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Researchers say there is room for improvement in ObGyn opioid prescribing practices
Drug overdose is the leading cause of death for Americans under age 50. And the number of men and women dying from drug overdose shows no abating, with a sharp 17% increase in 2016 over 2015.1 The rate of fatal overdoses rose to nearly 20 people per 100,000 in 2016, according to the Centers for Disease Control and Prevention. The highest death rates are reported in West Virginia, New Hampshire, Kentucky, Ohio, and Rhode Island.2
Dr. Andrew Kolodny, director of opioid policy research at Brandeis University, told The New York Times that there are “roughly two groups of Americans that are getting addicted. We have an older group that is overdosing on pain medicine, and we have a younger group that is overdosing on black market opioids.”1
Are ObGyns contributing to the over-prescription of opioid pain medications? Investigators from Florida Hospital, the University of Florida, and Orlando VA Medical Center are researching the question, and preliminary findings indicate that, yes, in fact “gynecologists are overprescribing postoperative prescription opioids in all levels of gynecologic surgery,” including after laparotomies and major and minor minimally invasive surgeries. Their work thus far, a prospective cohort study involving 113 patients enrolled to date, was presented November 15, 2017, in Washington, DC, as part of the 46th AAGL Global Congress on MIGS. They found that, on average, patients were prescribed 29.6 (SD, 9.3) opioid tablets, and they had 19.1 (SD, 12.6) tablets left over after surgery. Not surprisingly, patients undergoing major minimally invasive surgery and laparotomy were prescribed larger amounts of opioids than those undergoing minor minimally invasive surgery, but the amount of pain medication left over was similar regardless of surgery type.
The researchers also asked patients if they were told how to dispose of their leftover opioids; only 3 patients reported being told what to do if they had leftover medication.
Too many pills prescribed
In separate research presented at the meeting, investigators from Tufts Medical Center and Lahey Hospital and Medical Center in Boston, Massachusetts, sought to determine opioid prescription practices and patient opioid use after benign hysterectomy. Using retrospective online physician and telephone patient surveys, they found that 51 gynecologists prescribed a median of 30 tabs of oxycodone or hydromorphone after abdominal hysterectomy and a median of 20 tabs after laparoscopic or vaginal hysterectomy. Nearly 65% (36/56) of women used less than half of the opioids they were prescribed, and 16.1% (9/56) used zero tabs. Opioid use was not found to be significantly different for women undergoing abdominal versus minimally invasive hysterectomy.
Managing pain expectations
It takes only 3 days of opioid use for a patient to be at risk for continued use (1 to 3 years) of opioids, said Georgine Lamvu, MD, MPH, CPE, in the educational session “Perioperative Management of the Chronic Pain Patient” at the AAGL meeting. And long-term opioid use is associated with addiction, misuse, and mortality.3 It is therefore crucial to understand how to prescribe pain medications and how to educate women on expectations of pain relief.
Dr. Lamvu and fellow presenters described a 4-step process to pain management: 1) assess—including taking a history and physical exam and providing a risk assessment; 2) check—for other medications that a patient may be taking and possible interactions, as well make sure that the patient is not obtaining opioids or benzodiazepines from other providers; 3) discuss—what pain expectations you have for the patient following surgery; and 4) observe—for clinical improvement, overuse, and misuse, and go slow with dose increases and consult support pain management teams when needed.
Overall, they recommended that surgeons perform a risk assessment (determine the risks and benefits of available therapies); educate themselves and their patients on the risks and benefits; and document the risk assessment, the final recommendations to the patient, and the education provided to the patient.
“We need to do a lot better job at educating ourselves and our patients about pain medications and pain management strategies,” said Dr. Lamvu. The presenters provided these key points for patient and family education:
- Opioids are not first-line or routine therapy for chronic pain, and for acute pain they are used only for severe pain and in short-duration amounts.
- Analgesia will not make you pain free. It only helps to alleviate some pain, and most pain medications take 1 to 2 hours to take effect.
- A 30% improvement in pain and function can be expected for most therapies.
- Recovery from surgical or acute traumatic injury is not immediate; it is expected to take 2 to 4 weeks.
- Do not take extra medication doses beyond what is prescribed, and tell all of your providers what medications you are taking.
- Do not stop taking opioids suddenly, instead taper the dose slowly as instructed by your provider.
- Dispose of excess drugs appropriately—by taking unused pills back to your provider or crushing the pills, placing them in a small amount of liquid, and putting them in the trash.
“The reality is that the majority of patients are not using as many pills as we give them,” said Dr. Lamvu. “Adequate pain control does not supersede patient safety or the responsibility that we have as providers to our society.”
Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.
- Kaplan S. CDC reports a record jump in drug overdose deaths last year. The New York Times. November 3, 2017. https://www.nytimes.com/2017/11/03/health/deaths-drug-overdose-cdc.html. Accessed November 15, 2017.
- Drug overdose death data. Centers for Disease Control and Prevention website. https://www.cdc.gov/drugoverdose/data/statedeaths.html. Accessed November 15, 2017.
- Wapner J. CDC study finds opioid dependency begins within a few days of initial use. Newsweek. March 22, 2017. http://www.newsweek.com/cdc-opiate-addiction-572498. Accessed November 17, 2017.
Drug overdose is the leading cause of death for Americans under age 50. And the number of men and women dying from drug overdose shows no abating, with a sharp 17% increase in 2016 over 2015.1 The rate of fatal overdoses rose to nearly 20 people per 100,000 in 2016, according to the Centers for Disease Control and Prevention. The highest death rates are reported in West Virginia, New Hampshire, Kentucky, Ohio, and Rhode Island.2
Dr. Andrew Kolodny, director of opioid policy research at Brandeis University, told The New York Times that there are “roughly two groups of Americans that are getting addicted. We have an older group that is overdosing on pain medicine, and we have a younger group that is overdosing on black market opioids.”1
Are ObGyns contributing to the over-prescription of opioid pain medications? Investigators from Florida Hospital, the University of Florida, and Orlando VA Medical Center are researching the question, and preliminary findings indicate that, yes, in fact “gynecologists are overprescribing postoperative prescription opioids in all levels of gynecologic surgery,” including after laparotomies and major and minor minimally invasive surgeries. Their work thus far, a prospective cohort study involving 113 patients enrolled to date, was presented November 15, 2017, in Washington, DC, as part of the 46th AAGL Global Congress on MIGS. They found that, on average, patients were prescribed 29.6 (SD, 9.3) opioid tablets, and they had 19.1 (SD, 12.6) tablets left over after surgery. Not surprisingly, patients undergoing major minimally invasive surgery and laparotomy were prescribed larger amounts of opioids than those undergoing minor minimally invasive surgery, but the amount of pain medication left over was similar regardless of surgery type.
The researchers also asked patients if they were told how to dispose of their leftover opioids; only 3 patients reported being told what to do if they had leftover medication.
Too many pills prescribed
In separate research presented at the meeting, investigators from Tufts Medical Center and Lahey Hospital and Medical Center in Boston, Massachusetts, sought to determine opioid prescription practices and patient opioid use after benign hysterectomy. Using retrospective online physician and telephone patient surveys, they found that 51 gynecologists prescribed a median of 30 tabs of oxycodone or hydromorphone after abdominal hysterectomy and a median of 20 tabs after laparoscopic or vaginal hysterectomy. Nearly 65% (36/56) of women used less than half of the opioids they were prescribed, and 16.1% (9/56) used zero tabs. Opioid use was not found to be significantly different for women undergoing abdominal versus minimally invasive hysterectomy.
Managing pain expectations
It takes only 3 days of opioid use for a patient to be at risk for continued use (1 to 3 years) of opioids, said Georgine Lamvu, MD, MPH, CPE, in the educational session “Perioperative Management of the Chronic Pain Patient” at the AAGL meeting. And long-term opioid use is associated with addiction, misuse, and mortality.3 It is therefore crucial to understand how to prescribe pain medications and how to educate women on expectations of pain relief.
Dr. Lamvu and fellow presenters described a 4-step process to pain management: 1) assess—including taking a history and physical exam and providing a risk assessment; 2) check—for other medications that a patient may be taking and possible interactions, as well make sure that the patient is not obtaining opioids or benzodiazepines from other providers; 3) discuss—what pain expectations you have for the patient following surgery; and 4) observe—for clinical improvement, overuse, and misuse, and go slow with dose increases and consult support pain management teams when needed.
Overall, they recommended that surgeons perform a risk assessment (determine the risks and benefits of available therapies); educate themselves and their patients on the risks and benefits; and document the risk assessment, the final recommendations to the patient, and the education provided to the patient.
“We need to do a lot better job at educating ourselves and our patients about pain medications and pain management strategies,” said Dr. Lamvu. The presenters provided these key points for patient and family education:
- Opioids are not first-line or routine therapy for chronic pain, and for acute pain they are used only for severe pain and in short-duration amounts.
- Analgesia will not make you pain free. It only helps to alleviate some pain, and most pain medications take 1 to 2 hours to take effect.
- A 30% improvement in pain and function can be expected for most therapies.
- Recovery from surgical or acute traumatic injury is not immediate; it is expected to take 2 to 4 weeks.
- Do not take extra medication doses beyond what is prescribed, and tell all of your providers what medications you are taking.
- Do not stop taking opioids suddenly, instead taper the dose slowly as instructed by your provider.
- Dispose of excess drugs appropriately—by taking unused pills back to your provider or crushing the pills, placing them in a small amount of liquid, and putting them in the trash.
“The reality is that the majority of patients are not using as many pills as we give them,” said Dr. Lamvu. “Adequate pain control does not supersede patient safety or the responsibility that we have as providers to our society.”
Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.
Drug overdose is the leading cause of death for Americans under age 50. And the number of men and women dying from drug overdose shows no abating, with a sharp 17% increase in 2016 over 2015.1 The rate of fatal overdoses rose to nearly 20 people per 100,000 in 2016, according to the Centers for Disease Control and Prevention. The highest death rates are reported in West Virginia, New Hampshire, Kentucky, Ohio, and Rhode Island.2
Dr. Andrew Kolodny, director of opioid policy research at Brandeis University, told The New York Times that there are “roughly two groups of Americans that are getting addicted. We have an older group that is overdosing on pain medicine, and we have a younger group that is overdosing on black market opioids.”1
Are ObGyns contributing to the over-prescription of opioid pain medications? Investigators from Florida Hospital, the University of Florida, and Orlando VA Medical Center are researching the question, and preliminary findings indicate that, yes, in fact “gynecologists are overprescribing postoperative prescription opioids in all levels of gynecologic surgery,” including after laparotomies and major and minor minimally invasive surgeries. Their work thus far, a prospective cohort study involving 113 patients enrolled to date, was presented November 15, 2017, in Washington, DC, as part of the 46th AAGL Global Congress on MIGS. They found that, on average, patients were prescribed 29.6 (SD, 9.3) opioid tablets, and they had 19.1 (SD, 12.6) tablets left over after surgery. Not surprisingly, patients undergoing major minimally invasive surgery and laparotomy were prescribed larger amounts of opioids than those undergoing minor minimally invasive surgery, but the amount of pain medication left over was similar regardless of surgery type.
The researchers also asked patients if they were told how to dispose of their leftover opioids; only 3 patients reported being told what to do if they had leftover medication.
Too many pills prescribed
In separate research presented at the meeting, investigators from Tufts Medical Center and Lahey Hospital and Medical Center in Boston, Massachusetts, sought to determine opioid prescription practices and patient opioid use after benign hysterectomy. Using retrospective online physician and telephone patient surveys, they found that 51 gynecologists prescribed a median of 30 tabs of oxycodone or hydromorphone after abdominal hysterectomy and a median of 20 tabs after laparoscopic or vaginal hysterectomy. Nearly 65% (36/56) of women used less than half of the opioids they were prescribed, and 16.1% (9/56) used zero tabs. Opioid use was not found to be significantly different for women undergoing abdominal versus minimally invasive hysterectomy.
Managing pain expectations
It takes only 3 days of opioid use for a patient to be at risk for continued use (1 to 3 years) of opioids, said Georgine Lamvu, MD, MPH, CPE, in the educational session “Perioperative Management of the Chronic Pain Patient” at the AAGL meeting. And long-term opioid use is associated with addiction, misuse, and mortality.3 It is therefore crucial to understand how to prescribe pain medications and how to educate women on expectations of pain relief.
Dr. Lamvu and fellow presenters described a 4-step process to pain management: 1) assess—including taking a history and physical exam and providing a risk assessment; 2) check—for other medications that a patient may be taking and possible interactions, as well make sure that the patient is not obtaining opioids or benzodiazepines from other providers; 3) discuss—what pain expectations you have for the patient following surgery; and 4) observe—for clinical improvement, overuse, and misuse, and go slow with dose increases and consult support pain management teams when needed.
Overall, they recommended that surgeons perform a risk assessment (determine the risks and benefits of available therapies); educate themselves and their patients on the risks and benefits; and document the risk assessment, the final recommendations to the patient, and the education provided to the patient.
“We need to do a lot better job at educating ourselves and our patients about pain medications and pain management strategies,” said Dr. Lamvu. The presenters provided these key points for patient and family education:
- Opioids are not first-line or routine therapy for chronic pain, and for acute pain they are used only for severe pain and in short-duration amounts.
- Analgesia will not make you pain free. It only helps to alleviate some pain, and most pain medications take 1 to 2 hours to take effect.
- A 30% improvement in pain and function can be expected for most therapies.
- Recovery from surgical or acute traumatic injury is not immediate; it is expected to take 2 to 4 weeks.
- Do not take extra medication doses beyond what is prescribed, and tell all of your providers what medications you are taking.
- Do not stop taking opioids suddenly, instead taper the dose slowly as instructed by your provider.
- Dispose of excess drugs appropriately—by taking unused pills back to your provider or crushing the pills, placing them in a small amount of liquid, and putting them in the trash.
“The reality is that the majority of patients are not using as many pills as we give them,” said Dr. Lamvu. “Adequate pain control does not supersede patient safety or the responsibility that we have as providers to our society.”
Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.
- Kaplan S. CDC reports a record jump in drug overdose deaths last year. The New York Times. November 3, 2017. https://www.nytimes.com/2017/11/03/health/deaths-drug-overdose-cdc.html. Accessed November 15, 2017.
- Drug overdose death data. Centers for Disease Control and Prevention website. https://www.cdc.gov/drugoverdose/data/statedeaths.html. Accessed November 15, 2017.
- Wapner J. CDC study finds opioid dependency begins within a few days of initial use. Newsweek. March 22, 2017. http://www.newsweek.com/cdc-opiate-addiction-572498. Accessed November 17, 2017.
- Kaplan S. CDC reports a record jump in drug overdose deaths last year. The New York Times. November 3, 2017. https://www.nytimes.com/2017/11/03/health/deaths-drug-overdose-cdc.html. Accessed November 15, 2017.
- Drug overdose death data. Centers for Disease Control and Prevention website. https://www.cdc.gov/drugoverdose/data/statedeaths.html. Accessed November 15, 2017.
- Wapner J. CDC study finds opioid dependency begins within a few days of initial use. Newsweek. March 22, 2017. http://www.newsweek.com/cdc-opiate-addiction-572498. Accessed November 17, 2017.
Clinical implications of cesarean-induced isthmoceles
In a presentation of the Golden Hysteroscope Award Best Paper on Hysteroscopy at the 46th AAGL Global Congress on Minimally Invasive Surgery in National Harbor, Maryland, James Coad, MD, described a study that he and colleagues from West Virginia University School of Medicine in Morgantown, and Universidad Autónoma de Nuevo León in Monterrey, Mexico, conducted concerning the healing differences of cesarean incisions and the development of isthmoceles (cesarean scar defects).1
Detecting isthmoceles
Isthmoceles are variably sized evaginations into the anterior lower uterine segment at a previous cesarean delivery incision due to suboptimal myometrium healing. This leads to thinning of the anterior uterine wall, which creates an indentation and fluid-filled pouch at the cesarean scar site.1,2
Recent findings, say Coad and colleagues, associate isthmoceles with adverse reproductive and gynecologic conditions such as infertility, postmenstrual spotting, dysmenorrhea, and chronic pelvic pain. Patients who have undergone multiple cesarean deliveries tend to have larger isthmoceles with widths correlating to increased symptoms.1
While the presence of inner nonunion healing can be hysteroscopically visualized, it is difficult to detect outer nonunion healing. The reported incidence of isthmoceles differs by imaging technique used: up to 70% are found with transvaginal ultrasound, and up to 84% are detected by sonohysterography.3,4 This study found that 98% of isthomoceles can be detected by gross examination.1
Related article:
Cesarean scar defect: What is it and how should it be treated?
Study details
Researchers designed a prospective de-identified anatomic pathology study to evaluate the anatomy of uteri from 204 premenopausal women who underwent hysterectomy for benign disease due to abnormal uterine bleeding, fibroids, and/or adenomyosis. Uteri were midline sagittally sectioned and the area of cesarean section anatomy was documented, including the presence of inner and outer nonunion healing.1
Of the 204 uteri, 134 (66%) had at least 1 identifiable cesarean scar (22% had 1 scar, 19% had 2 scars, and 25% had 3 or more scars). Of these, 2 uteri (1.5%) had intact incisional healing with minimal wall narrowing showing complete union healing. Isolated inner nonunion healing with the formation of prominent isthmoceles was found in 111 uteri (82.8%). Five uteri (3.7%) showed isolated outer nonunion healing without the formation of isthmoceles. Fourteen uteri (10.5%) had both inner and outer nonunion healing. Two uteri (1.5%) had complete transmural union healing with localized loss of anterior lower segment wall integrity. No isthmoceles were detected in women who had not undergone cesarean delivery.1
Study results
When present, inner nonunion healing involved a mean (SD) 39% (23%; range, 5% – 90%) of the wall thickness and outer nonunion healing involved a mean (SD) 27% (17%; range, 10% – 60%). Due to nonunion healing, the resultant wall thicknesses at cesarean scar site were a mean (SD) 5.6 mm ( 2.60 mm; range, 0.0 mm – 14.2 mm). When compared with the adjacent uterine wall, the nonunion healing resulted in an approximate mean (SD) of 70% (16%) thinner wall. 1
Conclusions and a warning
The authors concluded that, following cesarean delivery, there is a high incidence of architectural healing–related change, including significant inner and outer wall thinning. While inner nonunion healing can be hysteroscopically visualized, outer-wall healing cannot be visualized and may result in finding a thinner wall than expected during procedures in this region, including isthmocele repairs.1
Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.
- Coad JE, Fugett II JH, Wolfe T, et al. Anatomy of cesarean-induced isthmoceles: Clinical implications [abstract 159]. In: Abstracts of the 46th AAGL Global Congress on Minimally Invasive Surgery. JMIG. 2017;24(7 suppl):S64.
- Nezhat C, Grace L, Soliemannjad R, Razavi GM, Nezhat A. Cesarean scar defect: What is it and how should it be treated? OBG Manag. 2016;28(4):32,34,36,38–39,53.
- Bij de Vaate AJ, van der Voet LF, Naji O, et al. Prevalenc, potential risk factors for development and symptoms related to the presence of uterine niches following Cesarean section: systematic review. Ultrasound Obstet Gynecol. 2014;43(4):372–382.
- Osser OV, Jokubkiene L, Valentin L. High prevalence of defects in Cesarean section scars at transvaginal ultrasound examination. Ultrasound Obstet Gynecol. 2009;34(1):90–97.
In a presentation of the Golden Hysteroscope Award Best Paper on Hysteroscopy at the 46th AAGL Global Congress on Minimally Invasive Surgery in National Harbor, Maryland, James Coad, MD, described a study that he and colleagues from West Virginia University School of Medicine in Morgantown, and Universidad Autónoma de Nuevo León in Monterrey, Mexico, conducted concerning the healing differences of cesarean incisions and the development of isthmoceles (cesarean scar defects).1
Detecting isthmoceles
Isthmoceles are variably sized evaginations into the anterior lower uterine segment at a previous cesarean delivery incision due to suboptimal myometrium healing. This leads to thinning of the anterior uterine wall, which creates an indentation and fluid-filled pouch at the cesarean scar site.1,2
Recent findings, say Coad and colleagues, associate isthmoceles with adverse reproductive and gynecologic conditions such as infertility, postmenstrual spotting, dysmenorrhea, and chronic pelvic pain. Patients who have undergone multiple cesarean deliveries tend to have larger isthmoceles with widths correlating to increased symptoms.1
While the presence of inner nonunion healing can be hysteroscopically visualized, it is difficult to detect outer nonunion healing. The reported incidence of isthmoceles differs by imaging technique used: up to 70% are found with transvaginal ultrasound, and up to 84% are detected by sonohysterography.3,4 This study found that 98% of isthomoceles can be detected by gross examination.1
Related article:
Cesarean scar defect: What is it and how should it be treated?
Study details
Researchers designed a prospective de-identified anatomic pathology study to evaluate the anatomy of uteri from 204 premenopausal women who underwent hysterectomy for benign disease due to abnormal uterine bleeding, fibroids, and/or adenomyosis. Uteri were midline sagittally sectioned and the area of cesarean section anatomy was documented, including the presence of inner and outer nonunion healing.1
Of the 204 uteri, 134 (66%) had at least 1 identifiable cesarean scar (22% had 1 scar, 19% had 2 scars, and 25% had 3 or more scars). Of these, 2 uteri (1.5%) had intact incisional healing with minimal wall narrowing showing complete union healing. Isolated inner nonunion healing with the formation of prominent isthmoceles was found in 111 uteri (82.8%). Five uteri (3.7%) showed isolated outer nonunion healing without the formation of isthmoceles. Fourteen uteri (10.5%) had both inner and outer nonunion healing. Two uteri (1.5%) had complete transmural union healing with localized loss of anterior lower segment wall integrity. No isthmoceles were detected in women who had not undergone cesarean delivery.1
Study results
When present, inner nonunion healing involved a mean (SD) 39% (23%; range, 5% – 90%) of the wall thickness and outer nonunion healing involved a mean (SD) 27% (17%; range, 10% – 60%). Due to nonunion healing, the resultant wall thicknesses at cesarean scar site were a mean (SD) 5.6 mm ( 2.60 mm; range, 0.0 mm – 14.2 mm). When compared with the adjacent uterine wall, the nonunion healing resulted in an approximate mean (SD) of 70% (16%) thinner wall. 1
Conclusions and a warning
The authors concluded that, following cesarean delivery, there is a high incidence of architectural healing–related change, including significant inner and outer wall thinning. While inner nonunion healing can be hysteroscopically visualized, outer-wall healing cannot be visualized and may result in finding a thinner wall than expected during procedures in this region, including isthmocele repairs.1
Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.
In a presentation of the Golden Hysteroscope Award Best Paper on Hysteroscopy at the 46th AAGL Global Congress on Minimally Invasive Surgery in National Harbor, Maryland, James Coad, MD, described a study that he and colleagues from West Virginia University School of Medicine in Morgantown, and Universidad Autónoma de Nuevo León in Monterrey, Mexico, conducted concerning the healing differences of cesarean incisions and the development of isthmoceles (cesarean scar defects).1
Detecting isthmoceles
Isthmoceles are variably sized evaginations into the anterior lower uterine segment at a previous cesarean delivery incision due to suboptimal myometrium healing. This leads to thinning of the anterior uterine wall, which creates an indentation and fluid-filled pouch at the cesarean scar site.1,2
Recent findings, say Coad and colleagues, associate isthmoceles with adverse reproductive and gynecologic conditions such as infertility, postmenstrual spotting, dysmenorrhea, and chronic pelvic pain. Patients who have undergone multiple cesarean deliveries tend to have larger isthmoceles with widths correlating to increased symptoms.1
While the presence of inner nonunion healing can be hysteroscopically visualized, it is difficult to detect outer nonunion healing. The reported incidence of isthmoceles differs by imaging technique used: up to 70% are found with transvaginal ultrasound, and up to 84% are detected by sonohysterography.3,4 This study found that 98% of isthomoceles can be detected by gross examination.1
Related article:
Cesarean scar defect: What is it and how should it be treated?
Study details
Researchers designed a prospective de-identified anatomic pathology study to evaluate the anatomy of uteri from 204 premenopausal women who underwent hysterectomy for benign disease due to abnormal uterine bleeding, fibroids, and/or adenomyosis. Uteri were midline sagittally sectioned and the area of cesarean section anatomy was documented, including the presence of inner and outer nonunion healing.1
Of the 204 uteri, 134 (66%) had at least 1 identifiable cesarean scar (22% had 1 scar, 19% had 2 scars, and 25% had 3 or more scars). Of these, 2 uteri (1.5%) had intact incisional healing with minimal wall narrowing showing complete union healing. Isolated inner nonunion healing with the formation of prominent isthmoceles was found in 111 uteri (82.8%). Five uteri (3.7%) showed isolated outer nonunion healing without the formation of isthmoceles. Fourteen uteri (10.5%) had both inner and outer nonunion healing. Two uteri (1.5%) had complete transmural union healing with localized loss of anterior lower segment wall integrity. No isthmoceles were detected in women who had not undergone cesarean delivery.1
Study results
When present, inner nonunion healing involved a mean (SD) 39% (23%; range, 5% – 90%) of the wall thickness and outer nonunion healing involved a mean (SD) 27% (17%; range, 10% – 60%). Due to nonunion healing, the resultant wall thicknesses at cesarean scar site were a mean (SD) 5.6 mm ( 2.60 mm; range, 0.0 mm – 14.2 mm). When compared with the adjacent uterine wall, the nonunion healing resulted in an approximate mean (SD) of 70% (16%) thinner wall. 1
Conclusions and a warning
The authors concluded that, following cesarean delivery, there is a high incidence of architectural healing–related change, including significant inner and outer wall thinning. While inner nonunion healing can be hysteroscopically visualized, outer-wall healing cannot be visualized and may result in finding a thinner wall than expected during procedures in this region, including isthmocele repairs.1
Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.
- Coad JE, Fugett II JH, Wolfe T, et al. Anatomy of cesarean-induced isthmoceles: Clinical implications [abstract 159]. In: Abstracts of the 46th AAGL Global Congress on Minimally Invasive Surgery. JMIG. 2017;24(7 suppl):S64.
- Nezhat C, Grace L, Soliemannjad R, Razavi GM, Nezhat A. Cesarean scar defect: What is it and how should it be treated? OBG Manag. 2016;28(4):32,34,36,38–39,53.
- Bij de Vaate AJ, van der Voet LF, Naji O, et al. Prevalenc, potential risk factors for development and symptoms related to the presence of uterine niches following Cesarean section: systematic review. Ultrasound Obstet Gynecol. 2014;43(4):372–382.
- Osser OV, Jokubkiene L, Valentin L. High prevalence of defects in Cesarean section scars at transvaginal ultrasound examination. Ultrasound Obstet Gynecol. 2009;34(1):90–97.
- Coad JE, Fugett II JH, Wolfe T, et al. Anatomy of cesarean-induced isthmoceles: Clinical implications [abstract 159]. In: Abstracts of the 46th AAGL Global Congress on Minimally Invasive Surgery. JMIG. 2017;24(7 suppl):S64.
- Nezhat C, Grace L, Soliemannjad R, Razavi GM, Nezhat A. Cesarean scar defect: What is it and how should it be treated? OBG Manag. 2016;28(4):32,34,36,38–39,53.
- Bij de Vaate AJ, van der Voet LF, Naji O, et al. Prevalenc, potential risk factors for development and symptoms related to the presence of uterine niches following Cesarean section: systematic review. Ultrasound Obstet Gynecol. 2014;43(4):372–382.
- Osser OV, Jokubkiene L, Valentin L. High prevalence of defects in Cesarean section scars at transvaginal ultrasound examination. Ultrasound Obstet Gynecol. 2009;34(1):90–97.
Surviving ovarian cancer: Is there an association between hospital volume and quality of care?
The relationship between procedure volume and outcomes has long been recognized: studies have concluded that patients operated on by high-volume surgeons at high-volume hospitals have improved outcomes.1,2 This paradigm is also associated with ovarian cancer outcomes. But what affect does adherence to evidence-based guidelines have on these statistics?
Jason D. Wright, MD, and colleagues at the Columbia University College of Physicians and Surgeons, in New York City, sought to determine whether strict adherence to quality metrics by hospitals could explain the association between hospital volume and ovarian cancer survival.3
Details of the study
Using the National Cancer Database (NCD), the research team identified 100,725 patients at 1,268 hospitals who were treated for invasive epithelial ovarian cancer between 2004 and 2013. Hospitals were stratified by annual case volume into quintiles: low-volume (≤2 cases; n = 299 [23.6%]), low-intermediate–volume (2.01–5 cases; n = 465 [36.7%]), intermediate-volume (5.01–9 cases; n = 157 [12.4%]), high-intermediate–volume (9.01–19.9 cases; n = 194 [15.3%]), and high-volume (≥20 cases; n = 153 [12.1%]).3
To measure quality, the authors defined hospital-level rates of 5 metrics based on clinical guidelines3:
- lymph node dissection performed for patients with stage I–IIIB tumors
- performance of omentectomy or cytoreduction for patients with advanced stage tumors
- use of chemotherapy among patients with early-stage, high-risk tumors
- omission of chemotherapy for women with early-stage, low-risk tumors
- use of chemotherapy (either neoadjuvant or adjuvant) for women with advanced-stage disease.
For each metric, the authors determined the rate of hospital-level compliance for all study-eligible patients. Then a composite variable of overall quality was derived using all 5 metrics. Based on the overall quality metric, hospitals were stratified into quartiles: low-quality, medium-low–quality, medium-high–quality, and high-quality.3
Hospital-level adjusted 2- and 5-year survival rates were compared based on volume and adherence to quality metrics.3
Related article:
2017 Update on ovarian cancer
Trends and conclusions
Researchers found that compliance with quality metrics generally increased with hospital volume. Trends of increased compliance were observed with lymph node dissection for early-stage tumors, cytoreduction for advanced-stage tumors, and use of chemotherapy for advanced-stage tumors. No trends were evident for use of chemotherapy for high-risk, early-stage tumors. By contrast, a trend for higher-volume hospitals to administer chemotherapy for low-risk, early-stage tumors was discovered. Adherence with the composite overall quality metric was noted in 64.2% of low-volume centers and increased with each volume category to 82.2% at the highest-volume hospitals.3
Study results indicated that survival increased with increasing hospital volume and with adherence to the quality metrics. The association between volume and quality was then examined. For each volume category, survival increased with increasing adherence to the quality metrics. In the highest-volume group, 2-year adjusted survival rose from 75.5% (95% confidence interval [CI], 73.2%–77.8%) at the lowest-quality hospitals, to 78.6% (95% CI, 78.0%–79.1%) at the highest-quality hospitals. Similar trends were found for intermediate-volume hospitals and for 5-year survival. However, the relationship between adherence to quality metrics and survival was less consistent for the low-, low-intermediate–, and high-intermediate–volume hospitals.3
The authors concluded that both hospital volume and adherence to quality metrics are associated with survival for ovarian cancer. Even though survival rates are improved at low-volume hospitals that are highly adherent to quality metrics, their survival rates are still lower than high-volume hospitals.
Read about the pros and cons of regionalization for high-risk ovarian cancer surgery.
Study limitations
The authors cite several limitations to this study:
- chosen quality metrics focused on care during initial treatment. Women with ovarian cancer are often treated for many years.
- the NCD lacks information on aspects like hospital infrastructure and staffing; there are probably other confounders that influence treatment and outcomes
- although NCD data have been validated, misclassification of a small number of patients may exist. Also, some hospitals did not treat patients who might be eligible for a quality metric and therefore were not included in this analysis.
- some study participants (13.7%) received treatment at multiple hospitals
- the volume cutpoints chosen by the research team were based on prior studies; there could be outcome variation within a volume strata.
Should high-risk surgeries be regionalized?
The association between higher surgical volume and improved outcomes has led to efforts to regionalize the care for high-risk operations to high-volume centers, say the authors. They conclude that this may be a reasonable strategy for some procedures. However, they suggest that regionalization presents practical difficulties:
- patients prefer to receive local care and are often unwilling to or cannot travel
- regionalization can worsen inequalities in access to care and may adversely affect low-volume hospitals
- high-volume centers do not exist in some areas of the country. A recent report suggested that 9% of the US female population had geographic barriers to receiving care from a gynecologic oncologist.4
Can low-volume facilities attain the same outcomes as high-volume centers?
The authors pose an important question: Can lower-volume facilities that deliver high-quality care achieve the same outcomes as higher-volume centers? With the difficulties associated with regionalization, many advocates seek strategies to raise the quality of care at low-volume centers, they say. The authors note that, “although outcomes improve at low-volume centers that are highly compliant with the quality metrics examined, survival at these centers is still lower than at high-volume centers.”3 The authors suggest that there are factors other than adherence to guidelines that play a role in how hospital volume affects ovarian cancer outcomes.3
Practice considerations
“Because the best outcomes appear to be achieved at high-volume hospitals, efforts to promote volume-based referral for women with ovarian cancer are reasonable,” the authors conclude.3 However, in practicality, many women will not be able to receive care at high-volume centers, they concede. “For low-volume centers, targeted quality improvement efforts and strict adherence to quality guidelines may help to optimize outcomes for women with ovarian cancer.”3
Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.
- Birkmeyer JC, Siewers AE, Finlayson EV, et al. Hospital volume and surgical mortality in the United States. N Eng J Med. 2002;346(15):1128–1137.
- Birkmeyer JC, Stukel TA, Siewers AE, Goodney PP, Wennberg DE, Lucas FL. Surgeon volume and operative mortality in the United States. New Engl J Med. 2003;349(22):2117–2127.
- Wright JD, Chen L, Hou JY, et al. Association of hospital volume and quality of care with survival for ovarian cancer. Obstet Gynecol. 2017;130(3):545–553.
- Shalowitz DI, Vinograd AM, Giuntoli RL II. Geographic access to gynecologic cancer care in the United States. Gynecol Oncol. 2015;138(1):115–120.
The relationship between procedure volume and outcomes has long been recognized: studies have concluded that patients operated on by high-volume surgeons at high-volume hospitals have improved outcomes.1,2 This paradigm is also associated with ovarian cancer outcomes. But what affect does adherence to evidence-based guidelines have on these statistics?
Jason D. Wright, MD, and colleagues at the Columbia University College of Physicians and Surgeons, in New York City, sought to determine whether strict adherence to quality metrics by hospitals could explain the association between hospital volume and ovarian cancer survival.3
Details of the study
Using the National Cancer Database (NCD), the research team identified 100,725 patients at 1,268 hospitals who were treated for invasive epithelial ovarian cancer between 2004 and 2013. Hospitals were stratified by annual case volume into quintiles: low-volume (≤2 cases; n = 299 [23.6%]), low-intermediate–volume (2.01–5 cases; n = 465 [36.7%]), intermediate-volume (5.01–9 cases; n = 157 [12.4%]), high-intermediate–volume (9.01–19.9 cases; n = 194 [15.3%]), and high-volume (≥20 cases; n = 153 [12.1%]).3
To measure quality, the authors defined hospital-level rates of 5 metrics based on clinical guidelines3:
- lymph node dissection performed for patients with stage I–IIIB tumors
- performance of omentectomy or cytoreduction for patients with advanced stage tumors
- use of chemotherapy among patients with early-stage, high-risk tumors
- omission of chemotherapy for women with early-stage, low-risk tumors
- use of chemotherapy (either neoadjuvant or adjuvant) for women with advanced-stage disease.
For each metric, the authors determined the rate of hospital-level compliance for all study-eligible patients. Then a composite variable of overall quality was derived using all 5 metrics. Based on the overall quality metric, hospitals were stratified into quartiles: low-quality, medium-low–quality, medium-high–quality, and high-quality.3
Hospital-level adjusted 2- and 5-year survival rates were compared based on volume and adherence to quality metrics.3
Related article:
2017 Update on ovarian cancer
Trends and conclusions
Researchers found that compliance with quality metrics generally increased with hospital volume. Trends of increased compliance were observed with lymph node dissection for early-stage tumors, cytoreduction for advanced-stage tumors, and use of chemotherapy for advanced-stage tumors. No trends were evident for use of chemotherapy for high-risk, early-stage tumors. By contrast, a trend for higher-volume hospitals to administer chemotherapy for low-risk, early-stage tumors was discovered. Adherence with the composite overall quality metric was noted in 64.2% of low-volume centers and increased with each volume category to 82.2% at the highest-volume hospitals.3
Study results indicated that survival increased with increasing hospital volume and with adherence to the quality metrics. The association between volume and quality was then examined. For each volume category, survival increased with increasing adherence to the quality metrics. In the highest-volume group, 2-year adjusted survival rose from 75.5% (95% confidence interval [CI], 73.2%–77.8%) at the lowest-quality hospitals, to 78.6% (95% CI, 78.0%–79.1%) at the highest-quality hospitals. Similar trends were found for intermediate-volume hospitals and for 5-year survival. However, the relationship between adherence to quality metrics and survival was less consistent for the low-, low-intermediate–, and high-intermediate–volume hospitals.3
The authors concluded that both hospital volume and adherence to quality metrics are associated with survival for ovarian cancer. Even though survival rates are improved at low-volume hospitals that are highly adherent to quality metrics, their survival rates are still lower than high-volume hospitals.
Read about the pros and cons of regionalization for high-risk ovarian cancer surgery.
Study limitations
The authors cite several limitations to this study:
- chosen quality metrics focused on care during initial treatment. Women with ovarian cancer are often treated for many years.
- the NCD lacks information on aspects like hospital infrastructure and staffing; there are probably other confounders that influence treatment and outcomes
- although NCD data have been validated, misclassification of a small number of patients may exist. Also, some hospitals did not treat patients who might be eligible for a quality metric and therefore were not included in this analysis.
- some study participants (13.7%) received treatment at multiple hospitals
- the volume cutpoints chosen by the research team were based on prior studies; there could be outcome variation within a volume strata.
Should high-risk surgeries be regionalized?
The association between higher surgical volume and improved outcomes has led to efforts to regionalize the care for high-risk operations to high-volume centers, say the authors. They conclude that this may be a reasonable strategy for some procedures. However, they suggest that regionalization presents practical difficulties:
- patients prefer to receive local care and are often unwilling to or cannot travel
- regionalization can worsen inequalities in access to care and may adversely affect low-volume hospitals
- high-volume centers do not exist in some areas of the country. A recent report suggested that 9% of the US female population had geographic barriers to receiving care from a gynecologic oncologist.4
Can low-volume facilities attain the same outcomes as high-volume centers?
The authors pose an important question: Can lower-volume facilities that deliver high-quality care achieve the same outcomes as higher-volume centers? With the difficulties associated with regionalization, many advocates seek strategies to raise the quality of care at low-volume centers, they say. The authors note that, “although outcomes improve at low-volume centers that are highly compliant with the quality metrics examined, survival at these centers is still lower than at high-volume centers.”3 The authors suggest that there are factors other than adherence to guidelines that play a role in how hospital volume affects ovarian cancer outcomes.3
Practice considerations
“Because the best outcomes appear to be achieved at high-volume hospitals, efforts to promote volume-based referral for women with ovarian cancer are reasonable,” the authors conclude.3 However, in practicality, many women will not be able to receive care at high-volume centers, they concede. “For low-volume centers, targeted quality improvement efforts and strict adherence to quality guidelines may help to optimize outcomes for women with ovarian cancer.”3
Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.
The relationship between procedure volume and outcomes has long been recognized: studies have concluded that patients operated on by high-volume surgeons at high-volume hospitals have improved outcomes.1,2 This paradigm is also associated with ovarian cancer outcomes. But what affect does adherence to evidence-based guidelines have on these statistics?
Jason D. Wright, MD, and colleagues at the Columbia University College of Physicians and Surgeons, in New York City, sought to determine whether strict adherence to quality metrics by hospitals could explain the association between hospital volume and ovarian cancer survival.3
Details of the study
Using the National Cancer Database (NCD), the research team identified 100,725 patients at 1,268 hospitals who were treated for invasive epithelial ovarian cancer between 2004 and 2013. Hospitals were stratified by annual case volume into quintiles: low-volume (≤2 cases; n = 299 [23.6%]), low-intermediate–volume (2.01–5 cases; n = 465 [36.7%]), intermediate-volume (5.01–9 cases; n = 157 [12.4%]), high-intermediate–volume (9.01–19.9 cases; n = 194 [15.3%]), and high-volume (≥20 cases; n = 153 [12.1%]).3
To measure quality, the authors defined hospital-level rates of 5 metrics based on clinical guidelines3:
- lymph node dissection performed for patients with stage I–IIIB tumors
- performance of omentectomy or cytoreduction for patients with advanced stage tumors
- use of chemotherapy among patients with early-stage, high-risk tumors
- omission of chemotherapy for women with early-stage, low-risk tumors
- use of chemotherapy (either neoadjuvant or adjuvant) for women with advanced-stage disease.
For each metric, the authors determined the rate of hospital-level compliance for all study-eligible patients. Then a composite variable of overall quality was derived using all 5 metrics. Based on the overall quality metric, hospitals were stratified into quartiles: low-quality, medium-low–quality, medium-high–quality, and high-quality.3
Hospital-level adjusted 2- and 5-year survival rates were compared based on volume and adherence to quality metrics.3
Related article:
2017 Update on ovarian cancer
Trends and conclusions
Researchers found that compliance with quality metrics generally increased with hospital volume. Trends of increased compliance were observed with lymph node dissection for early-stage tumors, cytoreduction for advanced-stage tumors, and use of chemotherapy for advanced-stage tumors. No trends were evident for use of chemotherapy for high-risk, early-stage tumors. By contrast, a trend for higher-volume hospitals to administer chemotherapy for low-risk, early-stage tumors was discovered. Adherence with the composite overall quality metric was noted in 64.2% of low-volume centers and increased with each volume category to 82.2% at the highest-volume hospitals.3
Study results indicated that survival increased with increasing hospital volume and with adherence to the quality metrics. The association between volume and quality was then examined. For each volume category, survival increased with increasing adherence to the quality metrics. In the highest-volume group, 2-year adjusted survival rose from 75.5% (95% confidence interval [CI], 73.2%–77.8%) at the lowest-quality hospitals, to 78.6% (95% CI, 78.0%–79.1%) at the highest-quality hospitals. Similar trends were found for intermediate-volume hospitals and for 5-year survival. However, the relationship between adherence to quality metrics and survival was less consistent for the low-, low-intermediate–, and high-intermediate–volume hospitals.3
The authors concluded that both hospital volume and adherence to quality metrics are associated with survival for ovarian cancer. Even though survival rates are improved at low-volume hospitals that are highly adherent to quality metrics, their survival rates are still lower than high-volume hospitals.
Read about the pros and cons of regionalization for high-risk ovarian cancer surgery.
Study limitations
The authors cite several limitations to this study:
- chosen quality metrics focused on care during initial treatment. Women with ovarian cancer are often treated for many years.
- the NCD lacks information on aspects like hospital infrastructure and staffing; there are probably other confounders that influence treatment and outcomes
- although NCD data have been validated, misclassification of a small number of patients may exist. Also, some hospitals did not treat patients who might be eligible for a quality metric and therefore were not included in this analysis.
- some study participants (13.7%) received treatment at multiple hospitals
- the volume cutpoints chosen by the research team were based on prior studies; there could be outcome variation within a volume strata.
Should high-risk surgeries be regionalized?
The association between higher surgical volume and improved outcomes has led to efforts to regionalize the care for high-risk operations to high-volume centers, say the authors. They conclude that this may be a reasonable strategy for some procedures. However, they suggest that regionalization presents practical difficulties:
- patients prefer to receive local care and are often unwilling to or cannot travel
- regionalization can worsen inequalities in access to care and may adversely affect low-volume hospitals
- high-volume centers do not exist in some areas of the country. A recent report suggested that 9% of the US female population had geographic barriers to receiving care from a gynecologic oncologist.4
Can low-volume facilities attain the same outcomes as high-volume centers?
The authors pose an important question: Can lower-volume facilities that deliver high-quality care achieve the same outcomes as higher-volume centers? With the difficulties associated with regionalization, many advocates seek strategies to raise the quality of care at low-volume centers, they say. The authors note that, “although outcomes improve at low-volume centers that are highly compliant with the quality metrics examined, survival at these centers is still lower than at high-volume centers.”3 The authors suggest that there are factors other than adherence to guidelines that play a role in how hospital volume affects ovarian cancer outcomes.3
Practice considerations
“Because the best outcomes appear to be achieved at high-volume hospitals, efforts to promote volume-based referral for women with ovarian cancer are reasonable,” the authors conclude.3 However, in practicality, many women will not be able to receive care at high-volume centers, they concede. “For low-volume centers, targeted quality improvement efforts and strict adherence to quality guidelines may help to optimize outcomes for women with ovarian cancer.”3
Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.
- Birkmeyer JC, Siewers AE, Finlayson EV, et al. Hospital volume and surgical mortality in the United States. N Eng J Med. 2002;346(15):1128–1137.
- Birkmeyer JC, Stukel TA, Siewers AE, Goodney PP, Wennberg DE, Lucas FL. Surgeon volume and operative mortality in the United States. New Engl J Med. 2003;349(22):2117–2127.
- Wright JD, Chen L, Hou JY, et al. Association of hospital volume and quality of care with survival for ovarian cancer. Obstet Gynecol. 2017;130(3):545–553.
- Shalowitz DI, Vinograd AM, Giuntoli RL II. Geographic access to gynecologic cancer care in the United States. Gynecol Oncol. 2015;138(1):115–120.
- Birkmeyer JC, Siewers AE, Finlayson EV, et al. Hospital volume and surgical mortality in the United States. N Eng J Med. 2002;346(15):1128–1137.
- Birkmeyer JC, Stukel TA, Siewers AE, Goodney PP, Wennberg DE, Lucas FL. Surgeon volume and operative mortality in the United States. New Engl J Med. 2003;349(22):2117–2127.
- Wright JD, Chen L, Hou JY, et al. Association of hospital volume and quality of care with survival for ovarian cancer. Obstet Gynecol. 2017;130(3):545–553.
- Shalowitz DI, Vinograd AM, Giuntoli RL II. Geographic access to gynecologic cancer care in the United States. Gynecol Oncol. 2015;138(1):115–120.
Dispensing hormonal contraceptives in 1-year supplies saves state $43 million and avoids 15,000 unintended pregnancies
Recent insurance coverage legislation enacted in California is expected to result in 15,000 fewer unintended pregnancies, 2,000 fewer miscarriages, and 7,000 fewer abortions, according to an analysis of the mandate’s potential impact by investigators at the University of California.1
Enacted in September 2016, the contraceptive supply legislation known as SB 999 requires health plans and insurers to cover a year-long supply of hormonal contraceptive pills, patches, and rings (formulations approved by the US Food and Drug Administration). Clinicians can now prescribe and pharmacists can dispense up to a 12-month supply at one time. California joins 5 other states and Washington, DC, that have such mandates.
Having a year’s worth of contraceptives on hand is anticipated to reduce the interruption in contraception use that may occur with a 30- or 90-day supply that needs frequent refilling and thereby lower the unplanned pregnancy rate as well as associated health care costs.
Understanding the legislation’s impact on the population’s health outcomes will be useful for other states considering similar proposed legislation.
Details of the study
In a short communication published in Contraception, McMenamin and colleagues described how University of California faculty and researchers, engaged by the California Health Benefits Review Program, assessed the utilization and cost implications of SB 999 and arrived at their estimated projections.1
The assessment was based on a literature review (including current use of hormonal contraceptives, unintended pregnancy rates among contraceptive users, and assumptions about shifts in dispensing patterns for contraceptive supplies), a survey of the state’s 5 largest health insurance providers, and a claims database review of the utilization and cost implications of SB 999.
Two scenarios. Projections for the use and costs of hormonal contraceptives were made for 2 situations: whether SB 999 was enacted into law or not. Approximately 25 million Californians would be affected by the legislation, including 744,000 who used hormonal contraceptives in 2016.
To calculate their projections, the researchers used a baseline estimate of a 9% unintended pregnancy rate among current users of hormonal contraceptives (or 67,000 unintended pregnancies leading to 28,000 live births, 9,000 miscarriages, and 30,000 abortions).2 They also used a previously reported 30% reduction in the odds of unintended pregnancy with 12-month dispensing.3
Impact of shift in dispensing patterns
With SB 999 versus without SB 999, a 30% reduction in the odds of unintended pregnancies would lead to 6,000 fewer live births, 2,000 fewer miscarriages, and 7,000 fewer abortions.
The legislation would also reduce projected health care expenditures. Total net health care costs would decrease by 0.03%, for a savings of about $43 million, due to avoidance of unintended pregnancies and related medical costs.
Benefits will be even greater over time
The authors noted that the reductions in unintended pregnancies and associated health care costs with the implementation of SB 999 may be even greater in later years as beneficial health outcomes and cost savings accrue over time.
This study’s findings provide support for the implementation of similar legislation in other states.
- McMenamin SB, Charles SA, Tabatabaeepour N, Shigekawa E, Corbett G. Implications of dispensing self-administered hormonal contraceptives in a 1-year supply: a California case study. Contraception. 2017;95(5):449–451.
- Trussel J. Contraceptive failure in the United States. Contraception. 2011;83(5):397–404.
- Foster DG, Hulett D, Bradsberry M, Darney P, Policar M. Number of oral contraceptive pill packages dispensed and subsequent unintended pregnancies. Obstet Gynecol. 2011;117(3):566–572.
Recent insurance coverage legislation enacted in California is expected to result in 15,000 fewer unintended pregnancies, 2,000 fewer miscarriages, and 7,000 fewer abortions, according to an analysis of the mandate’s potential impact by investigators at the University of California.1
Enacted in September 2016, the contraceptive supply legislation known as SB 999 requires health plans and insurers to cover a year-long supply of hormonal contraceptive pills, patches, and rings (formulations approved by the US Food and Drug Administration). Clinicians can now prescribe and pharmacists can dispense up to a 12-month supply at one time. California joins 5 other states and Washington, DC, that have such mandates.
Having a year’s worth of contraceptives on hand is anticipated to reduce the interruption in contraception use that may occur with a 30- or 90-day supply that needs frequent refilling and thereby lower the unplanned pregnancy rate as well as associated health care costs.
Understanding the legislation’s impact on the population’s health outcomes will be useful for other states considering similar proposed legislation.
Details of the study
In a short communication published in Contraception, McMenamin and colleagues described how University of California faculty and researchers, engaged by the California Health Benefits Review Program, assessed the utilization and cost implications of SB 999 and arrived at their estimated projections.1
The assessment was based on a literature review (including current use of hormonal contraceptives, unintended pregnancy rates among contraceptive users, and assumptions about shifts in dispensing patterns for contraceptive supplies), a survey of the state’s 5 largest health insurance providers, and a claims database review of the utilization and cost implications of SB 999.
Two scenarios. Projections for the use and costs of hormonal contraceptives were made for 2 situations: whether SB 999 was enacted into law or not. Approximately 25 million Californians would be affected by the legislation, including 744,000 who used hormonal contraceptives in 2016.
To calculate their projections, the researchers used a baseline estimate of a 9% unintended pregnancy rate among current users of hormonal contraceptives (or 67,000 unintended pregnancies leading to 28,000 live births, 9,000 miscarriages, and 30,000 abortions).2 They also used a previously reported 30% reduction in the odds of unintended pregnancy with 12-month dispensing.3
Impact of shift in dispensing patterns
With SB 999 versus without SB 999, a 30% reduction in the odds of unintended pregnancies would lead to 6,000 fewer live births, 2,000 fewer miscarriages, and 7,000 fewer abortions.
The legislation would also reduce projected health care expenditures. Total net health care costs would decrease by 0.03%, for a savings of about $43 million, due to avoidance of unintended pregnancies and related medical costs.
Benefits will be even greater over time
The authors noted that the reductions in unintended pregnancies and associated health care costs with the implementation of SB 999 may be even greater in later years as beneficial health outcomes and cost savings accrue over time.
This study’s findings provide support for the implementation of similar legislation in other states.
Recent insurance coverage legislation enacted in California is expected to result in 15,000 fewer unintended pregnancies, 2,000 fewer miscarriages, and 7,000 fewer abortions, according to an analysis of the mandate’s potential impact by investigators at the University of California.1
Enacted in September 2016, the contraceptive supply legislation known as SB 999 requires health plans and insurers to cover a year-long supply of hormonal contraceptive pills, patches, and rings (formulations approved by the US Food and Drug Administration). Clinicians can now prescribe and pharmacists can dispense up to a 12-month supply at one time. California joins 5 other states and Washington, DC, that have such mandates.
Having a year’s worth of contraceptives on hand is anticipated to reduce the interruption in contraception use that may occur with a 30- or 90-day supply that needs frequent refilling and thereby lower the unplanned pregnancy rate as well as associated health care costs.
Understanding the legislation’s impact on the population’s health outcomes will be useful for other states considering similar proposed legislation.
Details of the study
In a short communication published in Contraception, McMenamin and colleagues described how University of California faculty and researchers, engaged by the California Health Benefits Review Program, assessed the utilization and cost implications of SB 999 and arrived at their estimated projections.1
The assessment was based on a literature review (including current use of hormonal contraceptives, unintended pregnancy rates among contraceptive users, and assumptions about shifts in dispensing patterns for contraceptive supplies), a survey of the state’s 5 largest health insurance providers, and a claims database review of the utilization and cost implications of SB 999.
Two scenarios. Projections for the use and costs of hormonal contraceptives were made for 2 situations: whether SB 999 was enacted into law or not. Approximately 25 million Californians would be affected by the legislation, including 744,000 who used hormonal contraceptives in 2016.
To calculate their projections, the researchers used a baseline estimate of a 9% unintended pregnancy rate among current users of hormonal contraceptives (or 67,000 unintended pregnancies leading to 28,000 live births, 9,000 miscarriages, and 30,000 abortions).2 They also used a previously reported 30% reduction in the odds of unintended pregnancy with 12-month dispensing.3
Impact of shift in dispensing patterns
With SB 999 versus without SB 999, a 30% reduction in the odds of unintended pregnancies would lead to 6,000 fewer live births, 2,000 fewer miscarriages, and 7,000 fewer abortions.
The legislation would also reduce projected health care expenditures. Total net health care costs would decrease by 0.03%, for a savings of about $43 million, due to avoidance of unintended pregnancies and related medical costs.
Benefits will be even greater over time
The authors noted that the reductions in unintended pregnancies and associated health care costs with the implementation of SB 999 may be even greater in later years as beneficial health outcomes and cost savings accrue over time.
This study’s findings provide support for the implementation of similar legislation in other states.
- McMenamin SB, Charles SA, Tabatabaeepour N, Shigekawa E, Corbett G. Implications of dispensing self-administered hormonal contraceptives in a 1-year supply: a California case study. Contraception. 2017;95(5):449–451.
- Trussel J. Contraceptive failure in the United States. Contraception. 2011;83(5):397–404.
- Foster DG, Hulett D, Bradsberry M, Darney P, Policar M. Number of oral contraceptive pill packages dispensed and subsequent unintended pregnancies. Obstet Gynecol. 2011;117(3):566–572.
- McMenamin SB, Charles SA, Tabatabaeepour N, Shigekawa E, Corbett G. Implications of dispensing self-administered hormonal contraceptives in a 1-year supply: a California case study. Contraception. 2017;95(5):449–451.
- Trussel J. Contraceptive failure in the United States. Contraception. 2011;83(5):397–404.
- Foster DG, Hulett D, Bradsberry M, Darney P, Policar M. Number of oral contraceptive pill packages dispensed and subsequent unintended pregnancies. Obstet Gynecol. 2011;117(3):566–572.
Can low-dose aspirin reduce the risk of spontaneous preterm birth?
Antiplatelet agents (mainly low-dose aspirin) have been shown to reduce the risk of preeclampsia in women at risk for the condition. The American College of Obstetricians and Gynecologists currently supports consideration of the use of low-dose aspirin (81 mg/day), initiated between 12 and 28 weeks of gestation, for the prevention of preeclampsia in women at high risk.1
Can antiplatelet agents also reduce the risk of preterm birth? It is a reasonable question, postulate van Vliet and colleagues2: Women with a history of preeclampsia also have an increased risk of spontaneous preterm birth (SPB), and vice versa. Uteroplacental ischemia is present in cases of preeclampsia, and research is showing that uteroplacental ischemia also plays a role in the etiology of spontaneous preterm labor.3,4
Details of the study
To investigate their research question, van Vliet and colleagues performed an additional analysis of the Perinatal Antiplatelet Review of International Studies Individual Participant Data meta-analysis. The original meta-analysis involved the data of 32,217 women at risk for preeclampsia who were randomly assigned to low-dose aspirin-dipyridamole or placebo (no treatment); the study revealed a moderate risk reduction for preeclampsia as well as a significant reduction in preterm birth at less than 34 weeks of gestation in women treated with antiplatelets.2
In the additional analysis, for women with an SPB who began antiplatelet treatment before 20 weeks of gestation, the researchers assessed the time between 20 weeks and spontaneous preterm delivery, iatrogenic preterm delivery, and any preterm delivery. Overall, 9.7% of women (n = 2,670) had an SPB before 37 weeks of gestation, 2.8% (n = 773) had an SPB before 34 weeks of gestation, and 0.5% (n = 151) had an SPB before 28 weeks of gestation. Antiplatelet agents were associated with a significant reduction in the risk of SPB before 37 weeks (relative risk [RR], 0.93; 95% confidence interval [CI], 0.86–0.996) and before 34 weeks (RR, 0.86; 95% CI, 0.76–0.99). The RR of having an SPB at less than 37 weeks of gestation was 0.83 for women with a previous pregnancy and 0.98 for women in their first pregnancy.2
Bottom line
Antiplatelet use resulted in a 7% reduction in SPB risk in women at risk for preeclampsia. Antiplatelet use resulted in a 14% reduction in moderate to very preterm birth risk (<34 weeks’ gestation).
The authors advise that their study “provides clinicians with the best available evidence to counsel women regarding who might benefit from” antiplatelet use during pregnancy and suggest that antiplatelet use may be a promising intervention for women at high risk for SPB, especially in high-risk women with a previous pregnancy.2
Caveats
The researchers found no difference among those receiving and not receiving antiplatelets in the incidence of antepartum hemorrhage (RR, 1.02; 95% CI, 0.90–1.15), placental abruption (RR, 1.13; 95% CI, 0.87–1.48), or neonatal bleeding (RR, 0.93; 95% CI, 0.80–1.09). The incidence of postpartum hemorrhage (PPH) was again found to be borderline significant (RR, 1.06; 95% CI, 1.00–1.13), but it was more frequent. The authors caution that the SPB reduction that they found in their study (as well as the reduced risk for preeclampsia with low-dose aspirin use) be balanced against the potential higher risk for PPH.2
- The American College of Obstetricians and Gynecologists. Practice advisory on low-dose aspirin and prevention of preeclampsia: updated recommendations. https://www.acog.org/About-ACOG/News-Room/Practice-Advisories/Practice-Advisory-Low-Dose-Aspirin-and-Prevention-of-Preeclampsia-Updated-Recommendations. Updated July 11, 2016. Accessed August 14, 2017.
- van Vliet EO, Askie LA, Mol BW, Oudijk MA. Antiplatelet agents and the prevention of spontaneous preterm birth. Obstet Gynecol. 2017;129(2):327–336.
- Arias F, Rodriquez L, Rayne SC, Kraus FT. Maternal placental vasculopathy and infection: two distinct subgroups among patients with preterm labor and preterm ruptured membranes. Am J Obstet Gynecol. 1993;168(2):585–591.
- Kelly R, Holzman C, Senagore P, et al. Placental vascular pathology findings and pathways of preterm delivery. Am J Epidemiol. 2009;170(2):148–158.
Antiplatelet agents (mainly low-dose aspirin) have been shown to reduce the risk of preeclampsia in women at risk for the condition. The American College of Obstetricians and Gynecologists currently supports consideration of the use of low-dose aspirin (81 mg/day), initiated between 12 and 28 weeks of gestation, for the prevention of preeclampsia in women at high risk.1
Can antiplatelet agents also reduce the risk of preterm birth? It is a reasonable question, postulate van Vliet and colleagues2: Women with a history of preeclampsia also have an increased risk of spontaneous preterm birth (SPB), and vice versa. Uteroplacental ischemia is present in cases of preeclampsia, and research is showing that uteroplacental ischemia also plays a role in the etiology of spontaneous preterm labor.3,4
Details of the study
To investigate their research question, van Vliet and colleagues performed an additional analysis of the Perinatal Antiplatelet Review of International Studies Individual Participant Data meta-analysis. The original meta-analysis involved the data of 32,217 women at risk for preeclampsia who were randomly assigned to low-dose aspirin-dipyridamole or placebo (no treatment); the study revealed a moderate risk reduction for preeclampsia as well as a significant reduction in preterm birth at less than 34 weeks of gestation in women treated with antiplatelets.2
In the additional analysis, for women with an SPB who began antiplatelet treatment before 20 weeks of gestation, the researchers assessed the time between 20 weeks and spontaneous preterm delivery, iatrogenic preterm delivery, and any preterm delivery. Overall, 9.7% of women (n = 2,670) had an SPB before 37 weeks of gestation, 2.8% (n = 773) had an SPB before 34 weeks of gestation, and 0.5% (n = 151) had an SPB before 28 weeks of gestation. Antiplatelet agents were associated with a significant reduction in the risk of SPB before 37 weeks (relative risk [RR], 0.93; 95% confidence interval [CI], 0.86–0.996) and before 34 weeks (RR, 0.86; 95% CI, 0.76–0.99). The RR of having an SPB at less than 37 weeks of gestation was 0.83 for women with a previous pregnancy and 0.98 for women in their first pregnancy.2
Bottom line
Antiplatelet use resulted in a 7% reduction in SPB risk in women at risk for preeclampsia. Antiplatelet use resulted in a 14% reduction in moderate to very preterm birth risk (<34 weeks’ gestation).
The authors advise that their study “provides clinicians with the best available evidence to counsel women regarding who might benefit from” antiplatelet use during pregnancy and suggest that antiplatelet use may be a promising intervention for women at high risk for SPB, especially in high-risk women with a previous pregnancy.2
Caveats
The researchers found no difference among those receiving and not receiving antiplatelets in the incidence of antepartum hemorrhage (RR, 1.02; 95% CI, 0.90–1.15), placental abruption (RR, 1.13; 95% CI, 0.87–1.48), or neonatal bleeding (RR, 0.93; 95% CI, 0.80–1.09). The incidence of postpartum hemorrhage (PPH) was again found to be borderline significant (RR, 1.06; 95% CI, 1.00–1.13), but it was more frequent. The authors caution that the SPB reduction that they found in their study (as well as the reduced risk for preeclampsia with low-dose aspirin use) be balanced against the potential higher risk for PPH.2
Antiplatelet agents (mainly low-dose aspirin) have been shown to reduce the risk of preeclampsia in women at risk for the condition. The American College of Obstetricians and Gynecologists currently supports consideration of the use of low-dose aspirin (81 mg/day), initiated between 12 and 28 weeks of gestation, for the prevention of preeclampsia in women at high risk.1
Can antiplatelet agents also reduce the risk of preterm birth? It is a reasonable question, postulate van Vliet and colleagues2: Women with a history of preeclampsia also have an increased risk of spontaneous preterm birth (SPB), and vice versa. Uteroplacental ischemia is present in cases of preeclampsia, and research is showing that uteroplacental ischemia also plays a role in the etiology of spontaneous preterm labor.3,4
Details of the study
To investigate their research question, van Vliet and colleagues performed an additional analysis of the Perinatal Antiplatelet Review of International Studies Individual Participant Data meta-analysis. The original meta-analysis involved the data of 32,217 women at risk for preeclampsia who were randomly assigned to low-dose aspirin-dipyridamole or placebo (no treatment); the study revealed a moderate risk reduction for preeclampsia as well as a significant reduction in preterm birth at less than 34 weeks of gestation in women treated with antiplatelets.2
In the additional analysis, for women with an SPB who began antiplatelet treatment before 20 weeks of gestation, the researchers assessed the time between 20 weeks and spontaneous preterm delivery, iatrogenic preterm delivery, and any preterm delivery. Overall, 9.7% of women (n = 2,670) had an SPB before 37 weeks of gestation, 2.8% (n = 773) had an SPB before 34 weeks of gestation, and 0.5% (n = 151) had an SPB before 28 weeks of gestation. Antiplatelet agents were associated with a significant reduction in the risk of SPB before 37 weeks (relative risk [RR], 0.93; 95% confidence interval [CI], 0.86–0.996) and before 34 weeks (RR, 0.86; 95% CI, 0.76–0.99). The RR of having an SPB at less than 37 weeks of gestation was 0.83 for women with a previous pregnancy and 0.98 for women in their first pregnancy.2
Bottom line
Antiplatelet use resulted in a 7% reduction in SPB risk in women at risk for preeclampsia. Antiplatelet use resulted in a 14% reduction in moderate to very preterm birth risk (<34 weeks’ gestation).
The authors advise that their study “provides clinicians with the best available evidence to counsel women regarding who might benefit from” antiplatelet use during pregnancy and suggest that antiplatelet use may be a promising intervention for women at high risk for SPB, especially in high-risk women with a previous pregnancy.2
Caveats
The researchers found no difference among those receiving and not receiving antiplatelets in the incidence of antepartum hemorrhage (RR, 1.02; 95% CI, 0.90–1.15), placental abruption (RR, 1.13; 95% CI, 0.87–1.48), or neonatal bleeding (RR, 0.93; 95% CI, 0.80–1.09). The incidence of postpartum hemorrhage (PPH) was again found to be borderline significant (RR, 1.06; 95% CI, 1.00–1.13), but it was more frequent. The authors caution that the SPB reduction that they found in their study (as well as the reduced risk for preeclampsia with low-dose aspirin use) be balanced against the potential higher risk for PPH.2
- The American College of Obstetricians and Gynecologists. Practice advisory on low-dose aspirin and prevention of preeclampsia: updated recommendations. https://www.acog.org/About-ACOG/News-Room/Practice-Advisories/Practice-Advisory-Low-Dose-Aspirin-and-Prevention-of-Preeclampsia-Updated-Recommendations. Updated July 11, 2016. Accessed August 14, 2017.
- van Vliet EO, Askie LA, Mol BW, Oudijk MA. Antiplatelet agents and the prevention of spontaneous preterm birth. Obstet Gynecol. 2017;129(2):327–336.
- Arias F, Rodriquez L, Rayne SC, Kraus FT. Maternal placental vasculopathy and infection: two distinct subgroups among patients with preterm labor and preterm ruptured membranes. Am J Obstet Gynecol. 1993;168(2):585–591.
- Kelly R, Holzman C, Senagore P, et al. Placental vascular pathology findings and pathways of preterm delivery. Am J Epidemiol. 2009;170(2):148–158.
- The American College of Obstetricians and Gynecologists. Practice advisory on low-dose aspirin and prevention of preeclampsia: updated recommendations. https://www.acog.org/About-ACOG/News-Room/Practice-Advisories/Practice-Advisory-Low-Dose-Aspirin-and-Prevention-of-Preeclampsia-Updated-Recommendations. Updated July 11, 2016. Accessed August 14, 2017.
- van Vliet EO, Askie LA, Mol BW, Oudijk MA. Antiplatelet agents and the prevention of spontaneous preterm birth. Obstet Gynecol. 2017;129(2):327–336.
- Arias F, Rodriquez L, Rayne SC, Kraus FT. Maternal placental vasculopathy and infection: two distinct subgroups among patients with preterm labor and preterm ruptured membranes. Am J Obstet Gynecol. 1993;168(2):585–591.
- Kelly R, Holzman C, Senagore P, et al. Placental vascular pathology findings and pathways of preterm delivery. Am J Epidemiol. 2009;170(2):148–158.