Abstract
The value of pelvic examination for healthy asymptomatic women has been called into question given the lack of benefit for ovarian and endometrial cancer screening, the ability to screen for sexually transmitted infections without a pelvic examination, and the uncoupling of the procurement of contraception with a pelvic examination. Still, there are indications for performing pelvic examinations in symptomatic women and in some high risk women. How do we as clinicians apply current evidence and expert opinion to our medical practice? Our recommendation to consider a pelvic examination at 3-5-year intervals with cervical cancer screening to elicit gynecologic and sexual health concerns offers a compromise between continuation of unnecessary annual pelvic examinations and complete elimination of these examinations.
Background
Pelvic examination indications for healthy asymptomatic women have encompassed such preventive services as screening for cancer and infection. They have been associated with contraception counseling, evaluation and initiation. In previous years, pelvic examinations were performed annually for women in conjunction with cervical cancer screening, regardless of medical history or symptoms. In the past decade, cervical cancer screening guidelines have changed significantly favoring less frequent screening for most women. The most recent national guideline updates from the USA recommend cervical cytology every 3 years for women aged 21 years and older and include the option of 5-year cervical cytology/high-risk HPV co-testing for women 30–65 years old [1–3]. This has resulted in a major change in healthcare visit frequency. Women no longer need to schedule annual appointments for cervical cancer screening. Healthcare providers and researchers appropriately question the value of the annual pelvic examination for healthy asymptomatic women, its relationship to other gynecologic and preventive healthcare, and seek guidance regarding counseling patients. Herein, we will review traditional indications for pelvic examinations and review evidence and best practices from the USA and around the world. We will provide our perspective on answering the question: ‘Should the annual pelvic examination go the way of annual cervical cytology?’
What does a pelvic examination include?
A comprehensive pelvic examination entails more than cervical cancer screening. It generally includes visualization of the external genitalia, a speculum examination of the vaginal and cervix, a bimanual examination of the uterus and adnexal areas, and a rectovaginal examination. The examination may include collection of cervical cytology (with or without HPV testing) for cervical cancer screening and endocervical or vaginal specimens to evaluate for infection. Pelvic examinations have commonly been performed for screening, symptom assessment and surveillance [4].
Pelvic examination for cancer screening
Cervical cancer screening represents a preventive medicine success story with cervical cancer rates decreasing dramatically in countries with screening programs or practices [5–8]. In the USA, rates of cervical cancer diagnosis and mortality have fallen over 50% since 1975 [9]. Evidence supports 3-5-year interval screening as an effective and safe approach for detection of cervical precancer and cancer. The basis of this approach reflects that persistence of high-risk HPV causes the majority of cervical malignancy [10,11]. The value of a routine pelvic examination for gynecologic cancer screening has not been established, apart from cervical cytology (with or without HPV testing) for cervical cancer screening. Studies of pelvic examinations performed by physicians, residents and medical students for consenting patients under general anesthesia have demonstrated that the bimanual examination is of limited accuracy [12,13], although recent surveys have reported that some clinicians continue to perform pelvic examinations for ovarian and uterine cancer screening [14,15]. The United States Preventive Services Task Force (USPSTF) has clearly stated in their recent update on ovarian cancer screening that there are no randomized controlled trials showing utility of a bimanual pelvic examination for cancer screening [16].
Pelvic examination for sexually transmitted infection screening
Sexually transmitted infection (STI) screening for chlamydia and gonorrhea is recommended by the USPSTF annually in all sexually active women under 25 years of age and in older women with risk factors for STIs [17]. The CDC recommends a similar approach but suggests chlamydia screening annually through age 25 years [18]. Testing may be performed on cervical or vaginal specimens collected during a pelvic examination or on self-collected urine samples or vaginal swabs without a pelvic examination [19]. A decision analysis study reported that self-collected vaginal swabs are more cost effective as compared with cervical or urine samples [20]. Disease detection sensitivity of vaginal swabs is comparable whether collected by patient or healthcare provider [21]. A different decision analysis study comparing cervical swab to urine sample reported that urine screening is more cost effective [22]. Furthermore, a survey of 1090 women enrolled in a multiple method STI screening study reported patient preference for self-collected vaginal swab. The majority of women felt that the ease of collection would increase the likelihood of STI screening [23]. Therefore, performing a pelvic examination for the purpose of specimen collection for STI screening is no longer necessary.
Internet-based programs that offer STI screening with self-collected samples have been studied in the USA, Australia and Canada and may serve to further uncouple STI screening from the pelvic examination. They appear to successfully target a younger technology-savvy population and remove the need for a clinician visit or pelvic examination as a barrier to screening [24–27]. It is important to note that these studies were all supported by public health organizations in their respective countries. A 2010 study of worldwide internet sites offering STI self-collection kits attempted to survey 27 sites with questions about timeliness of test results, handling of positive results in terms of treatment or referral, and quality control issues; only two sites completed the survey. The study group then ordered test kits from six commercial sites and one public health site (their own) and submitted known positive specimens. From the six commercial sites, there were two false-negative results, two sites that never provided results and two true-positive results [28]. The importance of quality control and use of reputable and preferably noncommercial sites for internet-based testing is evident.
Pelvic examination for contraceptive management
Historically, providers have performed a pelvic examination as a prerequisite to providing a patient with a hormonal contraception prescription. This has now been challenged and changed as outlined by Stewart et al.'s review of recommendations from eight professional organizations including USA and international groups who conclude that a pelvic examination is not mandatory before providing hormonal contraception. Instead, a review of the patient's medical history and blood pressure evaluation is adequate screening [29]. In Tepper et al.'s more current review of examination prior to the initiation of hormonal contraception, they noted that a pelvic examination is not an effective screening mechanism for conditions that would alter use of hormonal contraceptives especially in asymptomatic women [30]. The CDC's publication ‘US Selected Practice Recommendations for Contraceptive Use, 2013’ reiterates that a pelvic examination is not needed prior to initiation of contraceptive implants, injectables, combined hormonal contraceptive pills, progestin-only pills or emergency contraceptive pills [31]. However, a recent study illustrates that health provider practice is slower to change in that a third of clinicians surveyed reported requiring patients to have a pelvic examination before prescribing oral contraception [32]. Given that nonuse of oral contraception has been linked to access [33] and cost issues, the American College of Obstetricians and Gynecologists (ACOG) published a Committee Opinion advocating the availability of oral contraceptives without a prescription in the USA [34]. There is significant interest among women in over-the-counter (OTC) availability of contraception, with 60% of 601 women indicating that they would be more likely to use an effective method, such as hormonal contraception, were it available without a prescription [35]. Grossman et al. found in a larger survey of 2046 women that 62% were strongly or somewhat supportive of the availability of OTC oral contraception and 37% would probably use it [36]. There is no evidence that such availability poses a risk to most healthy women, and concern about potential unrecognized contraindications to combined hormonal contraception, such as venous thromboembolism risk, should be balanced with a higher such risk associated with pregnancy. Certainly, clinician involvement for counseling and risk assessment is ideal. Its absence may be one of the shortcomings of OTC hormonal contraception availability reported in studies outside the USA (Mexico, Kuwait, Thailand and Jamaica) [34].
The US FDA recently approved levonorgestrel emergency contraception for all women without a prescription, effectively eliminating the need for a visit with a medical provider and a pelvic examination [37]. Clinicians should counsel all reproductive-age women about the availability and safety of emergency contraception, as one in nine reproductive-age women have used it during 2006–2010 [38]. The WHO [39] and the CDC [40] state that there is no medical condition wherein the risk of emergency contraception outweighs its benefits. This statement pertains to levonorgestrel, combined oral contraceptive pills and copper intrauterine contraception (IUC). Ulipristal acetate is a newer selective progesterone receptor modulator available as prescription emergency contraception in Europe since 2009 and the USA since 2010, with approval for use up to 5 days after unprotected intercourse. Caution is advised in the use of this medication in patients with hepatic or renal impairment or uncontrolled asthma [41].
Long-acting reversible contraception (LARC) has gained popularity in the USA with IUC use increasing from 1.3% in 2002 to 5.5% in 2006–2008 [42]. In the contraceptive CHOICE project, over 67% of 2500 women chose LARC when access, financial and clinician barriers were removed [43]. Given its safety, efficacy and convenience, ACOG recommends offering LARC to all women including nulliparous women and adolescents [44,45]. The latter group especially may benefit given that 82% of pregnancies in women aged 15–19 years are unintended compared with 52% in all women [46]. Initiation of IUC clearly requires a pelvic examination. However, as long as pregnancy can be reliably excluded, a single visit for counseling, STI screening and IUC placement is adequate [44]. By contrast, contraceptive implant, (e.g., Nexplanon) may be placed following pregnancy exclusion and appropriate counseling without a prior pelvic examination. Similarly, while in the authors' opinion a pelvic examination may be helpful for instruction regarding the use of a vaginal ring (e.g., Nuvaring) and may be needed for cervical cap (e.g., FemCap) and diaphragm fitting, there is no pressing reason to perform a pelvic examination prior to initiation of a contraceptive injection (e.g., Depo-Provera) or patch (e.g., Ortho Evra). Eliminating the pelvic examination prior to initiation of most contraception removes a potential barrier to contraceptive use, as in Planned Parenthood's HOPE program [47].
There are a variety of sources for contraceptive information in the form of websites from organizations such as the CDC and Association of Reproductive Health Professionals, and mobile applications such as US Medical Eligibility Criteria for Contraceptive Use [48] intended for clinicians, and Mayo Clinic about Birth Control [49] intended for both clinicians and patients. Both are available at iTunes for download and provide comprehensive information to make a more informed choice regarding their options at their convenience and without a clinical visit. As more women and their partners use these resources, clinicians recognize the value of the electronic application to help individualize counseling to a more time-efficient and meaningful experience for the patient and to interface with the electronic health record [50]. Furthermore, contraceptive counseling lends itself to other approaches such as e-consultation in which a consulting clinician reviews patient records and renders an opinion without a face-to-face visit, as has been piloted in Canada [51] and is being used internally at Mayo Clinic. Telehealth interactions, wherein patient and healthcare provider connect via a web video system, are offered at some Planned Parenthood sites in the USA for birth control consultation [52].
Is there a role for the annual pelvic examination in asymptomatic healthy women?
There is no evidence for performing a pelvic examination in healthy asymptomatic women. However, the examination may provide an opportunity to ask gynecologic and sexual health questions that women may not otherwise feel comfortable raising. Additional symptoms may also be volunteered around the time of the examination. The healthcare provider may use the visit as a time to educate women about their normal anatomy, which may be particularly helpful in adolescent women and others with limited knowledge on this topic, and about signs and symptoms warranting additional evaluation.
Potential risks of performing a pelvic examination include patient discomfort and subsequent patient avoidance of future appropriate screening. Patient-reported reasons for not participating in a cervical cancer screening program in a Swedish survey study included past experience of discomfort with a pelvic exam [53]. A Dutch survey of nonattendees of cervical cancer screening programs found they associated feelings of anxiety, shame and insecurity with screening [54]. Fear of pain and embarrassment were identified as barriers to cervical cancer screening in a recently published survey study from Brazil [55]. A specific potential harm was illustrated by a study reporting higher rates of urinary tract infection in the 7 weeks after a routine pelvic examination with cervical cancer screening [56].
Another potential disservice of performing a pelvic examination in asymptomatic women is providing false reassurance to the provider and the patient regarding the absence of gynecologic malignancy. This was demonstrated by Padilla et al.'s studies in which even under the most seemingly ideal circumstance for accuracy (patients were under general anesthesia), the ability to identify ovarian masses was poor and identification of uterine size and contour was also limited [12,13]. Obesity, which is increasingly common, further impairs the usefulness of a bimanual examination. In a study of 151 women undergoing oophorectomy for various reasons, an examination under anesthesia was performed as was transvaginal ultrasound with subsequent comparison to ovarian dimensions of the surgical specimens. Ovaries were clinically detected in 55% of women weighing <200 pounds, but in only 9% of women weighing 200 pounds or more [57]. Pelvic examinations lack high sensitivity and specificity for detecting adnexal masses and were dropped from the PLCO trial because no ovarian cancers were found by bimanual examination. Even annual pelvic ultrasound and CA-125 screening did not improve outcome for ovarian cancer mortality as illustrated in the PLCO trial, but false-positive results did lead to harms including unnecessary surgery [58].
In our opinion, while many women dislike pelvic examinations, providers may also avoid performing the examination. This may stem from their personal discomfort preforming the examination due to time pressures, lack of expertise, personal feelings, or trying to limit patient discomfort. Provider confidence in performing an examination may impact a woman's experience during a pelvic examination. As the frequency of cervical cancer screening decreases and the value of pelvic examinations are challenged, provider skills may wane.
Findings on pelvic examination may lead to further testing that does not impact morbidity or mortality. A Cochrane review of the benefits and harms of general health checks (i.e., preventive health or annual health examinations) found no reduction in total mortality or specifically for cancer or cardiovascular associated mortality for women or men [59]. Finally, in an increasingly resource-sensitive healthcare environment, time taken for a pelvic examination could be spent on preventive health issues or patient counseling.
Pelvic examination for symptom-based assessment
While the utility of a pelvic examination for screening is unproven, we recognize and support the importance of a pelvic examination for the evaluation of gynecologic, urinary and some gastrointestinal symptoms. Identification of symptoms that warrant evaluation with pelvic examination becomes much more important in the absence of routine examinations.
Vaginal discharge and pruritus are very common symptoms that are often self-managed by patients or managed over the phone by providers. Unfortunately, self-diagnosis of vulvovaginal candidiasis by women is often incorrect as demonstrated by Ferris et al. [60]. Only 33.7% of women in the study correctly self-diagnosed vulvovaginal candidiasis, while 18.9% actually had bacterial vaginosis, 21.1% had mixed vaginitis, 13.7% had no infection, 10.5% other diagnoses and 2.1% had trichomonas [60]. Especially in postmenopausal women in whom both vulvar cancer and lichen sclerosis are more common and vulvovaginal candidiasis is much less common, a pelvic examination is necessary in the evaluation of vulvar itching. At times women have received medical care often without pelvic examination for a year prior to biopsy and referral for vulvar cancer [61].
Vulvovaginal atrophy (VVA) affects approximately 50% of postmenopausal women and may cause vaginal dryness, irritation and dyspareunia, as well as urinary symptoms such as urinary frequency or urgency and recurrent urinary tract infections [62]. A recent online survey of 3046 postmenopausal women with VVA symptoms found barriers to treatment included low knowledge levels (only 24% surveyed recognized menopause as a cause of VVA), safety concerns about and perceived inconvenience of treatment. Only 56% of women reported ever discussing VVA concerns with a clinician, and in only 13% of that group did the clinician begin the conversation [63].
Vandborg et al. found that the presence of one or more alarm symptoms or warning signs (vaginal bleeding, abdominal swelling and lower abdominal pain) identified at presentation shortened the time to gynecologic cancer diagnosis. A pelvic examination by the primary clinician also shortened the time to diagnosis. Endometrial cancer was found to have the shortest time from initiation of symptoms to diagnosis with patients calling promptly about vaginal bleeding and general practitioners performing pelvic examinations more quickly with resultant faster referral for definitive diagnosis and treatment. Vulvar cancer had the longest time from initiation of symptoms to diagnosis. Potentially, women are less likely to identify the presenting symptoms of vulvar cancer as concerning and when they do present, the time to pelvic examination is longer [64].
Endometriosis is a common concern in reproductive-age women. Using symptoms alone, reporting any one of moderate-to-severe dysmenorrhea, pelvic pain, dyspareunia or infertility resulted in a 56% positive predictive value and a 78% negative predictive value for the definitive diagnosis of endometriosis. As a single symptom, dysmenorrhea was more likely to be associated with an endometriosis diagnosis at laparoscopy with infertility least likely [65]. Chapron et al. found that in women with symptomatic endometriosis confirmed by biopsy, 14.4% had an endometriotic lesion noted on speculum examination and 43.1% had a classical painful nodule to palpation [66]. In women presenting for laparoscopy for pelvic pain or infertility, focal tenderness on examination gave a positive predictive value of 64% with focal tenderness at the uterosacral ligament or cul de sac giving an 83% positive predictive value [65]. In comparison, only 3% of asymptomatic women undergoing laparoscopic sterilization were incidentally found to have endometriosis [67].
Pelvic organ prolapse may be associated with vaginal symptoms such as pressure or protrusion, urinary symptoms such as frequency, incontinence or urgency, and gastrointestinal symptoms such as incomplete evacuation requiring splinting, urgency or incontinence. Pelvic examination allows for grading with the Pelvic Organ Prolapse Quantitation system and determination of appropriate intervention [68].
Urinary and gastrointestinal symptoms are common, nonspecific and often benign, but may be indicative of ovarian malignancy. A retrospective study of 1725 women with ovarian cancer found that 95% had symptoms 3–6 months prior to diagnosis and the most common symptoms included abdominal symptoms such as increased girth, bloating and pain and urinary symptoms including frequency and incontinence [69]. In a smaller review of 107 women with ovarian cancer, abdominal pain and urinary symptoms were the most common symptoms in women with stage I and stage II cancer. In women with stage III or IV ovarian cancer, abdominal pain and increased abdominal girth/bloating were the most frequent symptoms [70]. In efforts to improve the early detection of epithelial ovarian cancer, Goff et al. identified an association of pelvic/abdominal pain, increased abdominal size/bloating, and difficulty eating/feeling full with ovarian cancer if the symptoms were present 12 or more days per month for less than a year [71].
Symptoms that warrant pelvic examination.
Vulvlir
– Ulcer
– Dermatitistis
– Mass
– Pruritus
– Dryness
– Vulvodynia
Vaginlil
– Discharge
– Odor
– Dryness
– Mass
– Bleeding
– Bulge or protrusion
– Fullness
– Pain
– Dyspareunia
Abnormal uterine bleeding
Absent
Infrequent
Heavy
Prolonged
Frequent
Postcoital
Intermenstrual
Postmenopausal
Pelvic pain
Dyspareunia
Dysmenorrhea
Urinary urgency
Frequency
Retention
Dysuria
Hematuria
Stress or urge incontinence
Abdominal bloating
Abdominal distention
Lower abdominal pain
Early satiety
Bowel changlis
– New onset constipation or diarrhea
– Sensation of incomplete evacuation
Pelvic examination for cancer surveillance in high-risk women
Women with a personal history of vulvar, vaginal, cervical, ovarian or endometrial cancer require ongoing review of systems and pelvic examinations as per expert opinion guidelines from the Society of Gynecologic Oncologists [72]. The combination of speculum, bimanual and rectovaginal examination has a recurrence detection rate of 35–68% for endometrial cancer, 15–78% for ovarian cancer and 29–75% for cervical cancer [72]. Women with a history of ovarian or endometrial cancer treated with total hysterectomy do not need vaginal cytology screening as this is not beneficial for detecting recurrence; vaginal cytology is advised for surveillance in women with cervical cancer although physical examination has higher detection rates even in that group of women [2,72]. Breast cancer surveillance guidelines from the American Society of Clinical Oncology include the expert opinion recommendation for a regular pelvic examination in women with an intact uterus and ovaries as part of an annual general physical examination, not specific to breast cancer surveillance apart from encouraging patients on tamoxifen to report vaginal bleeding [73]. Cervical cancer screening in these women still follows national guidelines as stated earlier.
Ovarian cancer risk is increased in women with BRCA1 and -2 mutations by 27–45 and 10–20%, respectively. Preventive options are limited to chemoprevention with combined oral contraceptive pills and surgical therapy. BRCA carriers are encouraged to complete childbearing before considering prophylactic surgery for prevention of ovarian cancer [74]. The evidence is poor for support of surveillance as a strategy for ovarian cancer mortality reduction in this population. Despite that fact, periodic CA-125 blood testing and transvaginal ultrasound is advised by ACOG starting at age 30–35 years or 5–10 years prior to the onset of ovarian cancer diagnosis in a family member [75] with intervals of 6–12 months proposed by a task force of the Cancer Genetics Studies Consortium [76]. Risk-reducing salpingo-oophorectomy was reported by Domchek et al. to decrease not only the risk of ovarian cancer and mortality due to ovarian cancer, but also to reduce risk of a first diagnosis of breast cancer and breast cancer mortality [77]. It is generally recommend that BRCA1 carriers be referred to a gynecologic oncologist or surgeon around age 35 years and BRCA2 carriers around age 40 years to discuss the role of prophylactic salpingo-oophorectomy [78]. Rosenthal et al. evaluated the consequences of delayed screening intervals and surgery in women with genetic conditions, placing them at high risk for ovarian cancer that did not elect a risk reducing bilateral salpingo-oophorectomy. The study supported a more frequent than annual surveillance regimen to improve early detection [79]. However, there is no evidence that a pelvic examination adds a decreased mortality benefit in these situations and the most recent National Comprehensive Cancer Network guidelines on managing patients with hereditary breast and/or ovarian cancer syndrome do not call for pelvic examinations [80].
Hereditary nonpolyposis colorectal cancer (Lynch syndrome) is associated with an increased risk of endometrial and ovarian cancer. Expert opinion recommendations from Germany [81] and the USA [82] advise annual pelvic examination along with endometrial sampling and transvaginal ultrasound for screening of identified high-risk women, while recognizing the insufficiency of the evidence for this practice.
A history of in utero diethylstilbestrol exposure is an indication for a yearly pelvic examination as well as cervical and vaginal cytology screening in the opinion of the National Cancer Institute at the NIH because of an increased risk of clear cell adenocarcinoma of the vagina and cervix [83]. Other experts support this recommendation but acknowledge the limitations of cytology for clear cell adenocarcinoma screening and encourage adequate visualization of the cervix and vagina to assess for gross lesions and bimanual and rectovaginal examination to assess for nodules or ridges that may require biopsy [84].
In our opinion, it is important to note that the potential harms of performing a pelvic examination remain regardless of risk status.
Box 2 includes a list of high-risk conditions in which annual pelvic examination may be recommended.
Guidelines & opinions from the USA
While several groups in the USA including American Cancer Society, ACOG, USPSTF, and American Society for Colposcopy and Cervical Pathology published cervical cancer screening updates in 2012 and 2013, these guidelines did not address the question of pelvic examinations [1–3,10]. In a 2012 publication addressing ovarian cancer screening, USPSTF stated that no randomized trial has assessed the role of bimanual pelvic examination for cancer screening [16]. In August of 2012, ACOG published a committee opinion on the well-woman visit in which they recommended an annual pelvic examination for all women 21 years or older while acknowledging that “no evidence supports or refutes” this recommendation. They suggested a shared decision-making approach for performing a pelvic examination in an asymptomatic woman [4].
High-risk conditions in which pelvic examination may be recommended.
History of gynecologic malignancies: vulvar, vaginal, cervical, ovarian or endometrial
History of genetic conditions: hereditary nonpolyposis colorectal cancer (Lynch syndrome)
History of in utero diethylstilbestrol exposure
A recent survey of beliefs and practices of USA family medicine, internal medicine and obstetrics and gynecology providers reported persistent beliefs of the usefulness of pelvic examinations for ovarian cancer screening and as a prerequisite for hormonal contraception [14]. To assess beliefs and practices of obstetrician-gynecologists, a survey used clinical vignettes involving asymptomatic patients aged 18–70 years. The vast majority of providers would perform bimanual pelvic examinations in all age groups for detection of ovarian cancer or benign conditions [15]. Additional analysis of this same group revealed that three-quarters of the 521 obstetrician-gynecologists responding to the survey felt that extending gynecologic examinations from annually to every 3 years would result in decreased patient health and well-being, patient satisfaction, and procurement of contraception [85]. The need to educate clinicians about the limited utility of the pelvic examination as a screening tool for ovarian cancer or as a prerequisite for contraception initiation is evident. There have been several publications questioning the need for annual or routine pelvic examinations. Westhoff et al. conclude that pelvic examinations are not needed for STI screening or hormonal contraception initiation and are not useful to screen for ovarian cancer. They rightly point out that limited healthcare resources may be more wisely spent elsewhere and propose elimination of bimanual examination for asymptomatic women [86]. A similar argument questioning the value of pelvic examination for asymptomatic women was made by Kauffman et al. in 2013 and included a call for systematic study of the pros and cons of pelvic examination in asymptomatic women to guide medical practice [87].
Another viewpoint was espoused by Bump in a recent editorial. He noted that using a pelvic examination as only a means of evaluating the cervix for cancer screening wastes the opportunity to assess other conditions that impact a woman's wellbeing. Identifying pelvic organ prolapse in an earlier state that is amenable to nonsurgical intervention was offered as an example. Additionally, he felt that examination findings lead to focused questions about symptoms that may not have been volunteered otherwise [88].
Notably, a recent systematic review by the Evidence-based Synthesis Program of the Health Services Research and Development service of the US Department of Veteran Affairs concluded that the only evidence-supported aspect of a screening pelvic examination in an average-risk asymptomatic woman is cervical cancer screening [89].
Guidelines & opinions from around the world
Similar to the USA, there are no specific international guidelines regarding pelvic examinations in asymptomatic women. Recently updated cervical cancer screening recommendations from the Canadian Task Force on Preventive Care did not address pelvic examinations [90]. Physician opinion regarding routine pelvic examinations varies by country, and probably by region. In some European countries, including Great Britain, the Netherlands, and Sweden, the pelvic examination is not considered necessary for contraception provision [91]. Although a literature review published in Australia counseled against routine pelvic examinations [92], clinicians interviewed still performed a pelvic examination in asymptomatic women for patient reassurance, documentation of a normal examination, concern regarding potential legal consequences and tradition. Furthermore, most of the physicians who participated in this study indicated they were unlikely to change their practice despite evidence regarding the lack of utility of the pelvic examination as a screening tool [93]. This study also highlights the challenge for clinician education and for implementing any change in current practice.
Conclusion
In our opinion, healthcare providers and patients should be familiar with gynecologic, urinary and gastro intestinal symptoms that may warrant further evaluation including a pelvic examination. Providers should identify, educate and counsel women in higher risk groups about the limited benefit of an annual pelvic examination for gynecologic cancer recurrence detection and review expert opinion guidelines for those with a history of gynecologic malignancy, genetic mutation or in utero diethylstilbestrol exposure. There are no evidence-based recommendations for these high-risk women to our knowledge. In addition, there is no evidence that an annual routine pelvic examination in healthy asymptomatic women at average risk is of value. In fact, it may result in further testing causing anxiety without clear patient benefit. With the wider focus on shared decision-making in medicine, discussion with women regarding the lack of evidence for benefit and the potential harm of routine pelvic examinations is appropriate. Even so, we propose that pelvic examination could be performed along with cervical cancer screening every 3–5 years in asymptomatic average risk women ages 21–65 years as an opportunity to elicit gynecologic and sexual health concerns from patients and to provide education. We recognize that patient concerns may be discussed without an examination but in our opinion and clinical experience, the examination process provides an opportunity for further discussion. In addition, our recommendation represents a compromise between complete discontinuation versus ongoing annual pelvic examinations that allows for an evolutionary practice change. Women over the age of 65 years who are low risk for cervical cancer with adequate history of negative past screening should discontinue cervical cancer screening. We suggest a symptom-based approach to pelvic examination for those women. Routine pelvic examinations should be deferred but education about and review of gynecologic warning signs and symptoms should not be abandoned. We prefer to redirect, not neglect, in our approach to the pelvic examination.
Future perspective
Changes in cervical cancer screening guidelines could potentially alter our proposal to consider combining pelvic examinations with cervical cancer screening in asymptomatic average-risk women. We anticipate that USA cervical cancer screening recommendations may eventually start later than 21 years of age consistent with international practices including those in Canada, England and Norway where screening begins at age 25 years [90,94,95], and in Finland and The Netherlands where screening begins at age 30 years [6,96]. Future cervical cancer screening guidelines may incorporate HPV vaccination history into their recommendations, although in the opinion of the American Cancer Society and American Society for Colposcopy and Cervical Pathology there is inadequate evidence to incorporate vaccine history into the starting age for screening at this time [1]. An HPV-based, compared with cytology-based, cervical cancer screening approach was shown to reduce invasive cervical cancer by 60–70% in a recent study combining data from four European randomized trials [97]. In March of 2014, an advisory committee of the FDA voted that the use of Roche's cobas high-risk HPV test as a primary screen for cervical cancer is “safe and effective” [98]. In our opinion, future FDA approval is likely and may simplify screening and management recommendations, but is unlikely to change testing intervals.
Randomized controlled trials to assess the risks and benefits of routine pelvic examinations in asymptomatic women would be helpful in providing evidence-based practice guidelines. However, as proposed by the Health Services Research and Development work group, the most helpful research may be that directed towards methods to reduce unnecessary pelvic examinations [89]. Furthermore, if examinations are otherwise to be tied to symptoms, development of complete but efficient means of determining that a woman is asymptomatic is needed. This may include age-based focused symptom screening that is delivered electronically, or assessed at a well-woman visit.
Executive summary
Routine pelvic examination is not useful for uterine or ovarian cancer screening.
Sexually transmitted infection screening does not require a pelvic examination.
Pelvic examination is not necessary to provide hormonal contraception.
Harms outweigh benefits of performing routine annual pelvic examination in asymptomatic low-risk women based on available evidence.
Pelvic examination is appropriate for symptom-based assessment.
Patients with a history of gynecologic malignancies, genetic mutations or in utero diethylstilbestrol exposure may be advised to have an annual pelvic examination based on expert opinion but evidence-based guidelines are lacking.
Consider patient visit with examination for cervical cancer screening at 3-5-year intervals as an opportunity to elicit gynecologic and sexual health questions from patients and to provide patient education.
Future studies are called for to further evaluate risks and benefits of routine pelvic examination and to develop interventions to decrease unnecessary examinations.
Acknowledgements
The authors thank K Simmons (Academic/Research Support, Mayo Clinic) for assistance with formatting Table 1 and Box 1.
Financial & competing interests disclosure
ME Long and PM Casey are certified Nexplanon trainers and receive research grant support from Merck (unrelated to this paper). The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.
No writing assistance was utilized in the production of this manuscript.
Open Access
This work is licensed under the Creative Commons Attribution-NonCommercial 3.0 Unported License. To view a copy of this license, visit http://creativecommons.org/licenses/by-nc-nd/3.0
