OBG Management

In this Update, I outline important findings from several studies published in the past year. First and foremost, what are best practices for performing colposcopy in the United States? The American Society for Colposcopy and Cervical Pathology (ASCCP) released guidelines addressing such practices. Second, what are the implications of repeated negative screening and patients’ acceptance of extended screening intervals? A recent observational cohort study and a large study of Kaiser Permanente’s practices since 2003 shed light on these questions. Last, where do we stand with HPV vaccination? Two studies shed light on the efficacy of vaccination against human papillomavirus (HPV), and subsequent cervical intraepithelial neoplasia (CIN) and cervical cancer.

ASCCP releases updated quality guidelines for performing colposcopy

Khan MJ, Werner CL, Darragh TM, et al. ASCCP colposcopy standards: Role of colposcopy, benefits, potential harms, and terminology for colposcopic practice. J Low Genit Tract Dis. 2017;21(4):223-229.

Waxman AG, Conageski C, Silver MI, et al. ASCCP colposcopy standards: How do we perform colposcopy? Implications for establishing standards. J Low Genit Tract Dis. 2017;21(4):235-241.

Wentzensen N, Schiffman M, Silver MI, et al. ASCCP colposcopy standards: Risk-based colposcopy practice. J Low Genit Tract Dis. 2017;21(4):230-234.

In October 2017, the ASCCP released a set of standards on the role and performance of colposcopy that represents best practices in women's health care in the United States. The work of these groups comprised a literature search, a national survey of ASCCP members, public comment, and expert consensus, and addressed:

• establishment of a common understanding of 1) the benefits of colposcopy in health maintenance and risk prevention, 2) risks presented by the procedure, and 3) terminology and criteria for reporting results that reduce subjectivity in reporting  
• the rationale for, approach to, and recommendations regarding assessment of cervical precancer at colposcopy
• both minimum and comprehensive guidelines for the colposcopic examination, from preprocedure evaluation to follow-up.

Each Working Group performed the analysis and produced its own report and recommendations, published sequentially in a 2017 issue of the Journal of Lower Urinary Tract Disease. The findings and standards that they produced 1) offer essential insight for high- and low-volume coloposcopists and 2) are intended to improve the quality of colposcopy, reduce subjectivity in reporting findings, and improve the sensitivity of the procedure. Aware of the concerns and objectives of payers and hospital credentialing committees, the ASCCP found it important to establish what would be considered US-based minimum quality standards and to present goals that providers and systems could strive to achieve.

Selected details of the 3 guideline reports

The past 6 years have brought us through a great deal of transition in the prevention of cervical precancer, with regard to screening intervals and types of screening (for example, see "HPV−cytology co-testing every 3 years lowers population rates of cervical precancer and cancer," in the 2017 "Cervical Disease Update," OBG Management, May 2017). The most significant change was in 2012, when American Cancer Society/ASCCP guidelines were revised to abandon screening with annual Pap testing on most patients--an effort to strike a balance between the lifesaving value of identifying precancer and the potential harm of excessive colposcopy.

If, as the US Preventive Services Task Force (USPSTF) has declared, excessive colposcopy is a harm of screening, then we should be adapting our practices, especially in terms of the frequency of screening, to 1) reduce the risk of unnecessarily screening and potentially triaging patients to colposcopy and 2) bring the highest standards of performance and reporting to colposcopic practice (see "Why aren't you doing a Pap on me?"). In other words, "This is the way I've always done it" shouldn't characterize efforts to detect disease, when the data are clear that doing less might be more beneficial for our patients. Adherence to extended screening intervals is not yet good enough to balance benefit and risk of harm, as Rendle and colleagues showed in an article this year in Preventive Medicine (discussed in the next section of this "Update"). We need to do better.

Here is a limited encapsulation of the 3 wide-ranging reports on the ASCCP colposcopy recommendations:

Role of colposcopy; benefits, potential harms, terminology (Khan et al; Working Group 1). The authors provide reinforcement: The strategic benefit of colposcopy is clear--a "drastic" reduction in excisional procedures by limiting them to patients in whom cervical cancer precursors have been confirmed or who present a high risk of occult invasive cervical cancer. Furthermore, the rate of adverse events for colposcopy−including significant bleeding and infection−is low.

Nevertheless, the potential for harm exists when an unskilled provider performs colposcopy; the Working Group emphasizes that proficiency comes with training and experience. Even in skilled hands, however, anxiety and the discomfort of a speculum examination and from acetic acid, as well as cramping and pain, might dissuade some women from receiving regular cervical screening subsequently. The authors cite research showing that educational interventions can help soothe anxiety about colposcopy and potential findings,^1,2 although consensus is lacking on the value of such interventions.

The Working Group 1) developed recommended terminology for reporting findings in colposcopy practice in the United States and 2) defined the comprehensive documentation of the procedure as comprising cervix and squamocolumnar junction visibility; acetowhitening; presence of a lesion; lesion visibility, size and location of lesion(s); vascular changes; other features; and colposcopic impression (TABLE 1).³ Minimum criteria for reporting colposcopy results were also proposed, extracted from the comprehensive standards.

Risk-based colposcopy practice (Wentzensen et al). Women referred to colposcopy present with a range of underlying risk of precancer. Assessing that risk at the colposcopy visit allows the provider to modify and individualize the procedure. Risk can be estimated by referral screening tests (eg, cytology, HPV testing) performed in conjunction with the colposcopic impression. As opposed to a lack of standards for a minimum number of biopsies, the Working Group recommends that, as a standard, multiple targeted biopsies (≥2, as many as 4) are needed to improve detection of prevalent precancers. Colposcopic impression alone is not enough to diagnose precancerous cells. Let's face it: Our eyes with a colposcopic magnification of 15X do not make a microscope.

Implementing the Working Group's recommendations is expected to lead to improved detection of cervical precancers at colposcopy and to provide stronger reassurance of negative colposcopy results. Regarding biopsy of lesions, ASCCP did not find added benefit to taking random (nondirected) biopsies for women at low risk for precancer. The sensitivity of biopsy is increased by taking multiple biopsies of suspicious lesions, based on a risk-based approach detailed in the ASCCP guidelines. So, depending on underlying risk (estimated from screening and triage tests), colposcopy practice can be adapted in a useful manner to account for differences in risk:

• When risk of precancer is very high, for example, immediate treatment might reduce cost and prevent the patient from being lost to follow-up. When risk is very low, consider expectant management (serial cytology and HPV testing) with limited need for biopsy. In a setting of intermediate risk, the Working Group proposes, "multiple biopsies of acetowhite lesions lead to increased detection of precancer."
• Perform multiple biopsies that target all areas characterized by 1) acetowhitening, 2) metaplasia, and 3) higher abnormalities.
• Do not perform nontargeted biopsies on patients at the lowest end of risk who have been referred to colposcopy−ie, those with cytology that is less than HSIL; no evidence of HPV types 16/18; and a normal colposcopic impression (ie, no acetowhitening or metaplasia, or other visible abnormality).  
• Immediate excision without biopsy confirmation or colposcopy with multiple targeted biopsies is acceptable in nonpregnant women 25 years and older whose risk of precancer is very high (≥2 of the following: HSIL cytology, HPV 16- or HPV 18-positive(or both), and high-grade colposcopy impression). Endocervical sampling should be conducted according to ASCCP's 2012 management guidelines. If biopsies do not show precancer, manage the patient using ASCCP's 2012 management guidelines, the Working Group recommends.

How do we perform colposcopy? Implications for establishing standards (Waxman et al; Working Group 3). To serve as a guide to standardizing colposcopy across the United States, the authors defined and delineated 6 major components (and their constituent parts) of a comprehensive colposcopy:

• precolposcopy evaluation
• the examination
• use of colposcopy adjuncts
• documentation
• biopsy sampling
• postcolposcopy procedures.

The constituent parts of these components are laid out in TABLE 2.⁴ A set of components for a minimum colposcopy procedure is drawn mostly from the comprehensive protocol.

The Working Group acknowledges that, in the United States, "the accuracy and reproducibility of colposcopy with biopsy as a diagnostic tool are limited." Why? Three contributing factors, the authors write, might be the absence of practice recommendations for colposcopy-biopsy procedures; of measures of quality assurance; and of standardized terminology.

Standards arrive for practice

Minimum quality standards are becoming part of almost everything US health care providers do−whether it is documentation, billing practices, or good care. Our work in gynecology, including colposcopy, is now being assessed as it is in much of the world, where minimum standards are already in place and guidelines must be followed. (In some countries standards require performing a minimum number of colposcopies per year to be identified as a "certified" colposcopist.)

What should be considered "minimum standards" for colposcopy in the United States? These ASCCP reports ask, and deliver answers to that question, bringing a broad range of concerns about high-quality practice into focus. Physicians and advanced-practice clinicians in this country who perform colposcopies have been trained to do so, but they have never had minimum standards by which to model and assess their performance. A procedure that has the potential to lead to additional testing for either cervical cancer, or to surveillance, should have minimum standards by which it is performed and documented in the United States as it is for much of the world that has widespread cervical cancer screening.

Read about adherence to cervical cancer screening.

Cervical screening adherence is relatively low, but safe. Extended intervals are very safe.

Castle PE, Kinney WK, Xue X, et al. Effect of several negative rounds of human papillomavirus and cytology co-testing on safety against cervical cancer: an observational cohort study. Ann Intern Med. 2018;168(1):20-29.

Rendle KA, Schiffman M, Cheung LC, et al. Adherence patterns to extended cervical screening intervals in women undergoing human papillomavirus (HPV) and cytology cotesting. Prev Med. 2018;109:44-50.

Patients who have been screened for cervical cancer for a long time--decades, even--have a diminishing likelihood that cancer will ever be detected. Furthermore, highest-risk patients already have been triaged into further testing or procedures, such as a loop excision electrosurgical procedure or hysterectomy. Two recent studies examined the implications of repeated negative screening and patients' acceptance of extended screening intervals.

Details of the studies

Several negative rounds of cotesting (HPV and cytology) might justify changes to the screening interval. To determine the rate of detection of CIN3, adenocarcinoma in situ, and cervical cancer (≥CIN3) in routine practice after successive negative screening at 3-year intervals, Castle and colleagues looked at records of more than 990,000 women in an integrated health care system who underwent cotesting (HPV and cytology) between 2003 and 2014. They determined that the risk of invasive cervical cancer and ≥CIN3 declined with each round of cotesting; the absolute risk fell more between first and second rounds than between second and third rounds.

At any given round of cotesting, Castle found that the ability to reassure a patient about cancer and cancer risk was similar when looking at an HPV result alone, whatever the cytology or HPV-cytology cotest result was. The investigators concluded that similar patterns of risk would have been seen had stand-alone HPV testing been used, instead of co-testing, (HPV testing alone might have missed a few cases of CIN3 and adenocarcinoma in situ leading to cancer). A single negative cotest was so effective at ruling out ≥CIN3 and cervical cancer that, after a second round of cotesting, they found that no interval cancer cases were detected among women who had a negative HPV result.

Women aged 50 years or older had a 5- to 6-fold lower risk after their third consecutive negative cotest than women aged 30 to 39 years had after their first negative cotest. These data support the ideas, Castle noted, that 1) assigning screening intervals based on both age and number of previous negative screens and 2) extending the screening interval even further than 3 years after 2--perhaps even after 1--negative cotests or HPV tests are worth entertaining. Screening women of this age becomes inefficient and cost-ineffective, even at 5-year intervals.

Is patients' adherence to an extended interval of cotesting reliable enough to change practice? Rendle and colleagues examined the records of more than 491,000 women (in the same integrated health care system that Castle studied) who had undergone routine cervical cancer screening between 2003 and 2015. Their goal was to determine how high adherence had become to the system's recommendation of an every-3-year screening interval--an interval that mirrors long-standing guidelines elsewhere.

In short, researchers observed increasing and relatively rapid clinical adoption of every-3-year cotesting for routine cervical screening over time; between 2003 and 2009, the cohort grew significantly less likely overall to come in early for screening. In this setting, adoption of an extended screeninginterval appears to run counter to earlier understanding that patients are likely to resist such extension.

Women aged 60 to 64 were most likely to screen early across 2 consecutive intervals. What Rendle termed a "modest" decrease in the percentage of late screeners (but still within a 5-year interval) was also noted during adoption of the 3-year interval.

What next?

Molecular-based testing. Research, mostly outside of the United States, is taking us in the direction of molecular-based technologies as at least a component of cervical cancer screening. Today, we rely mostly on Pap tests and colposcopy, but these are subjective screens, with a human operator. With molecular testing (mostly of components of HPV), results are objective--a "Yes" or "No" finding based on clinically validated thresholds. Methods such as genotyping, P16^INK4a/Ki-67 gene product dual-stain cytology, and testing for E6 and E7 HPV mRNA transcripts are in development, and hold promise to allow us to screen safely using almost completely molecular testing, thus eliminating human error and subjectivity and enriching the population that needs further management with very sensitive and potentially specific testing.

We are being presented with the possibility that almost all aspects of screening can be done without a provider, until the patient needs treatment.

Access to screening. Research is also looking at improving access, such as self-sampling for primary screening. That includes home cervical and vaginal sampling, with specimens mailed to the laboratory, from where results and follow-up instructions as communicated to patients. The Netherlands and the United Kingdom are moving to self-sampling primary screens; the United States is not--yet. But that is the direction research is taking us.

Modified guidelines. Eyes are on the work of the USPSTF. Last year, the Task Force issued draft recommendations (https://www.uspre ventiveservicestaskforce.org/Page/Document/draft-recommendation-statement/cervical-cancer-screening2#clinical), followed by a comment period (now closed), for updating 2012 cervical cancer screening guidelines in a way that would trigger a major change in clinical practice. Those draft recommendations and public comments are under review; final recommendations are possible within this calendar year.  

Read about the safety and efficacy of HPV vaccination.

Primary prevention of cervical cancer with vaccination is critical in any cancer prevention program

Benard VB, Castle PE, Jenison SA, et al; New Mexico HPV Pap Registry Steering Committee. Population-based incidence rates of cervical intraepithelial neoplasia in the human papillomavirus vaccine era. JAMA Oncol. 2017;3(6):833-837.

Luostarinen T, Apter D, Dillner J, et al. Vaccination protects against invasive HPV-associated cancers. Int J Cancer. 2018;142(10):2186-2187.

The success story of HPV vaccination, after more than a decade of use, continued to unfold in important ways over the past year.

Safety. With tens of millions of doses delivered, we know that the vaccine is safe, and we have retreated on some of the precautions that we once took: For example, we no longer perform a routine pregnancy test before vaccination on reproductive-age women.

Efficacy. We have learned, based on what we see in Australia and Western Europe, that vaccination is highly effective. We are also starting to see evidence of efficacy in areas of the United States, even though the vaccine is voluntary and there are no school-based recommendations. And we know that herd vaccination is very effective. The 2 studies described here add to our understanding of how vaccination is having an impact on endpoints.

Findings of the 2 studies

HPV vaccination has a direct impact on the precursor of cancer, CIN. Benard and colleagues examined data from the New Mexico HPV Pap Registry, a mandatory statewide surveillance system of cervical cancer screening that captured estimates of both screening prevalence and CIN since the time HPV vaccination was introduced in 2007 to 2014. The investigators examined registry data to gauge trends in the rate of CIN and to estimate the effect of HPV vaccination on that rate when adjusted for changes in screening for cervical cancer.

The incidence of CIN declined significantly across all grades in 2 groups between 2007 and 2015: females aged 15 to 19 years and females aged 20 to 24 years (but not in females 25 to 29 years of age). During those years, mean uptake of HPV vaccination among females 13 to 17 years of age reached as high as 40% (in 2014).

Although a reduction in CIN2 and CIN3 precancers "are early benchmarks for achieving this aim [of reducing the rate of cancer]," the investigators note, a reduction in CIN1 is "a direct measure of reductions in HPV infections requisite to the development of almost all invasive cervical cancer."

Benard moves on to conclude that a reduction in clinical outcomes of CIN among groups who are partially vaccinated for HPV is going to change clinical practice and reduce the cost-effectiveness of clinical care that supports prevention of cervical cancer. Of greatest importance, modalities and strategies for screening, and management algorithms, are going to need to evolve as HPV vaccination and cervical screening are integrated in a rational manner. Furthermore, it might be feasible to factor in population-level decreases in CIN among cohorts who are partially vaccinated for HPV when reassessing clinical practice guidelines for cervical cancer screening.

What does this mean? As we start to eliminate HPV from the population, any positive screening result will be that much more meaningful because the outcome--cervical cancer--will be much rarer. The onus will be on providers and public health officials to re-strategize how to screen what is going to be a widely-vaccinated population; more and more, we will be looking for needles in a haystack.

How are we going to someday screen women in their 20s who were vaccinated at 11 or 12 years of age? Likely, screening will start at a later age, and screening will be conducted at longer intervals. Any finding of HPV or disease is going to be highly significant, and likely, far less frequent.

HPV vaccination protects against invasive HPV-associated cancer. Luostarinen and colleagues report proof of highly efficacious protection offered by a population-based HPV vaccination program in Finland, in the form of a decrease in the key endpoint: cases of invasive HPV-associated cancer. Examining vaccinated (3,331 females) and unvaccinated (15,665 females) cohorts in the nationwide Finnish Cancer Registry, the investigators identified 10 cases of HPV-caused cancer (8 cervical, 1 oropharyngeal, 1 vulvar) in the unvaccinated females and 0 cases in vaccinated females--a statistically significant difference.

From the evidence gathered in this first intention-to-treat trial, the investigators conclude that vaccination protects against invasive HPV-associated cancer--what they call "an awaited, pivotal corollary" to high vaccine efficacy against HPV infection.

Summing up

This success story continues to unfold, despite well-organized, antivaccine campaigns. The HPV vaccine has been an easy target: It is novel, it involves a sexually transmitted infection, and the endpoint of protecting against invasive HPV-associated cancer is years--decades--away. But antivaccine groups can no longer argue the point that studies have not been designed to yield evidence of the impact of the vaccine on decisive endpoints, including cervical cancer.

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

In this Update, I outline important findings from several studies published in the past year. First and foremost, what are best practices for performing colposcopy in the United States? The American Society for Colposcopy and Cervical Pathology (ASCCP) released guidelines addressing such practices. Second, what are the implications of repeated negative screening and patients’ acceptance of extended screening intervals? A recent observational cohort study and a large study of Kaiser Permanente’s practices since 2003 shed light on these questions. Last, where do we stand with HPV vaccination? Two studies shed light on the efficacy of vaccination against human papillomavirus (HPV), and subsequent cervical intraepithelial neoplasia (CIN) and cervical cancer.

ASCCP releases updated quality guidelines for performing colposcopy

Khan MJ, Werner CL, Darragh TM, et al. ASCCP colposcopy standards: Role of colposcopy, benefits, potential harms, and terminology for colposcopic practice. J Low Genit Tract Dis. 2017;21(4):223-229.

Waxman AG, Conageski C, Silver MI, et al. ASCCP colposcopy standards: How do we perform colposcopy? Implications for establishing standards. J Low Genit Tract Dis. 2017;21(4):235-241.

Wentzensen N, Schiffman M, Silver MI, et al. ASCCP colposcopy standards: Risk-based colposcopy practice. J Low Genit Tract Dis. 2017;21(4):230-234.

In October 2017, the ASCCP released a set of standards on the role and performance of colposcopy that represents best practices in women's health care in the United States. The work of these groups comprised a literature search, a national survey of ASCCP members, public comment, and expert consensus, and addressed:

• establishment of a common understanding of 1) the benefits of colposcopy in health maintenance and risk prevention, 2) risks presented by the procedure, and 3) terminology and criteria for reporting results that reduce subjectivity in reporting  
• the rationale for, approach to, and recommendations regarding assessment of cervical precancer at colposcopy
• both minimum and comprehensive guidelines for the colposcopic examination, from preprocedure evaluation to follow-up.

Each Working Group performed the analysis and produced its own report and recommendations, published sequentially in a 2017 issue of the Journal of Lower Urinary Tract Disease. The findings and standards that they produced 1) offer essential insight for high- and low-volume coloposcopists and 2) are intended to improve the quality of colposcopy, reduce subjectivity in reporting findings, and improve the sensitivity of the procedure. Aware of the concerns and objectives of payers and hospital credentialing committees, the ASCCP found it important to establish what would be considered US-based minimum quality standards and to present goals that providers and systems could strive to achieve.

Selected details of the 3 guideline reports

The past 6 years have brought us through a great deal of transition in the prevention of cervical precancer, with regard to screening intervals and types of screening (for example, see "HPV−cytology co-testing every 3 years lowers population rates of cervical precancer and cancer," in the 2017 "Cervical Disease Update," OBG Management, May 2017). The most significant change was in 2012, when American Cancer Society/ASCCP guidelines were revised to abandon screening with annual Pap testing on most patients--an effort to strike a balance between the lifesaving value of identifying precancer and the potential harm of excessive colposcopy.

If, as the US Preventive Services Task Force (USPSTF) has declared, excessive colposcopy is a harm of screening, then we should be adapting our practices, especially in terms of the frequency of screening, to 1) reduce the risk of unnecessarily screening and potentially triaging patients to colposcopy and 2) bring the highest standards of performance and reporting to colposcopic practice (see "Why aren't you doing a Pap on me?"). In other words, "This is the way I've always done it" shouldn't characterize efforts to detect disease, when the data are clear that doing less might be more beneficial for our patients. Adherence to extended screening intervals is not yet good enough to balance benefit and risk of harm, as Rendle and colleagues showed in an article this year in Preventive Medicine (discussed in the next section of this "Update"). We need to do better.

Here is a limited encapsulation of the 3 wide-ranging reports on the ASCCP colposcopy recommendations:

Role of colposcopy; benefits, potential harms, terminology (Khan et al; Working Group 1). The authors provide reinforcement: The strategic benefit of colposcopy is clear--a "drastic" reduction in excisional procedures by limiting them to patients in whom cervical cancer precursors have been confirmed or who present a high risk of occult invasive cervical cancer. Furthermore, the rate of adverse events for colposcopy−including significant bleeding and infection−is low.

Nevertheless, the potential for harm exists when an unskilled provider performs colposcopy; the Working Group emphasizes that proficiency comes with training and experience. Even in skilled hands, however, anxiety and the discomfort of a speculum examination and from acetic acid, as well as cramping and pain, might dissuade some women from receiving regular cervical screening subsequently. The authors cite research showing that educational interventions can help soothe anxiety about colposcopy and potential findings,^1,2 although consensus is lacking on the value of such interventions.

The Working Group 1) developed recommended terminology for reporting findings in colposcopy practice in the United States and 2) defined the comprehensive documentation of the procedure as comprising cervix and squamocolumnar junction visibility; acetowhitening; presence of a lesion; lesion visibility, size and location of lesion(s); vascular changes; other features; and colposcopic impression (TABLE 1).³ Minimum criteria for reporting colposcopy results were also proposed, extracted from the comprehensive standards.

Risk-based colposcopy practice (Wentzensen et al). Women referred to colposcopy present with a range of underlying risk of precancer. Assessing that risk at the colposcopy visit allows the provider to modify and individualize the procedure. Risk can be estimated by referral screening tests (eg, cytology, HPV testing) performed in conjunction with the colposcopic impression. As opposed to a lack of standards for a minimum number of biopsies, the Working Group recommends that, as a standard, multiple targeted biopsies (≥2, as many as 4) are needed to improve detection of prevalent precancers. Colposcopic impression alone is not enough to diagnose precancerous cells. Let's face it: Our eyes with a colposcopic magnification of 15X do not make a microscope.

Implementing the Working Group's recommendations is expected to lead to improved detection of cervical precancers at colposcopy and to provide stronger reassurance of negative colposcopy results. Regarding biopsy of lesions, ASCCP did not find added benefit to taking random (nondirected) biopsies for women at low risk for precancer. The sensitivity of biopsy is increased by taking multiple biopsies of suspicious lesions, based on a risk-based approach detailed in the ASCCP guidelines. So, depending on underlying risk (estimated from screening and triage tests), colposcopy practice can be adapted in a useful manner to account for differences in risk:

• When risk of precancer is very high, for example, immediate treatment might reduce cost and prevent the patient from being lost to follow-up. When risk is very low, consider expectant management (serial cytology and HPV testing) with limited need for biopsy. In a setting of intermediate risk, the Working Group proposes, "multiple biopsies of acetowhite lesions lead to increased detection of precancer."
• Perform multiple biopsies that target all areas characterized by 1) acetowhitening, 2) metaplasia, and 3) higher abnormalities.
• Do not perform nontargeted biopsies on patients at the lowest end of risk who have been referred to colposcopy−ie, those with cytology that is less than HSIL; no evidence of HPV types 16/18; and a normal colposcopic impression (ie, no acetowhitening or metaplasia, or other visible abnormality).  
• Immediate excision without biopsy confirmation or colposcopy with multiple targeted biopsies is acceptable in nonpregnant women 25 years and older whose risk of precancer is very high (≥2 of the following: HSIL cytology, HPV 16- or HPV 18-positive(or both), and high-grade colposcopy impression). Endocervical sampling should be conducted according to ASCCP's 2012 management guidelines. If biopsies do not show precancer, manage the patient using ASCCP's 2012 management guidelines, the Working Group recommends.

How do we perform colposcopy? Implications for establishing standards (Waxman et al; Working Group 3). To serve as a guide to standardizing colposcopy across the United States, the authors defined and delineated 6 major components (and their constituent parts) of a comprehensive colposcopy:

• precolposcopy evaluation
• the examination
• use of colposcopy adjuncts
• documentation
• biopsy sampling
• postcolposcopy procedures.

The constituent parts of these components are laid out in TABLE 2.⁴ A set of components for a minimum colposcopy procedure is drawn mostly from the comprehensive protocol.

The Working Group acknowledges that, in the United States, "the accuracy and reproducibility of colposcopy with biopsy as a diagnostic tool are limited." Why? Three contributing factors, the authors write, might be the absence of practice recommendations for colposcopy-biopsy procedures; of measures of quality assurance; and of standardized terminology.

Standards arrive for practice

Minimum quality standards are becoming part of almost everything US health care providers do−whether it is documentation, billing practices, or good care. Our work in gynecology, including colposcopy, is now being assessed as it is in much of the world, where minimum standards are already in place and guidelines must be followed. (In some countries standards require performing a minimum number of colposcopies per year to be identified as a "certified" colposcopist.)

What should be considered "minimum standards" for colposcopy in the United States? These ASCCP reports ask, and deliver answers to that question, bringing a broad range of concerns about high-quality practice into focus. Physicians and advanced-practice clinicians in this country who perform colposcopies have been trained to do so, but they have never had minimum standards by which to model and assess their performance. A procedure that has the potential to lead to additional testing for either cervical cancer, or to surveillance, should have minimum standards by which it is performed and documented in the United States as it is for much of the world that has widespread cervical cancer screening.

Read about adherence to cervical cancer screening.

Cervical screening adherence is relatively low, but safe. Extended intervals are very safe.

Castle PE, Kinney WK, Xue X, et al. Effect of several negative rounds of human papillomavirus and cytology co-testing on safety against cervical cancer: an observational cohort study. Ann Intern Med. 2018;168(1):20-29.

Rendle KA, Schiffman M, Cheung LC, et al. Adherence patterns to extended cervical screening intervals in women undergoing human papillomavirus (HPV) and cytology cotesting. Prev Med. 2018;109:44-50.

Patients who have been screened for cervical cancer for a long time--decades, even--have a diminishing likelihood that cancer will ever be detected. Furthermore, highest-risk patients already have been triaged into further testing or procedures, such as a loop excision electrosurgical procedure or hysterectomy. Two recent studies examined the implications of repeated negative screening and patients' acceptance of extended screening intervals.

Details of the studies

Several negative rounds of cotesting (HPV and cytology) might justify changes to the screening interval. To determine the rate of detection of CIN3, adenocarcinoma in situ, and cervical cancer (≥CIN3) in routine practice after successive negative screening at 3-year intervals, Castle and colleagues looked at records of more than 990,000 women in an integrated health care system who underwent cotesting (HPV and cytology) between 2003 and 2014. They determined that the risk of invasive cervical cancer and ≥CIN3 declined with each round of cotesting; the absolute risk fell more between first and second rounds than between second and third rounds.

At any given round of cotesting, Castle found that the ability to reassure a patient about cancer and cancer risk was similar when looking at an HPV result alone, whatever the cytology or HPV-cytology cotest result was. The investigators concluded that similar patterns of risk would have been seen had stand-alone HPV testing been used, instead of co-testing, (HPV testing alone might have missed a few cases of CIN3 and adenocarcinoma in situ leading to cancer). A single negative cotest was so effective at ruling out ≥CIN3 and cervical cancer that, after a second round of cotesting, they found that no interval cancer cases were detected among women who had a negative HPV result.

Women aged 50 years or older had a 5- to 6-fold lower risk after their third consecutive negative cotest than women aged 30 to 39 years had after their first negative cotest. These data support the ideas, Castle noted, that 1) assigning screening intervals based on both age and number of previous negative screens and 2) extending the screening interval even further than 3 years after 2--perhaps even after 1--negative cotests or HPV tests are worth entertaining. Screening women of this age becomes inefficient and cost-ineffective, even at 5-year intervals.

Is patients' adherence to an extended interval of cotesting reliable enough to change practice? Rendle and colleagues examined the records of more than 491,000 women (in the same integrated health care system that Castle studied) who had undergone routine cervical cancer screening between 2003 and 2015. Their goal was to determine how high adherence had become to the system's recommendation of an every-3-year screening interval--an interval that mirrors long-standing guidelines elsewhere.

In short, researchers observed increasing and relatively rapid clinical adoption of every-3-year cotesting for routine cervical screening over time; between 2003 and 2009, the cohort grew significantly less likely overall to come in early for screening. In this setting, adoption of an extended screeninginterval appears to run counter to earlier understanding that patients are likely to resist such extension.

Women aged 60 to 64 were most likely to screen early across 2 consecutive intervals. What Rendle termed a "modest" decrease in the percentage of late screeners (but still within a 5-year interval) was also noted during adoption of the 3-year interval.

What next?

Molecular-based testing. Research, mostly outside of the United States, is taking us in the direction of molecular-based technologies as at least a component of cervical cancer screening. Today, we rely mostly on Pap tests and colposcopy, but these are subjective screens, with a human operator. With molecular testing (mostly of components of HPV), results are objective--a "Yes" or "No" finding based on clinically validated thresholds. Methods such as genotyping, P16^INK4a/Ki-67 gene product dual-stain cytology, and testing for E6 and E7 HPV mRNA transcripts are in development, and hold promise to allow us to screen safely using almost completely molecular testing, thus eliminating human error and subjectivity and enriching the population that needs further management with very sensitive and potentially specific testing.

We are being presented with the possibility that almost all aspects of screening can be done without a provider, until the patient needs treatment.

Access to screening. Research is also looking at improving access, such as self-sampling for primary screening. That includes home cervical and vaginal sampling, with specimens mailed to the laboratory, from where results and follow-up instructions as communicated to patients. The Netherlands and the United Kingdom are moving to self-sampling primary screens; the United States is not--yet. But that is the direction research is taking us.

Modified guidelines. Eyes are on the work of the USPSTF. Last year, the Task Force issued draft recommendations (https://www.uspre ventiveservicestaskforce.org/Page/Document/draft-recommendation-statement/cervical-cancer-screening2#clinical), followed by a comment period (now closed), for updating 2012 cervical cancer screening guidelines in a way that would trigger a major change in clinical practice. Those draft recommendations and public comments are under review; final recommendations are possible within this calendar year.  

Read about the safety and efficacy of HPV vaccination.

Primary prevention of cervical cancer with vaccination is critical in any cancer prevention program

Benard VB, Castle PE, Jenison SA, et al; New Mexico HPV Pap Registry Steering Committee. Population-based incidence rates of cervical intraepithelial neoplasia in the human papillomavirus vaccine era. JAMA Oncol. 2017;3(6):833-837.

Luostarinen T, Apter D, Dillner J, et al. Vaccination protects against invasive HPV-associated cancers. Int J Cancer. 2018;142(10):2186-2187.

The success story of HPV vaccination, after more than a decade of use, continued to unfold in important ways over the past year.

Safety. With tens of millions of doses delivered, we know that the vaccine is safe, and we have retreated on some of the precautions that we once took: For example, we no longer perform a routine pregnancy test before vaccination on reproductive-age women.

Efficacy. We have learned, based on what we see in Australia and Western Europe, that vaccination is highly effective. We are also starting to see evidence of efficacy in areas of the United States, even though the vaccine is voluntary and there are no school-based recommendations. And we know that herd vaccination is very effective. The 2 studies described here add to our understanding of how vaccination is having an impact on endpoints.

Findings of the 2 studies

HPV vaccination has a direct impact on the precursor of cancer, CIN. Benard and colleagues examined data from the New Mexico HPV Pap Registry, a mandatory statewide surveillance system of cervical cancer screening that captured estimates of both screening prevalence and CIN since the time HPV vaccination was introduced in 2007 to 2014. The investigators examined registry data to gauge trends in the rate of CIN and to estimate the effect of HPV vaccination on that rate when adjusted for changes in screening for cervical cancer.

The incidence of CIN declined significantly across all grades in 2 groups between 2007 and 2015: females aged 15 to 19 years and females aged 20 to 24 years (but not in females 25 to 29 years of age). During those years, mean uptake of HPV vaccination among females 13 to 17 years of age reached as high as 40% (in 2014).

Although a reduction in CIN2 and CIN3 precancers "are early benchmarks for achieving this aim [of reducing the rate of cancer]," the investigators note, a reduction in CIN1 is "a direct measure of reductions in HPV infections requisite to the development of almost all invasive cervical cancer."

Benard moves on to conclude that a reduction in clinical outcomes of CIN among groups who are partially vaccinated for HPV is going to change clinical practice and reduce the cost-effectiveness of clinical care that supports prevention of cervical cancer. Of greatest importance, modalities and strategies for screening, and management algorithms, are going to need to evolve as HPV vaccination and cervical screening are integrated in a rational manner. Furthermore, it might be feasible to factor in population-level decreases in CIN among cohorts who are partially vaccinated for HPV when reassessing clinical practice guidelines for cervical cancer screening.

What does this mean? As we start to eliminate HPV from the population, any positive screening result will be that much more meaningful because the outcome--cervical cancer--will be much rarer. The onus will be on providers and public health officials to re-strategize how to screen what is going to be a widely-vaccinated population; more and more, we will be looking for needles in a haystack.

How are we going to someday screen women in their 20s who were vaccinated at 11 or 12 years of age? Likely, screening will start at a later age, and screening will be conducted at longer intervals. Any finding of HPV or disease is going to be highly significant, and likely, far less frequent.

HPV vaccination protects against invasive HPV-associated cancer. Luostarinen and colleagues report proof of highly efficacious protection offered by a population-based HPV vaccination program in Finland, in the form of a decrease in the key endpoint: cases of invasive HPV-associated cancer. Examining vaccinated (3,331 females) and unvaccinated (15,665 females) cohorts in the nationwide Finnish Cancer Registry, the investigators identified 10 cases of HPV-caused cancer (8 cervical, 1 oropharyngeal, 1 vulvar) in the unvaccinated females and 0 cases in vaccinated females--a statistically significant difference.

From the evidence gathered in this first intention-to-treat trial, the investigators conclude that vaccination protects against invasive HPV-associated cancer--what they call "an awaited, pivotal corollary" to high vaccine efficacy against HPV infection.

Summing up

This success story continues to unfold, despite well-organized, antivaccine campaigns. The HPV vaccine has been an easy target: It is novel, it involves a sexually transmitted infection, and the endpoint of protecting against invasive HPV-associated cancer is years--decades--away. But antivaccine groups can no longer argue the point that studies have not been designed to yield evidence of the impact of the vaccine on decisive endpoints, including cervical cancer.

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

In this Update, I outline important findings from several studies published in the past year. First and foremost, what are best practices for performing colposcopy in the United States? The American Society for Colposcopy and Cervical Pathology (ASCCP) released guidelines addressing such practices. Second, what are the implications of repeated negative screening and patients’ acceptance of extended screening intervals? A recent observational cohort study and a large study of Kaiser Permanente’s practices since 2003 shed light on these questions. Last, where do we stand with HPV vaccination? Two studies shed light on the efficacy of vaccination against human papillomavirus (HPV), and subsequent cervical intraepithelial neoplasia (CIN) and cervical cancer.

ASCCP releases updated quality guidelines for performing colposcopy

Khan MJ, Werner CL, Darragh TM, et al. ASCCP colposcopy standards: Role of colposcopy, benefits, potential harms, and terminology for colposcopic practice. J Low Genit Tract Dis. 2017;21(4):223-229.

Waxman AG, Conageski C, Silver MI, et al. ASCCP colposcopy standards: How do we perform colposcopy? Implications for establishing standards. J Low Genit Tract Dis. 2017;21(4):235-241.

Wentzensen N, Schiffman M, Silver MI, et al. ASCCP colposcopy standards: Risk-based colposcopy practice. J Low Genit Tract Dis. 2017;21(4):230-234.

In October 2017, the ASCCP released a set of standards on the role and performance of colposcopy that represents best practices in women's health care in the United States. The work of these groups comprised a literature search, a national survey of ASCCP members, public comment, and expert consensus, and addressed:

• establishment of a common understanding of 1) the benefits of colposcopy in health maintenance and risk prevention, 2) risks presented by the procedure, and 3) terminology and criteria for reporting results that reduce subjectivity in reporting  
• the rationale for, approach to, and recommendations regarding assessment of cervical precancer at colposcopy
• both minimum and comprehensive guidelines for the colposcopic examination, from preprocedure evaluation to follow-up.

Each Working Group performed the analysis and produced its own report and recommendations, published sequentially in a 2017 issue of the Journal of Lower Urinary Tract Disease. The findings and standards that they produced 1) offer essential insight for high- and low-volume coloposcopists and 2) are intended to improve the quality of colposcopy, reduce subjectivity in reporting findings, and improve the sensitivity of the procedure. Aware of the concerns and objectives of payers and hospital credentialing committees, the ASCCP found it important to establish what would be considered US-based minimum quality standards and to present goals that providers and systems could strive to achieve.

Selected details of the 3 guideline reports

The past 6 years have brought us through a great deal of transition in the prevention of cervical precancer, with regard to screening intervals and types of screening (for example, see "HPV−cytology co-testing every 3 years lowers population rates of cervical precancer and cancer," in the 2017 "Cervical Disease Update," OBG Management, May 2017). The most significant change was in 2012, when American Cancer Society/ASCCP guidelines were revised to abandon screening with annual Pap testing on most patients--an effort to strike a balance between the lifesaving value of identifying precancer and the potential harm of excessive colposcopy.

If, as the US Preventive Services Task Force (USPSTF) has declared, excessive colposcopy is a harm of screening, then we should be adapting our practices, especially in terms of the frequency of screening, to 1) reduce the risk of unnecessarily screening and potentially triaging patients to colposcopy and 2) bring the highest standards of performance and reporting to colposcopic practice (see "Why aren't you doing a Pap on me?"). In other words, "This is the way I've always done it" shouldn't characterize efforts to detect disease, when the data are clear that doing less might be more beneficial for our patients. Adherence to extended screening intervals is not yet good enough to balance benefit and risk of harm, as Rendle and colleagues showed in an article this year in Preventive Medicine (discussed in the next section of this "Update"). We need to do better.

Here is a limited encapsulation of the 3 wide-ranging reports on the ASCCP colposcopy recommendations:

Role of colposcopy; benefits, potential harms, terminology (Khan et al; Working Group 1). The authors provide reinforcement: The strategic benefit of colposcopy is clear--a "drastic" reduction in excisional procedures by limiting them to patients in whom cervical cancer precursors have been confirmed or who present a high risk of occult invasive cervical cancer. Furthermore, the rate of adverse events for colposcopy−including significant bleeding and infection−is low.

Nevertheless, the potential for harm exists when an unskilled provider performs colposcopy; the Working Group emphasizes that proficiency comes with training and experience. Even in skilled hands, however, anxiety and the discomfort of a speculum examination and from acetic acid, as well as cramping and pain, might dissuade some women from receiving regular cervical screening subsequently. The authors cite research showing that educational interventions can help soothe anxiety about colposcopy and potential findings,^1,2 although consensus is lacking on the value of such interventions.

The Working Group 1) developed recommended terminology for reporting findings in colposcopy practice in the United States and 2) defined the comprehensive documentation of the procedure as comprising cervix and squamocolumnar junction visibility; acetowhitening; presence of a lesion; lesion visibility, size and location of lesion(s); vascular changes; other features; and colposcopic impression (TABLE 1).³ Minimum criteria for reporting colposcopy results were also proposed, extracted from the comprehensive standards.

Risk-based colposcopy practice (Wentzensen et al). Women referred to colposcopy present with a range of underlying risk of precancer. Assessing that risk at the colposcopy visit allows the provider to modify and individualize the procedure. Risk can be estimated by referral screening tests (eg, cytology, HPV testing) performed in conjunction with the colposcopic impression. As opposed to a lack of standards for a minimum number of biopsies, the Working Group recommends that, as a standard, multiple targeted biopsies (≥2, as many as 4) are needed to improve detection of prevalent precancers. Colposcopic impression alone is not enough to diagnose precancerous cells. Let's face it: Our eyes with a colposcopic magnification of 15X do not make a microscope.

Implementing the Working Group's recommendations is expected to lead to improved detection of cervical precancers at colposcopy and to provide stronger reassurance of negative colposcopy results. Regarding biopsy of lesions, ASCCP did not find added benefit to taking random (nondirected) biopsies for women at low risk for precancer. The sensitivity of biopsy is increased by taking multiple biopsies of suspicious lesions, based on a risk-based approach detailed in the ASCCP guidelines. So, depending on underlying risk (estimated from screening and triage tests), colposcopy practice can be adapted in a useful manner to account for differences in risk:

• When risk of precancer is very high, for example, immediate treatment might reduce cost and prevent the patient from being lost to follow-up. When risk is very low, consider expectant management (serial cytology and HPV testing) with limited need for biopsy. In a setting of intermediate risk, the Working Group proposes, "multiple biopsies of acetowhite lesions lead to increased detection of precancer."
• Perform multiple biopsies that target all areas characterized by 1) acetowhitening, 2) metaplasia, and 3) higher abnormalities.
• Do not perform nontargeted biopsies on patients at the lowest end of risk who have been referred to colposcopy−ie, those with cytology that is less than HSIL; no evidence of HPV types 16/18; and a normal colposcopic impression (ie, no acetowhitening or metaplasia, or other visible abnormality).  
• Immediate excision without biopsy confirmation or colposcopy with multiple targeted biopsies is acceptable in nonpregnant women 25 years and older whose risk of precancer is very high (≥2 of the following: HSIL cytology, HPV 16- or HPV 18-positive(or both), and high-grade colposcopy impression). Endocervical sampling should be conducted according to ASCCP's 2012 management guidelines. If biopsies do not show precancer, manage the patient using ASCCP's 2012 management guidelines, the Working Group recommends.

How do we perform colposcopy? Implications for establishing standards (Waxman et al; Working Group 3). To serve as a guide to standardizing colposcopy across the United States, the authors defined and delineated 6 major components (and their constituent parts) of a comprehensive colposcopy:

• precolposcopy evaluation
• the examination
• use of colposcopy adjuncts
• documentation
• biopsy sampling
• postcolposcopy procedures.

The constituent parts of these components are laid out in TABLE 2.⁴ A set of components for a minimum colposcopy procedure is drawn mostly from the comprehensive protocol.

The Working Group acknowledges that, in the United States, "the accuracy and reproducibility of colposcopy with biopsy as a diagnostic tool are limited." Why? Three contributing factors, the authors write, might be the absence of practice recommendations for colposcopy-biopsy procedures; of measures of quality assurance; and of standardized terminology.

Standards arrive for practice

Minimum quality standards are becoming part of almost everything US health care providers do−whether it is documentation, billing practices, or good care. Our work in gynecology, including colposcopy, is now being assessed as it is in much of the world, where minimum standards are already in place and guidelines must be followed. (In some countries standards require performing a minimum number of colposcopies per year to be identified as a "certified" colposcopist.)

What should be considered "minimum standards" for colposcopy in the United States? These ASCCP reports ask, and deliver answers to that question, bringing a broad range of concerns about high-quality practice into focus. Physicians and advanced-practice clinicians in this country who perform colposcopies have been trained to do so, but they have never had minimum standards by which to model and assess their performance. A procedure that has the potential to lead to additional testing for either cervical cancer, or to surveillance, should have minimum standards by which it is performed and documented in the United States as it is for much of the world that has widespread cervical cancer screening.

Read about adherence to cervical cancer screening.

Cervical screening adherence is relatively low, but safe. Extended intervals are very safe.

Castle PE, Kinney WK, Xue X, et al. Effect of several negative rounds of human papillomavirus and cytology co-testing on safety against cervical cancer: an observational cohort study. Ann Intern Med. 2018;168(1):20-29.

Rendle KA, Schiffman M, Cheung LC, et al. Adherence patterns to extended cervical screening intervals in women undergoing human papillomavirus (HPV) and cytology cotesting. Prev Med. 2018;109:44-50.

Patients who have been screened for cervical cancer for a long time--decades, even--have a diminishing likelihood that cancer will ever be detected. Furthermore, highest-risk patients already have been triaged into further testing or procedures, such as a loop excision electrosurgical procedure or hysterectomy. Two recent studies examined the implications of repeated negative screening and patients' acceptance of extended screening intervals.

Details of the studies

Several negative rounds of cotesting (HPV and cytology) might justify changes to the screening interval. To determine the rate of detection of CIN3, adenocarcinoma in situ, and cervical cancer (≥CIN3) in routine practice after successive negative screening at 3-year intervals, Castle and colleagues looked at records of more than 990,000 women in an integrated health care system who underwent cotesting (HPV and cytology) between 2003 and 2014. They determined that the risk of invasive cervical cancer and ≥CIN3 declined with each round of cotesting; the absolute risk fell more between first and second rounds than between second and third rounds.

At any given round of cotesting, Castle found that the ability to reassure a patient about cancer and cancer risk was similar when looking at an HPV result alone, whatever the cytology or HPV-cytology cotest result was. The investigators concluded that similar patterns of risk would have been seen had stand-alone HPV testing been used, instead of co-testing, (HPV testing alone might have missed a few cases of CIN3 and adenocarcinoma in situ leading to cancer). A single negative cotest was so effective at ruling out ≥CIN3 and cervical cancer that, after a second round of cotesting, they found that no interval cancer cases were detected among women who had a negative HPV result.

Women aged 50 years or older had a 5- to 6-fold lower risk after their third consecutive negative cotest than women aged 30 to 39 years had after their first negative cotest. These data support the ideas, Castle noted, that 1) assigning screening intervals based on both age and number of previous negative screens and 2) extending the screening interval even further than 3 years after 2--perhaps even after 1--negative cotests or HPV tests are worth entertaining. Screening women of this age becomes inefficient and cost-ineffective, even at 5-year intervals.

Is patients' adherence to an extended interval of cotesting reliable enough to change practice? Rendle and colleagues examined the records of more than 491,000 women (in the same integrated health care system that Castle studied) who had undergone routine cervical cancer screening between 2003 and 2015. Their goal was to determine how high adherence had become to the system's recommendation of an every-3-year screening interval--an interval that mirrors long-standing guidelines elsewhere.

In short, researchers observed increasing and relatively rapid clinical adoption of every-3-year cotesting for routine cervical screening over time; between 2003 and 2009, the cohort grew significantly less likely overall to come in early for screening. In this setting, adoption of an extended screeninginterval appears to run counter to earlier understanding that patients are likely to resist such extension.

Women aged 60 to 64 were most likely to screen early across 2 consecutive intervals. What Rendle termed a "modest" decrease in the percentage of late screeners (but still within a 5-year interval) was also noted during adoption of the 3-year interval.

What next?

Molecular-based testing. Research, mostly outside of the United States, is taking us in the direction of molecular-based technologies as at least a component of cervical cancer screening. Today, we rely mostly on Pap tests and colposcopy, but these are subjective screens, with a human operator. With molecular testing (mostly of components of HPV), results are objective--a "Yes" or "No" finding based on clinically validated thresholds. Methods such as genotyping, P16^INK4a/Ki-67 gene product dual-stain cytology, and testing for E6 and E7 HPV mRNA transcripts are in development, and hold promise to allow us to screen safely using almost completely molecular testing, thus eliminating human error and subjectivity and enriching the population that needs further management with very sensitive and potentially specific testing.

We are being presented with the possibility that almost all aspects of screening can be done without a provider, until the patient needs treatment.

Access to screening. Research is also looking at improving access, such as self-sampling for primary screening. That includes home cervical and vaginal sampling, with specimens mailed to the laboratory, from where results and follow-up instructions as communicated to patients. The Netherlands and the United Kingdom are moving to self-sampling primary screens; the United States is not--yet. But that is the direction research is taking us.

Modified guidelines. Eyes are on the work of the USPSTF. Last year, the Task Force issued draft recommendations (https://www.uspre ventiveservicestaskforce.org/Page/Document/draft-recommendation-statement/cervical-cancer-screening2#clinical), followed by a comment period (now closed), for updating 2012 cervical cancer screening guidelines in a way that would trigger a major change in clinical practice. Those draft recommendations and public comments are under review; final recommendations are possible within this calendar year.  

Read about the safety and efficacy of HPV vaccination.

Primary prevention of cervical cancer with vaccination is critical in any cancer prevention program

Benard VB, Castle PE, Jenison SA, et al; New Mexico HPV Pap Registry Steering Committee. Population-based incidence rates of cervical intraepithelial neoplasia in the human papillomavirus vaccine era. JAMA Oncol. 2017;3(6):833-837.

Luostarinen T, Apter D, Dillner J, et al. Vaccination protects against invasive HPV-associated cancers. Int J Cancer. 2018;142(10):2186-2187.

The success story of HPV vaccination, after more than a decade of use, continued to unfold in important ways over the past year.

Safety. With tens of millions of doses delivered, we know that the vaccine is safe, and we have retreated on some of the precautions that we once took: For example, we no longer perform a routine pregnancy test before vaccination on reproductive-age women.

Efficacy. We have learned, based on what we see in Australia and Western Europe, that vaccination is highly effective. We are also starting to see evidence of efficacy in areas of the United States, even though the vaccine is voluntary and there are no school-based recommendations. And we know that herd vaccination is very effective. The 2 studies described here add to our understanding of how vaccination is having an impact on endpoints.

Findings of the 2 studies

HPV vaccination has a direct impact on the precursor of cancer, CIN. Benard and colleagues examined data from the New Mexico HPV Pap Registry, a mandatory statewide surveillance system of cervical cancer screening that captured estimates of both screening prevalence and CIN since the time HPV vaccination was introduced in 2007 to 2014. The investigators examined registry data to gauge trends in the rate of CIN and to estimate the effect of HPV vaccination on that rate when adjusted for changes in screening for cervical cancer.

The incidence of CIN declined significantly across all grades in 2 groups between 2007 and 2015: females aged 15 to 19 years and females aged 20 to 24 years (but not in females 25 to 29 years of age). During those years, mean uptake of HPV vaccination among females 13 to 17 years of age reached as high as 40% (in 2014).

Although a reduction in CIN2 and CIN3 precancers "are early benchmarks for achieving this aim [of reducing the rate of cancer]," the investigators note, a reduction in CIN1 is "a direct measure of reductions in HPV infections requisite to the development of almost all invasive cervical cancer."

Benard moves on to conclude that a reduction in clinical outcomes of CIN among groups who are partially vaccinated for HPV is going to change clinical practice and reduce the cost-effectiveness of clinical care that supports prevention of cervical cancer. Of greatest importance, modalities and strategies for screening, and management algorithms, are going to need to evolve as HPV vaccination and cervical screening are integrated in a rational manner. Furthermore, it might be feasible to factor in population-level decreases in CIN among cohorts who are partially vaccinated for HPV when reassessing clinical practice guidelines for cervical cancer screening.

What does this mean? As we start to eliminate HPV from the population, any positive screening result will be that much more meaningful because the outcome--cervical cancer--will be much rarer. The onus will be on providers and public health officials to re-strategize how to screen what is going to be a widely-vaccinated population; more and more, we will be looking for needles in a haystack.

How are we going to someday screen women in their 20s who were vaccinated at 11 or 12 years of age? Likely, screening will start at a later age, and screening will be conducted at longer intervals. Any finding of HPV or disease is going to be highly significant, and likely, far less frequent.

HPV vaccination protects against invasive HPV-associated cancer. Luostarinen and colleagues report proof of highly efficacious protection offered by a population-based HPV vaccination program in Finland, in the form of a decrease in the key endpoint: cases of invasive HPV-associated cancer. Examining vaccinated (3,331 females) and unvaccinated (15,665 females) cohorts in the nationwide Finnish Cancer Registry, the investigators identified 10 cases of HPV-caused cancer (8 cervical, 1 oropharyngeal, 1 vulvar) in the unvaccinated females and 0 cases in vaccinated females--a statistically significant difference.

From the evidence gathered in this first intention-to-treat trial, the investigators conclude that vaccination protects against invasive HPV-associated cancer--what they call "an awaited, pivotal corollary" to high vaccine efficacy against HPV infection.

Summing up

This success story continues to unfold, despite well-organized, antivaccine campaigns. The HPV vaccine has been an easy target: It is novel, it involves a sexually transmitted infection, and the endpoint of protecting against invasive HPV-associated cancer is years--decades--away. But antivaccine groups can no longer argue the point that studies have not been designed to yield evidence of the impact of the vaccine on decisive endpoints, including cervical cancer.

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

EXPERT COMMENTARY

Hormonal contraception (HC), including OC, is a central component of women’s health care worldwide. In addition to its many potential health benefits (pregnancy prevention, menstrual symptom management), HC use modifies the risk of various cancers. As we discussed in the February 2018 issue of OBG Management, a recent large population-based study in Denmark showed a small but statistically significant increase in breast cancer risk in HC users.^1,2 Conversely, HC use has a long recognized protective effect against ovarian and endometrial cancers. These risk relationships may be altered by other modifiable lifestyle characteristics, such as smoking, alcohol use, obesity, and physical activity.

Details of the study

Michels and colleagues evaluated the association between OC use and multiple cancers, stratifying these risks by duration of use and various modifiable lifestyle characteristics.³ The authors used a prospective survey-based cohort (the NIH-AARP Diet and Health Study) linked with state cancer registries to evaluate this relationship in a diverse population of 196,536 women across 6 US states and 2 metropolitan areas. Women were enrolled in 1995–1996 and followed until 2011. Cancer risks were presented as hazard ratios (HR), which indicate the risk of developing a specific cancer type in OC users compared with nonusers. HRs differ from relative risks (RR) and odds ratios because they compare the instantaneous risk difference between the 2 groups, rather than the cumulative risk difference over the entire study period.⁴

Duration of OC use and risk reduction

In this study population, OC use was associated with a significantly decreased risk of ovarian cancer, and this risk increased with longer duration of use (TABLE). Similarly, long-term OC use was associated with a decreased risk for endometrial cancer. These effects were true across various lifestyle characteristics, including smoking status, alcohol use, body mass index (BMI), and physical activity level.

There was a nonsignificant trend toward increased risk of breast cancer among OC users. The most significant elevation in breast cancer risk was found in long-term users who were current smokers (HR, 1.21 [95% confidence interval (CI), 1.01–1.44]). OC use had a minimal effect on colorectal cancer risk.

The bottom line. US women using OCs were significantly less likely to develop ovarian and endometrial cancers compared with nonusers. This risk reduction increased with longer duration of OC use and was true regardless of lifestyle. Conversely, there was a trend toward a slightly increased risk of developing breast cancer in OC users.

Study strengths and weaknesses

The effect on breast cancer risk is less pronounced than that reported in a recent large, prospective cohort study in Denmark, which reported an RR of developing breast cancer of 1.20 (95% CI, 1.14–1.26) among all current or recent HC users.¹ These differing results may be due to the US study population’s increased heterogeneity compared with the Danish cohort; potential recall bias in the US study (not present in the Danish study because pharmacy records were used); the larger size of the Danish study (that is, ability to detect very small effect sizes); and lack of information on OC formulation, recency of use, and parity in the US study.

Nevertheless, the significant protective effect against ovarian and endometrial cancers (reported previously in numerous studies) should be a part of totality of cancer risk when counseling patients on any potential increased risk of breast cancer with OC use.

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.

EXPERT COMMENTARY

Hormonal contraception (HC), including OC, is a central component of women’s health care worldwide. In addition to its many potential health benefits (pregnancy prevention, menstrual symptom management), HC use modifies the risk of various cancers. As we discussed in the February 2018 issue of OBG Management, a recent large population-based study in Denmark showed a small but statistically significant increase in breast cancer risk in HC users.^1,2 Conversely, HC use has a long recognized protective effect against ovarian and endometrial cancers. These risk relationships may be altered by other modifiable lifestyle characteristics, such as smoking, alcohol use, obesity, and physical activity.

Details of the study

Michels and colleagues evaluated the association between OC use and multiple cancers, stratifying these risks by duration of use and various modifiable lifestyle characteristics.³ The authors used a prospective survey-based cohort (the NIH-AARP Diet and Health Study) linked with state cancer registries to evaluate this relationship in a diverse population of 196,536 women across 6 US states and 2 metropolitan areas. Women were enrolled in 1995–1996 and followed until 2011. Cancer risks were presented as hazard ratios (HR), which indicate the risk of developing a specific cancer type in OC users compared with nonusers. HRs differ from relative risks (RR) and odds ratios because they compare the instantaneous risk difference between the 2 groups, rather than the cumulative risk difference over the entire study period.⁴

Duration of OC use and risk reduction

In this study population, OC use was associated with a significantly decreased risk of ovarian cancer, and this risk increased with longer duration of use (TABLE). Similarly, long-term OC use was associated with a decreased risk for endometrial cancer. These effects were true across various lifestyle characteristics, including smoking status, alcohol use, body mass index (BMI), and physical activity level.

There was a nonsignificant trend toward increased risk of breast cancer among OC users. The most significant elevation in breast cancer risk was found in long-term users who were current smokers (HR, 1.21 [95% confidence interval (CI), 1.01–1.44]). OC use had a minimal effect on colorectal cancer risk.

The bottom line. US women using OCs were significantly less likely to develop ovarian and endometrial cancers compared with nonusers. This risk reduction increased with longer duration of OC use and was true regardless of lifestyle. Conversely, there was a trend toward a slightly increased risk of developing breast cancer in OC users.

Study strengths and weaknesses

The effect on breast cancer risk is less pronounced than that reported in a recent large, prospective cohort study in Denmark, which reported an RR of developing breast cancer of 1.20 (95% CI, 1.14–1.26) among all current or recent HC users.¹ These differing results may be due to the US study population’s increased heterogeneity compared with the Danish cohort; potential recall bias in the US study (not present in the Danish study because pharmacy records were used); the larger size of the Danish study (that is, ability to detect very small effect sizes); and lack of information on OC formulation, recency of use, and parity in the US study.

Nevertheless, the significant protective effect against ovarian and endometrial cancers (reported previously in numerous studies) should be a part of totality of cancer risk when counseling patients on any potential increased risk of breast cancer with OC use.

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.

EXPERT COMMENTARY

Hormonal contraception (HC), including OC, is a central component of women’s health care worldwide. In addition to its many potential health benefits (pregnancy prevention, menstrual symptom management), HC use modifies the risk of various cancers. As we discussed in the February 2018 issue of OBG Management, a recent large population-based study in Denmark showed a small but statistically significant increase in breast cancer risk in HC users.^1,2 Conversely, HC use has a long recognized protective effect against ovarian and endometrial cancers. These risk relationships may be altered by other modifiable lifestyle characteristics, such as smoking, alcohol use, obesity, and physical activity.

Details of the study

Michels and colleagues evaluated the association between OC use and multiple cancers, stratifying these risks by duration of use and various modifiable lifestyle characteristics.³ The authors used a prospective survey-based cohort (the NIH-AARP Diet and Health Study) linked with state cancer registries to evaluate this relationship in a diverse population of 196,536 women across 6 US states and 2 metropolitan areas. Women were enrolled in 1995–1996 and followed until 2011. Cancer risks were presented as hazard ratios (HR), which indicate the risk of developing a specific cancer type in OC users compared with nonusers. HRs differ from relative risks (RR) and odds ratios because they compare the instantaneous risk difference between the 2 groups, rather than the cumulative risk difference over the entire study period.⁴

Duration of OC use and risk reduction

In this study population, OC use was associated with a significantly decreased risk of ovarian cancer, and this risk increased with longer duration of use (TABLE). Similarly, long-term OC use was associated with a decreased risk for endometrial cancer. These effects were true across various lifestyle characteristics, including smoking status, alcohol use, body mass index (BMI), and physical activity level.

There was a nonsignificant trend toward increased risk of breast cancer among OC users. The most significant elevation in breast cancer risk was found in long-term users who were current smokers (HR, 1.21 [95% confidence interval (CI), 1.01–1.44]). OC use had a minimal effect on colorectal cancer risk.

The bottom line. US women using OCs were significantly less likely to develop ovarian and endometrial cancers compared with nonusers. This risk reduction increased with longer duration of OC use and was true regardless of lifestyle. Conversely, there was a trend toward a slightly increased risk of developing breast cancer in OC users.

Study strengths and weaknesses

The effect on breast cancer risk is less pronounced than that reported in a recent large, prospective cohort study in Denmark, which reported an RR of developing breast cancer of 1.20 (95% CI, 1.14–1.26) among all current or recent HC users.¹ These differing results may be due to the US study population’s increased heterogeneity compared with the Danish cohort; potential recall bias in the US study (not present in the Danish study because pharmacy records were used); the larger size of the Danish study (that is, ability to detect very small effect sizes); and lack of information on OC formulation, recency of use, and parity in the US study.

Nevertheless, the significant protective effect against ovarian and endometrial cancers (reported previously in numerous studies) should be a part of totality of cancer risk when counseling patients on any potential increased risk of breast cancer with OC use.

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.

Fertility preservation and sexual health are main concerns in reproductive-age cancer survivors. Approximately 1% of cancer survivors are younger than age 20 and up to 10% are estimated to be younger than age 45.¹ For many of these survivors, a cancer diagnosis may have occurred prior to their completion of childbearing.

Infertility or premature ovarian failure has been reported in 40% to 80% of cancer survivors due to chemotoxicity-induced accelerated loss of oocytes.² Most gonadotoxic chemotherapeutic agents cause DNA double-strand breaks that cannot be adequately repaired, eventually leading to apoptotic cell death.³ Therefore, any chemotherapeutic agent that induces apoptotic death will cause irreversible depletion of ovarian reserve, since primordial follicles cannot be regenerated.

Alkylating agents, such as cyclophosphamide, have been shown to be most cytotoxic, and young cancer survivors who have received a combination of alkylating agents and abdominopelvic radiation—such as those with Hodgkin’s lymphoma—are at higher risk. Other poor prognostic factors for fertility include a hypothalamic-pituitary radiation dose greater than 30 Gy, an ovarian-uterine radiation dose greater than 5 Gy, summed alkylating agent dose score of 3 to 4 for each agent, and treatment with lomustine or cyclophosphamide.⁴

In general, a woman’s age (which reflects her existing ovarian reserve), type of therapeutic agents used, and duration of therapy impact the posttreatment viability of ovarian function. Despite conflicting information in published literature, medical suppression by gonadotropin-releasing hormone agonists is not effective.

Fertility preservation options in the United States include egg, embryo, and ovarian tissue banking and ovarian transposition and ovarian transplantation.⁵

Oncofertility: Maximizing reproductive potential in cancer patients

In 2006, Dr. Teresa Woodruff of the Feinberg School of Medicine at Northwestern University coined the term oncofertility. Oncofertility is defined by the Merriam-Webster dictionary as “a field concerned with minimizing the negative effects of cancer treatment (such as chemotherapy or radiation) on the reproductive system and fertility and with assisting individuals with reproductive impairments resulting from cancer therapy.”

Recognition of the many barriers to fertility preservation led to the establishment of the Oncofertility Consortium, a multi-institution group that includes Northwestern University, the University of California San Diego, the University of Pennsylvania, the University of Missouri, and Oregon Health and Science University. The Consortium facilitates collaboration between biomedical and social scientists, pediatricians, oncologists, reproductive specialists, educators, social workers, and medical ethicists in an effort to assess the impact of cancer and its treatment on future fertility and reproductive health and to advance knowledge. The Consortium also is a valuable information resource on fertility preservation options for patients, their families, and providers.⁶

The oncofertility program at Northwestern University was established as an interdisciplinary team of oncologists, reproductive health specialists, supportive care staff, and researchers. Reproductive-age women with cancer can participate in a comprehensive interdisciplinary approach to the management of their malignancy with strict planning and coordination of care, if they wish to maintain fertility following treatment. Many hospitals and health care systems have established such programs, recognizing that the need to preserve fertility potential is an essential part of the comprehensive care of a reproductive-age woman undergoing treatment. When a cancer diagnosis is made, prompt referral to a fertility specialist and a multidisciplinary approach to treatment planning are critical to mitigate the negative impact of cancer treatment on fertility and the potential risk of ovarian damage.

Barriers to oncofertility care

Timely referral to fertility specialists may not occur because of lack of a formal oncofertility program or unawareness of available therapeutic options. In some instances, delaying cancer treatment is not feasible. Additionally, many other factors must be considered regarding societal, ethical, and legal implications. But most concerning is the lack of consistent and timely access to funding for fertility preservation by third-party payers. Although some funding options exist, these require both patient awareness and effort to pursue (TABLE).

National legislation does not include provision for this aspect of women’s health, and as of 2017 insurance coverage for oncofertility was mandated only in 2 states, Connecticut and Rhode Island. In New York, Governor Cuomo directed the Department of Financial Services to study how to ensure that New Yorkers can have access to oncofertility services, and legislation is pending in the New York state legislature.⁷

Recently, Cardozo and colleagues reported that 15 states currently require insurers to provide some form of infertility coverage.⁸ By contrast, RESOLVE: The National Infertility Association, reports information on fertility coverage and the status of bills by state on its website (https://resolve.org). For example, in California, Hawaii, Illinois, and Maryland, bills have been proposed and are in various stages of assessment. Connecticut and Rhode Island mandate coverage. As always, details matter. Cardozo and colleagues eloquently point out limitations of coverage based on age and definition of infertility, and potential financial impact.⁸

An actuarial consulting company called NovaRest prepared a document for the state of Maryland in which the estimated expected number of “cases” would amount to 1,327 women and 731 men aged 10 to 44.⁹ These individuals might require oncofertility services. NovaRest estimated that clients could experience up to a 0.4% increase in insurance premiums annually if this program was offered. Similar estimates are reported by other states. In Kentucky and Mississippi, such bills “died in committee.” The American Society for Reproductive Medicine (ASRM) is actively lobbying with partners, including the Coalition to Protect Parenthood After Cancer, to advocate for preservation of fertility.

Oncofertility efforts are moving in the right direction

---

Lucia DiVenere, MA

Drs. Ursillo and Chalas bring attention to an important issue. As technology advances, so do treatment and coverage needs, and so does the need for ongoing physician and patient education.

In 1990, the US Congress passed the Breast and Cervical Cancer Mortality Prevention Act to help ensure that low-income women would have access to screening for these diseases. It took 10 years before Congress passed the Breast and Cervical Cancer Prevention and Treatment Act so that women detected with breast or cervical cancer could be treated. A curious delay, I know.

Today, we seem to be in a similar situation regarding fertility preservation. Cancer treatment is advanced, coverage is available. Fertility-related treatment is now possible, but coverage is nearly absent.

In my research for this commentary, I learned (a little) about ovarian transplantation and translocation. Even that little was enough to see that we live in an amazing new world. Drs. Ursillo and Chalas put out an important call for physicians to learn, to teach their patients, and, especially, to consider fertility preservation options before (when possible) initiating cancer treatment. It also is imperative to consider fertility preservation in young patients who have not yet reached their fertile years. Cancer treatment begun before fertility preservation may mean future irreversible infertility.

They also call for insurers and public programs to cover fertility and fertility preservation as “essential in the comprehensive care” of cancer patients. To the American College of Obstetricians and Gynecologists (ACOG), that means a federal policy that would ensure public and private coverage for every woman, no matter where she lives, her income level, or her employer.

In many ways, this is a difficult time in public policy related to women’s health. With ACOG’s leadership, our physician colleague organizations and patient advocacy groups are fighting hard to retain women’s health protections already in law. At this moment, opportunities are rare for consideration of expansion. But a national solution is the right solution.

Until we reach that goal, we support state efforts to require private health insurers to cover fertility preservation. As Drs. Ursillo and Chalas point out, only 2 states require private insurers to cover fertility preservation treatment. State-by-state efforts are notoriously difficult, unique, and inequitable to patients. Patients in some states simply are luckier than patients in other states. That is not how to solve a health care problem.

As is often the case, employers—in this case big, cutting-edge companies—are leading the way. Recently, an article in the Wall Street Journal (February 7, 2018) described companies that offer fertility treatment coverage to attract potential employees, such as Pinterest, American Express, and Foursquare. This is an important first step that we can build upon, ensuring that coverage includes fertility protection and then leveraging employer coverage experience to influence coverage more broadly.

Big employers may help us find our way, showing just how little inclusion of this coverage relates to premiums; by some estimates, only 0.4%. That is a small investment for enormous results in a patient’s future.

My takeaways from this thoughtful editorial:

• Physicians should educate themselves about fertility preservation options.
• Physicians should educate their patients about the same.
• Physicians should consider these options before initiating treatment.
• We all should advocate for our patients, in this case, national, state, and employer coverage of fertility treatment, including preservation.

---

Ms. DiVenere is Officer, Government and Political Affairs, at the American College of Obstetricians and Gynecologists in Washington, DC. She is an OBG Management Contributing Editor.

The author reports no financial relationships relevant to this article.

We need a joint effort

Most recent statistics support an increase in cancer survivorship over the past decade.¹⁰ This trend likely will continue thanks to greater application of screening and more effective therapies. The use of targeted therapy is on the rise, but it is not applicable for most malignancies at this time, and its effect on fertility is largely unknown. Millennials now constitute the largest group in our population, and delaying childbearing to the late second and third decades is now common. These medical and societal trends will result in more women being interested in fertility preservation.

The ASRM and other organizations are lobbying to support legislation to mandate coverage for oncofertility on a state-by-state basis. Major limitations of this approach include inability to address oncofertility unless such legislation already has been introduced, the lack of impact on individuals residing in other states, and inefficiency of regional lobbying. In addition, those who are self-insured are not subject to state mandates and therefore will not benefit from such coverage mandates. Finally, nuances in the definition of infertility or age-based restrictions may limit access to these services even when mandated.

A cancer diagnosis is always potentially life-threatening and is often perceived as devastating on a personal level. In women of reproductive age, it represents a threat to their future ability to bear children and to ovarian function. These women deserve to have the opportunity to consider all options to maintain fertility, and they should not struggle with difficult financial choices at a time of such extreme stress.

To address this important issue, a 3-pronged approach is called for:

• All providers caring for cancer patients of reproductive age must be aware of fertility preservation and inform patients of these options.
• Cancer survivors and their caretakers must assist in legislative advocacy efforts.
• Nationally mandated coverage must be sought.

A joint effort by the medical community and women advocates is critical to bring attention to this issue in a national forum and provide a solution that benefits all women.

Acknowledgement

The authors express gratitude to Erin Kramer, Government Affairs, American Society for Reproductive Medicine, and Christa Christakis, Executive Director, American College of Obstetricians and Gynecologists District II, for their assistance.

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.

Fertility preservation and sexual health are main concerns in reproductive-age cancer survivors. Approximately 1% of cancer survivors are younger than age 20 and up to 10% are estimated to be younger than age 45.¹ For many of these survivors, a cancer diagnosis may have occurred prior to their completion of childbearing.

Infertility or premature ovarian failure has been reported in 40% to 80% of cancer survivors due to chemotoxicity-induced accelerated loss of oocytes.² Most gonadotoxic chemotherapeutic agents cause DNA double-strand breaks that cannot be adequately repaired, eventually leading to apoptotic cell death.³ Therefore, any chemotherapeutic agent that induces apoptotic death will cause irreversible depletion of ovarian reserve, since primordial follicles cannot be regenerated.

Alkylating agents, such as cyclophosphamide, have been shown to be most cytotoxic, and young cancer survivors who have received a combination of alkylating agents and abdominopelvic radiation—such as those with Hodgkin’s lymphoma—are at higher risk. Other poor prognostic factors for fertility include a hypothalamic-pituitary radiation dose greater than 30 Gy, an ovarian-uterine radiation dose greater than 5 Gy, summed alkylating agent dose score of 3 to 4 for each agent, and treatment with lomustine or cyclophosphamide.⁴

In general, a woman’s age (which reflects her existing ovarian reserve), type of therapeutic agents used, and duration of therapy impact the posttreatment viability of ovarian function. Despite conflicting information in published literature, medical suppression by gonadotropin-releasing hormone agonists is not effective.

Fertility preservation options in the United States include egg, embryo, and ovarian tissue banking and ovarian transposition and ovarian transplantation.⁵

Oncofertility: Maximizing reproductive potential in cancer patients

In 2006, Dr. Teresa Woodruff of the Feinberg School of Medicine at Northwestern University coined the term oncofertility. Oncofertility is defined by the Merriam-Webster dictionary as “a field concerned with minimizing the negative effects of cancer treatment (such as chemotherapy or radiation) on the reproductive system and fertility and with assisting individuals with reproductive impairments resulting from cancer therapy.”

Recognition of the many barriers to fertility preservation led to the establishment of the Oncofertility Consortium, a multi-institution group that includes Northwestern University, the University of California San Diego, the University of Pennsylvania, the University of Missouri, and Oregon Health and Science University. The Consortium facilitates collaboration between biomedical and social scientists, pediatricians, oncologists, reproductive specialists, educators, social workers, and medical ethicists in an effort to assess the impact of cancer and its treatment on future fertility and reproductive health and to advance knowledge. The Consortium also is a valuable information resource on fertility preservation options for patients, their families, and providers.⁶

The oncofertility program at Northwestern University was established as an interdisciplinary team of oncologists, reproductive health specialists, supportive care staff, and researchers. Reproductive-age women with cancer can participate in a comprehensive interdisciplinary approach to the management of their malignancy with strict planning and coordination of care, if they wish to maintain fertility following treatment. Many hospitals and health care systems have established such programs, recognizing that the need to preserve fertility potential is an essential part of the comprehensive care of a reproductive-age woman undergoing treatment. When a cancer diagnosis is made, prompt referral to a fertility specialist and a multidisciplinary approach to treatment planning are critical to mitigate the negative impact of cancer treatment on fertility and the potential risk of ovarian damage.

Barriers to oncofertility care

Timely referral to fertility specialists may not occur because of lack of a formal oncofertility program or unawareness of available therapeutic options. In some instances, delaying cancer treatment is not feasible. Additionally, many other factors must be considered regarding societal, ethical, and legal implications. But most concerning is the lack of consistent and timely access to funding for fertility preservation by third-party payers. Although some funding options exist, these require both patient awareness and effort to pursue (TABLE).

National legislation does not include provision for this aspect of women’s health, and as of 2017 insurance coverage for oncofertility was mandated only in 2 states, Connecticut and Rhode Island. In New York, Governor Cuomo directed the Department of Financial Services to study how to ensure that New Yorkers can have access to oncofertility services, and legislation is pending in the New York state legislature.⁷

Recently, Cardozo and colleagues reported that 15 states currently require insurers to provide some form of infertility coverage.⁸ By contrast, RESOLVE: The National Infertility Association, reports information on fertility coverage and the status of bills by state on its website (https://resolve.org). For example, in California, Hawaii, Illinois, and Maryland, bills have been proposed and are in various stages of assessment. Connecticut and Rhode Island mandate coverage. As always, details matter. Cardozo and colleagues eloquently point out limitations of coverage based on age and definition of infertility, and potential financial impact.⁸

An actuarial consulting company called NovaRest prepared a document for the state of Maryland in which the estimated expected number of “cases” would amount to 1,327 women and 731 men aged 10 to 44.⁹ These individuals might require oncofertility services. NovaRest estimated that clients could experience up to a 0.4% increase in insurance premiums annually if this program was offered. Similar estimates are reported by other states. In Kentucky and Mississippi, such bills “died in committee.” The American Society for Reproductive Medicine (ASRM) is actively lobbying with partners, including the Coalition to Protect Parenthood After Cancer, to advocate for preservation of fertility.

Oncofertility efforts are moving in the right direction

---

Lucia DiVenere, MA

Drs. Ursillo and Chalas bring attention to an important issue. As technology advances, so do treatment and coverage needs, and so does the need for ongoing physician and patient education.

In 1990, the US Congress passed the Breast and Cervical Cancer Mortality Prevention Act to help ensure that low-income women would have access to screening for these diseases. It took 10 years before Congress passed the Breast and Cervical Cancer Prevention and Treatment Act so that women detected with breast or cervical cancer could be treated. A curious delay, I know.

Today, we seem to be in a similar situation regarding fertility preservation. Cancer treatment is advanced, coverage is available. Fertility-related treatment is now possible, but coverage is nearly absent.

In my research for this commentary, I learned (a little) about ovarian transplantation and translocation. Even that little was enough to see that we live in an amazing new world. Drs. Ursillo and Chalas put out an important call for physicians to learn, to teach their patients, and, especially, to consider fertility preservation options before (when possible) initiating cancer treatment. It also is imperative to consider fertility preservation in young patients who have not yet reached their fertile years. Cancer treatment begun before fertility preservation may mean future irreversible infertility.

They also call for insurers and public programs to cover fertility and fertility preservation as “essential in the comprehensive care” of cancer patients. To the American College of Obstetricians and Gynecologists (ACOG), that means a federal policy that would ensure public and private coverage for every woman, no matter where she lives, her income level, or her employer.

In many ways, this is a difficult time in public policy related to women’s health. With ACOG’s leadership, our physician colleague organizations and patient advocacy groups are fighting hard to retain women’s health protections already in law. At this moment, opportunities are rare for consideration of expansion. But a national solution is the right solution.

Until we reach that goal, we support state efforts to require private health insurers to cover fertility preservation. As Drs. Ursillo and Chalas point out, only 2 states require private insurers to cover fertility preservation treatment. State-by-state efforts are notoriously difficult, unique, and inequitable to patients. Patients in some states simply are luckier than patients in other states. That is not how to solve a health care problem.

As is often the case, employers—in this case big, cutting-edge companies—are leading the way. Recently, an article in the Wall Street Journal (February 7, 2018) described companies that offer fertility treatment coverage to attract potential employees, such as Pinterest, American Express, and Foursquare. This is an important first step that we can build upon, ensuring that coverage includes fertility protection and then leveraging employer coverage experience to influence coverage more broadly.

Big employers may help us find our way, showing just how little inclusion of this coverage relates to premiums; by some estimates, only 0.4%. That is a small investment for enormous results in a patient’s future.

My takeaways from this thoughtful editorial:

• Physicians should educate themselves about fertility preservation options.
• Physicians should educate their patients about the same.
• Physicians should consider these options before initiating treatment.
• We all should advocate for our patients, in this case, national, state, and employer coverage of fertility treatment, including preservation.

---

Ms. DiVenere is Officer, Government and Political Affairs, at the American College of Obstetricians and Gynecologists in Washington, DC. She is an OBG Management Contributing Editor.

The author reports no financial relationships relevant to this article.

We need a joint effort

Most recent statistics support an increase in cancer survivorship over the past decade.¹⁰ This trend likely will continue thanks to greater application of screening and more effective therapies. The use of targeted therapy is on the rise, but it is not applicable for most malignancies at this time, and its effect on fertility is largely unknown. Millennials now constitute the largest group in our population, and delaying childbearing to the late second and third decades is now common. These medical and societal trends will result in more women being interested in fertility preservation.

The ASRM and other organizations are lobbying to support legislation to mandate coverage for oncofertility on a state-by-state basis. Major limitations of this approach include inability to address oncofertility unless such legislation already has been introduced, the lack of impact on individuals residing in other states, and inefficiency of regional lobbying. In addition, those who are self-insured are not subject to state mandates and therefore will not benefit from such coverage mandates. Finally, nuances in the definition of infertility or age-based restrictions may limit access to these services even when mandated.

A cancer diagnosis is always potentially life-threatening and is often perceived as devastating on a personal level. In women of reproductive age, it represents a threat to their future ability to bear children and to ovarian function. These women deserve to have the opportunity to consider all options to maintain fertility, and they should not struggle with difficult financial choices at a time of such extreme stress.

To address this important issue, a 3-pronged approach is called for:

• All providers caring for cancer patients of reproductive age must be aware of fertility preservation and inform patients of these options.
• Cancer survivors and their caretakers must assist in legislative advocacy efforts.
• Nationally mandated coverage must be sought.

A joint effort by the medical community and women advocates is critical to bring attention to this issue in a national forum and provide a solution that benefits all women.

Acknowledgement

The authors express gratitude to Erin Kramer, Government Affairs, American Society for Reproductive Medicine, and Christa Christakis, Executive Director, American College of Obstetricians and Gynecologists District II, for their assistance.

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.

Fertility preservation and sexual health are main concerns in reproductive-age cancer survivors. Approximately 1% of cancer survivors are younger than age 20 and up to 10% are estimated to be younger than age 45.¹ For many of these survivors, a cancer diagnosis may have occurred prior to their completion of childbearing.

Infertility or premature ovarian failure has been reported in 40% to 80% of cancer survivors due to chemotoxicity-induced accelerated loss of oocytes.² Most gonadotoxic chemotherapeutic agents cause DNA double-strand breaks that cannot be adequately repaired, eventually leading to apoptotic cell death.³ Therefore, any chemotherapeutic agent that induces apoptotic death will cause irreversible depletion of ovarian reserve, since primordial follicles cannot be regenerated.

Alkylating agents, such as cyclophosphamide, have been shown to be most cytotoxic, and young cancer survivors who have received a combination of alkylating agents and abdominopelvic radiation—such as those with Hodgkin’s lymphoma—are at higher risk. Other poor prognostic factors for fertility include a hypothalamic-pituitary radiation dose greater than 30 Gy, an ovarian-uterine radiation dose greater than 5 Gy, summed alkylating agent dose score of 3 to 4 for each agent, and treatment with lomustine or cyclophosphamide.⁴

In general, a woman’s age (which reflects her existing ovarian reserve), type of therapeutic agents used, and duration of therapy impact the posttreatment viability of ovarian function. Despite conflicting information in published literature, medical suppression by gonadotropin-releasing hormone agonists is not effective.

Fertility preservation options in the United States include egg, embryo, and ovarian tissue banking and ovarian transposition and ovarian transplantation.⁵

Oncofertility: Maximizing reproductive potential in cancer patients

In 2006, Dr. Teresa Woodruff of the Feinberg School of Medicine at Northwestern University coined the term oncofertility. Oncofertility is defined by the Merriam-Webster dictionary as “a field concerned with minimizing the negative effects of cancer treatment (such as chemotherapy or radiation) on the reproductive system and fertility and with assisting individuals with reproductive impairments resulting from cancer therapy.”

Recognition of the many barriers to fertility preservation led to the establishment of the Oncofertility Consortium, a multi-institution group that includes Northwestern University, the University of California San Diego, the University of Pennsylvania, the University of Missouri, and Oregon Health and Science University. The Consortium facilitates collaboration between biomedical and social scientists, pediatricians, oncologists, reproductive specialists, educators, social workers, and medical ethicists in an effort to assess the impact of cancer and its treatment on future fertility and reproductive health and to advance knowledge. The Consortium also is a valuable information resource on fertility preservation options for patients, their families, and providers.⁶

The oncofertility program at Northwestern University was established as an interdisciplinary team of oncologists, reproductive health specialists, supportive care staff, and researchers. Reproductive-age women with cancer can participate in a comprehensive interdisciplinary approach to the management of their malignancy with strict planning and coordination of care, if they wish to maintain fertility following treatment. Many hospitals and health care systems have established such programs, recognizing that the need to preserve fertility potential is an essential part of the comprehensive care of a reproductive-age woman undergoing treatment. When a cancer diagnosis is made, prompt referral to a fertility specialist and a multidisciplinary approach to treatment planning are critical to mitigate the negative impact of cancer treatment on fertility and the potential risk of ovarian damage.

Barriers to oncofertility care

Timely referral to fertility specialists may not occur because of lack of a formal oncofertility program or unawareness of available therapeutic options. In some instances, delaying cancer treatment is not feasible. Additionally, many other factors must be considered regarding societal, ethical, and legal implications. But most concerning is the lack of consistent and timely access to funding for fertility preservation by third-party payers. Although some funding options exist, these require both patient awareness and effort to pursue (TABLE).

National legislation does not include provision for this aspect of women’s health, and as of 2017 insurance coverage for oncofertility was mandated only in 2 states, Connecticut and Rhode Island. In New York, Governor Cuomo directed the Department of Financial Services to study how to ensure that New Yorkers can have access to oncofertility services, and legislation is pending in the New York state legislature.⁷

Recently, Cardozo and colleagues reported that 15 states currently require insurers to provide some form of infertility coverage.⁸ By contrast, RESOLVE: The National Infertility Association, reports information on fertility coverage and the status of bills by state on its website (https://resolve.org). For example, in California, Hawaii, Illinois, and Maryland, bills have been proposed and are in various stages of assessment. Connecticut and Rhode Island mandate coverage. As always, details matter. Cardozo and colleagues eloquently point out limitations of coverage based on age and definition of infertility, and potential financial impact.⁸

An actuarial consulting company called NovaRest prepared a document for the state of Maryland in which the estimated expected number of “cases” would amount to 1,327 women and 731 men aged 10 to 44.⁹ These individuals might require oncofertility services. NovaRest estimated that clients could experience up to a 0.4% increase in insurance premiums annually if this program was offered. Similar estimates are reported by other states. In Kentucky and Mississippi, such bills “died in committee.” The American Society for Reproductive Medicine (ASRM) is actively lobbying with partners, including the Coalition to Protect Parenthood After Cancer, to advocate for preservation of fertility.

Oncofertility efforts are moving in the right direction

---

Lucia DiVenere, MA

Drs. Ursillo and Chalas bring attention to an important issue. As technology advances, so do treatment and coverage needs, and so does the need for ongoing physician and patient education.

In 1990, the US Congress passed the Breast and Cervical Cancer Mortality Prevention Act to help ensure that low-income women would have access to screening for these diseases. It took 10 years before Congress passed the Breast and Cervical Cancer Prevention and Treatment Act so that women detected with breast or cervical cancer could be treated. A curious delay, I know.

Today, we seem to be in a similar situation regarding fertility preservation. Cancer treatment is advanced, coverage is available. Fertility-related treatment is now possible, but coverage is nearly absent.

In my research for this commentary, I learned (a little) about ovarian transplantation and translocation. Even that little was enough to see that we live in an amazing new world. Drs. Ursillo and Chalas put out an important call for physicians to learn, to teach their patients, and, especially, to consider fertility preservation options before (when possible) initiating cancer treatment. It also is imperative to consider fertility preservation in young patients who have not yet reached their fertile years. Cancer treatment begun before fertility preservation may mean future irreversible infertility.

They also call for insurers and public programs to cover fertility and fertility preservation as “essential in the comprehensive care” of cancer patients. To the American College of Obstetricians and Gynecologists (ACOG), that means a federal policy that would ensure public and private coverage for every woman, no matter where she lives, her income level, or her employer.

In many ways, this is a difficult time in public policy related to women’s health. With ACOG’s leadership, our physician colleague organizations and patient advocacy groups are fighting hard to retain women’s health protections already in law. At this moment, opportunities are rare for consideration of expansion. But a national solution is the right solution.

Until we reach that goal, we support state efforts to require private health insurers to cover fertility preservation. As Drs. Ursillo and Chalas point out, only 2 states require private insurers to cover fertility preservation treatment. State-by-state efforts are notoriously difficult, unique, and inequitable to patients. Patients in some states simply are luckier than patients in other states. That is not how to solve a health care problem.

As is often the case, employers—in this case big, cutting-edge companies—are leading the way. Recently, an article in the Wall Street Journal (February 7, 2018) described companies that offer fertility treatment coverage to attract potential employees, such as Pinterest, American Express, and Foursquare. This is an important first step that we can build upon, ensuring that coverage includes fertility protection and then leveraging employer coverage experience to influence coverage more broadly.

Big employers may help us find our way, showing just how little inclusion of this coverage relates to premiums; by some estimates, only 0.4%. That is a small investment for enormous results in a patient’s future.

My takeaways from this thoughtful editorial:

• Physicians should educate themselves about fertility preservation options.
• Physicians should educate their patients about the same.
• Physicians should consider these options before initiating treatment.
• We all should advocate for our patients, in this case, national, state, and employer coverage of fertility treatment, including preservation.

---

Ms. DiVenere is Officer, Government and Political Affairs, at the American College of Obstetricians and Gynecologists in Washington, DC. She is an OBG Management Contributing Editor.

The author reports no financial relationships relevant to this article.

We need a joint effort

Most recent statistics support an increase in cancer survivorship over the past decade.¹⁰ This trend likely will continue thanks to greater application of screening and more effective therapies. The use of targeted therapy is on the rise, but it is not applicable for most malignancies at this time, and its effect on fertility is largely unknown. Millennials now constitute the largest group in our population, and delaying childbearing to the late second and third decades is now common. These medical and societal trends will result in more women being interested in fertility preservation.

The ASRM and other organizations are lobbying to support legislation to mandate coverage for oncofertility on a state-by-state basis. Major limitations of this approach include inability to address oncofertility unless such legislation already has been introduced, the lack of impact on individuals residing in other states, and inefficiency of regional lobbying. In addition, those who are self-insured are not subject to state mandates and therefore will not benefit from such coverage mandates. Finally, nuances in the definition of infertility or age-based restrictions may limit access to these services even when mandated.

A cancer diagnosis is always potentially life-threatening and is often perceived as devastating on a personal level. In women of reproductive age, it represents a threat to their future ability to bear children and to ovarian function. These women deserve to have the opportunity to consider all options to maintain fertility, and they should not struggle with difficult financial choices at a time of such extreme stress.

To address this important issue, a 3-pronged approach is called for:

• All providers caring for cancer patients of reproductive age must be aware of fertility preservation and inform patients of these options.
• Cancer survivors and their caretakers must assist in legislative advocacy efforts.
• Nationally mandated coverage must be sought.

A joint effort by the medical community and women advocates is critical to bring attention to this issue in a national forum and provide a solution that benefits all women.

Acknowledgement

The authors express gratitude to Erin Kramer, Government Affairs, American Society for Reproductive Medicine, and Christa Christakis, Executive Director, American College of Obstetricians and Gynecologists District II, for their assistance.

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.

Mobile applications are useful for clinical decision making. An example is in the area of cervical cancer screening. The incidence of cervical cancer and mortality from the disease in the United States has decreased with the implementation of cervical cancer screening programs.¹ However, being up to date on the guidelines can be challenging. In 2001, the revised Bethesda system terminology for reporting cervical cytology results became available. In response, the American Society for Colposcopy and Cervical Pathology (ASCCP) developed comprehensive, evidence-based consensus guidelines to assist health care providers in managing abnormal screening results. In 2006, the guidelines were revised, and in 2012, revised again.²

In a search in the Apple iTunes and Google Play stores for apps useful for gynecologic oncology providers, Dr. Sara Farag, colleagues, and I identified and evaluated highly 2 cervical cancer screening apps: ASCCP Mobile and Pap Reader.³ These apps can aid any health care provider who performs Pap smear screening and who manages screening results.

ASCCP Mobile includes follow-up guidelines regarding colposcopy results as well as guidelines for posthysterectomy and pregnant women. The app also has a clinical decision support system (an active knowledge system that uses 2 or more items of patient data to generate case-specific advice).

Pap Reader includes guidelines for postmenopausal and pregnant women and also has a clinical decision support system. Unlike ASCCP Mobile, Pap Reader is free.

The recommended cervical cancer screening apps are listed in the TABLE alphabetically and are detailed with a shortened version of the APPLICATIONS scoring system, APPLI (app comprehensiveness, price, platform, literature use, and important special features).⁴ I hope these apps will assist you in your management of patients who undergo Pap smear screening.

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.

Mobile applications are useful for clinical decision making. An example is in the area of cervical cancer screening. The incidence of cervical cancer and mortality from the disease in the United States has decreased with the implementation of cervical cancer screening programs.¹ However, being up to date on the guidelines can be challenging. In 2001, the revised Bethesda system terminology for reporting cervical cytology results became available. In response, the American Society for Colposcopy and Cervical Pathology (ASCCP) developed comprehensive, evidence-based consensus guidelines to assist health care providers in managing abnormal screening results. In 2006, the guidelines were revised, and in 2012, revised again.²

In a search in the Apple iTunes and Google Play stores for apps useful for gynecologic oncology providers, Dr. Sara Farag, colleagues, and I identified and evaluated highly 2 cervical cancer screening apps: ASCCP Mobile and Pap Reader.³ These apps can aid any health care provider who performs Pap smear screening and who manages screening results.

ASCCP Mobile includes follow-up guidelines regarding colposcopy results as well as guidelines for posthysterectomy and pregnant women. The app also has a clinical decision support system (an active knowledge system that uses 2 or more items of patient data to generate case-specific advice).

Pap Reader includes guidelines for postmenopausal and pregnant women and also has a clinical decision support system. Unlike ASCCP Mobile, Pap Reader is free.

The recommended cervical cancer screening apps are listed in the TABLE alphabetically and are detailed with a shortened version of the APPLICATIONS scoring system, APPLI (app comprehensiveness, price, platform, literature use, and important special features).⁴ I hope these apps will assist you in your management of patients who undergo Pap smear screening.

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.

Mobile applications are useful for clinical decision making. An example is in the area of cervical cancer screening. The incidence of cervical cancer and mortality from the disease in the United States has decreased with the implementation of cervical cancer screening programs.¹ However, being up to date on the guidelines can be challenging. In 2001, the revised Bethesda system terminology for reporting cervical cytology results became available. In response, the American Society for Colposcopy and Cervical Pathology (ASCCP) developed comprehensive, evidence-based consensus guidelines to assist health care providers in managing abnormal screening results. In 2006, the guidelines were revised, and in 2012, revised again.²

In a search in the Apple iTunes and Google Play stores for apps useful for gynecologic oncology providers, Dr. Sara Farag, colleagues, and I identified and evaluated highly 2 cervical cancer screening apps: ASCCP Mobile and Pap Reader.³ These apps can aid any health care provider who performs Pap smear screening and who manages screening results.

ASCCP Mobile includes follow-up guidelines regarding colposcopy results as well as guidelines for posthysterectomy and pregnant women. The app also has a clinical decision support system (an active knowledge system that uses 2 or more items of patient data to generate case-specific advice).

Pap Reader includes guidelines for postmenopausal and pregnant women and also has a clinical decision support system. Unlike ASCCP Mobile, Pap Reader is free.

The recommended cervical cancer screening apps are listed in the TABLE alphabetically and are detailed with a shortened version of the APPLICATIONS scoring system, APPLI (app comprehensiveness, price, platform, literature use, and important special features).⁴ I hope these apps will assist you in your management of patients who undergo Pap smear screening.

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.

Providing state-of-the-art health care for women often requires the use of various types of medical equipment, and decisions regarding their purchase can be complicated. With rising costs and reduced reimbursements, capital expenditures must be made with great care. Some equipment may not generate revenue but is required at a basic care-giving level: examination tables, procedure instruments, autoclaves, etc. Conversely, other equipment may not be necessary but strongly desired to offer a full complement of care. Unfortunately, sometimes a decision to buy expensive equipment is based more on a sales representative's ability to rationalize the purchase as a sound investment than on its necessity or practicality. This article focuses on tools to help you make a decision to obtain revenue-generating medical equipment.

First consideration: Nonfinancial evaluation

Nonfinancial criteria should be your first concern. They may have a greater impact on your practice than any financial consideration.

Does this investment align with your overall goals?

If your focus is to provide the best and most efficient obstetric care in the community, it may not make sense to purchase urodynamic equipment, even if using the equipment could be profitable.¹ If the equipment begins to distract the practice from its strategic focus, then complications from managing this new equipment might be more harmful than helpful.

What are the pros and cons of the investment?

Concern that the equipment may not be effective or may become obsolete in a few years would preclude having to consider the financial purchase in the first place.¹

Consider a PESTLE analysis

Before starting a new project, use a PESTLE analysis to assess external factors that are political, economic, social, technological, legal, and environmental. Its purpose is to identify issues that are beyond the control of the organization and have some level of impact on the organization.^2,3

If you are considering the purchase of a laser hair removal machine, what could be the political considerations, such as your reputation among peers or other physicians who refer patients to your practice? What are the economic (financial) considerations? How would the social (or marketing) message be communicated, and do you have the organizational skills to implement a marketing strategy? What are the technical challenges required for maintaining this machine, and how much skill and training would be required to safely use it? What are the legal ramifications for implementing this service? Does your malpractice insurance cover it? And finally, what kind of environment (physical space) would be required?

What alternative investment opportunities might compete?

When considering a significant investment, other opportunities may no longer be feasible. Think about other ways your practice could use the money and which investment prospects would be the best fit.¹ For instance, purchasing equipment that is very time intensive may not necessarily be the most profitable decision, especially if it takes the provider away from other services with higher margins. Could investing in expensive equipment delay bringing in another provider who might have a higher financial impact?

Next stage: Financial evaluation

To begin a basic cash flow analysis of the new investment, gather your practice's financial data. Estimate the cash flow resulting from the equipment investment, including any additional expenses and revenues. Here are some steps:

1. Identify the revenue generated by each use of the equipment.
2. Estimate the variable costs (costs that increase with each incremental unit of activity). Variable costs include expenses associated with each use, such as disposable accessories. For a hysteroscope, the variable cost may be the tubing and fluid used. Some procedures, such as office hysteroscopic sterilization, require the purchase of intratubal occlusion devices.
   ‌

   Also consider the cost of your time. One way to determine this is to investigate the hourly rate you would be paid if you were hypothetically hired by a third party to perform the procedure.

3. Estimate the step costs. Step costs are constant over a narrow range of activity but shift to a higher level with increased activity. One example is staffing costs. If the number of these procedures significantly increases, additional staffing will be required. Include the hourly pay for your medical assistants in the analysis.
4. Determine the contribution margin. Subtract the revenue from the sum of the variable and step costs to find the contribution margin (dollar contribution per unit) to your practice.^4,5
5. Estimate the approximate volume of procedures. It is hard to predict future demand, but a good rule of thumb is to estimate the best, expected, and pessimistic volumes. Then average the 3 scenarios and use that figure as the anticipated volume. Multiply the volume by the contribution margin to calculate profit.

Additional financial tools

Once the basic cash flow analysis of the new investment is undertaken, add these methods to your analysis:

Net Present Value (NPV) is the difference between the present value of cash inflows and the present value of cash outflows (FIGURE 1).⁶ NPV takes into consideration the time value of money, where money in the present is worth more than the same value sometime in the future due to inflation and earning capacity. NPV is used in capital budgeting to analyze the profitability of a projected investment or project.^1,4,5

Consider the discount rate as the expected rate of return or cost of capital. By discounting the future cash flow each year by the discount rate, you can get the present value of cash flow. Subtract the present value of cash flow from the original investment to get the NPV for the equipment's investment. A positive value is a favorable analysis to purchase the equipment; a negative value may suggest that the equipment may be a poor investment.

The NPV can be calculated in a spreadsheet using the following NPV command formula: NPV(rate,value1,[value2],...). This formula gives you the present value of cash inflows. The rate is the discount rate and the values are the series of cash flows occurring over a period of time. The NPV command formula in Excel, despite its misleading name, only gives the present value of cash flows.⁷ Therefore, it is important that the present value of cash inflows is subtracted from the initial capital investment to get the NPV.

FIGURE 2 shows analysis of a piece of equipment that requires a $14,000 initial investment in Year 0. Each year the use of the equipment generates $25,300 per year through year 5. Assign a discount rate of 11%, about what you would expect for a stock market investment.

Consider other investment opportunities. The historical rate of return for a stock index fund is 11.5%.⁸ Using this discount rate, you can compare whether the money would be better invested in the medical equipment or stock.

Internal rate of return (IRR) is a metric used in capital budgeting to measure the profitability of potential investments. The IRR determines if the discount rate at which the present value of expected net cash inflow is equal to the cash outlay. In other words, the IRR is the discount rate that makes the net present cash flows from a project equal zero. The decision rule related to the IRR criterion is to accept a project in which the IRR is greater than the required rate of return (cutoff rate). The formula for the IRR is the same as the NPV formula, except that the NPV is set at zero and the discount rate is calculated through iterative calculation. The IRR can be calculated in a spreadsheet using the following command formula: IRR(values, [guess]).^1,5,9  In FIGURE 3, the IRR is 180%, far superior than the return you would find in other investments such as the stock market.

The IRR is somewhat different from return on investment (ROI). ROI is the percent of return on the initial investment over a period of time. Each piece of equipment has a different ROI over a different time period. ROI does not take into account the time value of money (TVM). Incorporating the IRR (or the TVM) allows for equal comparison between  2 pieces of equipment in the analysis.¹⁰

If you are not comparing 2 different types of equipment for purchase, then using the cutoff of 11.5% may be helpful (the historical average stock market return). If the IRR is less than 11.5%, then in theory, it would be better to put your money in the stock market than in new equipment.⁷

Breakeven analysis calculates the volume of procedures that would be needed to break even or make a profit. It can also determine if there is enough demand to meet the volume required to break even or profit. Unlike the first 2 methods, where you have to guess at future volume, this method calculates the volume required to break even, but does not specify a time period. Your practice would have to use subjective experience to determine how long it would take to reach that volume, given your patient population and the ability to reach the targeted market segment.

Fixed costs are costs that do not change with the varying volume of units of service or products sold. After calculating the contribution margin, divide the fixed costs of the equipment by the contribution margin. Then you will have the volume required to break even (FIGURE 4). Add the dollar amount of profit you would like to attain to the fixed costs, then divide that total by the contribution margin, and you'll have the volume required to meet those specifications.^1,4,5

Even though the calculations described above relate to medical equipment, you can use this same method to analyze the cost of adding new providers or any other business development project to determine the required volume to break even on the capital outlay.

CASE New equipment requests

A new ObGyn in your practice requests that you purchase a hysteroscope so that she can start performing office-based hysteroscopic sterilization. Another partner would like to acquire urodynamic equipment instead of referring urinary incontinent patients to a urogynecologist. How do you decide what to purchase?
 
First calculate the contribution margins for each product. Next, since you do not know for certain the volume you might achieve for each procedure, create 3 scenarios for the best, expected, and pessimistic situations. Assume equal probability for each of these categories and average the volumes of the estimates. Even though you may keep the equipment longer, estimate the financial analysis over  5 years. In this example, we assume a discount rate of 11% for the NPV calculation for both pieces of equipment.

Calculate the IRR using a spreadsheet based on the cash flow for each piece of equipment. Say that the practice anticipates doing 23 hysteroscopic sterilizations per year. If the reimbursement is $2,600 per procedure, and the variable costs are $1,500, the contribution margin is $1,100. So 23 procedures multiplied by $1,100 equals an annual profit of $25,300. Then discount the $25,300 for each year. In this example, we use a discount rate of 11%. The TABLE shows the amount discounted each year.

The sum of the discounted cash flows is $93,506. However, we have to subtract the initial investment of $14,000, so the final NPV equals $79,506 (FIGURE 5).

Apply the same financial NPV and IRR calculations used to assess the hysteroscope to the urodynamic equipment. From the analysis (FIGUREs 5 and 6), both purchases would be financially successful. However, it appears that the urodynamic equipment is a superior investment over the hysteroscope, with a higher NPV ($115,877 vs $81,880, respectively) and IRR (336% vs 180%, respectively). This is likely due to the higher anticipated volume of use with the urodynamic equipment and lower cost of initial investment, despite having a lower contribution margin than the hysteroscope.

Caveats

For simplicity, this analysis does not account for the fact that the hysteroscope could be used for other revenue-generating procedures such as diagnostic hysteroscopy. Factoring in these potential additional services using the same hysteroscope might change the decision analysis in favor of the hysteroscope.

Remember that, although the financial analysis is very helpful in decision making, nonfinancial evaluations should also influence your choice. In this example, while there may be a financial advantage to purchasing the urodynamic equipment over the hysteroscopic equipment, nonfinancial considerations can help you decide which purchase would be a better aligned with the goals and strategies of your practice.

These tools for nonfinancial and financial analysis can be used for any investment in your practice, whether it is in medical equipment, personnel, or development of other profit centers.

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.

Providing state-of-the-art health care for women often requires the use of various types of medical equipment, and decisions regarding their purchase can be complicated. With rising costs and reduced reimbursements, capital expenditures must be made with great care. Some equipment may not generate revenue but is required at a basic care-giving level: examination tables, procedure instruments, autoclaves, etc. Conversely, other equipment may not be necessary but strongly desired to offer a full complement of care. Unfortunately, sometimes a decision to buy expensive equipment is based more on a sales representative's ability to rationalize the purchase as a sound investment than on its necessity or practicality. This article focuses on tools to help you make a decision to obtain revenue-generating medical equipment.

First consideration: Nonfinancial evaluation

Nonfinancial criteria should be your first concern. They may have a greater impact on your practice than any financial consideration.

Does this investment align with your overall goals?

If your focus is to provide the best and most efficient obstetric care in the community, it may not make sense to purchase urodynamic equipment, even if using the equipment could be profitable.¹ If the equipment begins to distract the practice from its strategic focus, then complications from managing this new equipment might be more harmful than helpful.

What are the pros and cons of the investment?

Concern that the equipment may not be effective or may become obsolete in a few years would preclude having to consider the financial purchase in the first place.¹

Consider a PESTLE analysis

Before starting a new project, use a PESTLE analysis to assess external factors that are political, economic, social, technological, legal, and environmental. Its purpose is to identify issues that are beyond the control of the organization and have some level of impact on the organization.^2,3

If you are considering the purchase of a laser hair removal machine, what could be the political considerations, such as your reputation among peers or other physicians who refer patients to your practice? What are the economic (financial) considerations? How would the social (or marketing) message be communicated, and do you have the organizational skills to implement a marketing strategy? What are the technical challenges required for maintaining this machine, and how much skill and training would be required to safely use it? What are the legal ramifications for implementing this service? Does your malpractice insurance cover it? And finally, what kind of environment (physical space) would be required?

What alternative investment opportunities might compete?

When considering a significant investment, other opportunities may no longer be feasible. Think about other ways your practice could use the money and which investment prospects would be the best fit.¹ For instance, purchasing equipment that is very time intensive may not necessarily be the most profitable decision, especially if it takes the provider away from other services with higher margins. Could investing in expensive equipment delay bringing in another provider who might have a higher financial impact?

Next stage: Financial evaluation

To begin a basic cash flow analysis of the new investment, gather your practice's financial data. Estimate the cash flow resulting from the equipment investment, including any additional expenses and revenues. Here are some steps:

1. Identify the revenue generated by each use of the equipment.
2. Estimate the variable costs (costs that increase with each incremental unit of activity). Variable costs include expenses associated with each use, such as disposable accessories. For a hysteroscope, the variable cost may be the tubing and fluid used. Some procedures, such as office hysteroscopic sterilization, require the purchase of intratubal occlusion devices.
   ‌

   Also consider the cost of your time. One way to determine this is to investigate the hourly rate you would be paid if you were hypothetically hired by a third party to perform the procedure.

3. Estimate the step costs. Step costs are constant over a narrow range of activity but shift to a higher level with increased activity. One example is staffing costs. If the number of these procedures significantly increases, additional staffing will be required. Include the hourly pay for your medical assistants in the analysis.
4. Determine the contribution margin. Subtract the revenue from the sum of the variable and step costs to find the contribution margin (dollar contribution per unit) to your practice.^4,5
5. Estimate the approximate volume of procedures. It is hard to predict future demand, but a good rule of thumb is to estimate the best, expected, and pessimistic volumes. Then average the 3 scenarios and use that figure as the anticipated volume. Multiply the volume by the contribution margin to calculate profit.

Additional financial tools

Once the basic cash flow analysis of the new investment is undertaken, add these methods to your analysis:

Net Present Value (NPV) is the difference between the present value of cash inflows and the present value of cash outflows (FIGURE 1).⁶ NPV takes into consideration the time value of money, where money in the present is worth more than the same value sometime in the future due to inflation and earning capacity. NPV is used in capital budgeting to analyze the profitability of a projected investment or project.^1,4,5

Consider the discount rate as the expected rate of return or cost of capital. By discounting the future cash flow each year by the discount rate, you can get the present value of cash flow. Subtract the present value of cash flow from the original investment to get the NPV for the equipment's investment. A positive value is a favorable analysis to purchase the equipment; a negative value may suggest that the equipment may be a poor investment.

The NPV can be calculated in a spreadsheet using the following NPV command formula: NPV(rate,value1,[value2],...). This formula gives you the present value of cash inflows. The rate is the discount rate and the values are the series of cash flows occurring over a period of time. The NPV command formula in Excel, despite its misleading name, only gives the present value of cash flows.⁷ Therefore, it is important that the present value of cash inflows is subtracted from the initial capital investment to get the NPV.

FIGURE 2 shows analysis of a piece of equipment that requires a $14,000 initial investment in Year 0. Each year the use of the equipment generates $25,300 per year through year 5. Assign a discount rate of 11%, about what you would expect for a stock market investment.

Consider other investment opportunities. The historical rate of return for a stock index fund is 11.5%.⁸ Using this discount rate, you can compare whether the money would be better invested in the medical equipment or stock.

Internal rate of return (IRR) is a metric used in capital budgeting to measure the profitability of potential investments. The IRR determines if the discount rate at which the present value of expected net cash inflow is equal to the cash outlay. In other words, the IRR is the discount rate that makes the net present cash flows from a project equal zero. The decision rule related to the IRR criterion is to accept a project in which the IRR is greater than the required rate of return (cutoff rate). The formula for the IRR is the same as the NPV formula, except that the NPV is set at zero and the discount rate is calculated through iterative calculation. The IRR can be calculated in a spreadsheet using the following command formula: IRR(values, [guess]).^1,5,9  In FIGURE 3, the IRR is 180%, far superior than the return you would find in other investments such as the stock market.

The IRR is somewhat different from return on investment (ROI). ROI is the percent of return on the initial investment over a period of time. Each piece of equipment has a different ROI over a different time period. ROI does not take into account the time value of money (TVM). Incorporating the IRR (or the TVM) allows for equal comparison between  2 pieces of equipment in the analysis.¹⁰

If you are not comparing 2 different types of equipment for purchase, then using the cutoff of 11.5% may be helpful (the historical average stock market return). If the IRR is less than 11.5%, then in theory, it would be better to put your money in the stock market than in new equipment.⁷

Breakeven analysis calculates the volume of procedures that would be needed to break even or make a profit. It can also determine if there is enough demand to meet the volume required to break even or profit. Unlike the first 2 methods, where you have to guess at future volume, this method calculates the volume required to break even, but does not specify a time period. Your practice would have to use subjective experience to determine how long it would take to reach that volume, given your patient population and the ability to reach the targeted market segment.

Fixed costs are costs that do not change with the varying volume of units of service or products sold. After calculating the contribution margin, divide the fixed costs of the equipment by the contribution margin. Then you will have the volume required to break even (FIGURE 4). Add the dollar amount of profit you would like to attain to the fixed costs, then divide that total by the contribution margin, and you'll have the volume required to meet those specifications.^1,4,5

Even though the calculations described above relate to medical equipment, you can use this same method to analyze the cost of adding new providers or any other business development project to determine the required volume to break even on the capital outlay.

CASE New equipment requests

A new ObGyn in your practice requests that you purchase a hysteroscope so that she can start performing office-based hysteroscopic sterilization. Another partner would like to acquire urodynamic equipment instead of referring urinary incontinent patients to a urogynecologist. How do you decide what to purchase?
 
First calculate the contribution margins for each product. Next, since you do not know for certain the volume you might achieve for each procedure, create 3 scenarios for the best, expected, and pessimistic situations. Assume equal probability for each of these categories and average the volumes of the estimates. Even though you may keep the equipment longer, estimate the financial analysis over  5 years. In this example, we assume a discount rate of 11% for the NPV calculation for both pieces of equipment.

Calculate the IRR using a spreadsheet based on the cash flow for each piece of equipment. Say that the practice anticipates doing 23 hysteroscopic sterilizations per year. If the reimbursement is $2,600 per procedure, and the variable costs are $1,500, the contribution margin is $1,100. So 23 procedures multiplied by $1,100 equals an annual profit of $25,300. Then discount the $25,300 for each year. In this example, we use a discount rate of 11%. The TABLE shows the amount discounted each year.

The sum of the discounted cash flows is $93,506. However, we have to subtract the initial investment of $14,000, so the final NPV equals $79,506 (FIGURE 5).

Apply the same financial NPV and IRR calculations used to assess the hysteroscope to the urodynamic equipment. From the analysis (FIGUREs 5 and 6), both purchases would be financially successful. However, it appears that the urodynamic equipment is a superior investment over the hysteroscope, with a higher NPV ($115,877 vs $81,880, respectively) and IRR (336% vs 180%, respectively). This is likely due to the higher anticipated volume of use with the urodynamic equipment and lower cost of initial investment, despite having a lower contribution margin than the hysteroscope.

Caveats

For simplicity, this analysis does not account for the fact that the hysteroscope could be used for other revenue-generating procedures such as diagnostic hysteroscopy. Factoring in these potential additional services using the same hysteroscope might change the decision analysis in favor of the hysteroscope.

Remember that, although the financial analysis is very helpful in decision making, nonfinancial evaluations should also influence your choice. In this example, while there may be a financial advantage to purchasing the urodynamic equipment over the hysteroscopic equipment, nonfinancial considerations can help you decide which purchase would be a better aligned with the goals and strategies of your practice.

These tools for nonfinancial and financial analysis can be used for any investment in your practice, whether it is in medical equipment, personnel, or development of other profit centers.

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.

Providing state-of-the-art health care for women often requires the use of various types of medical equipment, and decisions regarding their purchase can be complicated. With rising costs and reduced reimbursements, capital expenditures must be made with great care. Some equipment may not generate revenue but is required at a basic care-giving level: examination tables, procedure instruments, autoclaves, etc. Conversely, other equipment may not be necessary but strongly desired to offer a full complement of care. Unfortunately, sometimes a decision to buy expensive equipment is based more on a sales representative's ability to rationalize the purchase as a sound investment than on its necessity or practicality. This article focuses on tools to help you make a decision to obtain revenue-generating medical equipment.

First consideration: Nonfinancial evaluation

Nonfinancial criteria should be your first concern. They may have a greater impact on your practice than any financial consideration.

Does this investment align with your overall goals?

If your focus is to provide the best and most efficient obstetric care in the community, it may not make sense to purchase urodynamic equipment, even if using the equipment could be profitable.¹ If the equipment begins to distract the practice from its strategic focus, then complications from managing this new equipment might be more harmful than helpful.

What are the pros and cons of the investment?

Concern that the equipment may not be effective or may become obsolete in a few years would preclude having to consider the financial purchase in the first place.¹

Consider a PESTLE analysis

Before starting a new project, use a PESTLE analysis to assess external factors that are political, economic, social, technological, legal, and environmental. Its purpose is to identify issues that are beyond the control of the organization and have some level of impact on the organization.^2,3

If you are considering the purchase of a laser hair removal machine, what could be the political considerations, such as your reputation among peers or other physicians who refer patients to your practice? What are the economic (financial) considerations? How would the social (or marketing) message be communicated, and do you have the organizational skills to implement a marketing strategy? What are the technical challenges required for maintaining this machine, and how much skill and training would be required to safely use it? What are the legal ramifications for implementing this service? Does your malpractice insurance cover it? And finally, what kind of environment (physical space) would be required?

What alternative investment opportunities might compete?

When considering a significant investment, other opportunities may no longer be feasible. Think about other ways your practice could use the money and which investment prospects would be the best fit.¹ For instance, purchasing equipment that is very time intensive may not necessarily be the most profitable decision, especially if it takes the provider away from other services with higher margins. Could investing in expensive equipment delay bringing in another provider who might have a higher financial impact?

Next stage: Financial evaluation

To begin a basic cash flow analysis of the new investment, gather your practice's financial data. Estimate the cash flow resulting from the equipment investment, including any additional expenses and revenues. Here are some steps:

1. Identify the revenue generated by each use of the equipment.
2. Estimate the variable costs (costs that increase with each incremental unit of activity). Variable costs include expenses associated with each use, such as disposable accessories. For a hysteroscope, the variable cost may be the tubing and fluid used. Some procedures, such as office hysteroscopic sterilization, require the purchase of intratubal occlusion devices.
   ‌

   Also consider the cost of your time. One way to determine this is to investigate the hourly rate you would be paid if you were hypothetically hired by a third party to perform the procedure.

3. Estimate the step costs. Step costs are constant over a narrow range of activity but shift to a higher level with increased activity. One example is staffing costs. If the number of these procedures significantly increases, additional staffing will be required. Include the hourly pay for your medical assistants in the analysis.
4. Determine the contribution margin. Subtract the revenue from the sum of the variable and step costs to find the contribution margin (dollar contribution per unit) to your practice.^4,5
5. Estimate the approximate volume of procedures. It is hard to predict future demand, but a good rule of thumb is to estimate the best, expected, and pessimistic volumes. Then average the 3 scenarios and use that figure as the anticipated volume. Multiply the volume by the contribution margin to calculate profit.

Additional financial tools

Once the basic cash flow analysis of the new investment is undertaken, add these methods to your analysis:

Net Present Value (NPV) is the difference between the present value of cash inflows and the present value of cash outflows (FIGURE 1).⁶ NPV takes into consideration the time value of money, where money in the present is worth more than the same value sometime in the future due to inflation and earning capacity. NPV is used in capital budgeting to analyze the profitability of a projected investment or project.^1,4,5

Consider the discount rate as the expected rate of return or cost of capital. By discounting the future cash flow each year by the discount rate, you can get the present value of cash flow. Subtract the present value of cash flow from the original investment to get the NPV for the equipment's investment. A positive value is a favorable analysis to purchase the equipment; a negative value may suggest that the equipment may be a poor investment.

The NPV can be calculated in a spreadsheet using the following NPV command formula: NPV(rate,value1,[value2],...). This formula gives you the present value of cash inflows. The rate is the discount rate and the values are the series of cash flows occurring over a period of time. The NPV command formula in Excel, despite its misleading name, only gives the present value of cash flows.⁷ Therefore, it is important that the present value of cash inflows is subtracted from the initial capital investment to get the NPV.

FIGURE 2 shows analysis of a piece of equipment that requires a $14,000 initial investment in Year 0. Each year the use of the equipment generates $25,300 per year through year 5. Assign a discount rate of 11%, about what you would expect for a stock market investment.

Consider other investment opportunities. The historical rate of return for a stock index fund is 11.5%.⁸ Using this discount rate, you can compare whether the money would be better invested in the medical equipment or stock.

Internal rate of return (IRR) is a metric used in capital budgeting to measure the profitability of potential investments. The IRR determines if the discount rate at which the present value of expected net cash inflow is equal to the cash outlay. In other words, the IRR is the discount rate that makes the net present cash flows from a project equal zero. The decision rule related to the IRR criterion is to accept a project in which the IRR is greater than the required rate of return (cutoff rate). The formula for the IRR is the same as the NPV formula, except that the NPV is set at zero and the discount rate is calculated through iterative calculation. The IRR can be calculated in a spreadsheet using the following command formula: IRR(values, [guess]).^1,5,9  In FIGURE 3, the IRR is 180%, far superior than the return you would find in other investments such as the stock market.

The IRR is somewhat different from return on investment (ROI). ROI is the percent of return on the initial investment over a period of time. Each piece of equipment has a different ROI over a different time period. ROI does not take into account the time value of money (TVM). Incorporating the IRR (or the TVM) allows for equal comparison between  2 pieces of equipment in the analysis.¹⁰

If you are not comparing 2 different types of equipment for purchase, then using the cutoff of 11.5% may be helpful (the historical average stock market return). If the IRR is less than 11.5%, then in theory, it would be better to put your money in the stock market than in new equipment.⁷

Breakeven analysis calculates the volume of procedures that would be needed to break even or make a profit. It can also determine if there is enough demand to meet the volume required to break even or profit. Unlike the first 2 methods, where you have to guess at future volume, this method calculates the volume required to break even, but does not specify a time period. Your practice would have to use subjective experience to determine how long it would take to reach that volume, given your patient population and the ability to reach the targeted market segment.

Fixed costs are costs that do not change with the varying volume of units of service or products sold. After calculating the contribution margin, divide the fixed costs of the equipment by the contribution margin. Then you will have the volume required to break even (FIGURE 4). Add the dollar amount of profit you would like to attain to the fixed costs, then divide that total by the contribution margin, and you'll have the volume required to meet those specifications.^1,4,5

Even though the calculations described above relate to medical equipment, you can use this same method to analyze the cost of adding new providers or any other business development project to determine the required volume to break even on the capital outlay.

CASE New equipment requests

A new ObGyn in your practice requests that you purchase a hysteroscope so that she can start performing office-based hysteroscopic sterilization. Another partner would like to acquire urodynamic equipment instead of referring urinary incontinent patients to a urogynecologist. How do you decide what to purchase?
 
First calculate the contribution margins for each product. Next, since you do not know for certain the volume you might achieve for each procedure, create 3 scenarios for the best, expected, and pessimistic situations. Assume equal probability for each of these categories and average the volumes of the estimates. Even though you may keep the equipment longer, estimate the financial analysis over  5 years. In this example, we assume a discount rate of 11% for the NPV calculation for both pieces of equipment.

Calculate the IRR using a spreadsheet based on the cash flow for each piece of equipment. Say that the practice anticipates doing 23 hysteroscopic sterilizations per year. If the reimbursement is $2,600 per procedure, and the variable costs are $1,500, the contribution margin is $1,100. So 23 procedures multiplied by $1,100 equals an annual profit of $25,300. Then discount the $25,300 for each year. In this example, we use a discount rate of 11%. The TABLE shows the amount discounted each year.

The sum of the discounted cash flows is $93,506. However, we have to subtract the initial investment of $14,000, so the final NPV equals $79,506 (FIGURE 5).

Apply the same financial NPV and IRR calculations used to assess the hysteroscope to the urodynamic equipment. From the analysis (FIGUREs 5 and 6), both purchases would be financially successful. However, it appears that the urodynamic equipment is a superior investment over the hysteroscope, with a higher NPV ($115,877 vs $81,880, respectively) and IRR (336% vs 180%, respectively). This is likely due to the higher anticipated volume of use with the urodynamic equipment and lower cost of initial investment, despite having a lower contribution margin than the hysteroscope.

Caveats

For simplicity, this analysis does not account for the fact that the hysteroscope could be used for other revenue-generating procedures such as diagnostic hysteroscopy. Factoring in these potential additional services using the same hysteroscope might change the decision analysis in favor of the hysteroscope.

Remember that, although the financial analysis is very helpful in decision making, nonfinancial evaluations should also influence your choice. In this example, while there may be a financial advantage to purchasing the urodynamic equipment over the hysteroscopic equipment, nonfinancial considerations can help you decide which purchase would be a better aligned with the goals and strategies of your practice.

These tools for nonfinancial and financial analysis can be used for any investment in your practice, whether it is in medical equipment, personnel, or development of other profit centers.

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 the United States, there are approximately 64 million women who are postmenopausal. Of these women, it is estimated that 50%—or more than 32 million— have symptoms of vulvovaginal atrophy (VVA) and/or dyspareunia (painful sexual intercourse). These two conditions, along with several others, are components of the Genitourinary Syndrome of Menopause (GSM).

This CME-designated journal supplement is comprised of three articles that provide information and strategies regarding best practices as to patient counseling, diagnosis, and treatment of VVA, and its associated dyspareunia. The goal is to provide women’s health clinicians the knowledge and tools they need to optimize the care they provide to their menopausal patients.

Click here to read the supplement. 

https://omniaeducation.com/dyspareunia/

In the United States, there are approximately 64 million women who are postmenopausal. Of these women, it is estimated that 50%—or more than 32 million— have symptoms of vulvovaginal atrophy (VVA) and/or dyspareunia (painful sexual intercourse). These two conditions, along with several others, are components of the Genitourinary Syndrome of Menopause (GSM).

This CME-designated journal supplement is comprised of three articles that provide information and strategies regarding best practices as to patient counseling, diagnosis, and treatment of VVA, and its associated dyspareunia. The goal is to provide women’s health clinicians the knowledge and tools they need to optimize the care they provide to their menopausal patients.

Click here to read the supplement. 

https://omniaeducation.com/dyspareunia/

In the United States, there are approximately 64 million women who are postmenopausal. Of these women, it is estimated that 50%—or more than 32 million— have symptoms of vulvovaginal atrophy (VVA) and/or dyspareunia (painful sexual intercourse). These two conditions, along with several others, are components of the Genitourinary Syndrome of Menopause (GSM).

This CME-designated journal supplement is comprised of three articles that provide information and strategies regarding best practices as to patient counseling, diagnosis, and treatment of VVA, and its associated dyspareunia. The goal is to provide women’s health clinicians the knowledge and tools they need to optimize the care they provide to their menopausal patients.

Click here to read the supplement. 

https://omniaeducation.com/dyspareunia/