The International Continence Society (ICS) defines overactive bladder (OAB) as a syndrome of "urinary urgency, usually accompanied by frequency and nocturia, with or without urgency urinary incontinence (UUI), in the absence of urinary tract infection [UTI] or obvious pathology."¹ The Agency for Healthcare Research and Quality (AHRQ) reported OAB prevalence to be 15% in US women, with 11% reporting UUI.² OAB represents a significant health care burden that impacts nearly every aspect of life, including physical, emotional, and psychological domains.^3,4 The economic impact is notable; the projected cost is estimated to reach $82.6 billion annually by 2020.⁵

The American Urological Association (AUA) and the Society for Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction (SUFU) have endorsed an algorithm for use in the evaluation of idiopathic OAB (FIGURE).⁶ If the patient's symptoms are certain, minimal evaluation is needed and it is reasonable to proceed with first-line therapy, which includes fluid management (decreasing caffeine intake and limiting evening fluid intake), bladder retraining drills such as timed voiding, and improving pelvic floor muscles with the use of biofeedback and functional electrical stimulation.^6,7 Pelvic floor muscle training can be facilitated with a referral to a physical therapist trained in pelvic floor muscle education.

If treatment goals are not met with first-line strategies, second-line therapy may be initiated with anticholinergic or β3-adrenergic receptor agonist medications. If symptoms persist after 4 to 8 weeks of pharmacologic therapy, clinicians are encouraged to reassess or refer the patient to a specialist. Further evaluation may include a bladder diary in which the patient documents voided volumes, voiding frequency, and number of incontinent episodes; symptom-specific questionnaires; and/or urodynamic testing.

Related article:
The latest treatments for urinary and fecal incontinence: Which hold water?

Based on that evaluation, the patient may be a candidate for third-line therapy with either intradetrusor onabotulinumtoxinA, posterior tibial nerve stimulation (PTNS), or sacral neuromodulation.

There is a paucity of information comparing third-line therapies. In this Update, we focus on 4 randomized clinical trials that compare third-line treatment options for idiopathic OAB.

Read about how anticholinergic medication and onabotulinumtoxinA compare for treating UUI.

Anticholinergic therapy and onabotulinumtoxinA produce equivalent reductions in the frequency of daily UUI episodes

Visco AG, Brubaker L, Richter HE, et al; for the Pelvic Floor Disorders Network. Anticholinergic therapy vs onabotulinumtoxinA for urgency urinary incontinence. N Engl J Med. 2012;367(19):1803-1813.

In a double-blind, double-placebo-controlled randomized trial, Visco and colleagues compared anticholinergic medication with onabotulinumtoxinA 100 U for the treatment of women with UUI.

Details of the study

Two hundred forty-one women with moderate to severe UUI received either 6 months of oral anticholinergic therapy (solifenacin 5 mg daily with the option of dose escalation to 10 mg daily or change to trospium XR 60 mg daily based on the Patient Global Symptom Control score) plus a single intradetrusor injection of saline, or a single intradetrusor injection of onabotulinumtoxinA 100 U plus a 6-month oral placebo regimen.

Inclusion criteria were 5 or more UUI episodes on a 3-day diary, insufficient resolution of symptoms after 2 medications, or being drug naive. Exclusions included a postvoid residual (PVR) urine volume greater than 150 mL or previous therapy with onabotulinumtoxinA.

Participants were scheduled for follow up every 2 to 6 months post randomization, at which time all study medications were discontinued. The primary outcome was reduction from baseline in the mean number of UUI episodes per day over the 6-month period, as recorded in the monthly 3-day bladder diaries. Secondary outcomes included the proportion of participants with complete resolution of UUI, the proportion of participants with 75% or more reduction in UUI episodes, Overactive Bladder Questionnaire Short Form (OABq-SF) scores, other symptom-specific questionnaire scores, and adverse events.

Related article:
Which treatments for pelvic floor disorders are backed by evidence?

Both treatments significantly reduced UUI episodes

At baseline, participants reported a mean (SD) of 5.0 (2.7) UUI episodes per day, and 41% of participants were drug naive. Both treatment groups experienced significant reductions compared with baseline in mean UUI episodes, and the reductions were similar between the 2 groups (reduction of 3.4 episodes per day in the anticholinergic group, reduction of 3.3 episodes in the onabotulinumtoxinA group; P = .81). Complete resolution of UUI was more common in the onabotulinumtoxinA group (27%) as compared with the anticholinergic group (13%) (P = .003). There were no differences in improvement in OABq-SF scores (37.05 in the anticholinergic group vs 37.13 in the onabotulinumtoxinA group; P = .98) or other quality-of-life measures.

Adverse events. The anticholinergic group experienced a higher rate of dry mouth compared with the onabotulinumtoxinA group (46% vs 31%; P = .02) but had lower rates of intermittent catheterization use at 2 months (0% vs 5%, P = .01) and UTIs (13% vs 33%, P<.001).

Strengths and limitations. This was a well-designed, multicenter, randomized double-blind, double placebo-controlled trial. The study design allowed for dose escalation and change to another medication for inadequate symptom control and included drug-naive participants, which increases the generalizability of the results. However, current guidelines recommend reserving onabotulinumtoxinA therapy for third-line therapy, thus deterring this treatment's use in the drug-naive population. Additionally, the lack of a pure placebo arm makes it difficult to interpret the extent to which a placebo effect contributed to observed improvements in clinical symptoms.

Read: onabotulinumtoxinA vs PTNS for OAB.

OnabotulinumtoxinA has greater 9-month durability for OAB symptoms compared with12 weeks of PTNS

Sherif H, Khalil M, Omar R. Management of refractory idiopathic overactive bladder: intradetrusor injection of botulinum toxin type A versus posterior tibial nerve stimulation. Can J Urol. 2017;24(3):8838-8846.

In this randomized clinical trial, Sherif and colleagues compared the safety and efficacy of a single intradetrusor injection of onabotulinumtoxinA 100 U with that of PTNS for OAB.

Details of the study

Sixty adult men and women with OAB who did not respond to medical therapy were randomly assigned to treatment with either onabotulinumtoxinA 100 U or PTNS. Criteria for exclusion were current UTI, PVR urine volume of more than 150 mL, previous radiation therapy or chemotherapy, previous incontinence surgery or bladder malignancy, or presence of mixed urinary incontinence.

At baseline, participants completed a 3-day bladder diary, an OAB symptom score (OABSS) questionnaire, and urodynamic testing. The OABSS questionnaire included 7 questions (scoring range, 0-28), with higher scores indicating worse symptoms, and included subscales for urgency and quality-of-life measures. Total OABSS, urgency score, quality-of-life score, bladder diary records, and urodynamic testing parameters were assessed at 6, 12, 24, and 36 weeks, along with adverse events.

OnabotulinumtoxinA injections were performed under spinal anesthesia. If PVR urine volume was greater than 200 mL at any follow-up visit, participants were instructed to begin clean intermittent self-catheterization. PTNS was administered as weekly 30-minute sessions for 12 consecutive weeks.

Participants' baseline demographics and symptoms were similar. Average age was 45 years. Averages (SD) for duration of anticholinergic use was 13 (0.8) weeks, UUI episode score was 4.5 (1) on 3-day bladder diary, and OABSS was 22 (2.7). Nine-month data were available for 29 participants in the onabotulinumtoxinA group and for 8 in the PTNS group.

Related article:
Update on pelvic floor dysfunction: Focus on urinary incontinence

OnabotulinumtoxinA treatment benefits sustained for 9 months

Through 6 months, compared with baseline assessments, both treatment groups had significant improvements in clinical symptoms and OABSS total score, as well as urgency and quality-of-life subscales. At 3 months, urodynamic study parameters were similarly improved from baseline in both groups.

At 9 months, however, only the onabotulinumtoxinA group, compared with the PTNS group, maintained the significant improvement from baseline in 3-day bladder diary voiding episodes (average [SD], 10.7 [1.01] vs 11.6 [1.09]; P = .009), 3-day bladder diary nocturia episodes (average [SD], 3.8 [1.09] vs 4.4 [0.8]; P = .02), and average [SD] UUI episodes over 3 days (3.5 [1.2] vs 4.2 [1.04]; P = .02). Similarly, onabotulinumtoxinA-treated participants, compared with those treated with PTNS, maintained improvements at 9 months in average (SD): OABSS total score (19.2 [2.4] vs 20.4 [1.7]; P = .03), urgency scores (10.9 [1.3] vs 11.8 [1.4]; P = .009), urine volume at first desire (177.8 [9.2] vs 171.8 [7.7]), maximum cystometric capacity (304 [17.6] vs 290 [13.1]), and Qmax (mL/sec) (20.7 [1.6] vs 22.2 [1.2]).

Adverse events. Average PVR urine volumes were higher in the onabotulinumtoxinA group compared with the PTNS group (36.8 [2.7] vs 32.4 [3.03]; P = .0001) at all time points, and self-catheterization was required in 6.6% of onabotulinumtoxinA-treated participants. Urinary tract infection occurred in 6.6% of participants in the onabotulinumtoxinA group and in none of the PTNS group. In the PTNS group, few experienced pain and minor bleeding at the needle site.

Strengths and limitations. This randomized, open-label trial comparing treatment with onabotulinumtoxinA 100 U and PTNS included both men and women with idiopathic OAB symptoms. The participants were assessed at regular intervals with various measures, and follow-up adherence was good. The sample size was small, so the study may not have been powered to see differences prior to 9 months.

Although at 9 months only the onabotulinumtoxinA group maintained significant improvement over baseline levels, the improvement was diminished, and therefore the clinical meaningfulness is uncertain. Further, participants in the PTNS group did not undergo monthly maintenance therapy after 3 months, which is recommended for those with a 12-week therapeutic response; this may have affected 9-month outcomes in this group. Since the one-time onabotulinumtoxinA 100 U injection was performed under spinal anesthesia, cost comparisons should be considered, since future onabotulinumtoxinA injections would be necessary. 

Read about using different doses of onabotulinumtoxinA for OAB.

OnabotulinumtoxinA 200-U injection provides longer OAB symptom  improvement than 100-U injection

Abdelwahab O, Sherif H, Soliman T, Elbarky I, Eshazly A. Efficacy of botulinum toxin type A 100 units versus 200 units for treatment of refractory idiopathic overactive bladder. Int Braz J Urol. 2015;41(6):1132-1140.

Abdelwahab and colleagues conducted a single-center, randomized clinical trial to investigate the safety and efficacy of a single injection of intradetrusor onabotulinumtoxinA in 2 different doses (100 U and 200 U) for treatment of OAB.

Details of the study

Eighty adults (63 women, 17 men) who did not benefit from anticholinergic medication during the previous 3 months were randomly assigned to receive either a 100-U (n = 40) or a 200-U (n = 40) injection of onabotulinumtoxinA. Exclusion criteria were PVR urine volume greater than 150 mL and previous radiation therapy or chemotherapy.

Initial assessments -- completed at baseline and at 1, 3, 6, and 9 months -- included the health-related quality-of-life (HR-QOL) questionnaire (maximum score, 100; higher score indicates better quality of life), an abbreviated OABSS questionnaire (4 questions; score range, 0-15; higher score indicates more severe symptoms), and urodynamic evaluation. Outcomes included OABSS, HR-QOL score, and urodynamic parameters at the various time points.

Related article:
Is there a link between impaired mobility and urinary incontinence in elderly, community-dwelling women?

Higher dose, greater symptom improvement and higher adverse event rate

At baseline, participants (average age, 31 years) had an average (SD) OABSS of 1.7 (1.6). OnabotulinumtoxinA treatment with both a 100-U and a 200-U dose resulted in significant improvements (compared with baseline levels) in frequency, nocturia, UUI episodes, OABSS, and urodynamic parameters throughout the 9 months. At 9 months, however, the group treated with the 200-U dose had greater improvements, compared with the group who received a 100-U dose, in urinary frequency symptom scores (mean [SD], 0.32 [0.47] vs 1.1 [0.51]; P<.05), nocturia symptom scores (mean [SD], 0.13 [0.34] vs 0.36 [0.49]; P<.05), UUI symptom scores (mean [SD], 0.68 [0.16] vs 1.26 [1.1]; P<.05), and mean (SD) total OABSS (2.6 [2.31] vs 5.3 [2.11]; P<.05). Similarly, at 9 months the 200-U dose resulted in greater improvements in volume at first desire (mean [SD], 291.8 [42.8] vs 246.8 [53.8] mL; P<.05), volume at strong desire (mean [SD], 392.1 [37.3] vs 313.1 [67.4] mL; P<.05), detrusor pressure (mean [SD], 10.4 [4.0] vs 19.2 [7.8] cm H₂O; P<.05), and maximum cystometric capacity (mean [SD], 430.5 [34.2] vs 350 [69.1] mL; P<.05) compared with the 100-U dose.

Adverse events. No participant had a PVR urine volume greater than 100 mL at any follow-up visit. Postoperative hematuria occurred in 23% of the group treated with onabotulinumtoxinA 200 U versus in 15% of those treated with a 100-U dose. Similarly, UTIs occurred in 17.5% of the 200-U dose group and in 7.5% of the 100-U dose group. Dysuria was reported in 37.5% and 15% of the 200-U and 100-U dose groups, respectively.

Strengths and limitations. This randomized, open-label trial comparing a single injection of 100 U versus 200 U of onabotulinumtoxinA included mostly women. OAB symptoms and urodynamic parameters improved after treatment with both dose levels, but a longer duration of improvement was seen with the 200-U dose. The cohort had a low baseline OAB severity, based on the OABSS questionnaire, and a young average age of participants, which limits the generalizability of the study results to a population with refractory OAB. The 0% rate of clean intermittent self-catheterization postinjection might be based on the study's criteria for requiring clean intermittent catheterization. In addition, the initial postinjection visit occurred at 1 month, possibly missing participants who had symptoms of retention soon after injection.

Read: onabotulinumtoxinA vs sacral neuromodulation therapy for UUI.

Treatment with onabotulinumtoxinA may control UUI symptoms better than sacral neuromodulation therapy

Amundsen CL, Richter HE, Menefee SA, et al; Pelvic Floor Disorders Network. OnabotulinumtoxinA vs sacral neuromodulation on refractory urgency urinary incontinence in women: a randomized clinical trial. JAMA. 2016;316(13):1366-1374.

In this multicenter open-label randomized trial, Amundsen and colleagues compared the efficacy and safety of onabotulinumtoxinA 200 U with that of sacral neuromodulation.

Details of the study

Three hundred sixty-four women with UUI had data available for primary analysis at  6 months. Women were considered eligible for the study if they had 6 or more UUI episodes on a 3-day bladder diary, persistent symptoms despite anticholinergic therapy, a PVR urine volume of less than 150 mL, and had never previously received either study treatment.

There were no differences in baseline characteristics of the participants. The average (SD) age of the study population was 63 (11.6) years, with an average (SD) daily number of UUI episodes of 5.3 (2.8). The average (SD) body mass index was 32 (8) kg/m².

Participants were randomly assigned to undergo either sacral neuromodulation (n = 174) or intradetrusor injection of onabotulinumtoxinA 200 U (n = 190). The primary outcome was change from baseline in mean number of daily UUI episodes averaged over 6 months as recorded on a monthly 3-day bladder diary. Secondary outcomes included complete resolution of urgency incontinence, 75% or more reduction in UUI episodes, the Overactive Bladder Questionnaire Short Form (SF) score (range, 0-100; higher score indicates higher symptom severity), the Overactive Bladder Satisfaction of Treatment questionnaire (range, 0-100; higher score indicates better satisfaction), other quality-of-life measures, and adverse events.

Related article:
2015 Update on pelvic floor dysfunction: Bladder pain syndrome

Greater symptom bother improvement, treatment satisfaction with onabotulinumtoxinA 200 U

Participants treated with onabotulinumtoxinA had a greater mean reduction of 3.9 UUI episodes per day than the sacral neuromodulation group's reduction of 3.3 UUI episodes per day (mean difference, 0.63; 95% confidence interval [CI], 0.13-1.14; P = .01). In addition, complete UUI resolution was higher in the onabotulinumtoxinA group as compared with the sacral neuromodulation group (20% vs 4%; P<.001). The onabotulinumtoxinA group also had higher rates of 75% or more reduction of UUI episodes compared with the sacral neuromodulation group (46% vs 26%; P<.001). Over 6 months, both groups had improvements in all quality-of-life measures, but the onabotulinumtoxinA group had greater improvement in symptom bother compared with the sacral neuromodulation group (-46.7 vs -38.6; mean difference, 8.1; 95% CI, 3.0-13.3; P = .002). Furthermore, the onabotulinumtoxinA group had greater treatment satisfaction compared with the sacral neuromodulation group (mean difference, 7.8; 95% CI, 1.6-14.1; P = .01).

Adverse events. Six women (3%) underwent sacral neuromodulation device revision or removal. Approximately 8% of onabotulinumtoxinA-treated participants required intermittent self-catheterization at 1 month, 4% at 3 months, and 2% at 6 months. The risk of UTI was higher in the onabotulinumtoxinA group compared with the sacral neuromodulation group (35% vs 11%; risk difference, 23%; 95% CI, -33% to -13%; P<.001).

Strengths and limitations. This is a well-designed randomized clinical trial comparing clinical outcomes and adverse events after treatment with onabotulinumtoxinA 200-U versus sacral neuromodulation. The interventions were standardized across investigators at multiple sites, and the study design required close follow-up to assess efficacy and adverse events. The study used a 200-U dose based on reported durability of effect at that time and findings of equivalency between onabotulinumtoxinA 100 U and anticholinergic therapy. The US Food and Drug Administration's recommendation to use a 100-U dose in all patients with idiopathic OAB might dissuade clinicians from considering the higher dose of onabotulinumtoxinA. The study was limited by the lack of a placebo group.

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

The International Continence Society (ICS) defines overactive bladder (OAB) as a syndrome of "urinary urgency, usually accompanied by frequency and nocturia, with or without urgency urinary incontinence (UUI), in the absence of urinary tract infection [UTI] or obvious pathology."¹ The Agency for Healthcare Research and Quality (AHRQ) reported OAB prevalence to be 15% in US women, with 11% reporting UUI.² OAB represents a significant health care burden that impacts nearly every aspect of life, including physical, emotional, and psychological domains.^3,4 The economic impact is notable; the projected cost is estimated to reach $82.6 billion annually by 2020.⁵

The American Urological Association (AUA) and the Society for Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction (SUFU) have endorsed an algorithm for use in the evaluation of idiopathic OAB (FIGURE).⁶ If the patient's symptoms are certain, minimal evaluation is needed and it is reasonable to proceed with first-line therapy, which includes fluid management (decreasing caffeine intake and limiting evening fluid intake), bladder retraining drills such as timed voiding, and improving pelvic floor muscles with the use of biofeedback and functional electrical stimulation.^6,7 Pelvic floor muscle training can be facilitated with a referral to a physical therapist trained in pelvic floor muscle education.

If treatment goals are not met with first-line strategies, second-line therapy may be initiated with anticholinergic or β3-adrenergic receptor agonist medications. If symptoms persist after 4 to 8 weeks of pharmacologic therapy, clinicians are encouraged to reassess or refer the patient to a specialist. Further evaluation may include a bladder diary in which the patient documents voided volumes, voiding frequency, and number of incontinent episodes; symptom-specific questionnaires; and/or urodynamic testing.

Related article:
The latest treatments for urinary and fecal incontinence: Which hold water?

Based on that evaluation, the patient may be a candidate for third-line therapy with either intradetrusor onabotulinumtoxinA, posterior tibial nerve stimulation (PTNS), or sacral neuromodulation.

There is a paucity of information comparing third-line therapies. In this Update, we focus on 4 randomized clinical trials that compare third-line treatment options for idiopathic OAB.

Read about how anticholinergic medication and onabotulinumtoxinA compare for treating UUI.

Anticholinergic therapy and onabotulinumtoxinA produce equivalent reductions in the frequency of daily UUI episodes

Visco AG, Brubaker L, Richter HE, et al; for the Pelvic Floor Disorders Network. Anticholinergic therapy vs onabotulinumtoxinA for urgency urinary incontinence. N Engl J Med. 2012;367(19):1803-1813.

In a double-blind, double-placebo-controlled randomized trial, Visco and colleagues compared anticholinergic medication with onabotulinumtoxinA 100 U for the treatment of women with UUI.

Details of the study

Two hundred forty-one women with moderate to severe UUI received either 6 months of oral anticholinergic therapy (solifenacin 5 mg daily with the option of dose escalation to 10 mg daily or change to trospium XR 60 mg daily based on the Patient Global Symptom Control score) plus a single intradetrusor injection of saline, or a single intradetrusor injection of onabotulinumtoxinA 100 U plus a 6-month oral placebo regimen.

Inclusion criteria were 5 or more UUI episodes on a 3-day diary, insufficient resolution of symptoms after 2 medications, or being drug naive. Exclusions included a postvoid residual (PVR) urine volume greater than 150 mL or previous therapy with onabotulinumtoxinA.

Participants were scheduled for follow up every 2 to 6 months post randomization, at which time all study medications were discontinued. The primary outcome was reduction from baseline in the mean number of UUI episodes per day over the 6-month period, as recorded in the monthly 3-day bladder diaries. Secondary outcomes included the proportion of participants with complete resolution of UUI, the proportion of participants with 75% or more reduction in UUI episodes, Overactive Bladder Questionnaire Short Form (OABq-SF) scores, other symptom-specific questionnaire scores, and adverse events.

Related article:
Which treatments for pelvic floor disorders are backed by evidence?

Both treatments significantly reduced UUI episodes

At baseline, participants reported a mean (SD) of 5.0 (2.7) UUI episodes per day, and 41% of participants were drug naive. Both treatment groups experienced significant reductions compared with baseline in mean UUI episodes, and the reductions were similar between the 2 groups (reduction of 3.4 episodes per day in the anticholinergic group, reduction of 3.3 episodes in the onabotulinumtoxinA group; P = .81). Complete resolution of UUI was more common in the onabotulinumtoxinA group (27%) as compared with the anticholinergic group (13%) (P = .003). There were no differences in improvement in OABq-SF scores (37.05 in the anticholinergic group vs 37.13 in the onabotulinumtoxinA group; P = .98) or other quality-of-life measures.

Adverse events. The anticholinergic group experienced a higher rate of dry mouth compared with the onabotulinumtoxinA group (46% vs 31%; P = .02) but had lower rates of intermittent catheterization use at 2 months (0% vs 5%, P = .01) and UTIs (13% vs 33%, P<.001).

Strengths and limitations. This was a well-designed, multicenter, randomized double-blind, double placebo-controlled trial. The study design allowed for dose escalation and change to another medication for inadequate symptom control and included drug-naive participants, which increases the generalizability of the results. However, current guidelines recommend reserving onabotulinumtoxinA therapy for third-line therapy, thus deterring this treatment's use in the drug-naive population. Additionally, the lack of a pure placebo arm makes it difficult to interpret the extent to which a placebo effect contributed to observed improvements in clinical symptoms.

Read: onabotulinumtoxinA vs PTNS for OAB.

OnabotulinumtoxinA has greater 9-month durability for OAB symptoms compared with12 weeks of PTNS

Sherif H, Khalil M, Omar R. Management of refractory idiopathic overactive bladder: intradetrusor injection of botulinum toxin type A versus posterior tibial nerve stimulation. Can J Urol. 2017;24(3):8838-8846.

In this randomized clinical trial, Sherif and colleagues compared the safety and efficacy of a single intradetrusor injection of onabotulinumtoxinA 100 U with that of PTNS for OAB.

Details of the study

Sixty adult men and women with OAB who did not respond to medical therapy were randomly assigned to treatment with either onabotulinumtoxinA 100 U or PTNS. Criteria for exclusion were current UTI, PVR urine volume of more than 150 mL, previous radiation therapy or chemotherapy, previous incontinence surgery or bladder malignancy, or presence of mixed urinary incontinence.

At baseline, participants completed a 3-day bladder diary, an OAB symptom score (OABSS) questionnaire, and urodynamic testing. The OABSS questionnaire included 7 questions (scoring range, 0-28), with higher scores indicating worse symptoms, and included subscales for urgency and quality-of-life measures. Total OABSS, urgency score, quality-of-life score, bladder diary records, and urodynamic testing parameters were assessed at 6, 12, 24, and 36 weeks, along with adverse events.

OnabotulinumtoxinA injections were performed under spinal anesthesia. If PVR urine volume was greater than 200 mL at any follow-up visit, participants were instructed to begin clean intermittent self-catheterization. PTNS was administered as weekly 30-minute sessions for 12 consecutive weeks.

Participants' baseline demographics and symptoms were similar. Average age was 45 years. Averages (SD) for duration of anticholinergic use was 13 (0.8) weeks, UUI episode score was 4.5 (1) on 3-day bladder diary, and OABSS was 22 (2.7). Nine-month data were available for 29 participants in the onabotulinumtoxinA group and for 8 in the PTNS group.

Related article:
Update on pelvic floor dysfunction: Focus on urinary incontinence

OnabotulinumtoxinA treatment benefits sustained for 9 months

Through 6 months, compared with baseline assessments, both treatment groups had significant improvements in clinical symptoms and OABSS total score, as well as urgency and quality-of-life subscales. At 3 months, urodynamic study parameters were similarly improved from baseline in both groups.

At 9 months, however, only the onabotulinumtoxinA group, compared with the PTNS group, maintained the significant improvement from baseline in 3-day bladder diary voiding episodes (average [SD], 10.7 [1.01] vs 11.6 [1.09]; P = .009), 3-day bladder diary nocturia episodes (average [SD], 3.8 [1.09] vs 4.4 [0.8]; P = .02), and average [SD] UUI episodes over 3 days (3.5 [1.2] vs 4.2 [1.04]; P = .02). Similarly, onabotulinumtoxinA-treated participants, compared with those treated with PTNS, maintained improvements at 9 months in average (SD): OABSS total score (19.2 [2.4] vs 20.4 [1.7]; P = .03), urgency scores (10.9 [1.3] vs 11.8 [1.4]; P = .009), urine volume at first desire (177.8 [9.2] vs 171.8 [7.7]), maximum cystometric capacity (304 [17.6] vs 290 [13.1]), and Qmax (mL/sec) (20.7 [1.6] vs 22.2 [1.2]).

Adverse events. Average PVR urine volumes were higher in the onabotulinumtoxinA group compared with the PTNS group (36.8 [2.7] vs 32.4 [3.03]; P = .0001) at all time points, and self-catheterization was required in 6.6% of onabotulinumtoxinA-treated participants. Urinary tract infection occurred in 6.6% of participants in the onabotulinumtoxinA group and in none of the PTNS group. In the PTNS group, few experienced pain and minor bleeding at the needle site.

Strengths and limitations. This randomized, open-label trial comparing treatment with onabotulinumtoxinA 100 U and PTNS included both men and women with idiopathic OAB symptoms. The participants were assessed at regular intervals with various measures, and follow-up adherence was good. The sample size was small, so the study may not have been powered to see differences prior to 9 months.

Although at 9 months only the onabotulinumtoxinA group maintained significant improvement over baseline levels, the improvement was diminished, and therefore the clinical meaningfulness is uncertain. Further, participants in the PTNS group did not undergo monthly maintenance therapy after 3 months, which is recommended for those with a 12-week therapeutic response; this may have affected 9-month outcomes in this group. Since the one-time onabotulinumtoxinA 100 U injection was performed under spinal anesthesia, cost comparisons should be considered, since future onabotulinumtoxinA injections would be necessary. 

Read about using different doses of onabotulinumtoxinA for OAB.

OnabotulinumtoxinA 200-U injection provides longer OAB symptom  improvement than 100-U injection

Abdelwahab O, Sherif H, Soliman T, Elbarky I, Eshazly A. Efficacy of botulinum toxin type A 100 units versus 200 units for treatment of refractory idiopathic overactive bladder. Int Braz J Urol. 2015;41(6):1132-1140.

Abdelwahab and colleagues conducted a single-center, randomized clinical trial to investigate the safety and efficacy of a single injection of intradetrusor onabotulinumtoxinA in 2 different doses (100 U and 200 U) for treatment of OAB.

Details of the study

Eighty adults (63 women, 17 men) who did not benefit from anticholinergic medication during the previous 3 months were randomly assigned to receive either a 100-U (n = 40) or a 200-U (n = 40) injection of onabotulinumtoxinA. Exclusion criteria were PVR urine volume greater than 150 mL and previous radiation therapy or chemotherapy.

Initial assessments -- completed at baseline and at 1, 3, 6, and 9 months -- included the health-related quality-of-life (HR-QOL) questionnaire (maximum score, 100; higher score indicates better quality of life), an abbreviated OABSS questionnaire (4 questions; score range, 0-15; higher score indicates more severe symptoms), and urodynamic evaluation. Outcomes included OABSS, HR-QOL score, and urodynamic parameters at the various time points.

Related article:
Is there a link between impaired mobility and urinary incontinence in elderly, community-dwelling women?

Higher dose, greater symptom improvement and higher adverse event rate

At baseline, participants (average age, 31 years) had an average (SD) OABSS of 1.7 (1.6). OnabotulinumtoxinA treatment with both a 100-U and a 200-U dose resulted in significant improvements (compared with baseline levels) in frequency, nocturia, UUI episodes, OABSS, and urodynamic parameters throughout the 9 months. At 9 months, however, the group treated with the 200-U dose had greater improvements, compared with the group who received a 100-U dose, in urinary frequency symptom scores (mean [SD], 0.32 [0.47] vs 1.1 [0.51]; P<.05), nocturia symptom scores (mean [SD], 0.13 [0.34] vs 0.36 [0.49]; P<.05), UUI symptom scores (mean [SD], 0.68 [0.16] vs 1.26 [1.1]; P<.05), and mean (SD) total OABSS (2.6 [2.31] vs 5.3 [2.11]; P<.05). Similarly, at 9 months the 200-U dose resulted in greater improvements in volume at first desire (mean [SD], 291.8 [42.8] vs 246.8 [53.8] mL; P<.05), volume at strong desire (mean [SD], 392.1 [37.3] vs 313.1 [67.4] mL; P<.05), detrusor pressure (mean [SD], 10.4 [4.0] vs 19.2 [7.8] cm H₂O; P<.05), and maximum cystometric capacity (mean [SD], 430.5 [34.2] vs 350 [69.1] mL; P<.05) compared with the 100-U dose.

Adverse events. No participant had a PVR urine volume greater than 100 mL at any follow-up visit. Postoperative hematuria occurred in 23% of the group treated with onabotulinumtoxinA 200 U versus in 15% of those treated with a 100-U dose. Similarly, UTIs occurred in 17.5% of the 200-U dose group and in 7.5% of the 100-U dose group. Dysuria was reported in 37.5% and 15% of the 200-U and 100-U dose groups, respectively.

Strengths and limitations. This randomized, open-label trial comparing a single injection of 100 U versus 200 U of onabotulinumtoxinA included mostly women. OAB symptoms and urodynamic parameters improved after treatment with both dose levels, but a longer duration of improvement was seen with the 200-U dose. The cohort had a low baseline OAB severity, based on the OABSS questionnaire, and a young average age of participants, which limits the generalizability of the study results to a population with refractory OAB. The 0% rate of clean intermittent self-catheterization postinjection might be based on the study's criteria for requiring clean intermittent catheterization. In addition, the initial postinjection visit occurred at 1 month, possibly missing participants who had symptoms of retention soon after injection.

Read: onabotulinumtoxinA vs sacral neuromodulation therapy for UUI.

Treatment with onabotulinumtoxinA may control UUI symptoms better than sacral neuromodulation therapy

Amundsen CL, Richter HE, Menefee SA, et al; Pelvic Floor Disorders Network. OnabotulinumtoxinA vs sacral neuromodulation on refractory urgency urinary incontinence in women: a randomized clinical trial. JAMA. 2016;316(13):1366-1374.

In this multicenter open-label randomized trial, Amundsen and colleagues compared the efficacy and safety of onabotulinumtoxinA 200 U with that of sacral neuromodulation.

Details of the study

Three hundred sixty-four women with UUI had data available for primary analysis at  6 months. Women were considered eligible for the study if they had 6 or more UUI episodes on a 3-day bladder diary, persistent symptoms despite anticholinergic therapy, a PVR urine volume of less than 150 mL, and had never previously received either study treatment.

There were no differences in baseline characteristics of the participants. The average (SD) age of the study population was 63 (11.6) years, with an average (SD) daily number of UUI episodes of 5.3 (2.8). The average (SD) body mass index was 32 (8) kg/m².

Participants were randomly assigned to undergo either sacral neuromodulation (n = 174) or intradetrusor injection of onabotulinumtoxinA 200 U (n = 190). The primary outcome was change from baseline in mean number of daily UUI episodes averaged over 6 months as recorded on a monthly 3-day bladder diary. Secondary outcomes included complete resolution of urgency incontinence, 75% or more reduction in UUI episodes, the Overactive Bladder Questionnaire Short Form (SF) score (range, 0-100; higher score indicates higher symptom severity), the Overactive Bladder Satisfaction of Treatment questionnaire (range, 0-100; higher score indicates better satisfaction), other quality-of-life measures, and adverse events.

Related article:
2015 Update on pelvic floor dysfunction: Bladder pain syndrome

Greater symptom bother improvement, treatment satisfaction with onabotulinumtoxinA 200 U

Participants treated with onabotulinumtoxinA had a greater mean reduction of 3.9 UUI episodes per day than the sacral neuromodulation group's reduction of 3.3 UUI episodes per day (mean difference, 0.63; 95% confidence interval [CI], 0.13-1.14; P = .01). In addition, complete UUI resolution was higher in the onabotulinumtoxinA group as compared with the sacral neuromodulation group (20% vs 4%; P<.001). The onabotulinumtoxinA group also had higher rates of 75% or more reduction of UUI episodes compared with the sacral neuromodulation group (46% vs 26%; P<.001). Over 6 months, both groups had improvements in all quality-of-life measures, but the onabotulinumtoxinA group had greater improvement in symptom bother compared with the sacral neuromodulation group (-46.7 vs -38.6; mean difference, 8.1; 95% CI, 3.0-13.3; P = .002). Furthermore, the onabotulinumtoxinA group had greater treatment satisfaction compared with the sacral neuromodulation group (mean difference, 7.8; 95% CI, 1.6-14.1; P = .01).

Adverse events. Six women (3%) underwent sacral neuromodulation device revision or removal. Approximately 8% of onabotulinumtoxinA-treated participants required intermittent self-catheterization at 1 month, 4% at 3 months, and 2% at 6 months. The risk of UTI was higher in the onabotulinumtoxinA group compared with the sacral neuromodulation group (35% vs 11%; risk difference, 23%; 95% CI, -33% to -13%; P<.001).

Strengths and limitations. This is a well-designed randomized clinical trial comparing clinical outcomes and adverse events after treatment with onabotulinumtoxinA 200-U versus sacral neuromodulation. The interventions were standardized across investigators at multiple sites, and the study design required close follow-up to assess efficacy and adverse events. The study used a 200-U dose based on reported durability of effect at that time and findings of equivalency between onabotulinumtoxinA 100 U and anticholinergic therapy. The US Food and Drug Administration's recommendation to use a 100-U dose in all patients with idiopathic OAB might dissuade clinicians from considering the higher dose of onabotulinumtoxinA. The study was limited by the lack of a placebo group.

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

The International Continence Society (ICS) defines overactive bladder (OAB) as a syndrome of "urinary urgency, usually accompanied by frequency and nocturia, with or without urgency urinary incontinence (UUI), in the absence of urinary tract infection [UTI] or obvious pathology."¹ The Agency for Healthcare Research and Quality (AHRQ) reported OAB prevalence to be 15% in US women, with 11% reporting UUI.² OAB represents a significant health care burden that impacts nearly every aspect of life, including physical, emotional, and psychological domains.^3,4 The economic impact is notable; the projected cost is estimated to reach $82.6 billion annually by 2020.⁵

The American Urological Association (AUA) and the Society for Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction (SUFU) have endorsed an algorithm for use in the evaluation of idiopathic OAB (FIGURE).⁶ If the patient's symptoms are certain, minimal evaluation is needed and it is reasonable to proceed with first-line therapy, which includes fluid management (decreasing caffeine intake and limiting evening fluid intake), bladder retraining drills such as timed voiding, and improving pelvic floor muscles with the use of biofeedback and functional electrical stimulation.^6,7 Pelvic floor muscle training can be facilitated with a referral to a physical therapist trained in pelvic floor muscle education.

If treatment goals are not met with first-line strategies, second-line therapy may be initiated with anticholinergic or β3-adrenergic receptor agonist medications. If symptoms persist after 4 to 8 weeks of pharmacologic therapy, clinicians are encouraged to reassess or refer the patient to a specialist. Further evaluation may include a bladder diary in which the patient documents voided volumes, voiding frequency, and number of incontinent episodes; symptom-specific questionnaires; and/or urodynamic testing.

Related article:
The latest treatments for urinary and fecal incontinence: Which hold water?

Based on that evaluation, the patient may be a candidate for third-line therapy with either intradetrusor onabotulinumtoxinA, posterior tibial nerve stimulation (PTNS), or sacral neuromodulation.

There is a paucity of information comparing third-line therapies. In this Update, we focus on 4 randomized clinical trials that compare third-line treatment options for idiopathic OAB.

Read about how anticholinergic medication and onabotulinumtoxinA compare for treating UUI.

Anticholinergic therapy and onabotulinumtoxinA produce equivalent reductions in the frequency of daily UUI episodes

Visco AG, Brubaker L, Richter HE, et al; for the Pelvic Floor Disorders Network. Anticholinergic therapy vs onabotulinumtoxinA for urgency urinary incontinence. N Engl J Med. 2012;367(19):1803-1813.

In a double-blind, double-placebo-controlled randomized trial, Visco and colleagues compared anticholinergic medication with onabotulinumtoxinA 100 U for the treatment of women with UUI.

Details of the study

Two hundred forty-one women with moderate to severe UUI received either 6 months of oral anticholinergic therapy (solifenacin 5 mg daily with the option of dose escalation to 10 mg daily or change to trospium XR 60 mg daily based on the Patient Global Symptom Control score) plus a single intradetrusor injection of saline, or a single intradetrusor injection of onabotulinumtoxinA 100 U plus a 6-month oral placebo regimen.

Inclusion criteria were 5 or more UUI episodes on a 3-day diary, insufficient resolution of symptoms after 2 medications, or being drug naive. Exclusions included a postvoid residual (PVR) urine volume greater than 150 mL or previous therapy with onabotulinumtoxinA.

Participants were scheduled for follow up every 2 to 6 months post randomization, at which time all study medications were discontinued. The primary outcome was reduction from baseline in the mean number of UUI episodes per day over the 6-month period, as recorded in the monthly 3-day bladder diaries. Secondary outcomes included the proportion of participants with complete resolution of UUI, the proportion of participants with 75% or more reduction in UUI episodes, Overactive Bladder Questionnaire Short Form (OABq-SF) scores, other symptom-specific questionnaire scores, and adverse events.

Related article:
Which treatments for pelvic floor disorders are backed by evidence?

Both treatments significantly reduced UUI episodes

At baseline, participants reported a mean (SD) of 5.0 (2.7) UUI episodes per day, and 41% of participants were drug naive. Both treatment groups experienced significant reductions compared with baseline in mean UUI episodes, and the reductions were similar between the 2 groups (reduction of 3.4 episodes per day in the anticholinergic group, reduction of 3.3 episodes in the onabotulinumtoxinA group; P = .81). Complete resolution of UUI was more common in the onabotulinumtoxinA group (27%) as compared with the anticholinergic group (13%) (P = .003). There were no differences in improvement in OABq-SF scores (37.05 in the anticholinergic group vs 37.13 in the onabotulinumtoxinA group; P = .98) or other quality-of-life measures.

Adverse events. The anticholinergic group experienced a higher rate of dry mouth compared with the onabotulinumtoxinA group (46% vs 31%; P = .02) but had lower rates of intermittent catheterization use at 2 months (0% vs 5%, P = .01) and UTIs (13% vs 33%, P<.001).

Strengths and limitations. This was a well-designed, multicenter, randomized double-blind, double placebo-controlled trial. The study design allowed for dose escalation and change to another medication for inadequate symptom control and included drug-naive participants, which increases the generalizability of the results. However, current guidelines recommend reserving onabotulinumtoxinA therapy for third-line therapy, thus deterring this treatment's use in the drug-naive population. Additionally, the lack of a pure placebo arm makes it difficult to interpret the extent to which a placebo effect contributed to observed improvements in clinical symptoms.

Read: onabotulinumtoxinA vs PTNS for OAB.

OnabotulinumtoxinA has greater 9-month durability for OAB symptoms compared with12 weeks of PTNS

Sherif H, Khalil M, Omar R. Management of refractory idiopathic overactive bladder: intradetrusor injection of botulinum toxin type A versus posterior tibial nerve stimulation. Can J Urol. 2017;24(3):8838-8846.

In this randomized clinical trial, Sherif and colleagues compared the safety and efficacy of a single intradetrusor injection of onabotulinumtoxinA 100 U with that of PTNS for OAB.

Details of the study

Sixty adult men and women with OAB who did not respond to medical therapy were randomly assigned to treatment with either onabotulinumtoxinA 100 U or PTNS. Criteria for exclusion were current UTI, PVR urine volume of more than 150 mL, previous radiation therapy or chemotherapy, previous incontinence surgery or bladder malignancy, or presence of mixed urinary incontinence.

At baseline, participants completed a 3-day bladder diary, an OAB symptom score (OABSS) questionnaire, and urodynamic testing. The OABSS questionnaire included 7 questions (scoring range, 0-28), with higher scores indicating worse symptoms, and included subscales for urgency and quality-of-life measures. Total OABSS, urgency score, quality-of-life score, bladder diary records, and urodynamic testing parameters were assessed at 6, 12, 24, and 36 weeks, along with adverse events.

OnabotulinumtoxinA injections were performed under spinal anesthesia. If PVR urine volume was greater than 200 mL at any follow-up visit, participants were instructed to begin clean intermittent self-catheterization. PTNS was administered as weekly 30-minute sessions for 12 consecutive weeks.

Participants' baseline demographics and symptoms were similar. Average age was 45 years. Averages (SD) for duration of anticholinergic use was 13 (0.8) weeks, UUI episode score was 4.5 (1) on 3-day bladder diary, and OABSS was 22 (2.7). Nine-month data were available for 29 participants in the onabotulinumtoxinA group and for 8 in the PTNS group.

Related article:
Update on pelvic floor dysfunction: Focus on urinary incontinence

OnabotulinumtoxinA treatment benefits sustained for 9 months

Through 6 months, compared with baseline assessments, both treatment groups had significant improvements in clinical symptoms and OABSS total score, as well as urgency and quality-of-life subscales. At 3 months, urodynamic study parameters were similarly improved from baseline in both groups.

At 9 months, however, only the onabotulinumtoxinA group, compared with the PTNS group, maintained the significant improvement from baseline in 3-day bladder diary voiding episodes (average [SD], 10.7 [1.01] vs 11.6 [1.09]; P = .009), 3-day bladder diary nocturia episodes (average [SD], 3.8 [1.09] vs 4.4 [0.8]; P = .02), and average [SD] UUI episodes over 3 days (3.5 [1.2] vs 4.2 [1.04]; P = .02). Similarly, onabotulinumtoxinA-treated participants, compared with those treated with PTNS, maintained improvements at 9 months in average (SD): OABSS total score (19.2 [2.4] vs 20.4 [1.7]; P = .03), urgency scores (10.9 [1.3] vs 11.8 [1.4]; P = .009), urine volume at first desire (177.8 [9.2] vs 171.8 [7.7]), maximum cystometric capacity (304 [17.6] vs 290 [13.1]), and Qmax (mL/sec) (20.7 [1.6] vs 22.2 [1.2]).

Adverse events. Average PVR urine volumes were higher in the onabotulinumtoxinA group compared with the PTNS group (36.8 [2.7] vs 32.4 [3.03]; P = .0001) at all time points, and self-catheterization was required in 6.6% of onabotulinumtoxinA-treated participants. Urinary tract infection occurred in 6.6% of participants in the onabotulinumtoxinA group and in none of the PTNS group. In the PTNS group, few experienced pain and minor bleeding at the needle site.

Strengths and limitations. This randomized, open-label trial comparing treatment with onabotulinumtoxinA 100 U and PTNS included both men and women with idiopathic OAB symptoms. The participants were assessed at regular intervals with various measures, and follow-up adherence was good. The sample size was small, so the study may not have been powered to see differences prior to 9 months.

Although at 9 months only the onabotulinumtoxinA group maintained significant improvement over baseline levels, the improvement was diminished, and therefore the clinical meaningfulness is uncertain. Further, participants in the PTNS group did not undergo monthly maintenance therapy after 3 months, which is recommended for those with a 12-week therapeutic response; this may have affected 9-month outcomes in this group. Since the one-time onabotulinumtoxinA 100 U injection was performed under spinal anesthesia, cost comparisons should be considered, since future onabotulinumtoxinA injections would be necessary. 

Read about using different doses of onabotulinumtoxinA for OAB.

OnabotulinumtoxinA 200-U injection provides longer OAB symptom  improvement than 100-U injection

Abdelwahab O, Sherif H, Soliman T, Elbarky I, Eshazly A. Efficacy of botulinum toxin type A 100 units versus 200 units for treatment of refractory idiopathic overactive bladder. Int Braz J Urol. 2015;41(6):1132-1140.

Abdelwahab and colleagues conducted a single-center, randomized clinical trial to investigate the safety and efficacy of a single injection of intradetrusor onabotulinumtoxinA in 2 different doses (100 U and 200 U) for treatment of OAB.

Details of the study

Eighty adults (63 women, 17 men) who did not benefit from anticholinergic medication during the previous 3 months were randomly assigned to receive either a 100-U (n = 40) or a 200-U (n = 40) injection of onabotulinumtoxinA. Exclusion criteria were PVR urine volume greater than 150 mL and previous radiation therapy or chemotherapy.

Initial assessments -- completed at baseline and at 1, 3, 6, and 9 months -- included the health-related quality-of-life (HR-QOL) questionnaire (maximum score, 100; higher score indicates better quality of life), an abbreviated OABSS questionnaire (4 questions; score range, 0-15; higher score indicates more severe symptoms), and urodynamic evaluation. Outcomes included OABSS, HR-QOL score, and urodynamic parameters at the various time points.

Related article:
Is there a link between impaired mobility and urinary incontinence in elderly, community-dwelling women?

Higher dose, greater symptom improvement and higher adverse event rate

At baseline, participants (average age, 31 years) had an average (SD) OABSS of 1.7 (1.6). OnabotulinumtoxinA treatment with both a 100-U and a 200-U dose resulted in significant improvements (compared with baseline levels) in frequency, nocturia, UUI episodes, OABSS, and urodynamic parameters throughout the 9 months. At 9 months, however, the group treated with the 200-U dose had greater improvements, compared with the group who received a 100-U dose, in urinary frequency symptom scores (mean [SD], 0.32 [0.47] vs 1.1 [0.51]; P<.05), nocturia symptom scores (mean [SD], 0.13 [0.34] vs 0.36 [0.49]; P<.05), UUI symptom scores (mean [SD], 0.68 [0.16] vs 1.26 [1.1]; P<.05), and mean (SD) total OABSS (2.6 [2.31] vs 5.3 [2.11]; P<.05). Similarly, at 9 months the 200-U dose resulted in greater improvements in volume at first desire (mean [SD], 291.8 [42.8] vs 246.8 [53.8] mL; P<.05), volume at strong desire (mean [SD], 392.1 [37.3] vs 313.1 [67.4] mL; P<.05), detrusor pressure (mean [SD], 10.4 [4.0] vs 19.2 [7.8] cm H₂O; P<.05), and maximum cystometric capacity (mean [SD], 430.5 [34.2] vs 350 [69.1] mL; P<.05) compared with the 100-U dose.

Adverse events. No participant had a PVR urine volume greater than 100 mL at any follow-up visit. Postoperative hematuria occurred in 23% of the group treated with onabotulinumtoxinA 200 U versus in 15% of those treated with a 100-U dose. Similarly, UTIs occurred in 17.5% of the 200-U dose group and in 7.5% of the 100-U dose group. Dysuria was reported in 37.5% and 15% of the 200-U and 100-U dose groups, respectively.

Strengths and limitations. This randomized, open-label trial comparing a single injection of 100 U versus 200 U of onabotulinumtoxinA included mostly women. OAB symptoms and urodynamic parameters improved after treatment with both dose levels, but a longer duration of improvement was seen with the 200-U dose. The cohort had a low baseline OAB severity, based on the OABSS questionnaire, and a young average age of participants, which limits the generalizability of the study results to a population with refractory OAB. The 0% rate of clean intermittent self-catheterization postinjection might be based on the study's criteria for requiring clean intermittent catheterization. In addition, the initial postinjection visit occurred at 1 month, possibly missing participants who had symptoms of retention soon after injection.

Read: onabotulinumtoxinA vs sacral neuromodulation therapy for UUI.

Treatment with onabotulinumtoxinA may control UUI symptoms better than sacral neuromodulation therapy

Amundsen CL, Richter HE, Menefee SA, et al; Pelvic Floor Disorders Network. OnabotulinumtoxinA vs sacral neuromodulation on refractory urgency urinary incontinence in women: a randomized clinical trial. JAMA. 2016;316(13):1366-1374.

In this multicenter open-label randomized trial, Amundsen and colleagues compared the efficacy and safety of onabotulinumtoxinA 200 U with that of sacral neuromodulation.

Details of the study

Three hundred sixty-four women with UUI had data available for primary analysis at  6 months. Women were considered eligible for the study if they had 6 or more UUI episodes on a 3-day bladder diary, persistent symptoms despite anticholinergic therapy, a PVR urine volume of less than 150 mL, and had never previously received either study treatment.

There were no differences in baseline characteristics of the participants. The average (SD) age of the study population was 63 (11.6) years, with an average (SD) daily number of UUI episodes of 5.3 (2.8). The average (SD) body mass index was 32 (8) kg/m².

Participants were randomly assigned to undergo either sacral neuromodulation (n = 174) or intradetrusor injection of onabotulinumtoxinA 200 U (n = 190). The primary outcome was change from baseline in mean number of daily UUI episodes averaged over 6 months as recorded on a monthly 3-day bladder diary. Secondary outcomes included complete resolution of urgency incontinence, 75% or more reduction in UUI episodes, the Overactive Bladder Questionnaire Short Form (SF) score (range, 0-100; higher score indicates higher symptom severity), the Overactive Bladder Satisfaction of Treatment questionnaire (range, 0-100; higher score indicates better satisfaction), other quality-of-life measures, and adverse events.

Related article:
2015 Update on pelvic floor dysfunction: Bladder pain syndrome

Greater symptom bother improvement, treatment satisfaction with onabotulinumtoxinA 200 U

Participants treated with onabotulinumtoxinA had a greater mean reduction of 3.9 UUI episodes per day than the sacral neuromodulation group's reduction of 3.3 UUI episodes per day (mean difference, 0.63; 95% confidence interval [CI], 0.13-1.14; P = .01). In addition, complete UUI resolution was higher in the onabotulinumtoxinA group as compared with the sacral neuromodulation group (20% vs 4%; P<.001). The onabotulinumtoxinA group also had higher rates of 75% or more reduction of UUI episodes compared with the sacral neuromodulation group (46% vs 26%; P<.001). Over 6 months, both groups had improvements in all quality-of-life measures, but the onabotulinumtoxinA group had greater improvement in symptom bother compared with the sacral neuromodulation group (-46.7 vs -38.6; mean difference, 8.1; 95% CI, 3.0-13.3; P = .002). Furthermore, the onabotulinumtoxinA group had greater treatment satisfaction compared with the sacral neuromodulation group (mean difference, 7.8; 95% CI, 1.6-14.1; P = .01).

Adverse events. Six women (3%) underwent sacral neuromodulation device revision or removal. Approximately 8% of onabotulinumtoxinA-treated participants required intermittent self-catheterization at 1 month, 4% at 3 months, and 2% at 6 months. The risk of UTI was higher in the onabotulinumtoxinA group compared with the sacral neuromodulation group (35% vs 11%; risk difference, 23%; 95% CI, -33% to -13%; P<.001).

Strengths and limitations. This is a well-designed randomized clinical trial comparing clinical outcomes and adverse events after treatment with onabotulinumtoxinA 200-U versus sacral neuromodulation. The interventions were standardized across investigators at multiple sites, and the study design required close follow-up to assess efficacy and adverse events. The study used a 200-U dose based on reported durability of effect at that time and findings of equivalency between onabotulinumtoxinA 100 U and anticholinergic therapy. The US Food and Drug Administration's recommendation to use a 100-U dose in all patients with idiopathic OAB might dissuade clinicians from considering the higher dose of onabotulinumtoxinA. The study was limited by the lack of a placebo group.

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

The final session of the course opened with Uri Ladabaum, MD, entertaining the question “Colon cancer screening and surveillance: who, when, and how?” Dr. Ladabaum pointed out that there is consensus that colorectal cancer screening for average-risk individuals should begin at age 50 with a choice of modalities and that surveillance depends on the findings on each colonoscopy. He reviewed the evidence for screening modalities and for surveillance and offered perspectives on the role of the gastroenterologist/colonoscopist in the quality of colonsocopy. Douglas K. Rex, MD, AGAF followed by asking “Does every big polyp need EMR?” Dr. Rex discussed the available approaches to the large colonic polyp, including endoscopic mucosal resection, endoscopic submucosal dissection, and surgery. He provided evidence for the advantages and expanded use of EMR, with the conclusion that almost every large benign polyp needs EMR.

This is a summary provided by the moderator of one of the AGA Postgraduate Courses held at DDW 2017. Dr. Cohen is the chief of the division of gastroenterology and hepatology in the Weill department of medicine, New York–Presbyterian Hospital Center, New York.

The final session of the course opened with Uri Ladabaum, MD, entertaining the question “Colon cancer screening and surveillance: who, when, and how?” Dr. Ladabaum pointed out that there is consensus that colorectal cancer screening for average-risk individuals should begin at age 50 with a choice of modalities and that surveillance depends on the findings on each colonoscopy. He reviewed the evidence for screening modalities and for surveillance and offered perspectives on the role of the gastroenterologist/colonoscopist in the quality of colonsocopy. Douglas K. Rex, MD, AGAF followed by asking “Does every big polyp need EMR?” Dr. Rex discussed the available approaches to the large colonic polyp, including endoscopic mucosal resection, endoscopic submucosal dissection, and surgery. He provided evidence for the advantages and expanded use of EMR, with the conclusion that almost every large benign polyp needs EMR.

This is a summary provided by the moderator of one of the AGA Postgraduate Courses held at DDW 2017. Dr. Cohen is the chief of the division of gastroenterology and hepatology in the Weill department of medicine, New York–Presbyterian Hospital Center, New York.

The final session of the course opened with Uri Ladabaum, MD, entertaining the question “Colon cancer screening and surveillance: who, when, and how?” Dr. Ladabaum pointed out that there is consensus that colorectal cancer screening for average-risk individuals should begin at age 50 with a choice of modalities and that surveillance depends on the findings on each colonoscopy. He reviewed the evidence for screening modalities and for surveillance and offered perspectives on the role of the gastroenterologist/colonoscopist in the quality of colonsocopy. Douglas K. Rex, MD, AGAF followed by asking “Does every big polyp need EMR?” Dr. Rex discussed the available approaches to the large colonic polyp, including endoscopic mucosal resection, endoscopic submucosal dissection, and surgery. He provided evidence for the advantages and expanded use of EMR, with the conclusion that almost every large benign polyp needs EMR.

This is a summary provided by the moderator of one of the AGA Postgraduate Courses held at DDW 2017. Dr. Cohen is the chief of the division of gastroenterology and hepatology in the Weill department of medicine, New York–Presbyterian Hospital Center, New York.

Clinical question: Is hospital acquired anemia associated with increased postdischarge adverse outcomes?

Background: Hospital acquired anemia (HAA) is defined as the development of anemia during the course of a hospitalization when starting with a normal hemoglobin on admission. The incidence of HAA is at least 25% when using the last hemoglobin prior to discharge as the index value. HAA is felt to be potentially preventable and usually iatrogenic due to phlebotomy.

Dr. Newsom is a hospitalist at Ochsner Health System, New Orleans.

Clinical question: Is hospital acquired anemia associated with increased postdischarge adverse outcomes?

Background: Hospital acquired anemia (HAA) is defined as the development of anemia during the course of a hospitalization when starting with a normal hemoglobin on admission. The incidence of HAA is at least 25% when using the last hemoglobin prior to discharge as the index value. HAA is felt to be potentially preventable and usually iatrogenic due to phlebotomy.

Dr. Newsom is a hospitalist at Ochsner Health System, New Orleans.

Clinical question: Is hospital acquired anemia associated with increased postdischarge adverse outcomes?

Background: Hospital acquired anemia (HAA) is defined as the development of anemia during the course of a hospitalization when starting with a normal hemoglobin on admission. The incidence of HAA is at least 25% when using the last hemoglobin prior to discharge as the index value. HAA is felt to be potentially preventable and usually iatrogenic due to phlebotomy.

Dr. Newsom is a hospitalist at Ochsner Health System, New Orleans.

Biotin supplementation showed signs of interference with biotinylated assays in a crossover trial.

The proposed benefits of biotin (vitamin B₇), including stimulating hair growth and assisting in the treatment of various forms of diabetes, have made it a popular supplement. Supplementation generally leads to artificially high levels of biotin, which was shown to cause inaccurate results in biotinylated assays, according to Danni Li, PhD, of the advanced research and diagnostic laboratory at the University of Minnesota, Minneapolis, and her colleagues.

They analyzed the results of both biotinylated and nonbiotinylated assays of six patients – two women and four men – who ingested 10 mg/day of biotin supplement for 7 days. Two blood samples were obtained in the course of the study: one prior to starting biotin supplementation as a baseline and one a week ofter biotin supplementation had ended. The assays tested the presence of nine hormones and two nonhormones using multiple diagnostic systems to run the assays. In total, 37 immunoassays were conducted on each sample (JAMA. 2017;318[12]:1150-60. doi: 10.1001/jama.2017.13705).

Two immunoassay testing techniques were used in the diagnostic assays. The sandwich technique was used in testing TSH, parathyroid hormone (PTH), prolactin, N-terminal pro-brain natriuretic peptide (NT-proBNP), PSA, and ferritin and competitive technique was used in testing total T₄, total T₃, free T₄, free T₃, and 25-OHD. In assays utilizing competitive techniques, false highs were reported in three Roche cobas e602 machines and one Siemens Vista Dimension 1500 machine.

Assays utilizing the sandwich technique experienced false decreases in TSH, PTH, and NT-proBNP when compared with baseline measurements in Roche cobas e602 and OCD Vitros 5600 machines. A predominance of the falsely low results were present in the assays conducted by the OCD Vitros machine, with significant changes from baseline measurements. TSH experienced a 94% decrease of 1.67 mIU/L, PTH experienced a 61% decrease of 25.8 pg/mL, and NT-proBNP falsely decreased by more than 13.9 pg/mL. In Roche cobas e602 assays, TSH levels were falsely low and measurements decreased by 0.72 mIU/L (37%) when compared with baseline measurements.

Biotin did not interfere in all biotinylated assays and was only observed in 9 of the 23 (39%) of the assays conducted. Specifically, 4 of 15 (27%) sandwich immunoassays were falsely decreased while five of eight (63%) competitive binding assays were falsely increased.

“Among the 23 biotinylated assays studied, biotin interference was of greatest clinical significance in the OCD Vitros TSH assay, where falsely decreased TSH concentrations (to less than 0.15 mU/L) could have resulted in misdiagnosis of thyrotoxicosis in otherwise euthyroid individuals,” according to Dr. Li and her associates, “Likewise, falsely decreased OCD Vitros NT-proBNP, to lower than assay detection limits, could possibly result in failure to identify congestive heart failure.”

One investigator received funding and nonfinanical support from Siemens Healthcare Diagnostics, one reported receiving financial support from Abbott Laboratories, and another reported receiving personal fees from Roche and Abbott Laboratories. Dr. Li and the other researchers had no relevant financial disclosures.

[email protected]

Biotin supplementation showed signs of interference with biotinylated assays in a crossover trial.

The proposed benefits of biotin (vitamin B₇), including stimulating hair growth and assisting in the treatment of various forms of diabetes, have made it a popular supplement. Supplementation generally leads to artificially high levels of biotin, which was shown to cause inaccurate results in biotinylated assays, according to Danni Li, PhD, of the advanced research and diagnostic laboratory at the University of Minnesota, Minneapolis, and her colleagues.

They analyzed the results of both biotinylated and nonbiotinylated assays of six patients – two women and four men – who ingested 10 mg/day of biotin supplement for 7 days. Two blood samples were obtained in the course of the study: one prior to starting biotin supplementation as a baseline and one a week ofter biotin supplementation had ended. The assays tested the presence of nine hormones and two nonhormones using multiple diagnostic systems to run the assays. In total, 37 immunoassays were conducted on each sample (JAMA. 2017;318[12]:1150-60. doi: 10.1001/jama.2017.13705).

Two immunoassay testing techniques were used in the diagnostic assays. The sandwich technique was used in testing TSH, parathyroid hormone (PTH), prolactin, N-terminal pro-brain natriuretic peptide (NT-proBNP), PSA, and ferritin and competitive technique was used in testing total T₄, total T₃, free T₄, free T₃, and 25-OHD. In assays utilizing competitive techniques, false highs were reported in three Roche cobas e602 machines and one Siemens Vista Dimension 1500 machine.

Assays utilizing the sandwich technique experienced false decreases in TSH, PTH, and NT-proBNP when compared with baseline measurements in Roche cobas e602 and OCD Vitros 5600 machines. A predominance of the falsely low results were present in the assays conducted by the OCD Vitros machine, with significant changes from baseline measurements. TSH experienced a 94% decrease of 1.67 mIU/L, PTH experienced a 61% decrease of 25.8 pg/mL, and NT-proBNP falsely decreased by more than 13.9 pg/mL. In Roche cobas e602 assays, TSH levels were falsely low and measurements decreased by 0.72 mIU/L (37%) when compared with baseline measurements.

Biotin did not interfere in all biotinylated assays and was only observed in 9 of the 23 (39%) of the assays conducted. Specifically, 4 of 15 (27%) sandwich immunoassays were falsely decreased while five of eight (63%) competitive binding assays were falsely increased.

“Among the 23 biotinylated assays studied, biotin interference was of greatest clinical significance in the OCD Vitros TSH assay, where falsely decreased TSH concentrations (to less than 0.15 mU/L) could have resulted in misdiagnosis of thyrotoxicosis in otherwise euthyroid individuals,” according to Dr. Li and her associates, “Likewise, falsely decreased OCD Vitros NT-proBNP, to lower than assay detection limits, could possibly result in failure to identify congestive heart failure.”

One investigator received funding and nonfinanical support from Siemens Healthcare Diagnostics, one reported receiving financial support from Abbott Laboratories, and another reported receiving personal fees from Roche and Abbott Laboratories. Dr. Li and the other researchers had no relevant financial disclosures.

[email protected]

Biotin supplementation showed signs of interference with biotinylated assays in a crossover trial.

The proposed benefits of biotin (vitamin B₇), including stimulating hair growth and assisting in the treatment of various forms of diabetes, have made it a popular supplement. Supplementation generally leads to artificially high levels of biotin, which was shown to cause inaccurate results in biotinylated assays, according to Danni Li, PhD, of the advanced research and diagnostic laboratory at the University of Minnesota, Minneapolis, and her colleagues.

They analyzed the results of both biotinylated and nonbiotinylated assays of six patients – two women and four men – who ingested 10 mg/day of biotin supplement for 7 days. Two blood samples were obtained in the course of the study: one prior to starting biotin supplementation as a baseline and one a week ofter biotin supplementation had ended. The assays tested the presence of nine hormones and two nonhormones using multiple diagnostic systems to run the assays. In total, 37 immunoassays were conducted on each sample (JAMA. 2017;318[12]:1150-60. doi: 10.1001/jama.2017.13705).

Two immunoassay testing techniques were used in the diagnostic assays. The sandwich technique was used in testing TSH, parathyroid hormone (PTH), prolactin, N-terminal pro-brain natriuretic peptide (NT-proBNP), PSA, and ferritin and competitive technique was used in testing total T₄, total T₃, free T₄, free T₃, and 25-OHD. In assays utilizing competitive techniques, false highs were reported in three Roche cobas e602 machines and one Siemens Vista Dimension 1500 machine.

Assays utilizing the sandwich technique experienced false decreases in TSH, PTH, and NT-proBNP when compared with baseline measurements in Roche cobas e602 and OCD Vitros 5600 machines. A predominance of the falsely low results were present in the assays conducted by the OCD Vitros machine, with significant changes from baseline measurements. TSH experienced a 94% decrease of 1.67 mIU/L, PTH experienced a 61% decrease of 25.8 pg/mL, and NT-proBNP falsely decreased by more than 13.9 pg/mL. In Roche cobas e602 assays, TSH levels were falsely low and measurements decreased by 0.72 mIU/L (37%) when compared with baseline measurements.

Biotin did not interfere in all biotinylated assays and was only observed in 9 of the 23 (39%) of the assays conducted. Specifically, 4 of 15 (27%) sandwich immunoassays were falsely decreased while five of eight (63%) competitive binding assays were falsely increased.

“Among the 23 biotinylated assays studied, biotin interference was of greatest clinical significance in the OCD Vitros TSH assay, where falsely decreased TSH concentrations (to less than 0.15 mU/L) could have resulted in misdiagnosis of thyrotoxicosis in otherwise euthyroid individuals,” according to Dr. Li and her associates, “Likewise, falsely decreased OCD Vitros NT-proBNP, to lower than assay detection limits, could possibly result in failure to identify congestive heart failure.”

One investigator received funding and nonfinanical support from Siemens Healthcare Diagnostics, one reported receiving financial support from Abbott Laboratories, and another reported receiving personal fees from Roche and Abbott Laboratories. Dr. Li and the other researchers had no relevant financial disclosures.

[email protected]

Uma Mahadevan, MD, AGAF, and I moderated this session on IBD, and we were fortunate enough to secure four of the best IBD educators in the AGA.

David Rubin, MD, AGAF, opened with “Selecting the correct therapy for your outpatients with IBD: From mesalamine to biologics.” Treatment goals have evolved from symptom control to remission based on measures of inflammation (e.g., serum C-reactive protein, fecal calprotectin, or endoscopy). For ulcerative colitis (UC), high-risk markers include extensive disease, deep ulcers, younger age at diagnosis, elevated biomarkers, and early need for steroids or hospitalization. For Crohn’s disease (CD), these include younger age, extensive involvement, and fistulizing disease. The 5-aminosalicylate drugs remain a backbone in mild to moderate UC. Judicious use of corticosteroids is reasonable, but we need an exit strategy. The thiopurines are decent drugs, but studies have called into question their efficacy as monotherapy, and safety issues persist. Methotrexate is underutilized. The anti–tumor necrosis factor (TNF) biologics are excellent therapies but controversies persist as to whether these drugs require combination therapy or if they can be managed as “optimized monotherapy” with therapeutic drug monitoring (TDM). There are now two infliximab biosimilars available in the U.S.. Vedolizumab is an efficacious gut-selective anti-integrin (for both CD and UC). Ustekinumab, an anti-IL-12/23 antibody, is now available for moderate to severe CD, and has a favorable safety profile.

This is a summary provided by the moderator of one of the AGA Postgraduate Courses held at DDW 2017. Dr. Loftus is a professor of medicine, division of gastroenterology and hepatology, Mayo Clinic, Rochester, Minn.

Uma Mahadevan, MD, AGAF, and I moderated this session on IBD, and we were fortunate enough to secure four of the best IBD educators in the AGA.

David Rubin, MD, AGAF, opened with “Selecting the correct therapy for your outpatients with IBD: From mesalamine to biologics.” Treatment goals have evolved from symptom control to remission based on measures of inflammation (e.g., serum C-reactive protein, fecal calprotectin, or endoscopy). For ulcerative colitis (UC), high-risk markers include extensive disease, deep ulcers, younger age at diagnosis, elevated biomarkers, and early need for steroids or hospitalization. For Crohn’s disease (CD), these include younger age, extensive involvement, and fistulizing disease. The 5-aminosalicylate drugs remain a backbone in mild to moderate UC. Judicious use of corticosteroids is reasonable, but we need an exit strategy. The thiopurines are decent drugs, but studies have called into question their efficacy as monotherapy, and safety issues persist. Methotrexate is underutilized. The anti–tumor necrosis factor (TNF) biologics are excellent therapies but controversies persist as to whether these drugs require combination therapy or if they can be managed as “optimized monotherapy” with therapeutic drug monitoring (TDM). There are now two infliximab biosimilars available in the U.S.. Vedolizumab is an efficacious gut-selective anti-integrin (for both CD and UC). Ustekinumab, an anti-IL-12/23 antibody, is now available for moderate to severe CD, and has a favorable safety profile.

This is a summary provided by the moderator of one of the AGA Postgraduate Courses held at DDW 2017. Dr. Loftus is a professor of medicine, division of gastroenterology and hepatology, Mayo Clinic, Rochester, Minn.

Uma Mahadevan, MD, AGAF, and I moderated this session on IBD, and we were fortunate enough to secure four of the best IBD educators in the AGA.

David Rubin, MD, AGAF, opened with “Selecting the correct therapy for your outpatients with IBD: From mesalamine to biologics.” Treatment goals have evolved from symptom control to remission based on measures of inflammation (e.g., serum C-reactive protein, fecal calprotectin, or endoscopy). For ulcerative colitis (UC), high-risk markers include extensive disease, deep ulcers, younger age at diagnosis, elevated biomarkers, and early need for steroids or hospitalization. For Crohn’s disease (CD), these include younger age, extensive involvement, and fistulizing disease. The 5-aminosalicylate drugs remain a backbone in mild to moderate UC. Judicious use of corticosteroids is reasonable, but we need an exit strategy. The thiopurines are decent drugs, but studies have called into question their efficacy as monotherapy, and safety issues persist. Methotrexate is underutilized. The anti–tumor necrosis factor (TNF) biologics are excellent therapies but controversies persist as to whether these drugs require combination therapy or if they can be managed as “optimized monotherapy” with therapeutic drug monitoring (TDM). There are now two infliximab biosimilars available in the U.S.. Vedolizumab is an efficacious gut-selective anti-integrin (for both CD and UC). Ustekinumab, an anti-IL-12/23 antibody, is now available for moderate to severe CD, and has a favorable safety profile.

This is a summary provided by the moderator of one of the AGA Postgraduate Courses held at DDW 2017. Dr. Loftus is a professor of medicine, division of gastroenterology and hepatology, Mayo Clinic, Rochester, Minn.

It is my privilege this month to assume responsibility for the “Practice Management: The Road Ahead” section of Clinical Gastroenterology and Hepatology. I am honored to join an impressive board of editors led by Dr Fasiha Kanwal, and anchored by global leaders in the field of gastroenterology and hepatology. This board of editors promises to continue the high level of excellence that has propelled the journal to its preeminent position among clinical journals. I am confident that the practice management section will uphold that tradition and continue to meet the expectation of our readers. I would like to mark this transition by acknowledging the history of the practice management section of Clinical Gastroenterology and Hepatology and outlining a vision for the future.

The section was introduced in 2010 under the leadership of Dr. Joel V. Brill. The section, titled “Practice Management: Opportunities and Challenges,” aimed to help practices navigate the disparate issues facing the field. Some of these issues included use of capnography in endoscopy, the importance of registries for quality reporting, and the burdens of meaningful use on physician practices. Dr Brill introduced this section in a video in May 2010 (https://www.youtube.com/watch?v=8FMsc2Wl5E8). Dr. Brill’s reference to these “interesting and challenging times” in gastroenterology resonates even more loudly today.

• • Governance and culture: The structure of health delivery systems, as conceptualized by Donabedian,¹³ is a key determinant of quality. Structural attributes include regulatory requirements on gastrointestinal practices, such as the rules governing use of anesthesia providers in ambulatory surgical settings; role of allied health professionals in clinical settings; and the impact of financial incentives in driving provider behavior.
• • Financial readiness: Value-based reimbursement, accountable care, medical homes, reference pricing, and physician tiering are some of the new terms in this era of value-based medicine. It is important for practices to assess patient costs longitudinally and manage financial risks. The Road Ahead section will continue to include papers that describe the impact of these reforms on gastroenterology and hepatology practices while providing guidance on implementation of these new models of care. Some examples include papers on the effect of payment policy on specialty practices, the development of a medical home in inflammatory bowel disease, and the physician experience with episode-based payments for colonoscopy.
• • Health information technology: All of the organizational competencies required for reform rely on a robust information technology platform that collects meaningful data and harnesses that data for analytic purposes. These platforms can be enterprise systems deployed by large health delivery systems or smaller, more nimble platforms, created by innovative start-up companies. The Road Ahead will include papers that share best practices in the use of these platforms to provide high-quality and cost-efficient care. In addition, the Road Ahead will continue to explore the use of health information technology to expand the reach of clinicians beyond brick and mortar clinics.
• • Patient risk assessment: Tailoring interventions to high-risk patients is necessary to deploy limited resources in a cost-effective manner. Risk assessment is also needed to more accurately and effectively personalize care for patients with chronic conditions. The Road Ahead will include papers that evaluate risk assessment tools and/or describe real-life implementation of these tools in different contexts.
• • Care coordination: The ability to provide team-based longitudinal care across the continuum of care will be integral to providing high value health care. The Road Ahead will serve as a means to disseminate best practices and innovative methods to care for increasingly complex patients, especially those with chronic diseases, such as cirrhosis and inflammatory bowel disease. For example, papers will explore the implementation of specialty medical homes, patient navigators, community-based care services, and involvement of patients in their own care.
• • Quality improvement: Providing high-value care by definition will require clinicians to accurately measure the quality of care provided to patients and use data to guide process improvement. The Road Ahead will continue to serve as an educational resource for clinicians with papers that discuss challenges and opportunities in quality measurement and improvement. Similarly, this section will present data on novel or impactful quality-improvement initiatives.
• • Patient centeredness: Patient experience measures and patient-reported outcomes are becoming increasingly important as meaningful indicators of quality. These measures are designed to ensure that patient perspectives are incorporated into the governance, design, and delivery of health care. The Road Ahead will serve as a dissemination mechanism for sharing best practices in developing, validating, implementing, and tracking patient-reported outcomes.

References

1. Allen, J.I. The road ahead. Clin Gastroenterol Hepatol. 2012;10:692-6.

2. Dorn, S.D., Vesy, C.J. Medicare’s revaluation of gastrointestinal endoscopic procedures: implications for academic and community-based practices. Clin Gastroenterol Hepatol. 2017;14:924-8.

3. Dorn, S.D. The road ahead 3.0: changing payments, changing practice. Clin Gastroenterol Hepatol. 2016;14:785-9.

4. Meier, S.K., Shah, N.D., Talwalkar, J.A. Adapting the patient-centered specialty practice model for populations with cirrhosis. Clin Gastroenterol Hepatol. 2016;14:492-6.

5. Mehta, S.J. Bundled payment for gastrointestinal hemorrhage. Clin Gastroenterol Hepatol. 2016;14:1681-4.

6. Weizman, A.V., Mosko, J., Bollegala, N., et al. Quality improvement primer series: launching a quality improvement initiative. Clin Gastroenterol Hepatol. 2017;14:1067-71.

7. Bernstein, M., Hou, J.K., Weizman, A.V., et al. Quality improvement primer series: how to sustain a quality improvement effort. Clin Gastroenterol Hepatol. 2017;14:1371-5.

8. Bollegala, N., Patel, K., Mosko, J.D., et al. Quality improvement primer series: the plan-do-study-act cycle and data display. Clin Gastroenterol Hepatol. 2016;14:1230-3.

9. Adams, M.A. Covert recording by patients of encounters with gastroenterology providers: path to empowerment or breach of trust?. Clin Gastroenterol Hepatol. 2017;15:13-6.

10. Oza, V.M., El-Dika, S., and Adams, M.A. Reaching safe harbor: legal implications of clinical practice guidelines. Clin Gastroenterol Hepatol. 2016;14:172-4.

11. Lin, M., Pappas, S.C., Sellin, J., et al. Curbside consultations: the good, the bad, and the ugly. Clin Gastroenterol Hepatol. 2016;14:2-4.

12. McClellan, M.B., Leavitt, M.O. Competencies and tools to shift payments from volume to value. JAMA. 2016; 316: 1655–1656

13. Donabedian, A. Evaluating the quality of medical care. Milbank Q. 1966;44:166-203.

14. Rosenberg, F.B., Kim, L.S., Ketover, S.R. Challenges facing independent integrated gastroenterology. Clin Gastroenterol Hepatol. 2017;15:335-8.

15. Leiman, D.A., Metz, D.C., Ginsberg, G.G., et al. A novel electronic medical record-based workflow to measure and report colonoscopy quality measures. Clin Gastroenterol Hepatol. 2016;14:333-7.

16. Cross, R.K., Kane, S. Integration of telemedicine into clinical gastroenterology and hepatology Practice. Clin Gastroenterol Hepatol. 2017;15:175-81.

17. Llor, X. Building a cancer genetics and prevention program. Clin Gastroenterol Hepatol. 2016;14:1516-20.

18. Patel, K.K., Cummings, S., Sellin, J., et al. Applying Lean design principles to a gastrointestinal endoscopy program for uninsured patients improves health care utilization. Clin Gastroenterol Hepatol. 2015;13:1556-9.

19. Saini, S.D., Adams, M.A., Brill, J.V., et al. Colorectal cancer screening quality measures: beyond colonoscopy. Clin Gastroenterol Hepatol. 2016;14:644-7.
 

Dr. Gellad is an associate professor of medicine in the division of gastroenterology at Durham VA Medical Center, Durham, N.C.; and Duke Clinical Research Institute, Durham, N.C. He reports a consulting relationship with Merck & Co. and he is also a cofounder and equity holder in Higgs Boson, LLC. He is funded by Veterans Affairs Health Services Research and Development Career Development Award (CDA 14-158 ).

It is my privilege this month to assume responsibility for the “Practice Management: The Road Ahead” section of Clinical Gastroenterology and Hepatology. I am honored to join an impressive board of editors led by Dr Fasiha Kanwal, and anchored by global leaders in the field of gastroenterology and hepatology. This board of editors promises to continue the high level of excellence that has propelled the journal to its preeminent position among clinical journals. I am confident that the practice management section will uphold that tradition and continue to meet the expectation of our readers. I would like to mark this transition by acknowledging the history of the practice management section of Clinical Gastroenterology and Hepatology and outlining a vision for the future.

The section was introduced in 2010 under the leadership of Dr. Joel V. Brill. The section, titled “Practice Management: Opportunities and Challenges,” aimed to help practices navigate the disparate issues facing the field. Some of these issues included use of capnography in endoscopy, the importance of registries for quality reporting, and the burdens of meaningful use on physician practices. Dr Brill introduced this section in a video in May 2010 (https://www.youtube.com/watch?v=8FMsc2Wl5E8). Dr. Brill’s reference to these “interesting and challenging times” in gastroenterology resonates even more loudly today.

• • Governance and culture: The structure of health delivery systems, as conceptualized by Donabedian,¹³ is a key determinant of quality. Structural attributes include regulatory requirements on gastrointestinal practices, such as the rules governing use of anesthesia providers in ambulatory surgical settings; role of allied health professionals in clinical settings; and the impact of financial incentives in driving provider behavior.
• • Financial readiness: Value-based reimbursement, accountable care, medical homes, reference pricing, and physician tiering are some of the new terms in this era of value-based medicine. It is important for practices to assess patient costs longitudinally and manage financial risks. The Road Ahead section will continue to include papers that describe the impact of these reforms on gastroenterology and hepatology practices while providing guidance on implementation of these new models of care. Some examples include papers on the effect of payment policy on specialty practices, the development of a medical home in inflammatory bowel disease, and the physician experience with episode-based payments for colonoscopy.
• • Health information technology: All of the organizational competencies required for reform rely on a robust information technology platform that collects meaningful data and harnesses that data for analytic purposes. These platforms can be enterprise systems deployed by large health delivery systems or smaller, more nimble platforms, created by innovative start-up companies. The Road Ahead will include papers that share best practices in the use of these platforms to provide high-quality and cost-efficient care. In addition, the Road Ahead will continue to explore the use of health information technology to expand the reach of clinicians beyond brick and mortar clinics.
• • Patient risk assessment: Tailoring interventions to high-risk patients is necessary to deploy limited resources in a cost-effective manner. Risk assessment is also needed to more accurately and effectively personalize care for patients with chronic conditions. The Road Ahead will include papers that evaluate risk assessment tools and/or describe real-life implementation of these tools in different contexts.
• • Care coordination: The ability to provide team-based longitudinal care across the continuum of care will be integral to providing high value health care. The Road Ahead will serve as a means to disseminate best practices and innovative methods to care for increasingly complex patients, especially those with chronic diseases, such as cirrhosis and inflammatory bowel disease. For example, papers will explore the implementation of specialty medical homes, patient navigators, community-based care services, and involvement of patients in their own care.
• • Quality improvement: Providing high-value care by definition will require clinicians to accurately measure the quality of care provided to patients and use data to guide process improvement. The Road Ahead will continue to serve as an educational resource for clinicians with papers that discuss challenges and opportunities in quality measurement and improvement. Similarly, this section will present data on novel or impactful quality-improvement initiatives.
• • Patient centeredness: Patient experience measures and patient-reported outcomes are becoming increasingly important as meaningful indicators of quality. These measures are designed to ensure that patient perspectives are incorporated into the governance, design, and delivery of health care. The Road Ahead will serve as a dissemination mechanism for sharing best practices in developing, validating, implementing, and tracking patient-reported outcomes.

References

1. Allen, J.I. The road ahead. Clin Gastroenterol Hepatol. 2012;10:692-6.

2. Dorn, S.D., Vesy, C.J. Medicare’s revaluation of gastrointestinal endoscopic procedures: implications for academic and community-based practices. Clin Gastroenterol Hepatol. 2017;14:924-8.

3. Dorn, S.D. The road ahead 3.0: changing payments, changing practice. Clin Gastroenterol Hepatol. 2016;14:785-9.

4. Meier, S.K., Shah, N.D., Talwalkar, J.A. Adapting the patient-centered specialty practice model for populations with cirrhosis. Clin Gastroenterol Hepatol. 2016;14:492-6.

5. Mehta, S.J. Bundled payment for gastrointestinal hemorrhage. Clin Gastroenterol Hepatol. 2016;14:1681-4.

6. Weizman, A.V., Mosko, J., Bollegala, N., et al. Quality improvement primer series: launching a quality improvement initiative. Clin Gastroenterol Hepatol. 2017;14:1067-71.

7. Bernstein, M., Hou, J.K., Weizman, A.V., et al. Quality improvement primer series: how to sustain a quality improvement effort. Clin Gastroenterol Hepatol. 2017;14:1371-5.

8. Bollegala, N., Patel, K., Mosko, J.D., et al. Quality improvement primer series: the plan-do-study-act cycle and data display. Clin Gastroenterol Hepatol. 2016;14:1230-3.

9. Adams, M.A. Covert recording by patients of encounters with gastroenterology providers: path to empowerment or breach of trust?. Clin Gastroenterol Hepatol. 2017;15:13-6.

10. Oza, V.M., El-Dika, S., and Adams, M.A. Reaching safe harbor: legal implications of clinical practice guidelines. Clin Gastroenterol Hepatol. 2016;14:172-4.

11. Lin, M., Pappas, S.C., Sellin, J., et al. Curbside consultations: the good, the bad, and the ugly. Clin Gastroenterol Hepatol. 2016;14:2-4.

12. McClellan, M.B., Leavitt, M.O. Competencies and tools to shift payments from volume to value. JAMA. 2016; 316: 1655–1656

13. Donabedian, A. Evaluating the quality of medical care. Milbank Q. 1966;44:166-203.

14. Rosenberg, F.B., Kim, L.S., Ketover, S.R. Challenges facing independent integrated gastroenterology. Clin Gastroenterol Hepatol. 2017;15:335-8.

15. Leiman, D.A., Metz, D.C., Ginsberg, G.G., et al. A novel electronic medical record-based workflow to measure and report colonoscopy quality measures. Clin Gastroenterol Hepatol. 2016;14:333-7.

16. Cross, R.K., Kane, S. Integration of telemedicine into clinical gastroenterology and hepatology Practice. Clin Gastroenterol Hepatol. 2017;15:175-81.

17. Llor, X. Building a cancer genetics and prevention program. Clin Gastroenterol Hepatol. 2016;14:1516-20.

18. Patel, K.K., Cummings, S., Sellin, J., et al. Applying Lean design principles to a gastrointestinal endoscopy program for uninsured patients improves health care utilization. Clin Gastroenterol Hepatol. 2015;13:1556-9.

19. Saini, S.D., Adams, M.A., Brill, J.V., et al. Colorectal cancer screening quality measures: beyond colonoscopy. Clin Gastroenterol Hepatol. 2016;14:644-7.
 

Dr. Gellad is an associate professor of medicine in the division of gastroenterology at Durham VA Medical Center, Durham, N.C.; and Duke Clinical Research Institute, Durham, N.C. He reports a consulting relationship with Merck & Co. and he is also a cofounder and equity holder in Higgs Boson, LLC. He is funded by Veterans Affairs Health Services Research and Development Career Development Award (CDA 14-158 ).

It is my privilege this month to assume responsibility for the “Practice Management: The Road Ahead” section of Clinical Gastroenterology and Hepatology. I am honored to join an impressive board of editors led by Dr Fasiha Kanwal, and anchored by global leaders in the field of gastroenterology and hepatology. This board of editors promises to continue the high level of excellence that has propelled the journal to its preeminent position among clinical journals. I am confident that the practice management section will uphold that tradition and continue to meet the expectation of our readers. I would like to mark this transition by acknowledging the history of the practice management section of Clinical Gastroenterology and Hepatology and outlining a vision for the future.

The section was introduced in 2010 under the leadership of Dr. Joel V. Brill. The section, titled “Practice Management: Opportunities and Challenges,” aimed to help practices navigate the disparate issues facing the field. Some of these issues included use of capnography in endoscopy, the importance of registries for quality reporting, and the burdens of meaningful use on physician practices. Dr Brill introduced this section in a video in May 2010 (https://www.youtube.com/watch?v=8FMsc2Wl5E8). Dr. Brill’s reference to these “interesting and challenging times” in gastroenterology resonates even more loudly today.

• • Governance and culture: The structure of health delivery systems, as conceptualized by Donabedian,¹³ is a key determinant of quality. Structural attributes include regulatory requirements on gastrointestinal practices, such as the rules governing use of anesthesia providers in ambulatory surgical settings; role of allied health professionals in clinical settings; and the impact of financial incentives in driving provider behavior.
• • Financial readiness: Value-based reimbursement, accountable care, medical homes, reference pricing, and physician tiering are some of the new terms in this era of value-based medicine. It is important for practices to assess patient costs longitudinally and manage financial risks. The Road Ahead section will continue to include papers that describe the impact of these reforms on gastroenterology and hepatology practices while providing guidance on implementation of these new models of care. Some examples include papers on the effect of payment policy on specialty practices, the development of a medical home in inflammatory bowel disease, and the physician experience with episode-based payments for colonoscopy.
• • Health information technology: All of the organizational competencies required for reform rely on a robust information technology platform that collects meaningful data and harnesses that data for analytic purposes. These platforms can be enterprise systems deployed by large health delivery systems or smaller, more nimble platforms, created by innovative start-up companies. The Road Ahead will include papers that share best practices in the use of these platforms to provide high-quality and cost-efficient care. In addition, the Road Ahead will continue to explore the use of health information technology to expand the reach of clinicians beyond brick and mortar clinics.
• • Patient risk assessment: Tailoring interventions to high-risk patients is necessary to deploy limited resources in a cost-effective manner. Risk assessment is also needed to more accurately and effectively personalize care for patients with chronic conditions. The Road Ahead will include papers that evaluate risk assessment tools and/or describe real-life implementation of these tools in different contexts.
• • Care coordination: The ability to provide team-based longitudinal care across the continuum of care will be integral to providing high value health care. The Road Ahead will serve as a means to disseminate best practices and innovative methods to care for increasingly complex patients, especially those with chronic diseases, such as cirrhosis and inflammatory bowel disease. For example, papers will explore the implementation of specialty medical homes, patient navigators, community-based care services, and involvement of patients in their own care.
• • Quality improvement: Providing high-value care by definition will require clinicians to accurately measure the quality of care provided to patients and use data to guide process improvement. The Road Ahead will continue to serve as an educational resource for clinicians with papers that discuss challenges and opportunities in quality measurement and improvement. Similarly, this section will present data on novel or impactful quality-improvement initiatives.
• • Patient centeredness: Patient experience measures and patient-reported outcomes are becoming increasingly important as meaningful indicators of quality. These measures are designed to ensure that patient perspectives are incorporated into the governance, design, and delivery of health care. The Road Ahead will serve as a dissemination mechanism for sharing best practices in developing, validating, implementing, and tracking patient-reported outcomes.

References

1. Allen, J.I. The road ahead. Clin Gastroenterol Hepatol. 2012;10:692-6.

2. Dorn, S.D., Vesy, C.J. Medicare’s revaluation of gastrointestinal endoscopic procedures: implications for academic and community-based practices. Clin Gastroenterol Hepatol. 2017;14:924-8.

3. Dorn, S.D. The road ahead 3.0: changing payments, changing practice. Clin Gastroenterol Hepatol. 2016;14:785-9.

4. Meier, S.K., Shah, N.D., Talwalkar, J.A. Adapting the patient-centered specialty practice model for populations with cirrhosis. Clin Gastroenterol Hepatol. 2016;14:492-6.

5. Mehta, S.J. Bundled payment for gastrointestinal hemorrhage. Clin Gastroenterol Hepatol. 2016;14:1681-4.

6. Weizman, A.V., Mosko, J., Bollegala, N., et al. Quality improvement primer series: launching a quality improvement initiative. Clin Gastroenterol Hepatol. 2017;14:1067-71.

7. Bernstein, M., Hou, J.K., Weizman, A.V., et al. Quality improvement primer series: how to sustain a quality improvement effort. Clin Gastroenterol Hepatol. 2017;14:1371-5.

8. Bollegala, N., Patel, K., Mosko, J.D., et al. Quality improvement primer series: the plan-do-study-act cycle and data display. Clin Gastroenterol Hepatol. 2016;14:1230-3.

9. Adams, M.A. Covert recording by patients of encounters with gastroenterology providers: path to empowerment or breach of trust?. Clin Gastroenterol Hepatol. 2017;15:13-6.

10. Oza, V.M., El-Dika, S., and Adams, M.A. Reaching safe harbor: legal implications of clinical practice guidelines. Clin Gastroenterol Hepatol. 2016;14:172-4.

11. Lin, M., Pappas, S.C., Sellin, J., et al. Curbside consultations: the good, the bad, and the ugly. Clin Gastroenterol Hepatol. 2016;14:2-4.

12. McClellan, M.B., Leavitt, M.O. Competencies and tools to shift payments from volume to value. JAMA. 2016; 316: 1655–1656

13. Donabedian, A. Evaluating the quality of medical care. Milbank Q. 1966;44:166-203.

14. Rosenberg, F.B., Kim, L.S., Ketover, S.R. Challenges facing independent integrated gastroenterology. Clin Gastroenterol Hepatol. 2017;15:335-8.

15. Leiman, D.A., Metz, D.C., Ginsberg, G.G., et al. A novel electronic medical record-based workflow to measure and report colonoscopy quality measures. Clin Gastroenterol Hepatol. 2016;14:333-7.

16. Cross, R.K., Kane, S. Integration of telemedicine into clinical gastroenterology and hepatology Practice. Clin Gastroenterol Hepatol. 2017;15:175-81.

17. Llor, X. Building a cancer genetics and prevention program. Clin Gastroenterol Hepatol. 2016;14:1516-20.

18. Patel, K.K., Cummings, S., Sellin, J., et al. Applying Lean design principles to a gastrointestinal endoscopy program for uninsured patients improves health care utilization. Clin Gastroenterol Hepatol. 2015;13:1556-9.

19. Saini, S.D., Adams, M.A., Brill, J.V., et al. Colorectal cancer screening quality measures: beyond colonoscopy. Clin Gastroenterol Hepatol. 2016;14:644-7.
 

Dr. Gellad is an associate professor of medicine in the division of gastroenterology at Durham VA Medical Center, Durham, N.C.; and Duke Clinical Research Institute, Durham, N.C. He reports a consulting relationship with Merck & Co. and he is also a cofounder and equity holder in Higgs Boson, LLC. He is funded by Veterans Affairs Health Services Research and Development Career Development Award (CDA 14-158 ).

As the population of patients with limited English proficiency increases throughout English-speaking countries, health care providers often need translator services. Medical translator smartphone applications (apps) are useful tools that can provide ad hoc translator services.

According to the US Census Bureau in 2015, more than 60 million individuals — about 19% of Americans — reported speaking a language other than English at home, and more than 25 million said that they speak English “less than very well.”^1,2 The top 5 non-English languages spoken at home were Spanish, French, Chinese, Tagalog, and Vietnamese, encompassing 72% of non-English speakers.

In the health care sector, translator services are essential for providing accurate and culturally competent care. Current options for translator services include face-to-face interpreters, phone-based translator services, and translator apps on mobile devices. In settings where face-to-face interpreters or phone-based translator services are not available, translator apps may provide reasonable alternatives. My colleagues, Dr. Amrin Khander and Dr. Sara Farag, and I identified and evaluated medical translator apps that are available from the Apple iTunes and Google Play stores to aid clinicians in using such apps during clinical encounters.³

Three types of translator apps

Preset medical phrase translator apps require the user to search for or find a question or statement in order to facilitate a conversation. With these types of apps, a health care provider can choose fully conjugated sentences, which then can be played or read back to the patient in the chosen translated language. Within this group of apps, Canopy Speak and Universal Doctor Speaker are highly accessible, since both apps are available from the Apple iTunes and Google Play stores and both are free.

Medical dictionary apps require the user to search for a medical term in one language to receive a translation in another language. These apps are less useful, but they can help providers find and define specific terms in a given language.

General language translator apps require the user to enter a term, statement, or question in one language and then provide a translation in another language. Google Translate and Vocre Translate are examples.

The top recommended translator apps are listed in the TABLE alphabetically and are detailed with a shortened version of the APPLICATIONS scoring system, APPLI (app comprehensiveness, price, platform, literature use, and important special features).⁴ I hope the apps described here will help you enhance communication with your patients who have limited English proficiency.

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

As the population of patients with limited English proficiency increases throughout English-speaking countries, health care providers often need translator services. Medical translator smartphone applications (apps) are useful tools that can provide ad hoc translator services.

According to the US Census Bureau in 2015, more than 60 million individuals — about 19% of Americans — reported speaking a language other than English at home, and more than 25 million said that they speak English “less than very well.”^1,2 The top 5 non-English languages spoken at home were Spanish, French, Chinese, Tagalog, and Vietnamese, encompassing 72% of non-English speakers.

In the health care sector, translator services are essential for providing accurate and culturally competent care. Current options for translator services include face-to-face interpreters, phone-based translator services, and translator apps on mobile devices. In settings where face-to-face interpreters or phone-based translator services are not available, translator apps may provide reasonable alternatives. My colleagues, Dr. Amrin Khander and Dr. Sara Farag, and I identified and evaluated medical translator apps that are available from the Apple iTunes and Google Play stores to aid clinicians in using such apps during clinical encounters.³

Three types of translator apps

Preset medical phrase translator apps require the user to search for or find a question or statement in order to facilitate a conversation. With these types of apps, a health care provider can choose fully conjugated sentences, which then can be played or read back to the patient in the chosen translated language. Within this group of apps, Canopy Speak and Universal Doctor Speaker are highly accessible, since both apps are available from the Apple iTunes and Google Play stores and both are free.

Medical dictionary apps require the user to search for a medical term in one language to receive a translation in another language. These apps are less useful, but they can help providers find and define specific terms in a given language.

General language translator apps require the user to enter a term, statement, or question in one language and then provide a translation in another language. Google Translate and Vocre Translate are examples.

The top recommended translator apps are listed in the TABLE alphabetically and are detailed with a shortened version of the APPLICATIONS scoring system, APPLI (app comprehensiveness, price, platform, literature use, and important special features).⁴ I hope the apps described here will help you enhance communication with your patients who have limited English proficiency.

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

As the population of patients with limited English proficiency increases throughout English-speaking countries, health care providers often need translator services. Medical translator smartphone applications (apps) are useful tools that can provide ad hoc translator services.

According to the US Census Bureau in 2015, more than 60 million individuals — about 19% of Americans — reported speaking a language other than English at home, and more than 25 million said that they speak English “less than very well.”^1,2 The top 5 non-English languages spoken at home were Spanish, French, Chinese, Tagalog, and Vietnamese, encompassing 72% of non-English speakers.

In the health care sector, translator services are essential for providing accurate and culturally competent care. Current options for translator services include face-to-face interpreters, phone-based translator services, and translator apps on mobile devices. In settings where face-to-face interpreters or phone-based translator services are not available, translator apps may provide reasonable alternatives. My colleagues, Dr. Amrin Khander and Dr. Sara Farag, and I identified and evaluated medical translator apps that are available from the Apple iTunes and Google Play stores to aid clinicians in using such apps during clinical encounters.³

Three types of translator apps

Preset medical phrase translator apps require the user to search for or find a question or statement in order to facilitate a conversation. With these types of apps, a health care provider can choose fully conjugated sentences, which then can be played or read back to the patient in the chosen translated language. Within this group of apps, Canopy Speak and Universal Doctor Speaker are highly accessible, since both apps are available from the Apple iTunes and Google Play stores and both are free.

Medical dictionary apps require the user to search for a medical term in one language to receive a translation in another language. These apps are less useful, but they can help providers find and define specific terms in a given language.

General language translator apps require the user to enter a term, statement, or question in one language and then provide a translation in another language. Google Translate and Vocre Translate are examples.

The top recommended translator apps are listed in the TABLE alphabetically and are detailed with a shortened version of the APPLICATIONS scoring system, APPLI (app comprehensiveness, price, platform, literature use, and important special features).⁴ I hope the apps described here will help you enhance communication with your patients who have limited English proficiency.

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

Routine use of low-dose oxygen supplementation in the first days after stroke doesn’t improve overall survival or reduce disability, according to a large new study.

The poststroke death and disability odds ratio was 0.97 for those receiving one of two continuous low-dose oxygen protocols, compared with the control group (95% confidence interval, 0.89-1.05; P = .47).

Photodisc/ThinkStock

[email protected]

On Twitter @karioakes

Routine use of low-dose oxygen supplementation in the first days after stroke doesn’t improve overall survival or reduce disability, according to a large new study.

The poststroke death and disability odds ratio was 0.97 for those receiving one of two continuous low-dose oxygen protocols, compared with the control group (95% confidence interval, 0.89-1.05; P = .47).

Photodisc/ThinkStock

[email protected]

On Twitter @karioakes

Routine use of low-dose oxygen supplementation in the first days after stroke doesn’t improve overall survival or reduce disability, according to a large new study.

The poststroke death and disability odds ratio was 0.97 for those receiving one of two continuous low-dose oxygen protocols, compared with the control group (95% confidence interval, 0.89-1.05; P = .47).

Photodisc/ThinkStock

[email protected]

On Twitter @karioakes

Sen. Susan Collins (R-Maine) became the third GOP senator to confirm a no vote on the latest Republican attempt to repeal and replace the Affordable Care Act (ACA), a move that likely seals the bill’s fate.

The bill has the support of President Trump and many GOP leaders but has been roundly criticized by medical groups for insuring fewer Americans, failing to provide adequate protections for people with preexisting conditions, and barring Planned Parenthood from Medicaid participation.

designer491/Thinkstock

[email protected]

Sen. Susan Collins (R-Maine) became the third GOP senator to confirm a no vote on the latest Republican attempt to repeal and replace the Affordable Care Act (ACA), a move that likely seals the bill’s fate.

The bill has the support of President Trump and many GOP leaders but has been roundly criticized by medical groups for insuring fewer Americans, failing to provide adequate protections for people with preexisting conditions, and barring Planned Parenthood from Medicaid participation.

designer491/Thinkstock

[email protected]

Sen. Susan Collins (R-Maine) became the third GOP senator to confirm a no vote on the latest Republican attempt to repeal and replace the Affordable Care Act (ACA), a move that likely seals the bill’s fate.

The bill has the support of President Trump and many GOP leaders but has been roundly criticized by medical groups for insuring fewer Americans, failing to provide adequate protections for people with preexisting conditions, and barring Planned Parenthood from Medicaid participation.

designer491/Thinkstock

[email protected]

MY STORY: Prologue

My aunt received a breast cancer diagnosis at age 40, and she died at age 60, in 1970. Then, in 1975, my mother’s breast cancer was found at age 55, but only after she was examined for nipple retraction; on mammography, the cancer had been obscured by dense breast tissue. Mom had 2 metastatic nodes but participated in the earliest clinical trials of chemotherapy and lived free of breast cancer for another 41 years. Naturally I thought that, were I to develop this disease, I would want it found earlier. Ironically, it was, but only because I had spent my career trying to understand the optimal screening approaches for women with dense breasts—women like me.

Cancers are masked on mammography in dense breasts

For women, screening mammography is an important step in reducing the risk of dying from breast cancer. The greatest benefits are realized by those who start annual screening at age 40, or 45 at the latest.¹ As it takes 9 to 10 years to see a benefit from breast cancer screening at the population level, it is not logical to continue this testing when life expectancy is less than 10 years, as is the case with women age 85 or older, even those in the healthiest quartile.^2–4 However, despite recent advances, the development of 3D mammography (tomosynthesis) (FIGURE 1) in particular, cancers can still be masked by dense breast tissue. Both 2D and 3D mammograms are x-rays; both dense tissue and cancers absorb x-rays and appear white.

Breast density is determined on mammography and is categorized as fatty, scattered fibroglandular, heterogeneously dense, or extremely dense (FIGURE 2).⁵ Tissue in the heterogeneous and extreme categories is considered dense. More than half of women in their 40s have dense breasts; with some fatty involution occurring around menopause, the proportion drops to 25% for women in their 60s.⁶ About half of breast cancers have calcifications, which on mammography are usually easily visible even in dense breasts. The problem is with noncalcified invasive cancers that can be hidden by dense tissue (FIGURE 3).

3D mammography improves cancer detection but is of minimal benefit in extremely dense breasts

Although 3D mammography improves cancer detection in most women, any benefit is minimal in women with extremely dense breasts, as there is no inherent soft-tissue contrast.⁷ Masked cancers are often only discovered because of a lump after a normal screening mammogram, as so-called “interval cancers.” Compared with screen-detected cancers, interval cancers tend to be more biologically aggressive, to have spread to lymph nodes, and to have worse prognoses. However, even some small screen-detected cancers are biologically aggressive and can spread to lymph nodes quickly, and no screening test or combination of screening tests can prevent this occurrence completely, regardless of breast density.

Related article:
Get smart about dense breasts

ILLUSTRATION: KIMBERLY MARTENS FOR OBG MANAGEMENT/COURTESY OF WENDIE A. BERG, MD, PHD

MRI provides early detection across all breast densities

In all tissue densities, contrast-enhanced magnetic resonance imaging (MRI) is far better than mammography in detecting breast cancer.⁸ Women at high risk for breast cancer caused by mutations in BRCA1, BRCA2, p53, and other genes have poor outcomes with screening mammography alone—up to 50% of cancers are interval cancers. Annual screening MRI reduces this percentage significantly, to 11% in women with pathogenic BRCA1 mutations and to 4% in women with BRCA2 mutations.⁹ Warner and colleagues found a decrease in late-stage cancers in high-risk women who underwent annual MRI screenings compared to high-risk women unable to have MRI.¹⁰

The use of MRI for screening is limited by availability, patient tolerance,¹¹ and high cost. Research is being conducted to further validate approaches using shortened screening MRI times (so-called “abbreviated” or “fast” MRI) and, thereby, improve access, tolerance, and reduce associated costs; several investigators already have reported promising results, and a few centers offer this modality directly to patients willing to pay $300 to $350 out of pocket.^12,13 Even in normal-risk women, MRI significantly increases detection of early breast cancer after a normal mammogram and ultrasound, and the cancer detection benefit of MRI is seen across all breast densities.¹⁴

Most health insurance plans cover screening MRI only for women who meet defined risk criteria, including women who have a known disease-causing mutation—or are suspected of having one, given a family history of breast cancer with higher than 20% to 25% lifetime risk by a model that predicts mutation carrier status—as well as women who had chest radiation therapy before age 30, typically for Hodgkin lymphoma, and at least 8 years earlier.¹⁵ In addition, MRI can be considered in women with atypical breast biopsy results or a personal history of lobular carcinoma in situ (LCIS).¹⁶

Screening MRI should start by age 25 in women with disease-causing mutations, or at the time of atypical or LCIS biopsy results, and should be performed annually unless the woman is pregnant or has a metallic implant, renal insufficiency, or another contraindication to MRI. MRI can be beneficial in women with a personal history of cancer, although annual mammography remains the standard of care.^17–19

MRI and mammography can be performed at the same time or on an alternating 6-month basis, with mammography usually starting only after age 30 because of the small risk that radiation poses for younger women. There are a few other impediments to having breast MRI: The woman must lie on her stomach within a confined space (tunnel), the contrast that is injected may not be well tolerated, and insurance does not cover the test for women who do not meet the defined risk criteria.¹¹

Read why mammography supplemented by US is best for women with dense breasts.

Ultrasonography supplements mammography

Mammography supplemented with ultrasonography (US) has been studied as a “Goldilocks” or best-fit solution for the screening of women with dense breasts, as detection of invasive cancers is improved with the 2 modalities over mammography alone, and US is less invasive, better tolerated, and lower in cost than the more sensitive MRI.

In women with dense breasts, US has been found to improve cancer detection over mammography alone, and early results suggest a larger cancer detection benefit from US than from 3D mammography, although research is ongoing.²⁰ Adding US reduces the interval cancer rate in women with dense breasts to less than 10% of all cancers found—similar to results for women with fatty breasts.^17,21,22

US can be performed by a trained technologist or a physician using a small transducer, which usually provides diagnostic images (so that most callbacks would be for a true finding), or a larger transducer and an automated system can be used to create more than a thousand images for radiologist review.^23,24 Use of a hybrid system, a small transducer with an automated arm, has been validated as well.²⁵ Screening US is not available universally, and with all these approaches optimal performance requires trained personnel. Supplemental screening US usually is covered by insurance but is nearly always subject to a deductible/copay.

Related article:
Educate patients about dense breasts and cancer risk

Reducing false-positives, callbacks, and additional testing

Mammography carries a risk of false-positives. On average, 11% to 12% of women are called back for additional testing after a screening mammogram, and in more than 95% of women brought back for extra testing, no cancer is found.²⁶ Women with dense breasts are more likely than those with less dense breasts to be called back.²⁷ US and MRI improve cancer detection and therefore yield additional positive, but also false-positive, findings. Notably, callbacks decrease after the first round of screening with any modality or combination of tests, as long as prior examinations are available for comparison.

One advantage of 3D over 2D mammography is a decrease in extra testing for areas of asymmetry, which are often recognizable on 3D mammography as representing normal superimposed tissue.^28–30 Architectural distortion, which is better seen on 3D mammography and usually represents either cancer or a benign radial scar, can lead to false-positive biopsies, although the average biopsy rate is no higher for 3D than for 2D alone.³¹ Typically, the 3D and 2D examinations are performed together (slightly more than doubling the radiation dose), or synthetic 2D images can be created from the 3D slices (resulting in a total radiation dose almost the same as standard 2D alone).

Most additional cancers seen on 3D mammography or US are lower-grade invasive cancers with good prognoses. Some aggressive high-grade breast cancers go undetected even when mammography is supplemented with US, either because they are too small to be seen or because they resemble common benign masses and may not be recognized. MRI is particularly effective in depicting high-grade cancers, even small ones.

The TABLE summarizes the relative rates of cancer detection and additional testing by various breast screening tests or combinations of tests. Neither clinical breast examination by a physician or other health care professional nor routine breast self-examination reduces the number of deaths caused by breast cancer. Nevertheless, women should monitor any changes in their breasts and report these changes to their clinician. A new lump, skin or nipple retraction, or a spontaneous clear or bloody nipple discharge merits diagnostic breast imaging even if a recent screening mammogram was normal.

Read how to take advantage of today’s technology for breast density screening

MY STORY: Epilogue

My annual 3D mammograms were normal, even the year my cancer was present. In 2014, I entered my family history into the IBIS Breast Cancer Risk Evaluation Tool (Tyrer-Cuzick model of breast cancer risk) (http://www.ems-trials.org/riskevaluator/) and calculated my lifetime risk at 19.7%. That is when I decided to have a screening MRI. My invasive breast cancer was easily seen on MRI and then on US. The cancer was node-negative, easily confirmed with needle biopsy, and treated with lumpectomy and radiation. There was no need for chemotherapy.

My personal experience prompted me to join JoAnn Pushkin and Cindy Henke-Sarmento, RT(R)(M), BA, in developing a website, www.DenseBreast-info.org, to give women and their physicians easy access to information on making decisions about screening in dense breasts.

My colleagues and I are often asked what is the best way to order supplemental imaging for a patient who may have dense breasts. Even in cases in which a mammogram does not exist or is unavailable, the following prescription can be implemented easily at centers that offer US: “2D plus 3D mammogram if available; if dense, perform ultrasound as needed.”

Related article:
DenseBreast-info.org: What this resource can offer you, and your patients

Breast density screening: Take advantage of today’s technology

Breast screening and diagnostic imaging have improved significantly since the 1970s, when many of the randomized trials of mammography were conducted. Breast density is one of the most common and important risk factors for development of breast cancer and is now incorporated into the Breast Cancer Surveillance Consortium model (https://tools.bcsc-scc.org/BC5yearRisk/calculator.htm) and the Tyrer-Cuzick model (see also http://densebreast-info.org/explanation-of-dense-breast-risk-models.aspx).³² Although we continue to validate newer approaches, women should take advantage of the improved methods of early cancer detection, particularly if they have dense breasts or are at high risk for breast cancer.

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

MY STORY: Prologue

My aunt received a breast cancer diagnosis at age 40, and she died at age 60, in 1970. Then, in 1975, my mother’s breast cancer was found at age 55, but only after she was examined for nipple retraction; on mammography, the cancer had been obscured by dense breast tissue. Mom had 2 metastatic nodes but participated in the earliest clinical trials of chemotherapy and lived free of breast cancer for another 41 years. Naturally I thought that, were I to develop this disease, I would want it found earlier. Ironically, it was, but only because I had spent my career trying to understand the optimal screening approaches for women with dense breasts—women like me.

Cancers are masked on mammography in dense breasts

For women, screening mammography is an important step in reducing the risk of dying from breast cancer. The greatest benefits are realized by those who start annual screening at age 40, or 45 at the latest.¹ As it takes 9 to 10 years to see a benefit from breast cancer screening at the population level, it is not logical to continue this testing when life expectancy is less than 10 years, as is the case with women age 85 or older, even those in the healthiest quartile.^2–4 However, despite recent advances, the development of 3D mammography (tomosynthesis) (FIGURE 1) in particular, cancers can still be masked by dense breast tissue. Both 2D and 3D mammograms are x-rays; both dense tissue and cancers absorb x-rays and appear white.

Breast density is determined on mammography and is categorized as fatty, scattered fibroglandular, heterogeneously dense, or extremely dense (FIGURE 2).⁵ Tissue in the heterogeneous and extreme categories is considered dense. More than half of women in their 40s have dense breasts; with some fatty involution occurring around menopause, the proportion drops to 25% for women in their 60s.⁶ About half of breast cancers have calcifications, which on mammography are usually easily visible even in dense breasts. The problem is with noncalcified invasive cancers that can be hidden by dense tissue (FIGURE 3).

3D mammography improves cancer detection but is of minimal benefit in extremely dense breasts

Although 3D mammography improves cancer detection in most women, any benefit is minimal in women with extremely dense breasts, as there is no inherent soft-tissue contrast.⁷ Masked cancers are often only discovered because of a lump after a normal screening mammogram, as so-called “interval cancers.” Compared with screen-detected cancers, interval cancers tend to be more biologically aggressive, to have spread to lymph nodes, and to have worse prognoses. However, even some small screen-detected cancers are biologically aggressive and can spread to lymph nodes quickly, and no screening test or combination of screening tests can prevent this occurrence completely, regardless of breast density.

Related article:
Get smart about dense breasts

ILLUSTRATION: KIMBERLY MARTENS FOR OBG MANAGEMENT/COURTESY OF WENDIE A. BERG, MD, PHD

MRI provides early detection across all breast densities

In all tissue densities, contrast-enhanced magnetic resonance imaging (MRI) is far better than mammography in detecting breast cancer.⁸ Women at high risk for breast cancer caused by mutations in BRCA1, BRCA2, p53, and other genes have poor outcomes with screening mammography alone—up to 50% of cancers are interval cancers. Annual screening MRI reduces this percentage significantly, to 11% in women with pathogenic BRCA1 mutations and to 4% in women with BRCA2 mutations.⁹ Warner and colleagues found a decrease in late-stage cancers in high-risk women who underwent annual MRI screenings compared to high-risk women unable to have MRI.¹⁰

The use of MRI for screening is limited by availability, patient tolerance,¹¹ and high cost. Research is being conducted to further validate approaches using shortened screening MRI times (so-called “abbreviated” or “fast” MRI) and, thereby, improve access, tolerance, and reduce associated costs; several investigators already have reported promising results, and a few centers offer this modality directly to patients willing to pay $300 to $350 out of pocket.^12,13 Even in normal-risk women, MRI significantly increases detection of early breast cancer after a normal mammogram and ultrasound, and the cancer detection benefit of MRI is seen across all breast densities.¹⁴

Most health insurance plans cover screening MRI only for women who meet defined risk criteria, including women who have a known disease-causing mutation—or are suspected of having one, given a family history of breast cancer with higher than 20% to 25% lifetime risk by a model that predicts mutation carrier status—as well as women who had chest radiation therapy before age 30, typically for Hodgkin lymphoma, and at least 8 years earlier.¹⁵ In addition, MRI can be considered in women with atypical breast biopsy results or a personal history of lobular carcinoma in situ (LCIS).¹⁶

Screening MRI should start by age 25 in women with disease-causing mutations, or at the time of atypical or LCIS biopsy results, and should be performed annually unless the woman is pregnant or has a metallic implant, renal insufficiency, or another contraindication to MRI. MRI can be beneficial in women with a personal history of cancer, although annual mammography remains the standard of care.^17–19

MRI and mammography can be performed at the same time or on an alternating 6-month basis, with mammography usually starting only after age 30 because of the small risk that radiation poses for younger women. There are a few other impediments to having breast MRI: The woman must lie on her stomach within a confined space (tunnel), the contrast that is injected may not be well tolerated, and insurance does not cover the test for women who do not meet the defined risk criteria.¹¹

Read why mammography supplemented by US is best for women with dense breasts.

Ultrasonography supplements mammography

Mammography supplemented with ultrasonography (US) has been studied as a “Goldilocks” or best-fit solution for the screening of women with dense breasts, as detection of invasive cancers is improved with the 2 modalities over mammography alone, and US is less invasive, better tolerated, and lower in cost than the more sensitive MRI.

In women with dense breasts, US has been found to improve cancer detection over mammography alone, and early results suggest a larger cancer detection benefit from US than from 3D mammography, although research is ongoing.²⁰ Adding US reduces the interval cancer rate in women with dense breasts to less than 10% of all cancers found—similar to results for women with fatty breasts.^17,21,22

US can be performed by a trained technologist or a physician using a small transducer, which usually provides diagnostic images (so that most callbacks would be for a true finding), or a larger transducer and an automated system can be used to create more than a thousand images for radiologist review.^23,24 Use of a hybrid system, a small transducer with an automated arm, has been validated as well.²⁵ Screening US is not available universally, and with all these approaches optimal performance requires trained personnel. Supplemental screening US usually is covered by insurance but is nearly always subject to a deductible/copay.

Related article:
Educate patients about dense breasts and cancer risk

Reducing false-positives, callbacks, and additional testing

Mammography carries a risk of false-positives. On average, 11% to 12% of women are called back for additional testing after a screening mammogram, and in more than 95% of women brought back for extra testing, no cancer is found.²⁶ Women with dense breasts are more likely than those with less dense breasts to be called back.²⁷ US and MRI improve cancer detection and therefore yield additional positive, but also false-positive, findings. Notably, callbacks decrease after the first round of screening with any modality or combination of tests, as long as prior examinations are available for comparison.

One advantage of 3D over 2D mammography is a decrease in extra testing for areas of asymmetry, which are often recognizable on 3D mammography as representing normal superimposed tissue.^28–30 Architectural distortion, which is better seen on 3D mammography and usually represents either cancer or a benign radial scar, can lead to false-positive biopsies, although the average biopsy rate is no higher for 3D than for 2D alone.³¹ Typically, the 3D and 2D examinations are performed together (slightly more than doubling the radiation dose), or synthetic 2D images can be created from the 3D slices (resulting in a total radiation dose almost the same as standard 2D alone).

Most additional cancers seen on 3D mammography or US are lower-grade invasive cancers with good prognoses. Some aggressive high-grade breast cancers go undetected even when mammography is supplemented with US, either because they are too small to be seen or because they resemble common benign masses and may not be recognized. MRI is particularly effective in depicting high-grade cancers, even small ones.

The TABLE summarizes the relative rates of cancer detection and additional testing by various breast screening tests or combinations of tests. Neither clinical breast examination by a physician or other health care professional nor routine breast self-examination reduces the number of deaths caused by breast cancer. Nevertheless, women should monitor any changes in their breasts and report these changes to their clinician. A new lump, skin or nipple retraction, or a spontaneous clear or bloody nipple discharge merits diagnostic breast imaging even if a recent screening mammogram was normal.

Read how to take advantage of today’s technology for breast density screening

MY STORY: Epilogue

My annual 3D mammograms were normal, even the year my cancer was present. In 2014, I entered my family history into the IBIS Breast Cancer Risk Evaluation Tool (Tyrer-Cuzick model of breast cancer risk) (http://www.ems-trials.org/riskevaluator/) and calculated my lifetime risk at 19.7%. That is when I decided to have a screening MRI. My invasive breast cancer was easily seen on MRI and then on US. The cancer was node-negative, easily confirmed with needle biopsy, and treated with lumpectomy and radiation. There was no need for chemotherapy.

My personal experience prompted me to join JoAnn Pushkin and Cindy Henke-Sarmento, RT(R)(M), BA, in developing a website, www.DenseBreast-info.org, to give women and their physicians easy access to information on making decisions about screening in dense breasts.

My colleagues and I are often asked what is the best way to order supplemental imaging for a patient who may have dense breasts. Even in cases in which a mammogram does not exist or is unavailable, the following prescription can be implemented easily at centers that offer US: “2D plus 3D mammogram if available; if dense, perform ultrasound as needed.”

Related article:
DenseBreast-info.org: What this resource can offer you, and your patients

Breast density screening: Take advantage of today’s technology

Breast screening and diagnostic imaging have improved significantly since the 1970s, when many of the randomized trials of mammography were conducted. Breast density is one of the most common and important risk factors for development of breast cancer and is now incorporated into the Breast Cancer Surveillance Consortium model (https://tools.bcsc-scc.org/BC5yearRisk/calculator.htm) and the Tyrer-Cuzick model (see also http://densebreast-info.org/explanation-of-dense-breast-risk-models.aspx).³² Although we continue to validate newer approaches, women should take advantage of the improved methods of early cancer detection, particularly if they have dense breasts or are at high risk for breast cancer.

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

MY STORY: Prologue

My aunt received a breast cancer diagnosis at age 40, and she died at age 60, in 1970. Then, in 1975, my mother’s breast cancer was found at age 55, but only after she was examined for nipple retraction; on mammography, the cancer had been obscured by dense breast tissue. Mom had 2 metastatic nodes but participated in the earliest clinical trials of chemotherapy and lived free of breast cancer for another 41 years. Naturally I thought that, were I to develop this disease, I would want it found earlier. Ironically, it was, but only because I had spent my career trying to understand the optimal screening approaches for women with dense breasts—women like me.

Cancers are masked on mammography in dense breasts

For women, screening mammography is an important step in reducing the risk of dying from breast cancer. The greatest benefits are realized by those who start annual screening at age 40, or 45 at the latest.¹ As it takes 9 to 10 years to see a benefit from breast cancer screening at the population level, it is not logical to continue this testing when life expectancy is less than 10 years, as is the case with women age 85 or older, even those in the healthiest quartile.^2–4 However, despite recent advances, the development of 3D mammography (tomosynthesis) (FIGURE 1) in particular, cancers can still be masked by dense breast tissue. Both 2D and 3D mammograms are x-rays; both dense tissue and cancers absorb x-rays and appear white.

Breast density is determined on mammography and is categorized as fatty, scattered fibroglandular, heterogeneously dense, or extremely dense (FIGURE 2).⁵ Tissue in the heterogeneous and extreme categories is considered dense. More than half of women in their 40s have dense breasts; with some fatty involution occurring around menopause, the proportion drops to 25% for women in their 60s.⁶ About half of breast cancers have calcifications, which on mammography are usually easily visible even in dense breasts. The problem is with noncalcified invasive cancers that can be hidden by dense tissue (FIGURE 3).

3D mammography improves cancer detection but is of minimal benefit in extremely dense breasts

Although 3D mammography improves cancer detection in most women, any benefit is minimal in women with extremely dense breasts, as there is no inherent soft-tissue contrast.⁷ Masked cancers are often only discovered because of a lump after a normal screening mammogram, as so-called “interval cancers.” Compared with screen-detected cancers, interval cancers tend to be more biologically aggressive, to have spread to lymph nodes, and to have worse prognoses. However, even some small screen-detected cancers are biologically aggressive and can spread to lymph nodes quickly, and no screening test or combination of screening tests can prevent this occurrence completely, regardless of breast density.

Related article:
Get smart about dense breasts

ILLUSTRATION: KIMBERLY MARTENS FOR OBG MANAGEMENT/COURTESY OF WENDIE A. BERG, MD, PHD

MRI provides early detection across all breast densities

In all tissue densities, contrast-enhanced magnetic resonance imaging (MRI) is far better than mammography in detecting breast cancer.⁸ Women at high risk for breast cancer caused by mutations in BRCA1, BRCA2, p53, and other genes have poor outcomes with screening mammography alone—up to 50% of cancers are interval cancers. Annual screening MRI reduces this percentage significantly, to 11% in women with pathogenic BRCA1 mutations and to 4% in women with BRCA2 mutations.⁹ Warner and colleagues found a decrease in late-stage cancers in high-risk women who underwent annual MRI screenings compared to high-risk women unable to have MRI.¹⁰

The use of MRI for screening is limited by availability, patient tolerance,¹¹ and high cost. Research is being conducted to further validate approaches using shortened screening MRI times (so-called “abbreviated” or “fast” MRI) and, thereby, improve access, tolerance, and reduce associated costs; several investigators already have reported promising results, and a few centers offer this modality directly to patients willing to pay $300 to $350 out of pocket.^12,13 Even in normal-risk women, MRI significantly increases detection of early breast cancer after a normal mammogram and ultrasound, and the cancer detection benefit of MRI is seen across all breast densities.¹⁴

Most health insurance plans cover screening MRI only for women who meet defined risk criteria, including women who have a known disease-causing mutation—or are suspected of having one, given a family history of breast cancer with higher than 20% to 25% lifetime risk by a model that predicts mutation carrier status—as well as women who had chest radiation therapy before age 30, typically for Hodgkin lymphoma, and at least 8 years earlier.¹⁵ In addition, MRI can be considered in women with atypical breast biopsy results or a personal history of lobular carcinoma in situ (LCIS).¹⁶

Screening MRI should start by age 25 in women with disease-causing mutations, or at the time of atypical or LCIS biopsy results, and should be performed annually unless the woman is pregnant or has a metallic implant, renal insufficiency, or another contraindication to MRI. MRI can be beneficial in women with a personal history of cancer, although annual mammography remains the standard of care.^17–19

MRI and mammography can be performed at the same time or on an alternating 6-month basis, with mammography usually starting only after age 30 because of the small risk that radiation poses for younger women. There are a few other impediments to having breast MRI: The woman must lie on her stomach within a confined space (tunnel), the contrast that is injected may not be well tolerated, and insurance does not cover the test for women who do not meet the defined risk criteria.¹¹

Read why mammography supplemented by US is best for women with dense breasts.

Ultrasonography supplements mammography

Mammography supplemented with ultrasonography (US) has been studied as a “Goldilocks” or best-fit solution for the screening of women with dense breasts, as detection of invasive cancers is improved with the 2 modalities over mammography alone, and US is less invasive, better tolerated, and lower in cost than the more sensitive MRI.

In women with dense breasts, US has been found to improve cancer detection over mammography alone, and early results suggest a larger cancer detection benefit from US than from 3D mammography, although research is ongoing.²⁰ Adding US reduces the interval cancer rate in women with dense breasts to less than 10% of all cancers found—similar to results for women with fatty breasts.^17,21,22

US can be performed by a trained technologist or a physician using a small transducer, which usually provides diagnostic images (so that most callbacks would be for a true finding), or a larger transducer and an automated system can be used to create more than a thousand images for radiologist review.^23,24 Use of a hybrid system, a small transducer with an automated arm, has been validated as well.²⁵ Screening US is not available universally, and with all these approaches optimal performance requires trained personnel. Supplemental screening US usually is covered by insurance but is nearly always subject to a deductible/copay.

Related article:
Educate patients about dense breasts and cancer risk

Reducing false-positives, callbacks, and additional testing

Mammography carries a risk of false-positives. On average, 11% to 12% of women are called back for additional testing after a screening mammogram, and in more than 95% of women brought back for extra testing, no cancer is found.²⁶ Women with dense breasts are more likely than those with less dense breasts to be called back.²⁷ US and MRI improve cancer detection and therefore yield additional positive, but also false-positive, findings. Notably, callbacks decrease after the first round of screening with any modality or combination of tests, as long as prior examinations are available for comparison.

One advantage of 3D over 2D mammography is a decrease in extra testing for areas of asymmetry, which are often recognizable on 3D mammography as representing normal superimposed tissue.^28–30 Architectural distortion, which is better seen on 3D mammography and usually represents either cancer or a benign radial scar, can lead to false-positive biopsies, although the average biopsy rate is no higher for 3D than for 2D alone.³¹ Typically, the 3D and 2D examinations are performed together (slightly more than doubling the radiation dose), or synthetic 2D images can be created from the 3D slices (resulting in a total radiation dose almost the same as standard 2D alone).

Most additional cancers seen on 3D mammography or US are lower-grade invasive cancers with good prognoses. Some aggressive high-grade breast cancers go undetected even when mammography is supplemented with US, either because they are too small to be seen or because they resemble common benign masses and may not be recognized. MRI is particularly effective in depicting high-grade cancers, even small ones.

The TABLE summarizes the relative rates of cancer detection and additional testing by various breast screening tests or combinations of tests. Neither clinical breast examination by a physician or other health care professional nor routine breast self-examination reduces the number of deaths caused by breast cancer. Nevertheless, women should monitor any changes in their breasts and report these changes to their clinician. A new lump, skin or nipple retraction, or a spontaneous clear or bloody nipple discharge merits diagnostic breast imaging even if a recent screening mammogram was normal.

Read how to take advantage of today’s technology for breast density screening

MY STORY: Epilogue

My annual 3D mammograms were normal, even the year my cancer was present. In 2014, I entered my family history into the IBIS Breast Cancer Risk Evaluation Tool (Tyrer-Cuzick model of breast cancer risk) (http://www.ems-trials.org/riskevaluator/) and calculated my lifetime risk at 19.7%. That is when I decided to have a screening MRI. My invasive breast cancer was easily seen on MRI and then on US. The cancer was node-negative, easily confirmed with needle biopsy, and treated with lumpectomy and radiation. There was no need for chemotherapy.

My personal experience prompted me to join JoAnn Pushkin and Cindy Henke-Sarmento, RT(R)(M), BA, in developing a website, www.DenseBreast-info.org, to give women and their physicians easy access to information on making decisions about screening in dense breasts.

My colleagues and I are often asked what is the best way to order supplemental imaging for a patient who may have dense breasts. Even in cases in which a mammogram does not exist or is unavailable, the following prescription can be implemented easily at centers that offer US: “2D plus 3D mammogram if available; if dense, perform ultrasound as needed.”

Related article:
DenseBreast-info.org: What this resource can offer you, and your patients

Breast density screening: Take advantage of today’s technology

Breast screening and diagnostic imaging have improved significantly since the 1970s, when many of the randomized trials of mammography were conducted. Breast density is one of the most common and important risk factors for development of breast cancer and is now incorporated into the Breast Cancer Surveillance Consortium model (https://tools.bcsc-scc.org/BC5yearRisk/calculator.htm) and the Tyrer-Cuzick model (see also http://densebreast-info.org/explanation-of-dense-breast-risk-models.aspx).³² Although we continue to validate newer approaches, women should take advantage of the improved methods of early cancer detection, particularly if they have dense breasts or are at high risk for breast cancer.

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