Article

Key clinical point: Preventive B-Lynch suture seemed safe and effective in preventing excessive maternal hemorrhage in patients at a high risk for postpartum hemorrhage.

Major finding: Overall, 92% of patients who underwent the B-Lynch suture procedure showed no apparent postoperative bleeding within 2 hours after the cesarean section (CS), with 24 patients requiring intraoperative or postoperative blood transfusion, none requiring hysterectomy, and only 1 patient with a twin pregnancy requiring additional treatment because of secondary postpartum hemorrhage 5 days after the CS. Adverse events seemed unrelated to the procedure.

Study details: Findings are from a retrospective study including 663 patients who underwent CS, of which 38 patients underwent the preventive B-Lynch suture procedure before excessive blood loss occurred during CS.

Disclosures: No source of funding was reported. The authors declared no conflicts of interest.

Source: Kuwabara M et al. Effectiveness of preventive B-Lynch sutures in patients at a high risk of postpartum hemorrhage. J Obstet Gynaecol Res. 2022 (Sep 11). Doi: 10.1111/jog.15415

Key clinical point: Preventive B-Lynch suture seemed safe and effective in preventing excessive maternal hemorrhage in patients at a high risk for postpartum hemorrhage.

Major finding: Overall, 92% of patients who underwent the B-Lynch suture procedure showed no apparent postoperative bleeding within 2 hours after the cesarean section (CS), with 24 patients requiring intraoperative or postoperative blood transfusion, none requiring hysterectomy, and only 1 patient with a twin pregnancy requiring additional treatment because of secondary postpartum hemorrhage 5 days after the CS. Adverse events seemed unrelated to the procedure.

Study details: Findings are from a retrospective study including 663 patients who underwent CS, of which 38 patients underwent the preventive B-Lynch suture procedure before excessive blood loss occurred during CS.

Disclosures: No source of funding was reported. The authors declared no conflicts of interest.

Source: Kuwabara M et al. Effectiveness of preventive B-Lynch sutures in patients at a high risk of postpartum hemorrhage. J Obstet Gynaecol Res. 2022 (Sep 11). Doi: 10.1111/jog.15415

Key clinical point: Preventive B-Lynch suture seemed safe and effective in preventing excessive maternal hemorrhage in patients at a high risk for postpartum hemorrhage.

Major finding: Overall, 92% of patients who underwent the B-Lynch suture procedure showed no apparent postoperative bleeding within 2 hours after the cesarean section (CS), with 24 patients requiring intraoperative or postoperative blood transfusion, none requiring hysterectomy, and only 1 patient with a twin pregnancy requiring additional treatment because of secondary postpartum hemorrhage 5 days after the CS. Adverse events seemed unrelated to the procedure.

Study details: Findings are from a retrospective study including 663 patients who underwent CS, of which 38 patients underwent the preventive B-Lynch suture procedure before excessive blood loss occurred during CS.

Disclosures: No source of funding was reported. The authors declared no conflicts of interest.

Source: Kuwabara M et al. Effectiveness of preventive B-Lynch sutures in patients at a high risk of postpartum hemorrhage. J Obstet Gynaecol Res. 2022 (Sep 11). Doi: 10.1111/jog.15415

Key clinical point: Birth injuries are rare with breech vaginal delivery (VD); however, severe birth injury incidence is nearly 2-times higher with breech VD compared with cephalic VD, with brachial plexus palsy (BPP) being more common with breech vs cephalic VD.

Major finding: The incidence of severe birth injury with breech VD, cephalic VD, and cesarean section with breech presentation were 0.76/100, 0.31/100, and 0.059/100 live births, respectively. BPP occurred more frequently with breech VD (0.6% of live births) than with cephalic VD (0.3% of live births).

Study details: The data come from a retrospective study including 650,528 neonates who were delivered by breech VD (0.7%), breech cesarean section (2.6%), or cephalic VD (96.7%).

Disclosures: This study was partly funded by competitive State Research Financing of the Expert Responsibility area of Tampere University Hospital, Finland. The authors declared no conflicts of interest.

Source: Kekki M et al. Birth injury in breech delivery: A nationwide population-based cohort study in Finland. Arch Gynecol Obstet. 2022 (Sep 8). Doi: 10.1007/s00404-022-06772-1

Key clinical point: Birth injuries are rare with breech vaginal delivery (VD); however, severe birth injury incidence is nearly 2-times higher with breech VD compared with cephalic VD, with brachial plexus palsy (BPP) being more common with breech vs cephalic VD.

Major finding: The incidence of severe birth injury with breech VD, cephalic VD, and cesarean section with breech presentation were 0.76/100, 0.31/100, and 0.059/100 live births, respectively. BPP occurred more frequently with breech VD (0.6% of live births) than with cephalic VD (0.3% of live births).

Study details: The data come from a retrospective study including 650,528 neonates who were delivered by breech VD (0.7%), breech cesarean section (2.6%), or cephalic VD (96.7%).

Disclosures: This study was partly funded by competitive State Research Financing of the Expert Responsibility area of Tampere University Hospital, Finland. The authors declared no conflicts of interest.

Source: Kekki M et al. Birth injury in breech delivery: A nationwide population-based cohort study in Finland. Arch Gynecol Obstet. 2022 (Sep 8). Doi: 10.1007/s00404-022-06772-1

Key clinical point: Birth injuries are rare with breech vaginal delivery (VD); however, severe birth injury incidence is nearly 2-times higher with breech VD compared with cephalic VD, with brachial plexus palsy (BPP) being more common with breech vs cephalic VD.

Major finding: The incidence of severe birth injury with breech VD, cephalic VD, and cesarean section with breech presentation were 0.76/100, 0.31/100, and 0.059/100 live births, respectively. BPP occurred more frequently with breech VD (0.6% of live births) than with cephalic VD (0.3% of live births).

Study details: The data come from a retrospective study including 650,528 neonates who were delivered by breech VD (0.7%), breech cesarean section (2.6%), or cephalic VD (96.7%).

Disclosures: This study was partly funded by competitive State Research Financing of the Expert Responsibility area of Tampere University Hospital, Finland. The authors declared no conflicts of interest.

Source: Kekki M et al. Birth injury in breech delivery: A nationwide population-based cohort study in Finland. Arch Gynecol Obstet. 2022 (Sep 8). Doi: 10.1007/s00404-022-06772-1

Key clinical point: A majority of women with preterm preeclampsia showed persistent cardiovascular morbidity at 6 months postpartum, which may have significant implications to long-term cardiovascular health.

Major finding: At 6 months postpartum, diastolic dysfunction, increased total vascular resistance (TVR), and persistent left ventricular remodeling were observed in 61%, 75%, and 41% of women, respectively, with 46% of women with no pre-existing hypertension having de novo hypertension and only 5% of women having a completely normal echocardiogram. A significant association was observed between prolonged preeclampsia duration and increased TVR at 6 months (P = .02).

Study details: Findings are from a sub-study of PICk-UP trial involving 44 postnatal women with preterm preeclampsia who delivered before 37 weeks.

Disclosures: This study was funded by the Medical Research Council, UK. The authors declared no competing financial interests.

Source: Ormesher L et al. Postnatal cardiovascular morbidity following preterm pre-eclampsia: An observational study. Pregnancy Hypertens. 2022;30:68-81 (Aug 17). Doi: 10.1016/j.preghy.2022.08.007

Key clinical point: A majority of women with preterm preeclampsia showed persistent cardiovascular morbidity at 6 months postpartum, which may have significant implications to long-term cardiovascular health.

Major finding: At 6 months postpartum, diastolic dysfunction, increased total vascular resistance (TVR), and persistent left ventricular remodeling were observed in 61%, 75%, and 41% of women, respectively, with 46% of women with no pre-existing hypertension having de novo hypertension and only 5% of women having a completely normal echocardiogram. A significant association was observed between prolonged preeclampsia duration and increased TVR at 6 months (P = .02).

Study details: Findings are from a sub-study of PICk-UP trial involving 44 postnatal women with preterm preeclampsia who delivered before 37 weeks.

Disclosures: This study was funded by the Medical Research Council, UK. The authors declared no competing financial interests.

Source: Ormesher L et al. Postnatal cardiovascular morbidity following preterm pre-eclampsia: An observational study. Pregnancy Hypertens. 2022;30:68-81 (Aug 17). Doi: 10.1016/j.preghy.2022.08.007

Key clinical point: A majority of women with preterm preeclampsia showed persistent cardiovascular morbidity at 6 months postpartum, which may have significant implications to long-term cardiovascular health.

Major finding: At 6 months postpartum, diastolic dysfunction, increased total vascular resistance (TVR), and persistent left ventricular remodeling were observed in 61%, 75%, and 41% of women, respectively, with 46% of women with no pre-existing hypertension having de novo hypertension and only 5% of women having a completely normal echocardiogram. A significant association was observed between prolonged preeclampsia duration and increased TVR at 6 months (P = .02).

Study details: Findings are from a sub-study of PICk-UP trial involving 44 postnatal women with preterm preeclampsia who delivered before 37 weeks.

Disclosures: This study was funded by the Medical Research Council, UK. The authors declared no competing financial interests.

Source: Ormesher L et al. Postnatal cardiovascular morbidity following preterm pre-eclampsia: An observational study. Pregnancy Hypertens. 2022;30:68-81 (Aug 17). Doi: 10.1016/j.preghy.2022.08.007

Key clinical point: The incidence of acute high-risk chest pain (AHRCP) diseases during pregnancy and puerperium has increased consistently over a decade, with advanced maternal age being a significant risk factor.

Major finding: The incidence of AHRCP diseases during pregnancy and puerperium increased from 79.92/100,000 hospitalizations in 2008 to 114.79/100,000 hospitalizations in 2017 (P_trend < .0001), with pulmonary embolism (86.5%) occurring 10-fold and 26-fold more frequently than acute myocardial infarction (9.6%) and aortic dissection (3.3%), respectively. Maternal age over 45 years was a significant risk factor (odds ratio 4.25; 95% CI 3.80-4.75).

Study details: Findings are from an observational analysis of 41,174,101 patients hospitalized for pregnancy and puerperium, of which 40,285 were diagnosed with AHRCP diseases.

Disclosures: This study was supported by the 3-Year Action Plan for Strengthening Public Health System in Shanghai (2020–2022) and other sources. The authors declared no conflicts of interest.

Source: Wu S et al. Incidence and outcomes of acute high-risk chest pain diseases during pregnancy and puerperium. Front Cardiovasc Med. 2022;9:968964 (Aug 11). Doi: 10.3389/fcvm.2022.968964

Key clinical point: The incidence of acute high-risk chest pain (AHRCP) diseases during pregnancy and puerperium has increased consistently over a decade, with advanced maternal age being a significant risk factor.

Major finding: The incidence of AHRCP diseases during pregnancy and puerperium increased from 79.92/100,000 hospitalizations in 2008 to 114.79/100,000 hospitalizations in 2017 (P_trend < .0001), with pulmonary embolism (86.5%) occurring 10-fold and 26-fold more frequently than acute myocardial infarction (9.6%) and aortic dissection (3.3%), respectively. Maternal age over 45 years was a significant risk factor (odds ratio 4.25; 95% CI 3.80-4.75).

Study details: Findings are from an observational analysis of 41,174,101 patients hospitalized for pregnancy and puerperium, of which 40,285 were diagnosed with AHRCP diseases.

Disclosures: This study was supported by the 3-Year Action Plan for Strengthening Public Health System in Shanghai (2020–2022) and other sources. The authors declared no conflicts of interest.

Source: Wu S et al. Incidence and outcomes of acute high-risk chest pain diseases during pregnancy and puerperium. Front Cardiovasc Med. 2022;9:968964 (Aug 11). Doi: 10.3389/fcvm.2022.968964

Key clinical point: The incidence of acute high-risk chest pain (AHRCP) diseases during pregnancy and puerperium has increased consistently over a decade, with advanced maternal age being a significant risk factor.

Major finding: The incidence of AHRCP diseases during pregnancy and puerperium increased from 79.92/100,000 hospitalizations in 2008 to 114.79/100,000 hospitalizations in 2017 (P_trend < .0001), with pulmonary embolism (86.5%) occurring 10-fold and 26-fold more frequently than acute myocardial infarction (9.6%) and aortic dissection (3.3%), respectively. Maternal age over 45 years was a significant risk factor (odds ratio 4.25; 95% CI 3.80-4.75).

Study details: Findings are from an observational analysis of 41,174,101 patients hospitalized for pregnancy and puerperium, of which 40,285 were diagnosed with AHRCP diseases.

Disclosures: This study was supported by the 3-Year Action Plan for Strengthening Public Health System in Shanghai (2020–2022) and other sources. The authors declared no conflicts of interest.

Source: Wu S et al. Incidence and outcomes of acute high-risk chest pain diseases during pregnancy and puerperium. Front Cardiovasc Med. 2022;9:968964 (Aug 11). Doi: 10.3389/fcvm.2022.968964

Key clinical point: Analysis over 2 decades demonstrated trend changes in individual contribution of risk factors for postpartum hemorrhage, with perineal or vaginal tears increasing, large for gestational age neonate decreasing, and other risk factors remaining stable.

Major finding: The incidence of postpartum hemorrhage increased from 0.5% in 1988 to 0.6% in 2014. Among risk factors for postpartum hemorrhage, perineal or vaginal tear demonstrated a rising trend (P = .01), delivery of large for gestational age neonate demonstrated a declining trend (P < .001), and other risk factors, such as preeclampsia, vacuum extraction delivery, and retained placenta, remained stable during the study period.

Study details: Findings are from a population-based, retrospective, nested, case-control study including 285,992 pregnancies, of which 1684 were complicated by postpartum hemorrhage.

Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.

Source: Sade S et al. Trend changes in the individual contribution of risk factors for postpartum hemorrhage over more than two decades. Matern Child Health J. 2022 (Aug 24). Doi: 10.1007/s10995-022-03461-y

Key clinical point: Analysis over 2 decades demonstrated trend changes in individual contribution of risk factors for postpartum hemorrhage, with perineal or vaginal tears increasing, large for gestational age neonate decreasing, and other risk factors remaining stable.

Major finding: The incidence of postpartum hemorrhage increased from 0.5% in 1988 to 0.6% in 2014. Among risk factors for postpartum hemorrhage, perineal or vaginal tear demonstrated a rising trend (P = .01), delivery of large for gestational age neonate demonstrated a declining trend (P < .001), and other risk factors, such as preeclampsia, vacuum extraction delivery, and retained placenta, remained stable during the study period.

Study details: Findings are from a population-based, retrospective, nested, case-control study including 285,992 pregnancies, of which 1684 were complicated by postpartum hemorrhage.

Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.

Source: Sade S et al. Trend changes in the individual contribution of risk factors for postpartum hemorrhage over more than two decades. Matern Child Health J. 2022 (Aug 24). Doi: 10.1007/s10995-022-03461-y

Key clinical point: Analysis over 2 decades demonstrated trend changes in individual contribution of risk factors for postpartum hemorrhage, with perineal or vaginal tears increasing, large for gestational age neonate decreasing, and other risk factors remaining stable.

Major finding: The incidence of postpartum hemorrhage increased from 0.5% in 1988 to 0.6% in 2014. Among risk factors for postpartum hemorrhage, perineal or vaginal tear demonstrated a rising trend (P = .01), delivery of large for gestational age neonate demonstrated a declining trend (P < .001), and other risk factors, such as preeclampsia, vacuum extraction delivery, and retained placenta, remained stable during the study period.

Study details: Findings are from a population-based, retrospective, nested, case-control study including 285,992 pregnancies, of which 1684 were complicated by postpartum hemorrhage.

Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.

Source: Sade S et al. Trend changes in the individual contribution of risk factors for postpartum hemorrhage over more than two decades. Matern Child Health J. 2022 (Aug 24). Doi: 10.1007/s10995-022-03461-y

Key clinical point: Cesarean delivery, preeclampsia, and uterine rupture were independently associated with a higher risk for intrauterine tamponade failure in women with deliveries complicated by postpartum hemorrhage.

Major finding: Intrauterine tamponade failure rate was 11.1%. The risk for intrauterine tamponade failure was higher in women with cesarean delivery (adjusted odds ratio [aOR] 4.2; 95% CI 2.9-6.0), preeclampsia (aOR 2.3; 95% CI 1.3-3.9), and uterine rupture (aOR 14.1; 95% CI 2.4-83.0).

Study details: Findings are from a population-based retrospective cohort study including 1761 women with deliveries complicated by postpartum hemorrhage who underwent intrauterine tamponade within 24 hours of postpartum hemorrhage to manage persistent bleeding.

Disclosures: This study did not report any source of funding. No conflicts of interest were declared.

Source: Gibier M et al. Risk factors for intrauterine tamponade failure in postpartum hemorrhage. Obstet Gynecol. 2022;140(3):439-446 (Aug 3). Doi: 10.1097/AOG.0000000000004888

Key clinical point: Cesarean delivery, preeclampsia, and uterine rupture were independently associated with a higher risk for intrauterine tamponade failure in women with deliveries complicated by postpartum hemorrhage.

Major finding: Intrauterine tamponade failure rate was 11.1%. The risk for intrauterine tamponade failure was higher in women with cesarean delivery (adjusted odds ratio [aOR] 4.2; 95% CI 2.9-6.0), preeclampsia (aOR 2.3; 95% CI 1.3-3.9), and uterine rupture (aOR 14.1; 95% CI 2.4-83.0).

Study details: Findings are from a population-based retrospective cohort study including 1761 women with deliveries complicated by postpartum hemorrhage who underwent intrauterine tamponade within 24 hours of postpartum hemorrhage to manage persistent bleeding.

Disclosures: This study did not report any source of funding. No conflicts of interest were declared.

Source: Gibier M et al. Risk factors for intrauterine tamponade failure in postpartum hemorrhage. Obstet Gynecol. 2022;140(3):439-446 (Aug 3). Doi: 10.1097/AOG.0000000000004888

Key clinical point: Cesarean delivery, preeclampsia, and uterine rupture were independently associated with a higher risk for intrauterine tamponade failure in women with deliveries complicated by postpartum hemorrhage.

Major finding: Intrauterine tamponade failure rate was 11.1%. The risk for intrauterine tamponade failure was higher in women with cesarean delivery (adjusted odds ratio [aOR] 4.2; 95% CI 2.9-6.0), preeclampsia (aOR 2.3; 95% CI 1.3-3.9), and uterine rupture (aOR 14.1; 95% CI 2.4-83.0).

Study details: Findings are from a population-based retrospective cohort study including 1761 women with deliveries complicated by postpartum hemorrhage who underwent intrauterine tamponade within 24 hours of postpartum hemorrhage to manage persistent bleeding.

Disclosures: This study did not report any source of funding. No conflicts of interest were declared.

Source: Gibier M et al. Risk factors for intrauterine tamponade failure in postpartum hemorrhage. Obstet Gynecol. 2022;140(3):439-446 (Aug 3). Doi: 10.1097/AOG.0000000000004888

Key clinical point: The chances of postpartum readmission for hypertension were significantly higher among patients discharged with labetalol vs nifedipine after delivery, irrespective of the severity of their hypertensive disorder of pregnancy.

Major finding: Compared with nifedipine, the chances of postpartum readmission for hypertension were higher with labetalol (adjusted odds ratio [aOR] 1.63, 95% CI 1.43-1.85), with the risk being persistent among patients with mild (aOR 1.57; 95% CI 1.29-1.93) and severe (aOR 1.63, 95% CI 1.43-1.85) hypertensive disorders.

Study details: This study evaluated 24,477 patients who were discharged with nifedipine (36.8%), labetalol (57.7%), or both medications (5.6%) after delivery.

Disclosures: This study did not report any source of funding. DJ Lyell declared receiving payment from various sources.

Source: Do SC et al. Postpartum readmission for hypertension after discharge on labetalol or nifedipine. Obstet Gynecol. 2022;140(4):591-598 (Sep 8). Doi: 10.1097/AOG.0000000000004918

Key clinical point: The chances of postpartum readmission for hypertension were significantly higher among patients discharged with labetalol vs nifedipine after delivery, irrespective of the severity of their hypertensive disorder of pregnancy.

Major finding: Compared with nifedipine, the chances of postpartum readmission for hypertension were higher with labetalol (adjusted odds ratio [aOR] 1.63, 95% CI 1.43-1.85), with the risk being persistent among patients with mild (aOR 1.57; 95% CI 1.29-1.93) and severe (aOR 1.63, 95% CI 1.43-1.85) hypertensive disorders.

Study details: This study evaluated 24,477 patients who were discharged with nifedipine (36.8%), labetalol (57.7%), or both medications (5.6%) after delivery.

Disclosures: This study did not report any source of funding. DJ Lyell declared receiving payment from various sources.

Source: Do SC et al. Postpartum readmission for hypertension after discharge on labetalol or nifedipine. Obstet Gynecol. 2022;140(4):591-598 (Sep 8). Doi: 10.1097/AOG.0000000000004918

Key clinical point: The chances of postpartum readmission for hypertension were significantly higher among patients discharged with labetalol vs nifedipine after delivery, irrespective of the severity of their hypertensive disorder of pregnancy.

Major finding: Compared with nifedipine, the chances of postpartum readmission for hypertension were higher with labetalol (adjusted odds ratio [aOR] 1.63, 95% CI 1.43-1.85), with the risk being persistent among patients with mild (aOR 1.57; 95% CI 1.29-1.93) and severe (aOR 1.63, 95% CI 1.43-1.85) hypertensive disorders.

Study details: This study evaluated 24,477 patients who were discharged with nifedipine (36.8%), labetalol (57.7%), or both medications (5.6%) after delivery.

Disclosures: This study did not report any source of funding. DJ Lyell declared receiving payment from various sources.

Source: Do SC et al. Postpartum readmission for hypertension after discharge on labetalol or nifedipine. Obstet Gynecol. 2022;140(4):591-598 (Sep 8). Doi: 10.1097/AOG.0000000000004918

Key clinical point: Weekly 3-hour simulation-based training of midwives and doctors on shoulder dystocia (SD) management significantly reduced the incidence of permanent brachial plexus birth injury (BPBI).

Major finding: Despite an increase in the incidence of SD cases (0.1% vs 0.3%; P < .001) and risk factors in pre-training vs post-training period, the incidence of permanent BPBI decreased significantly (0.05% vs 0.02%; P < .001), with the risk for permanent BPBI among those with SD reducing (43.5% vs 6.0%; P < .001) and the rate of successful posterior arm delivery increasing (11.3% vs 23.4%; P = .04) significantly after the implementation of systematic simulation-based training.

Study details: Findings are from a retrospective observational study including 113,785 vertex deliveries performed by a team of doctors and midwives after receiving the weekly 3-hour simulation-based training.

Disclosures: This study was funded by Helsinki University State Research Funding. No conflicts of interest were declared.

Source: Kaijomaa M et al. Impact of simulation training on the management of shoulder dystocia and incidence of permanent brachial plexus birth injury: An observational study. BJOG. 2022 (Aug 10). Doi: 10.1111/1471-0528.17278

Key clinical point: Weekly 3-hour simulation-based training of midwives and doctors on shoulder dystocia (SD) management significantly reduced the incidence of permanent brachial plexus birth injury (BPBI).

Major finding: Despite an increase in the incidence of SD cases (0.1% vs 0.3%; P < .001) and risk factors in pre-training vs post-training period, the incidence of permanent BPBI decreased significantly (0.05% vs 0.02%; P < .001), with the risk for permanent BPBI among those with SD reducing (43.5% vs 6.0%; P < .001) and the rate of successful posterior arm delivery increasing (11.3% vs 23.4%; P = .04) significantly after the implementation of systematic simulation-based training.

Study details: Findings are from a retrospective observational study including 113,785 vertex deliveries performed by a team of doctors and midwives after receiving the weekly 3-hour simulation-based training.

Disclosures: This study was funded by Helsinki University State Research Funding. No conflicts of interest were declared.

Source: Kaijomaa M et al. Impact of simulation training on the management of shoulder dystocia and incidence of permanent brachial plexus birth injury: An observational study. BJOG. 2022 (Aug 10). Doi: 10.1111/1471-0528.17278

Key clinical point: Weekly 3-hour simulation-based training of midwives and doctors on shoulder dystocia (SD) management significantly reduced the incidence of permanent brachial plexus birth injury (BPBI).

Major finding: Despite an increase in the incidence of SD cases (0.1% vs 0.3%; P < .001) and risk factors in pre-training vs post-training period, the incidence of permanent BPBI decreased significantly (0.05% vs 0.02%; P < .001), with the risk for permanent BPBI among those with SD reducing (43.5% vs 6.0%; P < .001) and the rate of successful posterior arm delivery increasing (11.3% vs 23.4%; P = .04) significantly after the implementation of systematic simulation-based training.

Study details: Findings are from a retrospective observational study including 113,785 vertex deliveries performed by a team of doctors and midwives after receiving the weekly 3-hour simulation-based training.

Disclosures: This study was funded by Helsinki University State Research Funding. No conflicts of interest were declared.

Source: Kaijomaa M et al. Impact of simulation training on the management of shoulder dystocia and incidence of permanent brachial plexus birth injury: An observational study. BJOG. 2022 (Aug 10). Doi: 10.1111/1471-0528.17278

In 2019, diabetes mellitus (DM) was the seventh leading cause of death in the United States, and currently, about 11% of the American population has a DM diagnosis.¹ Most have a diagnosis of type 2 diabetes (T2DM), which has a strong genetic predisposition, and the risk of developing T2DM increases with age, obesity, and lack of physical activity.^1,2 Nearly one-quarter of veterans have a diagnosis of DM, and DM is the leading cause of comorbidities, such as blindness, end-stage renal disease, and amputation for patients receiving care from the Veterans Health Administration (VHA).² The elevated incidence of DM in the veteran population is attributed to a variety of factors, including exposure to herbicides, such as Agent Orange, advanced age, increased risk of obesity, and limited access to high-quality food.³

After diagnosis, both the American Diabetes Association (ADA) and the American Association of Clinical Endocrinologists and American College of Endocrinology (AACE/ACE) emphasize the appropriate use of lifestyle management and pharmacologic therapy for DM care. The use of pharmacologic agents (oral medications, insulin, or noninsulin injectables) is often determined by efficacy, cost, potential adverse effects (AEs), and patient factors and comorbidities.^4,5

The initial recommendation for pharmacologic treatment for T2DM differs slightly between expert guidelines. The ADA and AACE/ACE recommend any of the following as initial monotherapy, listed in order to represent a hierarchy of usage: metformin, glucagon-like peptide-1 receptor agonists (GLP-1 RAs), sodium-glucose cotransporter 2 (SGLT-2) inhibitors, or dipeptidyl peptidase-4 (DPP-4) inhibitors, with the first 3 agents carrying the strongest recommendations.^4,5 For patients with established atherosclerotic cardiovascular disease (CVD), chronic kidney disease, or heart failure, it is recommended to start a long-acting GLP-1 RA or SGLT-2 inhibitor. For patients with T2DM and hemoglobin A_1c (HbA_1c) between 7.5% and 9.0% at diagnosis, the AACE/ACE recommend initiation of dual therapy using metformin alongside another first-line agent and recommend the addition of another antidiabetic agent if glycemic goals are not met after regular follow-up. AACE/ACE recommend the consideration of insulin therapy in symptomatic patients with HbA_1c > 9.0%.⁵ In contrast, the ADA recommends metformin as first-line therapy for all patients with T2DM and recommends dual therapy using metformin and another preferred agent (selection based on comorbidities) when HbA_1c is 1.5% to 2% above target. The ADA recommends the consideration of insulin with HbA_1c > 10% or with evidence of ongoing catabolism or symptoms of hyperglycemia.⁴ There are several reasons why insulin may be initiated prior to GLP-1 RAs, including profound hyperglycemia at time of diagnosis or implementation of insulin agents prior to commercial availability of GLP-1 RA.

GLP-1 RAs are analogs of the hormone incretin, which increases glucose-dependent insulin secretion, decreases postprandial glucagon secretion, increases satiety, and slows gastric emptying.^6,7 When used in combination with noninsulin agents, GLP-1 RAs have demonstrated HbA_1c reductions of 0.5% to 1.5%.⁸ The use of GLP-1 RAs with basal insulin also has been studied extensively.^6,8-10 When the combination of GLP-1 RAs and basal insulin was compared with basal/bolus insulin regimens, the use of the GLP-1 RAs resulted in lower HbA_1c levels and lower incidence of hypoglycemia.^6,9 Data have demonstrated the complementary mechanisms of using basal insulin and GLP 1 RAs in decreasing HbA_1c levels, insulin requirements, and weight compared with using basal insulin monotherapy and basal/bolus combinations.^6,9-13 Moreover, 3 GLP-1 RA medications currently on the market (liraglutide, dulaglutide, and semaglutide) have displayed cardiovascular and renal benefits, further supporting the use of these medications.^2,5

Despite these benefits, GLP-1 RAs may have bothersome AEs and are associated with a high cost.⁶ In addition, some studies have found that as the length of therapy increases, the positive effects of these agents may diminish.^9,11 In one study, which looked at the impact of the addition of exenatide to patients taking basal or basal/bolus insulin regimens, mean changes in weight were −2.4 kg at 0 to 6 months, −4.3 kg at 6 to 12 months, −6.2 kg at 12 to 18 months, and −5.5 kg at 18 to 27 months. After 18 months, an increase in weight was observed, but the increase remained lower than baseline.¹¹ Another study, conducted over 12 months, found no significant decrease in weight or total daily dose (TDD) of insulin when exenatide or liraglutide were added to various insulin regimens (basal or basal/bolus).¹³ To date, minimal published data exist regarding the addition of newer GLP-1 RAs and the long-term use of these agents beyond 12 months in patients taking basal/bolus insulin regimens. The primary goal of this study was to evaluate the effect of adding GLP-1 RAs to basal/bolus insulin regimens over a 24-month period.

Methods

This study was a retrospective, electronic health record review of all patients on basal and bolus insulin regimens who received additional therapy with a GLP-1 RA at Veteran Health Indiana in Indianapolis from September 1, 2015, to June 30, 2019. Patients meeting inclusion criteria served as their own control. The primary outcome was change in HbA_1c at 3, 6, 12, 18, and 24 months after initiation of the GLP-1 RA. Secondary outcomes included change in weight and TDD of insulin at 3, 6, 12, 18, and 24 months after the initiation of the GLP-1 RAs and incidence of patient-reported or laboratory-confirmed hypoglycemia and other AEs.

Patients were included if they were aged ≥ 18 years with a diagnosis of T2DM, had concomitant prescriptions for both a basal insulin (glargine, detemir, or NPH) and a bolus insulin (aspart, lispro, or regular) before receiving add-on therapy with a GLP-1 RA (exenatide, liraglutide, albiglutide, lixisenatide, dulaglutide, or semaglutide) from September 1, 2015, to June 30, 2019, and had baseline and subsequent Hb A_1c measurements available in the electronic health record. Patients were excluded if they had a diagnosis of T1DM, were followed by an outside clinician for DM care, or if the GLP-1 RA was discontinued before subsequent HbA_1c measurement. The study protocol was approved by the Research and Development Office of Veteran Health Indiana, and the project was deemed exempt from review by the Indiana University Institutional Review Board due to the retrospective nature of the study.

Data analysis was performed using Excel. Change from baseline for each interval was computed, and 1 sample t tests (2-tailed) compared change from baseline to no change. Due to the disparity in the number of patients with data available at each of the time intervals, a mean plot was presented for each group of patients within each interval, allowing mean changes in individual groups to be observed over time.

Results

One hundred twenty-three subjects met inclusion criteria; 16 patients were excluded due to GLP-1 RA discontinuation before follow-up measurement of HbA_1c; 14 were excluded due to patients being managed by a clinician outside of the facility; 1 patient was excluded for lack of documentation regarding baseline and subsequent insulin doses. Ninety-two patient charts were reviewed. Participants had a mean age of 64 years, 95% were male, and 89% were White. Mean baseline Hb A_1c was 9.2%, mean body mass index was 38.9, and the mean TDD of insulin was 184 units. Mean duration of DM was 10 years, and mean use of basal/bolus insulin regimen was 6.1 years. Most participants (91%) used an insulin regimen containing insulin glargine and insulin aspart; the remaining participants used insulin detemir and insulin aspart. Semaglutide and liraglutide were the most commonly used GLP-1 RAs (44% and 39%, respectively) (Table 1).

Since some patients switched between GLP-1 RAs throughout the study and there was variation in timing of laboratory and clinic follow-up, a different number of patient charts were available for review at each period (Table 2). Glycemic control was significantly improved at all time points when compared with baseline, but over time the benefit declined. The mean change in HbA_1c was −1.1% (95% CI, −1.3 to −0.8; P < .001) at 3 months; −1.0% (95% CI, −1.3 to −0.7; P < .001) at 6 months; −0.9% (95% CI, −1.3 to −0.6; P < .001) at 12 months; −0.9% (95% CI −1.4 to −0.3; P = .002) at 18 months; and −0.7% (95% CI, −1.4 to 0.1; P = .07) at 24 months (Figure 1). Mean weight decreased from baseline −2.7 kg (95% CI, −3.7 to −1.6; P < .001); −4.4 kg (95% CI −5.7 to −3.2; P < .001) at 6 months; −3.9 kg (95% CI −6.0 to −1.9; P < .001) at 12 months; −4.7 kg (95% CI −6.7 to −2.6; P < .001) at 18 months; and −2.8 kg (95% CI, −5.9 to 0.3; P = .07) at 24 months (Figure 2). Mean TDD decreased at 3 months −12 units (95% CI, −19 to −5; P < .001); −18 units (95% CI, −27 to −9; P < .001) at 6 months; −14 units (95% CI, −24 to −5; P = .004) at 12 months; −9 units (95% CI, −21 to 3; P = .15) at 18 months; and −18 units (95% CI, −43 to 5 units; P = .12) at 24 months (Figure 3). The most common AEs were hypoglycemia (30%), diarrhea (11%), nausea (4%), and abdominal pain (3%).

Discussion

Adding a GLP-1 RA to basal/bolus insulin regimens was associated with a statistically significant decrease in HbA_1c at each time point through 18 months. The greatest improvement in glycemic control from baseline was seen at 3 months, with improvements in HbA_1c diminishing at each subsequent period. The study also demonstrated a significant decrease in weight at each time point through 18 months. The greatest decrease in weight was observed at both 6 and 12 months. Statistically significant decreases in TDD were observed at 3, 6, and 12 months. Insulin changes after 12 months were not found to be statistically significant.

Few studies have previously evaluated the use of GLP-1 RAs in patients with T2DM who are already taking basal/bolus insulin regimens. Gyorffy and colleagues reported significant improvements in glycemic control at 3 and 6 months in a sample of 54 patients taking basal/bolus insulin when liraglutide or exenatide was added, although statistical significance was not found at the final 12-month time point.¹³ That study also found a significant decrease in weight at 6 months; however there was not a significant reduction in weight at both 3 and 12 months of GLP-1 RA therapy. There was not a significant decrease in TDD at any of the collected time points. Nonetheless, Gyorffy and colleagues concluded that reduction in TDD leveled off after 12 months, which is consistent with this study’s findings. The small size of the study may have limited the ability to detect statistical significance; however, this study was conducted in a population that was racially diverse and included a higher proportion of women, though average age was similar.¹³

Yoon and colleagues reported weight loss through 18 months, then saw weight increase, though weights did remain lover than baseline. The study also showed no significant change in TDD of insulin after 12 months of concomitant exenatide and insulin therapy.¹¹ Although these results mirror the outcomes observed in this study, Yoon and colleagues did not differentiate results between basal and basal/bolus insulin groups.¹¹ Seino and colleagues observed no significant change in weight after 36 weeks of GLP-1 RA therapy in Japanese patients when used with basal and basal/bolus insulin regimens. Despite the consideration that the population in the study was not overweight (mean body mass index was 25.6), the results of these studies support the idea that effects of GLP-1 RAs on weight and TDD may diminish over time.¹⁴

Within the VHA, GLP-1 RAs are nonformulary medications. Patients must meet certain criteria in order to be approved for these agents, which may include diagnosis of CVD, renal disease, or failure to reach glycemic control with the use of oral agents or insulin. Therefore, participants of this study represent a particular subset of VHA patients, many of whom may have been selected for consideration due to long-standing or uncontrolled T2DM and failure of previous therapies. The baseline demographics support this idea, given poor glycemic control at baseline and high insulin requirements. Once approved for GLP-1 RA therapy, semaglutide is currently the preferred agent within the VHA, with other agents being available for select considerations. It should be noted that albiglutide, which was the primary agent selected for some of the patients included in this study, was removed from the market in 2017 for economic considerations.¹⁵ In the case for these patients, a conversion to a formulary-preferred GLP-1 RA was made.

Most of the patients included in this study (70%) were maintained on metformin from baseline throughout the study period. Fifty-seven percent of patients were taking TDD of insulin > 150 units. Considering the significant cost of concentrated insulins, the addition of GLP-1 RAs to standard insulin may prove to be beneficial from a cost standpoint. Additional research in this area may be warranted to establish more data regarding this potential benefit of GLP-1 RAs as add-on therapy.

Limitations and Strengths

Limitations of this study include a small patient population and a gradual reduction in available data as time periods progressed, making even smaller sample sizes for subsequent time periods. A majority of participants were older males of White race. This could have limited the determination of statistical significance and applicability of the results to other patient populations. Another potential limitation was the retrospective nature of the study design, which may have limited reporting of hypoglycemia and other AEs based on the documentation of the clinician.

Strengths included the length of study duration and the diversity of GLP-1 RAs used by participants, as the impact of many of these agents has not yet been assessed in the literature. In addition, the retrospective nature of the study allows for a more realistic representation of patient adherence, education, and motivation, which are likely different from those of patients included in prospective clinical trials.

There are no clear guidelines dictating the optimal duration of concomitant GLP-1 RA and insulin therapy; however, our study suggests that there may be continued benefits past short-term use. Also our study suggests that patients with T2DM treated with basal/bolus insulin regimens may glean additional benefit from adding GLP-1 RAs; however, further randomized, controlled studies are warranted, particularly in poorly controlled patients requiring even more aggressive treatment regimens, such as concentrated insulins.

Conclusions

In our study, adding GLP-1 RA to basal/bolus insulin was associated with a significant decrease in HbA_1c from baseline through 18 months. An overall decrease in weight and TDD of insulin was observed through 24 months, but the change in weight was not significant past 18 months, and the change in insulin requirement was not significant past 12 months. Hypoglycemia was observed in almost one-third of patients, and gastrointestinal symptoms were the most common AE observed as a result adding GLP-1 RAs. More studies are needed to better evaluate the durability and cost benefit of GLP-1 RAs, especially in patients with high insulin requirements.

Acknowledgments

This material is the result of work supported with resources and facilities at Veteran Health Indiana in Indianapolis. Study data were collected and managed using REDCap electronic data capture tools hosted at Veteran Health Indiana. The authors also acknowledge George Eckert for his assistance with data analysis.

In 2019, diabetes mellitus (DM) was the seventh leading cause of death in the United States, and currently, about 11% of the American population has a DM diagnosis.¹ Most have a diagnosis of type 2 diabetes (T2DM), which has a strong genetic predisposition, and the risk of developing T2DM increases with age, obesity, and lack of physical activity.^1,2 Nearly one-quarter of veterans have a diagnosis of DM, and DM is the leading cause of comorbidities, such as blindness, end-stage renal disease, and amputation for patients receiving care from the Veterans Health Administration (VHA).² The elevated incidence of DM in the veteran population is attributed to a variety of factors, including exposure to herbicides, such as Agent Orange, advanced age, increased risk of obesity, and limited access to high-quality food.³

After diagnosis, both the American Diabetes Association (ADA) and the American Association of Clinical Endocrinologists and American College of Endocrinology (AACE/ACE) emphasize the appropriate use of lifestyle management and pharmacologic therapy for DM care. The use of pharmacologic agents (oral medications, insulin, or noninsulin injectables) is often determined by efficacy, cost, potential adverse effects (AEs), and patient factors and comorbidities.^4,5

The initial recommendation for pharmacologic treatment for T2DM differs slightly between expert guidelines. The ADA and AACE/ACE recommend any of the following as initial monotherapy, listed in order to represent a hierarchy of usage: metformin, glucagon-like peptide-1 receptor agonists (GLP-1 RAs), sodium-glucose cotransporter 2 (SGLT-2) inhibitors, or dipeptidyl peptidase-4 (DPP-4) inhibitors, with the first 3 agents carrying the strongest recommendations.^4,5 For patients with established atherosclerotic cardiovascular disease (CVD), chronic kidney disease, or heart failure, it is recommended to start a long-acting GLP-1 RA or SGLT-2 inhibitor. For patients with T2DM and hemoglobin A_1c (HbA_1c) between 7.5% and 9.0% at diagnosis, the AACE/ACE recommend initiation of dual therapy using metformin alongside another first-line agent and recommend the addition of another antidiabetic agent if glycemic goals are not met after regular follow-up. AACE/ACE recommend the consideration of insulin therapy in symptomatic patients with HbA_1c > 9.0%.⁵ In contrast, the ADA recommends metformin as first-line therapy for all patients with T2DM and recommends dual therapy using metformin and another preferred agent (selection based on comorbidities) when HbA_1c is 1.5% to 2% above target. The ADA recommends the consideration of insulin with HbA_1c > 10% or with evidence of ongoing catabolism or symptoms of hyperglycemia.⁴ There are several reasons why insulin may be initiated prior to GLP-1 RAs, including profound hyperglycemia at time of diagnosis or implementation of insulin agents prior to commercial availability of GLP-1 RA.

GLP-1 RAs are analogs of the hormone incretin, which increases glucose-dependent insulin secretion, decreases postprandial glucagon secretion, increases satiety, and slows gastric emptying.^6,7 When used in combination with noninsulin agents, GLP-1 RAs have demonstrated HbA_1c reductions of 0.5% to 1.5%.⁸ The use of GLP-1 RAs with basal insulin also has been studied extensively.^6,8-10 When the combination of GLP-1 RAs and basal insulin was compared with basal/bolus insulin regimens, the use of the GLP-1 RAs resulted in lower HbA_1c levels and lower incidence of hypoglycemia.^6,9 Data have demonstrated the complementary mechanisms of using basal insulin and GLP 1 RAs in decreasing HbA_1c levels, insulin requirements, and weight compared with using basal insulin monotherapy and basal/bolus combinations.^6,9-13 Moreover, 3 GLP-1 RA medications currently on the market (liraglutide, dulaglutide, and semaglutide) have displayed cardiovascular and renal benefits, further supporting the use of these medications.^2,5

Despite these benefits, GLP-1 RAs may have bothersome AEs and are associated with a high cost.⁶ In addition, some studies have found that as the length of therapy increases, the positive effects of these agents may diminish.^9,11 In one study, which looked at the impact of the addition of exenatide to patients taking basal or basal/bolus insulin regimens, mean changes in weight were −2.4 kg at 0 to 6 months, −4.3 kg at 6 to 12 months, −6.2 kg at 12 to 18 months, and −5.5 kg at 18 to 27 months. After 18 months, an increase in weight was observed, but the increase remained lower than baseline.¹¹ Another study, conducted over 12 months, found no significant decrease in weight or total daily dose (TDD) of insulin when exenatide or liraglutide were added to various insulin regimens (basal or basal/bolus).¹³ To date, minimal published data exist regarding the addition of newer GLP-1 RAs and the long-term use of these agents beyond 12 months in patients taking basal/bolus insulin regimens. The primary goal of this study was to evaluate the effect of adding GLP-1 RAs to basal/bolus insulin regimens over a 24-month period.

Methods

This study was a retrospective, electronic health record review of all patients on basal and bolus insulin regimens who received additional therapy with a GLP-1 RA at Veteran Health Indiana in Indianapolis from September 1, 2015, to June 30, 2019. Patients meeting inclusion criteria served as their own control. The primary outcome was change in HbA_1c at 3, 6, 12, 18, and 24 months after initiation of the GLP-1 RA. Secondary outcomes included change in weight and TDD of insulin at 3, 6, 12, 18, and 24 months after the initiation of the GLP-1 RAs and incidence of patient-reported or laboratory-confirmed hypoglycemia and other AEs.

Patients were included if they were aged ≥ 18 years with a diagnosis of T2DM, had concomitant prescriptions for both a basal insulin (glargine, detemir, or NPH) and a bolus insulin (aspart, lispro, or regular) before receiving add-on therapy with a GLP-1 RA (exenatide, liraglutide, albiglutide, lixisenatide, dulaglutide, or semaglutide) from September 1, 2015, to June 30, 2019, and had baseline and subsequent Hb A_1c measurements available in the electronic health record. Patients were excluded if they had a diagnosis of T1DM, were followed by an outside clinician for DM care, or if the GLP-1 RA was discontinued before subsequent HbA_1c measurement. The study protocol was approved by the Research and Development Office of Veteran Health Indiana, and the project was deemed exempt from review by the Indiana University Institutional Review Board due to the retrospective nature of the study.

Data analysis was performed using Excel. Change from baseline for each interval was computed, and 1 sample t tests (2-tailed) compared change from baseline to no change. Due to the disparity in the number of patients with data available at each of the time intervals, a mean plot was presented for each group of patients within each interval, allowing mean changes in individual groups to be observed over time.

Results

One hundred twenty-three subjects met inclusion criteria; 16 patients were excluded due to GLP-1 RA discontinuation before follow-up measurement of HbA_1c; 14 were excluded due to patients being managed by a clinician outside of the facility; 1 patient was excluded for lack of documentation regarding baseline and subsequent insulin doses. Ninety-two patient charts were reviewed. Participants had a mean age of 64 years, 95% were male, and 89% were White. Mean baseline Hb A_1c was 9.2%, mean body mass index was 38.9, and the mean TDD of insulin was 184 units. Mean duration of DM was 10 years, and mean use of basal/bolus insulin regimen was 6.1 years. Most participants (91%) used an insulin regimen containing insulin glargine and insulin aspart; the remaining participants used insulin detemir and insulin aspart. Semaglutide and liraglutide were the most commonly used GLP-1 RAs (44% and 39%, respectively) (Table 1).

Since some patients switched between GLP-1 RAs throughout the study and there was variation in timing of laboratory and clinic follow-up, a different number of patient charts were available for review at each period (Table 2). Glycemic control was significantly improved at all time points when compared with baseline, but over time the benefit declined. The mean change in HbA_1c was −1.1% (95% CI, −1.3 to −0.8; P < .001) at 3 months; −1.0% (95% CI, −1.3 to −0.7; P < .001) at 6 months; −0.9% (95% CI, −1.3 to −0.6; P < .001) at 12 months; −0.9% (95% CI −1.4 to −0.3; P = .002) at 18 months; and −0.7% (95% CI, −1.4 to 0.1; P = .07) at 24 months (Figure 1). Mean weight decreased from baseline −2.7 kg (95% CI, −3.7 to −1.6; P < .001); −4.4 kg (95% CI −5.7 to −3.2; P < .001) at 6 months; −3.9 kg (95% CI −6.0 to −1.9; P < .001) at 12 months; −4.7 kg (95% CI −6.7 to −2.6; P < .001) at 18 months; and −2.8 kg (95% CI, −5.9 to 0.3; P = .07) at 24 months (Figure 2). Mean TDD decreased at 3 months −12 units (95% CI, −19 to −5; P < .001); −18 units (95% CI, −27 to −9; P < .001) at 6 months; −14 units (95% CI, −24 to −5; P = .004) at 12 months; −9 units (95% CI, −21 to 3; P = .15) at 18 months; and −18 units (95% CI, −43 to 5 units; P = .12) at 24 months (Figure 3). The most common AEs were hypoglycemia (30%), diarrhea (11%), nausea (4%), and abdominal pain (3%).

Discussion

Adding a GLP-1 RA to basal/bolus insulin regimens was associated with a statistically significant decrease in HbA_1c at each time point through 18 months. The greatest improvement in glycemic control from baseline was seen at 3 months, with improvements in HbA_1c diminishing at each subsequent period. The study also demonstrated a significant decrease in weight at each time point through 18 months. The greatest decrease in weight was observed at both 6 and 12 months. Statistically significant decreases in TDD were observed at 3, 6, and 12 months. Insulin changes after 12 months were not found to be statistically significant.

Few studies have previously evaluated the use of GLP-1 RAs in patients with T2DM who are already taking basal/bolus insulin regimens. Gyorffy and colleagues reported significant improvements in glycemic control at 3 and 6 months in a sample of 54 patients taking basal/bolus insulin when liraglutide or exenatide was added, although statistical significance was not found at the final 12-month time point.¹³ That study also found a significant decrease in weight at 6 months; however there was not a significant reduction in weight at both 3 and 12 months of GLP-1 RA therapy. There was not a significant decrease in TDD at any of the collected time points. Nonetheless, Gyorffy and colleagues concluded that reduction in TDD leveled off after 12 months, which is consistent with this study’s findings. The small size of the study may have limited the ability to detect statistical significance; however, this study was conducted in a population that was racially diverse and included a higher proportion of women, though average age was similar.¹³

Yoon and colleagues reported weight loss through 18 months, then saw weight increase, though weights did remain lover than baseline. The study also showed no significant change in TDD of insulin after 12 months of concomitant exenatide and insulin therapy.¹¹ Although these results mirror the outcomes observed in this study, Yoon and colleagues did not differentiate results between basal and basal/bolus insulin groups.¹¹ Seino and colleagues observed no significant change in weight after 36 weeks of GLP-1 RA therapy in Japanese patients when used with basal and basal/bolus insulin regimens. Despite the consideration that the population in the study was not overweight (mean body mass index was 25.6), the results of these studies support the idea that effects of GLP-1 RAs on weight and TDD may diminish over time.¹⁴

Within the VHA, GLP-1 RAs are nonformulary medications. Patients must meet certain criteria in order to be approved for these agents, which may include diagnosis of CVD, renal disease, or failure to reach glycemic control with the use of oral agents or insulin. Therefore, participants of this study represent a particular subset of VHA patients, many of whom may have been selected for consideration due to long-standing or uncontrolled T2DM and failure of previous therapies. The baseline demographics support this idea, given poor glycemic control at baseline and high insulin requirements. Once approved for GLP-1 RA therapy, semaglutide is currently the preferred agent within the VHA, with other agents being available for select considerations. It should be noted that albiglutide, which was the primary agent selected for some of the patients included in this study, was removed from the market in 2017 for economic considerations.¹⁵ In the case for these patients, a conversion to a formulary-preferred GLP-1 RA was made.

Most of the patients included in this study (70%) were maintained on metformin from baseline throughout the study period. Fifty-seven percent of patients were taking TDD of insulin > 150 units. Considering the significant cost of concentrated insulins, the addition of GLP-1 RAs to standard insulin may prove to be beneficial from a cost standpoint. Additional research in this area may be warranted to establish more data regarding this potential benefit of GLP-1 RAs as add-on therapy.

Limitations and Strengths

Limitations of this study include a small patient population and a gradual reduction in available data as time periods progressed, making even smaller sample sizes for subsequent time periods. A majority of participants were older males of White race. This could have limited the determination of statistical significance and applicability of the results to other patient populations. Another potential limitation was the retrospective nature of the study design, which may have limited reporting of hypoglycemia and other AEs based on the documentation of the clinician.

Strengths included the length of study duration and the diversity of GLP-1 RAs used by participants, as the impact of many of these agents has not yet been assessed in the literature. In addition, the retrospective nature of the study allows for a more realistic representation of patient adherence, education, and motivation, which are likely different from those of patients included in prospective clinical trials.

There are no clear guidelines dictating the optimal duration of concomitant GLP-1 RA and insulin therapy; however, our study suggests that there may be continued benefits past short-term use. Also our study suggests that patients with T2DM treated with basal/bolus insulin regimens may glean additional benefit from adding GLP-1 RAs; however, further randomized, controlled studies are warranted, particularly in poorly controlled patients requiring even more aggressive treatment regimens, such as concentrated insulins.

Conclusions

In our study, adding GLP-1 RA to basal/bolus insulin was associated with a significant decrease in HbA_1c from baseline through 18 months. An overall decrease in weight and TDD of insulin was observed through 24 months, but the change in weight was not significant past 18 months, and the change in insulin requirement was not significant past 12 months. Hypoglycemia was observed in almost one-third of patients, and gastrointestinal symptoms were the most common AE observed as a result adding GLP-1 RAs. More studies are needed to better evaluate the durability and cost benefit of GLP-1 RAs, especially in patients with high insulin requirements.

Acknowledgments

This material is the result of work supported with resources and facilities at Veteran Health Indiana in Indianapolis. Study data were collected and managed using REDCap electronic data capture tools hosted at Veteran Health Indiana. The authors also acknowledge George Eckert for his assistance with data analysis.

In 2019, diabetes mellitus (DM) was the seventh leading cause of death in the United States, and currently, about 11% of the American population has a DM diagnosis.¹ Most have a diagnosis of type 2 diabetes (T2DM), which has a strong genetic predisposition, and the risk of developing T2DM increases with age, obesity, and lack of physical activity.^1,2 Nearly one-quarter of veterans have a diagnosis of DM, and DM is the leading cause of comorbidities, such as blindness, end-stage renal disease, and amputation for patients receiving care from the Veterans Health Administration (VHA).² The elevated incidence of DM in the veteran population is attributed to a variety of factors, including exposure to herbicides, such as Agent Orange, advanced age, increased risk of obesity, and limited access to high-quality food.³

After diagnosis, both the American Diabetes Association (ADA) and the American Association of Clinical Endocrinologists and American College of Endocrinology (AACE/ACE) emphasize the appropriate use of lifestyle management and pharmacologic therapy for DM care. The use of pharmacologic agents (oral medications, insulin, or noninsulin injectables) is often determined by efficacy, cost, potential adverse effects (AEs), and patient factors and comorbidities.^4,5

The initial recommendation for pharmacologic treatment for T2DM differs slightly between expert guidelines. The ADA and AACE/ACE recommend any of the following as initial monotherapy, listed in order to represent a hierarchy of usage: metformin, glucagon-like peptide-1 receptor agonists (GLP-1 RAs), sodium-glucose cotransporter 2 (SGLT-2) inhibitors, or dipeptidyl peptidase-4 (DPP-4) inhibitors, with the first 3 agents carrying the strongest recommendations.^4,5 For patients with established atherosclerotic cardiovascular disease (CVD), chronic kidney disease, or heart failure, it is recommended to start a long-acting GLP-1 RA or SGLT-2 inhibitor. For patients with T2DM and hemoglobin A_1c (HbA_1c) between 7.5% and 9.0% at diagnosis, the AACE/ACE recommend initiation of dual therapy using metformin alongside another first-line agent and recommend the addition of another antidiabetic agent if glycemic goals are not met after regular follow-up. AACE/ACE recommend the consideration of insulin therapy in symptomatic patients with HbA_1c > 9.0%.⁵ In contrast, the ADA recommends metformin as first-line therapy for all patients with T2DM and recommends dual therapy using metformin and another preferred agent (selection based on comorbidities) when HbA_1c is 1.5% to 2% above target. The ADA recommends the consideration of insulin with HbA_1c > 10% or with evidence of ongoing catabolism or symptoms of hyperglycemia.⁴ There are several reasons why insulin may be initiated prior to GLP-1 RAs, including profound hyperglycemia at time of diagnosis or implementation of insulin agents prior to commercial availability of GLP-1 RA.

GLP-1 RAs are analogs of the hormone incretin, which increases glucose-dependent insulin secretion, decreases postprandial glucagon secretion, increases satiety, and slows gastric emptying.^6,7 When used in combination with noninsulin agents, GLP-1 RAs have demonstrated HbA_1c reductions of 0.5% to 1.5%.⁸ The use of GLP-1 RAs with basal insulin also has been studied extensively.^6,8-10 When the combination of GLP-1 RAs and basal insulin was compared with basal/bolus insulin regimens, the use of the GLP-1 RAs resulted in lower HbA_1c levels and lower incidence of hypoglycemia.^6,9 Data have demonstrated the complementary mechanisms of using basal insulin and GLP 1 RAs in decreasing HbA_1c levels, insulin requirements, and weight compared with using basal insulin monotherapy and basal/bolus combinations.^6,9-13 Moreover, 3 GLP-1 RA medications currently on the market (liraglutide, dulaglutide, and semaglutide) have displayed cardiovascular and renal benefits, further supporting the use of these medications.^2,5

Despite these benefits, GLP-1 RAs may have bothersome AEs and are associated with a high cost.⁶ In addition, some studies have found that as the length of therapy increases, the positive effects of these agents may diminish.^9,11 In one study, which looked at the impact of the addition of exenatide to patients taking basal or basal/bolus insulin regimens, mean changes in weight were −2.4 kg at 0 to 6 months, −4.3 kg at 6 to 12 months, −6.2 kg at 12 to 18 months, and −5.5 kg at 18 to 27 months. After 18 months, an increase in weight was observed, but the increase remained lower than baseline.¹¹ Another study, conducted over 12 months, found no significant decrease in weight or total daily dose (TDD) of insulin when exenatide or liraglutide were added to various insulin regimens (basal or basal/bolus).¹³ To date, minimal published data exist regarding the addition of newer GLP-1 RAs and the long-term use of these agents beyond 12 months in patients taking basal/bolus insulin regimens. The primary goal of this study was to evaluate the effect of adding GLP-1 RAs to basal/bolus insulin regimens over a 24-month period.

Methods

This study was a retrospective, electronic health record review of all patients on basal and bolus insulin regimens who received additional therapy with a GLP-1 RA at Veteran Health Indiana in Indianapolis from September 1, 2015, to June 30, 2019. Patients meeting inclusion criteria served as their own control. The primary outcome was change in HbA_1c at 3, 6, 12, 18, and 24 months after initiation of the GLP-1 RA. Secondary outcomes included change in weight and TDD of insulin at 3, 6, 12, 18, and 24 months after the initiation of the GLP-1 RAs and incidence of patient-reported or laboratory-confirmed hypoglycemia and other AEs.

Patients were included if they were aged ≥ 18 years with a diagnosis of T2DM, had concomitant prescriptions for both a basal insulin (glargine, detemir, or NPH) and a bolus insulin (aspart, lispro, or regular) before receiving add-on therapy with a GLP-1 RA (exenatide, liraglutide, albiglutide, lixisenatide, dulaglutide, or semaglutide) from September 1, 2015, to June 30, 2019, and had baseline and subsequent Hb A_1c measurements available in the electronic health record. Patients were excluded if they had a diagnosis of T1DM, were followed by an outside clinician for DM care, or if the GLP-1 RA was discontinued before subsequent HbA_1c measurement. The study protocol was approved by the Research and Development Office of Veteran Health Indiana, and the project was deemed exempt from review by the Indiana University Institutional Review Board due to the retrospective nature of the study.

Data analysis was performed using Excel. Change from baseline for each interval was computed, and 1 sample t tests (2-tailed) compared change from baseline to no change. Due to the disparity in the number of patients with data available at each of the time intervals, a mean plot was presented for each group of patients within each interval, allowing mean changes in individual groups to be observed over time.

Results

One hundred twenty-three subjects met inclusion criteria; 16 patients were excluded due to GLP-1 RA discontinuation before follow-up measurement of HbA_1c; 14 were excluded due to patients being managed by a clinician outside of the facility; 1 patient was excluded for lack of documentation regarding baseline and subsequent insulin doses. Ninety-two patient charts were reviewed. Participants had a mean age of 64 years, 95% were male, and 89% were White. Mean baseline Hb A_1c was 9.2%, mean body mass index was 38.9, and the mean TDD of insulin was 184 units. Mean duration of DM was 10 years, and mean use of basal/bolus insulin regimen was 6.1 years. Most participants (91%) used an insulin regimen containing insulin glargine and insulin aspart; the remaining participants used insulin detemir and insulin aspart. Semaglutide and liraglutide were the most commonly used GLP-1 RAs (44% and 39%, respectively) (Table 1).

Since some patients switched between GLP-1 RAs throughout the study and there was variation in timing of laboratory and clinic follow-up, a different number of patient charts were available for review at each period (Table 2). Glycemic control was significantly improved at all time points when compared with baseline, but over time the benefit declined. The mean change in HbA_1c was −1.1% (95% CI, −1.3 to −0.8; P < .001) at 3 months; −1.0% (95% CI, −1.3 to −0.7; P < .001) at 6 months; −0.9% (95% CI, −1.3 to −0.6; P < .001) at 12 months; −0.9% (95% CI −1.4 to −0.3; P = .002) at 18 months; and −0.7% (95% CI, −1.4 to 0.1; P = .07) at 24 months (Figure 1). Mean weight decreased from baseline −2.7 kg (95% CI, −3.7 to −1.6; P < .001); −4.4 kg (95% CI −5.7 to −3.2; P < .001) at 6 months; −3.9 kg (95% CI −6.0 to −1.9; P < .001) at 12 months; −4.7 kg (95% CI −6.7 to −2.6; P < .001) at 18 months; and −2.8 kg (95% CI, −5.9 to 0.3; P = .07) at 24 months (Figure 2). Mean TDD decreased at 3 months −12 units (95% CI, −19 to −5; P < .001); −18 units (95% CI, −27 to −9; P < .001) at 6 months; −14 units (95% CI, −24 to −5; P = .004) at 12 months; −9 units (95% CI, −21 to 3; P = .15) at 18 months; and −18 units (95% CI, −43 to 5 units; P = .12) at 24 months (Figure 3). The most common AEs were hypoglycemia (30%), diarrhea (11%), nausea (4%), and abdominal pain (3%).

Discussion

Adding a GLP-1 RA to basal/bolus insulin regimens was associated with a statistically significant decrease in HbA_1c at each time point through 18 months. The greatest improvement in glycemic control from baseline was seen at 3 months, with improvements in HbA_1c diminishing at each subsequent period. The study also demonstrated a significant decrease in weight at each time point through 18 months. The greatest decrease in weight was observed at both 6 and 12 months. Statistically significant decreases in TDD were observed at 3, 6, and 12 months. Insulin changes after 12 months were not found to be statistically significant.

Few studies have previously evaluated the use of GLP-1 RAs in patients with T2DM who are already taking basal/bolus insulin regimens. Gyorffy and colleagues reported significant improvements in glycemic control at 3 and 6 months in a sample of 54 patients taking basal/bolus insulin when liraglutide or exenatide was added, although statistical significance was not found at the final 12-month time point.¹³ That study also found a significant decrease in weight at 6 months; however there was not a significant reduction in weight at both 3 and 12 months of GLP-1 RA therapy. There was not a significant decrease in TDD at any of the collected time points. Nonetheless, Gyorffy and colleagues concluded that reduction in TDD leveled off after 12 months, which is consistent with this study’s findings. The small size of the study may have limited the ability to detect statistical significance; however, this study was conducted in a population that was racially diverse and included a higher proportion of women, though average age was similar.¹³

Yoon and colleagues reported weight loss through 18 months, then saw weight increase, though weights did remain lover than baseline. The study also showed no significant change in TDD of insulin after 12 months of concomitant exenatide and insulin therapy.¹¹ Although these results mirror the outcomes observed in this study, Yoon and colleagues did not differentiate results between basal and basal/bolus insulin groups.¹¹ Seino and colleagues observed no significant change in weight after 36 weeks of GLP-1 RA therapy in Japanese patients when used with basal and basal/bolus insulin regimens. Despite the consideration that the population in the study was not overweight (mean body mass index was 25.6), the results of these studies support the idea that effects of GLP-1 RAs on weight and TDD may diminish over time.¹⁴

Within the VHA, GLP-1 RAs are nonformulary medications. Patients must meet certain criteria in order to be approved for these agents, which may include diagnosis of CVD, renal disease, or failure to reach glycemic control with the use of oral agents or insulin. Therefore, participants of this study represent a particular subset of VHA patients, many of whom may have been selected for consideration due to long-standing or uncontrolled T2DM and failure of previous therapies. The baseline demographics support this idea, given poor glycemic control at baseline and high insulin requirements. Once approved for GLP-1 RA therapy, semaglutide is currently the preferred agent within the VHA, with other agents being available for select considerations. It should be noted that albiglutide, which was the primary agent selected for some of the patients included in this study, was removed from the market in 2017 for economic considerations.¹⁵ In the case for these patients, a conversion to a formulary-preferred GLP-1 RA was made.

Most of the patients included in this study (70%) were maintained on metformin from baseline throughout the study period. Fifty-seven percent of patients were taking TDD of insulin > 150 units. Considering the significant cost of concentrated insulins, the addition of GLP-1 RAs to standard insulin may prove to be beneficial from a cost standpoint. Additional research in this area may be warranted to establish more data regarding this potential benefit of GLP-1 RAs as add-on therapy.

Limitations and Strengths

Limitations of this study include a small patient population and a gradual reduction in available data as time periods progressed, making even smaller sample sizes for subsequent time periods. A majority of participants were older males of White race. This could have limited the determination of statistical significance and applicability of the results to other patient populations. Another potential limitation was the retrospective nature of the study design, which may have limited reporting of hypoglycemia and other AEs based on the documentation of the clinician.

Strengths included the length of study duration and the diversity of GLP-1 RAs used by participants, as the impact of many of these agents has not yet been assessed in the literature. In addition, the retrospective nature of the study allows for a more realistic representation of patient adherence, education, and motivation, which are likely different from those of patients included in prospective clinical trials.

There are no clear guidelines dictating the optimal duration of concomitant GLP-1 RA and insulin therapy; however, our study suggests that there may be continued benefits past short-term use. Also our study suggests that patients with T2DM treated with basal/bolus insulin regimens may glean additional benefit from adding GLP-1 RAs; however, further randomized, controlled studies are warranted, particularly in poorly controlled patients requiring even more aggressive treatment regimens, such as concentrated insulins.

Conclusions

In our study, adding GLP-1 RA to basal/bolus insulin was associated with a significant decrease in HbA_1c from baseline through 18 months. An overall decrease in weight and TDD of insulin was observed through 24 months, but the change in weight was not significant past 18 months, and the change in insulin requirement was not significant past 12 months. Hypoglycemia was observed in almost one-third of patients, and gastrointestinal symptoms were the most common AE observed as a result adding GLP-1 RAs. More studies are needed to better evaluate the durability and cost benefit of GLP-1 RAs, especially in patients with high insulin requirements.

Acknowledgments

This material is the result of work supported with resources and facilities at Veteran Health Indiana in Indianapolis. Study data were collected and managed using REDCap electronic data capture tools hosted at Veteran Health Indiana. The authors also acknowledge George Eckert for his assistance with data analysis.

CAN WE RETURN TO THE ABCS OF CRAFTING A MEDICAL RECORD NOTE? 

ROBERT L. BARBIERI, MD (OCTOBER 2021)

Physicians can  help provide EMR fixes

I appreciate Dr. Barbieri’s editorials and insight on many issues facing our profession. I would like to offer my comments on a recent article.

If you want your brakes fixed, don’t go to a shoe maker. Physicians seem to have lost our sense of who is most competent in determining the best way to practice and communicate medical care. Somehow we have turned this over to the bureaucrats, who seem to find ways to complicate the lives of both providers and patients. Maybe we are too busy caring for patients and trying to find ways to alleviate the burden placed on our time by the electronic medical record (EMR) system, which was touted as an improvement in medical care and increasing provider efficiency. Most of the time I hear my colleagues describing ways to “work around” an EMR system that has immense deficiencies in providing accurate information in a way that is easily digested by whomever is viewing the record. The universal ability to transfer information is simply not true. One colleague had the same office version of Cerner as was used in the hospital setting but was unable to send information back and forth due to the danger of the potential to corrupt the system. 

Dr. Barbieri mentioned his work around to make the record easier for the patient to read. I ask, what about the coding descriptions, which most systems are now requiring physicians to put in at the time of the encounter? In the past this was done by certified coders, who undergo a 1- to 2-year training program, and is now being performed by physicians who have minimal to no training in coding. (And who, by the way, can be fined for both under- and over coding.) The example Dr. Barbieri put forth for obesity comes to mind and is part of the medical record in all cases. The terminology used by ICD10 is not so kind and requires some imagination when trying to find the right code for many diagnoses.

When will we stop allowing others, who know little about medicine and caring for patients, to tell us how to provide the care that we have trained for 7-12 years on how  best to deliver?

William Sutton, MD

Muncie, Indiana

Dr. Barbieri responds

I thank Dr. Sutton for providing his experience with the electronic medical record. I agree with him that bureaucrats often create health care rules that do more to hinder than help patients. With regard to coding and billing, I use ICD-10 codes and  usually bill based on time, which includes both face-to-face time with the patient and time spent reviewing the patient’s medical records. Now that federal regulations require medical notes to be shared with patients, I craft my history, assessment, and plan with language that is easy for a patient to accept and understand, avoiding medical terms that patients might misinterpret.

Should microscopy  be replaced? 

I agree with many points Dr. Barbieri made in his editorial. However, I do not agree that the microscopic examination of the vaginal discharge should be replaced. NAAT offers some advantages, but it does not offer a complete assessment of the vaginal ecosystem and microbiome. I believe that NAAT should be used in conjunction with the pelvic examination and microscopic examination of the vaginal discharge.

Microscopic examination of the vaginal discharge can reveal:

• whether or not the squamous epithelial cells are estrogenized. The absence of estrogen will, along with physical findings, indicate the possibility that the patient is experiencing atrophic vaginitis.
• the presence of estrogenized squamous epithelial cells. Plus, a finding of erythema of the vaginal epithelium indicates that the patient has an inflammatory condition and vaginitis, suggesting a possible infection in addition to vaginitis. 
• the presence of white blood cells >5/40X magnification, which indicates the possible presence of infection in addition to vaginitis (eg, BV). 

I agree that NAAT can confirm an initial diagnosis or refute it. In the latter case, the physician can change treatment accordingly. In the absence or in conjunction with the presence of a sexually transmitted infection, the composition of the vaginal microbiome is significant (ie, determining if vaginal dysbiosis is present). Performing a comprehensive evaluation, determining if the most common pathogens are present in aerobic vaginitis and/or BV, plus completing a Lactobacillus panel can be expensive. If insurance companies do not pay for such testing, patients will be reluctant to pay out of pocket for these tests. 

My final comment addresses the administration of NAAT for aerobic vaginitis, and for BV, it is probably an ineffective treatment. Vaginal dysbiosis is based on whether the appropriate species of Lactobacillus is present, and the concentration. Treatment most likely will be based on replenishing or restoring the appropriate species of Lactobacillus to dominance. 

Sebastian Faro, MD, PhD

Houston, Texas

Dr. Barbieri responds

I agree with Dr. Faro; when used by highly trained clinicians, microscopy is an excellent tool for evaluating vaginal specimens. Expert clinicians, such as Dr. Faro, with a focus on infectious diseases do not need to rely on NAAT testing except for identifying cases of T vaginalis infection. However, in standard clinical practice, microscopy performs poorly, resulting in misdiagnosis.¹ In the average clinical practice, NAAT testing may help improve patient outcomes. 

1. Gaydos CA, Beqaj S, Schwebke JR, et al. Clinical validation of a test for the diagnosis of vaginitis. Obstet Gynecol. 2017;130:181-189.

A note of thanks

I am a 74-year-old ObGyn who finished training at the University of North Carolina in 1979. Currently, I am working at a rural health group 2 days a week as a source of in-house gyn referral for 17 primary care physicians and mid-level providers. Our patients are almost all underserved and self-pay. The bulk of my work is related to evaluating abnormal uterine bleeding and abnormal Pap tests. Your publication of OBG Management serves now as one of my main sources of information. I just wanted to thank you and let you know that the publication is important. Keep up the good work and best wishes. 

Julian Brantley, MD

Rocky Mountain, North Carolina
 

Dr. Barbieri responds

I thank Dr. Brantley for taking time from a busy practice to write about how OBG Management provides practical information relevant to practice. Each issue of OBG Management is built on a foundation of insights from expert clinicians, which is crafted into a finished product by a superb editorial team. Our goal is to enhance the quality of women’s health care and the professional development of obstetrician-gynecologists and all women’s health care clinicians. ●

CAN WE RETURN TO THE ABCS OF CRAFTING A MEDICAL RECORD NOTE? 

ROBERT L. BARBIERI, MD (OCTOBER 2021)

Physicians can  help provide EMR fixes

I appreciate Dr. Barbieri’s editorials and insight on many issues facing our profession. I would like to offer my comments on a recent article.

If you want your brakes fixed, don’t go to a shoe maker. Physicians seem to have lost our sense of who is most competent in determining the best way to practice and communicate medical care. Somehow we have turned this over to the bureaucrats, who seem to find ways to complicate the lives of both providers and patients. Maybe we are too busy caring for patients and trying to find ways to alleviate the burden placed on our time by the electronic medical record (EMR) system, which was touted as an improvement in medical care and increasing provider efficiency. Most of the time I hear my colleagues describing ways to “work around” an EMR system that has immense deficiencies in providing accurate information in a way that is easily digested by whomever is viewing the record. The universal ability to transfer information is simply not true. One colleague had the same office version of Cerner as was used in the hospital setting but was unable to send information back and forth due to the danger of the potential to corrupt the system. 

Dr. Barbieri mentioned his work around to make the record easier for the patient to read. I ask, what about the coding descriptions, which most systems are now requiring physicians to put in at the time of the encounter? In the past this was done by certified coders, who undergo a 1- to 2-year training program, and is now being performed by physicians who have minimal to no training in coding. (And who, by the way, can be fined for both under- and over coding.) The example Dr. Barbieri put forth for obesity comes to mind and is part of the medical record in all cases. The terminology used by ICD10 is not so kind and requires some imagination when trying to find the right code for many diagnoses.

When will we stop allowing others, who know little about medicine and caring for patients, to tell us how to provide the care that we have trained for 7-12 years on how  best to deliver?

William Sutton, MD

Muncie, Indiana

Dr. Barbieri responds

I thank Dr. Sutton for providing his experience with the electronic medical record. I agree with him that bureaucrats often create health care rules that do more to hinder than help patients. With regard to coding and billing, I use ICD-10 codes and  usually bill based on time, which includes both face-to-face time with the patient and time spent reviewing the patient’s medical records. Now that federal regulations require medical notes to be shared with patients, I craft my history, assessment, and plan with language that is easy for a patient to accept and understand, avoiding medical terms that patients might misinterpret.

Should microscopy  be replaced? 

I agree with many points Dr. Barbieri made in his editorial. However, I do not agree that the microscopic examination of the vaginal discharge should be replaced. NAAT offers some advantages, but it does not offer a complete assessment of the vaginal ecosystem and microbiome. I believe that NAAT should be used in conjunction with the pelvic examination and microscopic examination of the vaginal discharge.

Microscopic examination of the vaginal discharge can reveal:

• whether or not the squamous epithelial cells are estrogenized. The absence of estrogen will, along with physical findings, indicate the possibility that the patient is experiencing atrophic vaginitis.
• the presence of estrogenized squamous epithelial cells. Plus, a finding of erythema of the vaginal epithelium indicates that the patient has an inflammatory condition and vaginitis, suggesting a possible infection in addition to vaginitis. 
• the presence of white blood cells >5/40X magnification, which indicates the possible presence of infection in addition to vaginitis (eg, BV). 

I agree that NAAT can confirm an initial diagnosis or refute it. In the latter case, the physician can change treatment accordingly. In the absence or in conjunction with the presence of a sexually transmitted infection, the composition of the vaginal microbiome is significant (ie, determining if vaginal dysbiosis is present). Performing a comprehensive evaluation, determining if the most common pathogens are present in aerobic vaginitis and/or BV, plus completing a Lactobacillus panel can be expensive. If insurance companies do not pay for such testing, patients will be reluctant to pay out of pocket for these tests. 

My final comment addresses the administration of NAAT for aerobic vaginitis, and for BV, it is probably an ineffective treatment. Vaginal dysbiosis is based on whether the appropriate species of Lactobacillus is present, and the concentration. Treatment most likely will be based on replenishing or restoring the appropriate species of Lactobacillus to dominance. 

Sebastian Faro, MD, PhD

Houston, Texas

Dr. Barbieri responds

I agree with Dr. Faro; when used by highly trained clinicians, microscopy is an excellent tool for evaluating vaginal specimens. Expert clinicians, such as Dr. Faro, with a focus on infectious diseases do not need to rely on NAAT testing except for identifying cases of T vaginalis infection. However, in standard clinical practice, microscopy performs poorly, resulting in misdiagnosis.¹ In the average clinical practice, NAAT testing may help improve patient outcomes. 

1. Gaydos CA, Beqaj S, Schwebke JR, et al. Clinical validation of a test for the diagnosis of vaginitis. Obstet Gynecol. 2017;130:181-189.

A note of thanks

I am a 74-year-old ObGyn who finished training at the University of North Carolina in 1979. Currently, I am working at a rural health group 2 days a week as a source of in-house gyn referral for 17 primary care physicians and mid-level providers. Our patients are almost all underserved and self-pay. The bulk of my work is related to evaluating abnormal uterine bleeding and abnormal Pap tests. Your publication of OBG Management serves now as one of my main sources of information. I just wanted to thank you and let you know that the publication is important. Keep up the good work and best wishes. 

Julian Brantley, MD

Rocky Mountain, North Carolina
 

Dr. Barbieri responds

I thank Dr. Brantley for taking time from a busy practice to write about how OBG Management provides practical information relevant to practice. Each issue of OBG Management is built on a foundation of insights from expert clinicians, which is crafted into a finished product by a superb editorial team. Our goal is to enhance the quality of women’s health care and the professional development of obstetrician-gynecologists and all women’s health care clinicians. ●

CAN WE RETURN TO THE ABCS OF CRAFTING A MEDICAL RECORD NOTE? 

ROBERT L. BARBIERI, MD (OCTOBER 2021)

Physicians can  help provide EMR fixes

I appreciate Dr. Barbieri’s editorials and insight on many issues facing our profession. I would like to offer my comments on a recent article.

If you want your brakes fixed, don’t go to a shoe maker. Physicians seem to have lost our sense of who is most competent in determining the best way to practice and communicate medical care. Somehow we have turned this over to the bureaucrats, who seem to find ways to complicate the lives of both providers and patients. Maybe we are too busy caring for patients and trying to find ways to alleviate the burden placed on our time by the electronic medical record (EMR) system, which was touted as an improvement in medical care and increasing provider efficiency. Most of the time I hear my colleagues describing ways to “work around” an EMR system that has immense deficiencies in providing accurate information in a way that is easily digested by whomever is viewing the record. The universal ability to transfer information is simply not true. One colleague had the same office version of Cerner as was used in the hospital setting but was unable to send information back and forth due to the danger of the potential to corrupt the system. 

Dr. Barbieri mentioned his work around to make the record easier for the patient to read. I ask, what about the coding descriptions, which most systems are now requiring physicians to put in at the time of the encounter? In the past this was done by certified coders, who undergo a 1- to 2-year training program, and is now being performed by physicians who have minimal to no training in coding. (And who, by the way, can be fined for both under- and over coding.) The example Dr. Barbieri put forth for obesity comes to mind and is part of the medical record in all cases. The terminology used by ICD10 is not so kind and requires some imagination when trying to find the right code for many diagnoses.

When will we stop allowing others, who know little about medicine and caring for patients, to tell us how to provide the care that we have trained for 7-12 years on how  best to deliver?

William Sutton, MD

Muncie, Indiana

Dr. Barbieri responds

I thank Dr. Sutton for providing his experience with the electronic medical record. I agree with him that bureaucrats often create health care rules that do more to hinder than help patients. With regard to coding and billing, I use ICD-10 codes and  usually bill based on time, which includes both face-to-face time with the patient and time spent reviewing the patient’s medical records. Now that federal regulations require medical notes to be shared with patients, I craft my history, assessment, and plan with language that is easy for a patient to accept and understand, avoiding medical terms that patients might misinterpret.

Should microscopy  be replaced? 

I agree with many points Dr. Barbieri made in his editorial. However, I do not agree that the microscopic examination of the vaginal discharge should be replaced. NAAT offers some advantages, but it does not offer a complete assessment of the vaginal ecosystem and microbiome. I believe that NAAT should be used in conjunction with the pelvic examination and microscopic examination of the vaginal discharge.

Microscopic examination of the vaginal discharge can reveal:

• whether or not the squamous epithelial cells are estrogenized. The absence of estrogen will, along with physical findings, indicate the possibility that the patient is experiencing atrophic vaginitis.
• the presence of estrogenized squamous epithelial cells. Plus, a finding of erythema of the vaginal epithelium indicates that the patient has an inflammatory condition and vaginitis, suggesting a possible infection in addition to vaginitis. 
• the presence of white blood cells >5/40X magnification, which indicates the possible presence of infection in addition to vaginitis (eg, BV). 

I agree that NAAT can confirm an initial diagnosis or refute it. In the latter case, the physician can change treatment accordingly. In the absence or in conjunction with the presence of a sexually transmitted infection, the composition of the vaginal microbiome is significant (ie, determining if vaginal dysbiosis is present). Performing a comprehensive evaluation, determining if the most common pathogens are present in aerobic vaginitis and/or BV, plus completing a Lactobacillus panel can be expensive. If insurance companies do not pay for such testing, patients will be reluctant to pay out of pocket for these tests. 

My final comment addresses the administration of NAAT for aerobic vaginitis, and for BV, it is probably an ineffective treatment. Vaginal dysbiosis is based on whether the appropriate species of Lactobacillus is present, and the concentration. Treatment most likely will be based on replenishing or restoring the appropriate species of Lactobacillus to dominance. 

Sebastian Faro, MD, PhD

Houston, Texas

Dr. Barbieri responds

I agree with Dr. Faro; when used by highly trained clinicians, microscopy is an excellent tool for evaluating vaginal specimens. Expert clinicians, such as Dr. Faro, with a focus on infectious diseases do not need to rely on NAAT testing except for identifying cases of T vaginalis infection. However, in standard clinical practice, microscopy performs poorly, resulting in misdiagnosis.¹ In the average clinical practice, NAAT testing may help improve patient outcomes. 

1. Gaydos CA, Beqaj S, Schwebke JR, et al. Clinical validation of a test for the diagnosis of vaginitis. Obstet Gynecol. 2017;130:181-189.

A note of thanks

I am a 74-year-old ObGyn who finished training at the University of North Carolina in 1979. Currently, I am working at a rural health group 2 days a week as a source of in-house gyn referral for 17 primary care physicians and mid-level providers. Our patients are almost all underserved and self-pay. The bulk of my work is related to evaluating abnormal uterine bleeding and abnormal Pap tests. Your publication of OBG Management serves now as one of my main sources of information. I just wanted to thank you and let you know that the publication is important. Keep up the good work and best wishes. 

Julian Brantley, MD

Rocky Mountain, North Carolina
 

Dr. Barbieri responds

I thank Dr. Brantley for taking time from a busy practice to write about how OBG Management provides practical information relevant to practice. Each issue of OBG Management is built on a foundation of insights from expert clinicians, which is crafted into a finished product by a superb editorial team. Our goal is to enhance the quality of women’s health care and the professional development of obstetrician-gynecologists and all women’s health care clinicians. ●