325-2 compression sleeves at $433.76 per pair²⁴ with pumps costing $7,518.07 for Venodyne 610 Advantage,²⁵ $6,965.98 for VenaFlow Elite,²⁶ and $5,750.50 for Covidien 29525 700 series Kendall SCD.²⁷ However, using these prices would be overestimating costs given that hospitals do not pay retail prices. A prior surgical cost/benefit analysis used a prevalence of 6.9% and a 69% reduction of DVT.²⁸ However, recent data showed that VTE incidence in 31,219 medical patients was only 0.57% and RR for a large VTE prevention initiative was a nonsignificant 10% reduction.²⁹ Even if we use a VTE prevalence of 1% for the general medical floor and 0.5% RR reduction, 200 patients would need to be treated to prevent one symptomatic VTE and would cost about $24,000 for IPC sleeves alone (estimating $120 per patient) without factoring in additional costs of pump purchase or rental and six additional episodes of anticipated skin breakdown. In comparison, the cost for VTE treatment ranges from $7,712 to $16,644.³⁰

First, one should consider if VTE prophylaxis is needed based on risk assessment. According to the Agency for Healthcare Research and Quality (AHRQ), the most widely used risk stratification model is the University of California San Diego “3 bucket model” (Table 1) derived from tables in ACCP-AT8 guidelines.³¹The Caprini risk assessment model has been validated for surgical patients, but AHRQ offers caveats related to the complexity of the tool, the difficulty many sites have integrating it into order sets, and the negative experience of the Michigan Hospital Medicine Safety Consortium. The consortium enrolled 43 hospitals with the great majority using the Caprini risk assessment model, but it failed to reduce VTE in medical patients.³¹ Alternatively, the ACCP-AT9 guidelines recommend the Padua prediction score for risk assessment of medical patients (Table 2). VTE occurs in 0.3% of low-risk patients (Padua score <4) and 11.0% of high-risk patients (Padua score ≥4). If IPC is used in the low-risk populations with a predicted VTE rate of 0.3, then 666 patients would need to be treated to prevent one VTE. Treating 666 patients would cost $79,920 for IPC sleeves alone plus $5,500-$7,500 per pump and result in 20 additional episodes of skin breakdown. Therefore, IPC should be reserved for high-risk populations with contraindications to pharmacologic prophylaxis.

• The VTE risk of general medicine ward patients should be assessed, preferably with the “3 bucket” or Padua risk assessment models.
• For low-risk patients, no VTE prophylaxis is indicated. Ambulation ought to be encouraged for low-risk patients.
• If prophylaxis is indicated, then bleeding risk should be assessed to determine a contraindication to pharmacologic prophylaxis. If there is excessive bleeding risk, then treatment with IPC may be considered even though there are only data to support this in high-risk populations such as surgical, stroke, trauma, and critical care patients.
• If using IPC, then strategies that ensure compliance and consider patient comfort based on type and location of sleeves should be implemented.
• Combined IPC and pharmacologic prophylaxis should be used for high-risk trauma or surgical patients.

No current evidence supports IPC efficacy in general medical ward patients despite its widespread use; thus, prospective trials in this population are needed. Given costs, potential side effects, and uncertain efficacy in general medical ward patients, IPC should be reserved for surgical, trauma, critical care, or stroke patients. It may be considered for moderate to high-risk medical patients with excessive bleeding risk. Our clinical scenario patient bled within the past three months (odds ratio for bleeding 3.64; 95% CI, 2.21-5.99).³² On the basis of the increased risk, a dutiful hospitalist might be tempted to order IPC. However, given that our patient is ambulatory, is toileting frequently, and has an expected observation stay of less than 48 hours, he is considered low risk for VTE (Table 1). Additionally, his Padua score of two confirms his low risk status (Table 2). No VTE prophylaxis would be indicated.

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

Disclosures

The authors have nothing to disclose.