Abstract
Background:
In 2012, new cervical cancer screening guidelines were published by three widely recognized entities which advocate delayed onset of testing, fewer screenings, selective use of human papilloma virus co-testing, and no further screening in women over age 65 years. Early observations report that these recommendations are not being followed and overscreening is common. This study seeks to understand why primary care providers might not adhere to these new ‘best practice’ health policy protocols.
Methods:
A total of 4,909 randomly selected primary care providers (physicians, nurse practitioners, and physician assistants) practicing in California were mailed a study questionnaire. Participants were asked if they consider current published screening guidelines to be authoritative, reliable, and/or clinically appropriate. Clinical vignettes captured individual provider beliefs on timing and method of cervical cancer screening in women within the four key age groups embedded in current screening guidelines.
Results:
Of the 4,909 surveys mailed, 1,268 (25.8%) qualified responses were received. Fundamentally, 35.0% of all primary care providers do not believe current guidelines are clinically appropriate, with 58.6% of obstetrician/gynecologist physicians having this same skepticism. Even among those who affirmatively believe current guidelines are authoritative, reliable, and clinically appropriate, only 15.3% recommend screening intervals and methodology of testing in women of four differing ages consistent with that of current policy guidelines.
Conclusion:
Among the primary care providers surveyed, distrust and confusion likely limit adherence to current evidence-based cervical cancer screening health policy recommendations, and contribute to the current high rates of overscreening that have been observed.
Introduction
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Unfortunately, however, the guidelines of these organizations were frequently neither in concordance nor updated within similar time frames. 3 –5 Providers were forced to pick and choose from sometimes differing recommendations, which might contain directives such as “might,” or “at the discretion of patient or provider.” Lastly, prior recommendations lacked clear consensus on screening intervals and the definitive age at which cervical testing should cease. As expected, wide variations in clinical practice were seen, influenced by age of provider, specialty of provider, and a multitude of other factors. 6
Within 8 months of each other in 2012, ACOG, ACS, and USPSTF published new cervical cancer screening guidelines. 7 –9 Although not explicitly by intent, for the first time, these organizational guidelines were essentially identical. In fact, the recommendations of ACS also encompassed the opinions of the American Society for Colposcopy and Cervical Pathology and the American Society for Clinical Pathology—organizations who have not always previously been in agreement. Clear age brackets for differing screening intervals and methodology were created, and many other confounding variables were removed from consideration. From a health policy standpoint, significant improvements were achieved; these organizations were simultaneously in unison, guidelines were seemingly simple to understand, prior ambiguities had been removed, and new technologies (HPV co-testing) were emphasized to lessen unnecessary testing. Relative to the long-standing tradition of the “annual Pap,” these new published guidelines safely allow healthy women (without significant prior cervical abnormalities), a significantly reduced number of lifetime cervical cancer screenings. The increased emphasis on use of HPV co-testing acknowledges that only some women are in need of greater clinical focus.
Since release of these new guidelines, however, studies suggest that adherence is suboptimal. 10 Since 2013, evidence is accumulating that wide practice patterns persist with significant over screening present. 11 The existence of this unnecessary testing has significant impact upon primary care providers (who are increasingly in short supply), payers, and the patients themselves who undergo more frequent examinations without evidence of incremental clinical benefit, and in fact may produce harm. 8
To correctly perform cervical cancer screenings as recommended, three factors must be true: providers must find the guidelines authoritative and reliable, providers who find the guidelines intrinsically correct must not knowingly disregard them for other clinical reasons, and providers must be able to understand and correctly interpret them. This study seeks to understand the various issues that may limit the adherence to these new screening policies, and in particular understand the basis for the overscreening phenomenon that is being witnessed both in California and nationwide.
Methods
For purposes of this study, primary care providers included obstetrician/gynecologists (OB/GYNs), family practitioners, primary care internists, primary care nurse practitioners, and primary care physician assistants. A subset of 4,909 randomly selected primary care providers was derived from a commercial database of all active licensed practitioners within the state of California (Healthcare Data Solutions:
A survey composed of four elements was designed specifically for this study and was mailed to this sample group. A series of qualifying questions verified that respondents in fact both recommend and perform cervical cancer screening, thus defining them as a qualified respondent. Participants were asked which (if any), of the three guiding organizations (ACOG, ACS, and USPSTF) they find authoritative and rely upon in the recommendation and performance of cervical cancer screening under ideal circumstances. Four clinical vignettes captured the providers' individual beliefs as to optimal cervical cancer screening in women without prior cervical abnormalities. Specifically, these vignettes asked participants their recommendation on frequency and methodology (primary cytology screening versus cytology with HPV co-testing) of future testing in four hypothetical women of ages 19, 26, 41, and 67 years to assess their individual screening beliefs relative to current published age-associated policy recommendations. Lastly, providers were questioned, based upon their own beliefs and circumstance, whether they would knowingly ignore the guidelines they otherwise consider authoritative and reliable. Prior to mailing, the survey tool was screened by over 20 community and faculty primary care providers of all five provider types, to ensure that questions were simple, unambiguous, and could be answered without difficulty or confusion. Statistical testing included calculation of confidence intervals, independent t-testing and analysis of variance.
Lastly, providers were allowed to add general comments as they felt appropriate. Practitioners provided considerable and often impassioned written commentary on the survey document. These opinions and statements provide significant insight into the participants' rationale, which drives the wide variety of screening opinions.
Results
In the last half of 2014, surveys were mailed to 4,909 California primary care practitioners, with responses received from 1,352 providers. Of these, 1,268 were deemed qualified by virtue of their role in recommending and performing cervical cancer screening as part of their professional duties (Table 1). The overall qualified response rate was 25.8%. The proportional mix of provider types among respondents was not statistically different than that of all primary care providers statewide (p < 0.05).
No statistically significant difference in response rates among all provider types by 95% confidence interval testing.
OB/GYN, obstetrician/gynecologists; FP, family practice; IM, internal medicine; NP, nurse practitioner; PA, physician assistant.
Responses were received from providers practicing in all regions of California, comprising 370 distinct zip codes. While respondents where clumped unevenly across the state, the same geographical pattern is true of all California primary care providers. There was no statistical difference in distribution between the location of survey respondents, and that of all primary care providers statewide (p < 0.05).
Providers participating in this study practiced in regions that were highly diverse in terms of population density, median household income, and racial and ethnic composition. This diversity of practice locations was consistent with the very broad and diverse demographic makeup of zip codes across California as reflected in 2010 U.S. Census data. Survey respondents practiced in zip codes that varied greatly: mean population density (persons/square mile) 4,526 (range 1.3–50,559); mean household income $55,870 (range $14,870–$154,243); white race: 62.0% (range: 5.5%–93.9%); Hispanic ethnicity: 38.4% (range 3.3%–97.7%); black or African American: 5.5% (range 0.05%–83.7%); Asian: 8.4% (range 0.1%–63.2%); Native American or Pacific Islander 2.1% (range 0.1%–80.6%); one other race 17.3% (range 0.05%–50.8%); and two or more races 4.6% (range 1.9%–11.5%). Compared with the entire population of primary care providers in California, the demographic composition of the locations where these study respondents practice is not statistically different by 95% confidence interval testing.
The majority of study providers consider at least one screening guideline by ACOG, ACS, or USPSTF to be authoritative in nature and reliable. (Table 2). Despite that screening recommendations are essentially identical for all three organizations, providers do not consider the differing organizations equally trustworthy. Compared with other provider types, internal medicine and family practice physicians were statistically more likely to find the recommendations by USPSTF “authoritative and reliable,” and conversely, OB/GYN physicians were statistically less so. For ACOG and ACS this split of opinion did not exist between provider types. Perhaps this speaks to a differing bias that these three provider types have towards USPSTF. Significantly, OB/GYN physicians were less likely to find any organization's guidelines authoritative and reliable, including those by their own professional organization: ACOG.
Statistically significant difference among provider types: p < 0.05.
ACOG, American College of Obstetricians and Gynecologists; ACS, American Cancer Society; USPSTF, United States Preventive Services Task Force.
For screening policy recommendations to be considered clinically appropriate, they must be authoritative (represent the standard), reliable (safe and effective), and clinically deployable (no significant barriers to implementation). Among all primary care provider types, varying percentages hold a belief that the current cervical screening guidelines are not clinically appropriate (Table 3). Interestingly, over fifty percent of OB-GYN providers hold this belief, which represents a dramatic and statistically higher level of bias against current screening recommendations compared with all other provider types.
[95% confidence intervals] listed for all provider types.
Statistically different from other provider types at 95% confidence interval testing.
Among all primary care respondents (including those that do not find current policy clinically appropriate), respondent recommendations on cervical cancer screening are frequently out of compliance with existing guidelines (Table 4). Even among primary care providers who have no reservations and affirmatively consider current published recommendations to be clinically appropriate, individual beliefs on screening by these practitioners similarly do not match current recommendations. With a few exceptions, those who believe the current guidelines are clinically appropriate do little better in providing screening beliefs that match current published recommendations. In both cases, poor adherence and overscreening by both frequency and methodology of testing would be expected.
Most common type of recommended screening error(s) by 95% confidence interval testing.
Among primary care respondents, failure of providers to recommend screening consistent with current guidelines was common. For women under 21 years of age, the most common error was to recommend premature initiation of cervical cancer screening. For women ages 21 to 30, practitioner recommendations would translate into overscreening both in terms of increased frequency of testing and/or inappropriate use of HPV co-testing. In women ages 30 to 65, respondents recommended screening more frequent than guidelines dictate both when either cytology alone or HPV co-testing is utilized. The most common provider error for women in this age group was to recommend cervical cancer screening with cytology and HPV co-testing on an every 3 year basis, when all guidelines recommend this co-testing only every 5 years. For women over 65, most providers seem to agree with the current guideline that further cervical cancer screening should cease if adequate prior testing has been normal. There remain, however, 33% of providers who continue to recommend ongoing screening beyond that cutoff age.
Even among primary care providers who believe current screening recommendations are clinically appropriate, few providers make screening recommendations that are in complete agreement with these guidelines (Table 5).
No statistically significant difference between provider types at 95% confidence interval testing [95% confidence intervals] listed for all provider types.
Discussion
Prior to 2012, primary care providers practiced in an era in which cervical cancer screening guidelines were often vague or contradictory. In 2012, however, ACOG, ACS, and USPSTF independently published evidence-based guidelines that were simplified, specific and essentially in agreement. Relative to prior recommendations, these new guidelines safely allow healthy women to undergo fewer lifetime cervical cancer screenings.
Since release of these guidelines, however, there is growing evidence that compliance with these new recommendations is limited, and that overscreening for cervical cancer is a common phenomenon. Early studies reveal that the benefits of these consensus protocols are not being realized and that over screening remains a common and pervasive occurrence. 10 In September 2014, California's Integrated Healthcare Alliance reported that nearly 50% of patients, whose medical group or insurance plan reports data, did not undergo appropriate screening for cervical cancer 11 . This included large and highly organized medical groups with the ideal environment for correct adherence to current recommendations.
The impact of adopting these guidelines would be significant. From a health economics standpoint, it has been estimated that the mere laboratory cost of cytology and HPV co-testing from over screening translates into billions of dollars per year within the United States. 13 This cost does not include other significant financial components: the practitioners' professional fee, the cost of pursuing false positive test results, and the financial impact upon the patients themselves in terms of co-pays, co-insurance, and time/wages lost from work. Absent these financial considerations, the unnecessary consumption of primary care provider resources at a time of growing shortage is not insignificant.
Prior to this study, little has been published in an attempt to understand the basis for nonadherence to these new evidence-based guidelines and the subsequent overscreening. While smaller studies at a single medical group have shown that adherence to current recommendations is suboptimal, 10 to our knowledge, this is the first and largest published study that has sought to understand why these patterns of poor adoption and overscreening by providers exist across wide geographies, diverse populations, various payer categories, and differing types of primary care providers including mid-level practitioners.
Our study showed a qualified response rate of 25.8%. As expected, the respondents practice in areas that differ greatly in terms of population density, household income, racial makeup, and ethnic composition. The 1,268 primary care respondents in this study were statistically representative of primary care providers statewide not only by provider type, but in the demographics of the zip codes in which they practice.
It is interesting to observe that 35.0% of respondents do not believe current guidelines are clinically appropriate, with over half of OB/GYN physicians having similar skepticism. This specialty of physicians is also the largest to reject any of the three recommending bodies, including their own professional organization, ACOG. Many respondents wrote they are not convinced that less screening is safe; they find it “risky.” Among a number of providers, actual contempt was expressed: that new guidelines were created “for the express purpose of saving money” and that the “insurance companies,” “Medicare,” or “Obamacare” are prioritizing cost savings over patient safety.
This study also shows that there are a significant number of primary care practitioners who believe the guidelines are authoritative and reliable but intentionally disregard them. Commentary by study participants explain some of the rationale. Primary care providers complain that they are frequently and exclusively in the position of trying to explain the full implications of these new guidelines during an already scheduled appointment in the midst of a typically hectic schedule. Patients are suspicious of what they perceive as a sudden change in cancer screening, and suspect a wide variety of inappropriate motives. Many patients have never heard of the Human Papilloma Virus, and do not understand its implication or why testing has changed. Providers relate that patients perceive longer intervals between testing as a lesser quality of care, and do not understand how these new policy recommendations are in their best interest. As many practitioners pointed out, sometimes merely performing the less valuable cytology-only testing more frequently is the path of least resistance. In general, providers feel that ACOG, ACS, and USPSTF have left primary care providers with little support as they face the challenges associated with implementing what patients perceive as a radically different screening approach.
Some practitioners fear that failing to perform cervical cancer screening will invalidate or lessen reimbursement for a yearly preventive examination. Other practitioners shared the difficulty they are having explaining to patients that a yearly speculum and pelvic exam might still be indicated, but not to simultaneously sample for cervical cancer abnormalities, stating, “Patients find that strange.” Lastly, many providers in California participate in “pay for performance” programs in which cervical cancer screening rates play a role in financial reward or public recognition. In many of these programs, providers perceive that a perverse strategy of intentional overscreening may yield greater rewards, especially when it is hard to guarantee any patient will reliably return in 3 or 5 years. Lastly, a few providers were honest enough to acknowledge that performing more frequent cervical cancer screening was a significant component of their income, and among some in whom well-women exams are a majority of their practice, the new recommendations might threatened the financial viability of their practice.
Confusion may present the largest impediment to accurate implementation. Most practitioners in this study endorse their belief in the evidence-based nature of these current guidelines and find them appropriate. Yet the data shows there is a great difference between practitioners' individual recommendations, and the actual guidelines they believe they are following. As this study shows, among providers who find current guidelines reliable and clinically appropriate, only 15.3% of practitioners are able to provide accurate screening recommendations in terms of testing frequency and methodology in all four of the key age brackets. Practitioners are having a hard time accurately remembering the current recommended intervals of testing and when to appropriately utilize HPV co-testing. This might not be surprising given the time horizon over which many of these providers have practiced, during which screening guidelines where inconsistent, vague, and changing.
Many primary care providers hold beliefs that a wide variety of other considerations should influence testing frequency and methodology. Age of sexual onset, degree of sexual activity, monogamy, family history, marital status, menopausal status, smoking history, and race were acknowledged by some respondents to be determinants in their screening recommendations. Some providers still believe performance of a cervical cancer screening is a required standard of care before prescribing or renewing contraception. As to HPV detection, many respondents described a theory exactly opposite to that of the evidence-based guidelines. These individuals expressed the belief that detection of HPV in women under 30 was a useful endeavor, to identify women who would require focused monitoring in the future. In fact, all three organizations state that detection of HPV infection in younger women is not clinically useful given its common occurrence and spontaneous clearance in most cases. In all of these situations, practitioners are applying criteria to screening decisions that are specifically not recommended in current guidelines.
These study providers also expressed that aspects of current guidelines are unclear. For example, a number of providers communicated confusion regarding how the guidelines are interpreted in the history of a distant “abnormal” screening. Even those who understand current guidelines in the setting of each and every prior screening having been normal, few understand how a history of a prior distant and poorly described “abnormal Pap” affects these evidence-based guidelines. What this study clearly shows is that when the slightest element of confusion exists, providers will revert to over screening as to “play it safe.”
Limitations of this study, however, do exist. Although the number of primary care providers surveyed was large relative to other published studies, the geography studied was limited to the state of California. While this state has the largest population, the greatest number of primary care providers, and specifically contains more primary care providers than 24 states combined, we can only speculate that the observations found in our study would be true throughout the United States. This study did not record individual characteristics of the primary care providers themselves other than their provider type and practice location. It might be reassuring, however, that the population demographics of the zip codes in which the respondents practice are statistically similar to providers statewide. This might suggest that these providers are not different from the entire state's primary care provider base. And while participation bias might exist, the characteristics of nonresponders were statistically no different compared with study participants or of all primary care providers statewide.
Lastly, there are certain circumstances in which knowledge of guidelines may not be absolutely critical. In some clinical settings, patients rely upon automated reminders to schedule screening appointments. The actual testing on the cervical sample (whether to perform HPV co-testing or not) is sometimes defined by laboratory protocol, not by provider opinion at the time of performance. In other words, screening consistent with recommendations might occur in spite of inaccurate provider opinions.
Nevertheless, differing screening behaviors including over testing is a widely recognized phenomenon. As this study shows, the reasons vary. For some practitioners, inadequate evidence has been presented to create a comfort level with these less frequent screening protocols. For many providers who otherwise believe these guidelines are sound, recommendations are intentionally ignored when significant barriers makes adherence clinically impossible or intolerable. For most primary care providers, a complete knowledge of current guidelines is not easily articulated.
Conclusion
In 2012, the simplification and unity of cervical cancer screening guidelines created the opportunity for excellent provider and patient compliance. The advantages of these new guidelines were significant: fewer and more targeted screenings without fear of increased numbers of late stage cervical cancer. The savings associated with these new guidelines might not only be in healthcare expenditures, but in the time spent on unnecessary screening in an era where widespread shortages of primary care providers exist.
Early studies, however, reveal that the benefits of these consensus recommendations are not being realized. These guidelines have not been widely adopted, and overscreening is a common occurrence. This study suggests that the failure of primary care providers to implement these new screening recommendations may be due to three reasons. Some participants simply do not believe these recommendations are authoritative or reliable in safely screening women for cervical cancer. Even among primary care providers who fundamentally agree with new guidelines, various barriers contribute to the intention disregard of these screening recommendations. Although most primary care providers believe current guidelines are authoritative, reliable and appropriate, confusion exists as to the appropriate execution.
In addition to the numerical data, provider opinions and commentary from this study provide significant insight into the specific issues which limit optimal adoption of these best practices. These findings provide those interested in improving health policy in this area, an understanding of the various components necessary to overcome the discontent and confusion among primary care providers relative to current consensus screening recommendations for cervical cancer.
Footnotes
Acknowledgments
This research was funded by university research grants provided by the Sol Price School of Public Policy, University of Southern California.
Author Disclosure Statement
No competing financial interests exist.
