Screening Pelvic Examinations in Asymptomatic 

Average Risk Adult Women Evidence-based Synthesis Program

9 41 CONTENTS 34

APPENDIX A. SEARCH STRATEGIES

Database: Ovid MEDLINE(R) <1946 to July 2013>

Search Strategy:

--------------------------------------------------------------------------------

1 (pelvic exam$ or gynaecol$ exam$).mp. or exp Gynecological Examination/ 

2 pelvi$.mp. or exp Pelvis/ 

3 palpation.mp. or exp Palpation/ 

4 or/1-3 

5 women$ health.mp. or exp Women’s Health/ 

6 exp Female/ 

7 5 or 6 

8 (asymptom$ or routin$ or screen$ or mandat$).mp. or exp Mass Screening/ 

9 4 and 7 and 8 

10 ovar$ cancer.mp. or exp Ovarian Neoplasms/ 

11 exp Uterine Cervical Neoplasms/ or uter$ cancer.mp.

12 adnexa uteri.mp. or exp Adnexa Uteri/ 

13 vagin$ smear$.mp.

14 vagin$ disease$.mp. or exp Vaginal Diseases/ 

15 contracept$.mp. or exp Contraception/ 

16 contraceptives.mp. or exp Contraceptive Agents/ 

17 chlamydia.mp. or exp Chlamydia Infections/ or exp Chlamydia/

18 std.mp. or exp Sexually Transmitted Diseases/ 

19 or/10-18 

20 9 and 19

21 limit 20 to English language 

22 limit 21 to humans 

23 case report.mp. or exp Case Reports/ 

24 case series.mp. 

25 23 or 24 

26 22 not 25 

27 prostate.mp. or exp Prostate/

28 26 not 27
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R REVIEW COMMENTS AND AUTHOR RESPONSES

RESPONSE

nd methods for this review clearly described? 

None required (NR)

work seems somewhat atypical since KQ1 often pertains to the most 

t (indicated by KQ2 in the current plan).

NR

methods are clearly described. I do have two minor comments that 

ves:

mary, there can be a “Bottom Line” statement right after the 

able to quickly surmise the clinical implications of the review

 be helpful to highlight that the review seeks to assess the accuracy 

than cervical cancer.

Thank you. The suggestions have been incorporated in the final version of the review.

ell described. NR

NR

cribed and complete. (Minor point: For KQ3 reword as “Harms from 

rforming exam) 

 of bias or quality of studies for KQs other than KQ1 are not given, 

ity levels are included (more on this below). Some presentation of the 

y for all key questions should be included.

The studies were primarily survey studies. There is no established method for evaluating the quality of survey studies so we identified key elements of survey research and report on whether the included studies addressed those key elements. More detail is provided in the Methods section.

s in our synthesis of the evidence? 

NRNR

owever, in the review of the potential psychological harms associated 

e that the studies could not be pooled but then report median values 

 they obtained these median values.

The median is a descriptive statistic – the middle value of the values reported for a particular outcome. For example, 7 studies reported percentage endorsing fear etc. The middle value of those 7 percentages was 34%. NRNR

uthor bias in the synthesis, the report does in places draw 

a high risk of bias. In some cases, it seems more correct to say that 

raw a conclusion rather than making a statement of findings. For 

ce and pelvic exam experiences, one study from 1973 with an n=163 

ents seeing black providers experience more pain and discomfort 

 I would hesitate to even hint at this with the evidence from that Paper 

clinic and patients saw a limited number of providers – even if 20 

half of these were black and half were white (I suspect it was far less), 

peak to the examination practices of very few practitioners (trained 

culums from 40 years ago). That the results can be generalized at 

of patients by provider probably was not accounted for, and that 

s of women in the current era seems highly unlikely. (I recommend 

w as not relevant.) 
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RESPONSE

efit from more careful accounting of the merits of the evidence from 

mmary of the strength of the evidence for conclusions drawn. A 

gth of evidence and conclusions for each KQ would be helpful. 

a used to exclude studies? For example – one included study for 

nd has an n=40 and no response rate reported. This seems no 

 is included. In fact, this study serves as the high end of the range of 

– a misleading range perhaps.

d survey of 74 women with no response rate reported that has 

neralizable accurate estimates

Thank you. The suggestions have been incorporated in the final version of the review. Specifically, we have provided an assessment of the quality of the survey studies (as noted above). We did not exclude studies based on study quality.

published studies that we may have overlooked?

NR

dies from the 1970s included pelvic exams and may be useful. Thank you for the suggestion.

n comprehensive. NR

NR

bout receipt of clinical preventive services, including Pap smears, by 

5. doi: 10.1016/j.ypmed.2012.02.010. Epub 2012 Feb 25. Prospective dex and receipt of preventive services: results from the Central 

dy (CePAWHS). Kraschnewski JL, McCall-Hosenfeld JS, Weisman 

465-72. doi: 10.1016/j.amepre.2011.07.020. Preventive care in 

large, national survey. Littman AJ, Koepsell TD, Forsberg CW, Boyko 

p;18(9):1827-35. doi: 10.1038/oby.2010.40. Epub 2010 Mar 4. 

entive services in veterans. Yancy WS Jr, McDuffie JR, Stechuchak 

ger LS, Datta SK, Fisher DA, Krause KM, Østbye T.

Thank you for the suggested references. We reviewed all these articles and they did not meet inclusion criteria.

not overlooked, but gives some additional information that might be 

vider concerns about extended gynecologic screening intervals. 

d Gorin S, Schulkin JA. Challenges in cervical cancer prevention: 

cologists. Am J Prev Med. 2013 Aug;45(2):175-81. doi: 10.1016/j.

Included

ggestions or comments below. If applicable, please indicate the page and line numbers from the draft report.

nts or corrections. Thank you.

al is to page and paragraph.

ents in the Henderson survey reported bimanual exams as being 

ntify benign ovarian processes (eg, cysts). From a clinical perspective, 

id subsequent ovarian torsion (a surgical emergency); this reasoning 

the 2011 Stormo article but is not specifically stated in the current 

st describe benign lesions specifically as an “other gynecologic 

ncer, the second paragraph (“There are likely...”) This paragraph is 

 in the benefits section. 
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RESPONSE

P acronym.

s incorrect. The addition of CA-125 seems to increase the PPV of 

efined as both a positive pelvic exam and a positive CA-125, the PPV 

oman with a positive pelvic exam and a positive CA-125 was the one 

 cancer. The confidence limit is certainly wide. 

S (Smith, 2011, mid-page) perhaps should be “asymptomatic ovarian 

screening for BV is not articulated in the document. Is it to prompt 

mall-case “k” is used where traditionally an “n” is used to denote 

mber of studies). This is confusing. 

Here, a study is described as “the Schmittdiel study” but the 

lsewhere (instead referring to studies by parenthetical reference and 

e). 

OG is “College” (page 31) and other times “Congress” (page 6)

hat cervical cancer screening has limited provision of contraception; 

 72 (2005) 179– 181). 

well woman exams also articulates reasons for doing the exam: 

actors, patient expectations, or medical–legal concerns may influence 

pelvic examination or clinical breast examination.” Consider citing this 

tewart. 

aph, last line. As indicated earlier, the Buys study included BME but no 

ose found by U/S or CA-125 (so dropped). By extension, the results 

on no effect of BME on ovarian cancer mortality. 

ntences of the first and third paragraphs are nearly identical. 

o sentences are important (and likely true) but seem out of scope for 

em to making judgments about the adequacy of evidence about both 

lvic exams, although the report states a striking lack of any evidence 

er suggest that the net benefit is zero or in the direction of harm, 

e change. This is all (very) likely true, but seems to be a conclusion 

ort should make. 

Thank you. These suggestions have been incorporated in the final version. Specifically, suggested references have been reviewed and included if relevant to the scope of the review. We have corrected the typographical errors and verified any confusing statements in the review.

sarily repetitive. I wonder if the final summary by question. I thought 

cinctly summarized the findings already discussed in the main body.

ment to inform their screening practices for both Chlamydia and 

r if it would be worthwhile to highlight in the executive summary 

men < 21 years regardless of sexual activity and that Chlamydia 

ll sexually active women <25 – especially since these practices are 

even be included since most experts do not even recommend treating 

men (treatment in pregnant women, I believe, is controversial – a 

 If it is included, perhaps a discussion of the harms of detection 

nt does not lead to improved outcomes, and may be associated with 

on (harms related to overdiagnosis or overtreatment). The authors 

y but I think this should be discussed earlier on. 
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cumented harms (or benefits), I think that KQ 2 and 3 could be 

rms and benefits. Then KQ3a could just be the 3rd main question. 

dits to the conceptual/analytic framework.

worth mentioning that pelvic exams can also reduce likelihood for 

ch do have proven benefit.

graph of the evidence report introduction in the executive summary 

ssed all impact initial screening, not harms associated with screening. 

ated – essentially that studies do not really assess association 

harms of screening but rather focus on likelihood of undergoing 

garding detection belong under question 1 (accuracy of diagnosis) 

ithin the main text, not the summary section. 

Thank you. The suggestions have been incorporated in the final version of the review. Specifically, we have attempted to reduce the repetitiveness. for Item #3, we decided to include BV for completeness. For item #4, we considered this suggestion but decided to follow the original plan. We agreed with the suggestions in items 6 and 7 and have made changes to the review.

 review and will be very important clinically. Please see comments 

efully as I know it is likely to be published and may guide guideline 

c. 

e logic better that if TVUS has not been shown to be beneficial, given 

 (if this is true—I believe it is but maybe no data) that it is highly 

ss specific test would be beneficial.

son for separating harms as done in KQ 2 and 3. Also, I suggest you ms in KQ2 and 3 so it is easier to follow

egative”?

ess, deferral of care, avoidance of care are also harms.

”? 

d”? Did any studies compare pelvic exam to transvaginal us? What 

V pertains to diagnosing ovarian cancer. 

r dx BV

 dx accuracy” one of the topics of the review? 

bute to the statement “screening ....lead to unnecc...surger 1.5%”

ning trials? 24-33—During topic development, I recall that one of 

r review/editorial dealing with this topic was that the exam has been 

g birth control. Did you find evidence about this? Also, reduced Pap 

ding/harm. What was the effect size? 

amer soc of clin path listed? 

Thank you. We have incorporated many of these suggestions in the final review (one exception- we kept the 2 harms section separate.PLCO is discussed in the discussion section; we changed the language to make sure it was clear that PPV pertains to diagnosis of ovarian cancer. We identified only 1 study that compared the pelvic exam to TVUS in asymptomatic women. This study concluded that about 20% of pelvic examinations differed from TVUS findings.We clarified that the gold standard for diagnosis of BV is the Amsel criteria.We clarified that there are no screening trials of pelvic examInformation about deterring women from further healthcare Is included in text - too complicated for the executive summaryWe have modified the statement about systematic review quality in the body of the report and in the executive summary. We did not assess the quality of the existing systematic reviews.Regarding use of a biopsy as a gold standard: We stand by our 

selection of biopsy as the “gold standard” for cancer detection whereby the diagnostic accuracy of the pelvic examination should be measured. This is consistent with the assessment of other cancer screening tests such as the digital rectal examination for prostate cancer and mammography for breast cancer. We understand that no studies have
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RESPONSE

? 

u are defining gold standard. I have never seen biopsy considered 

creening test. The gold standard in screening typically is: follow-up 

s case ? TVUS) or perhaps surgery that looks at both ovaries in this 

aring the pelvic exam to TVUS? Sure would be easy to do this if it 

s????

n provide any data on what happens to the women with no pelvic 

xt years of fu? How many of these pts develop ovarian cancer? I am 

is

 asymptomatic, non-preg women? 

urance in this section on harms would be good. I am sure there are 

emains (and is plausible)

his section differs from harms in KQ2. Also, keep same order as in 

en’t lines 10-12 results?

 of the inclusion of the pelvic exam??? 

uate likelihood of return visits based on embarrassment/fear of the 

assuming it is the “n”

that because overwt women have less intention to get an exam there 

er? Can you connect this with your review? I don’t see this as a 

s the point that you are making that because disabled people are as 

e is no difference in how they perceive the exam? I am not sure of 

here a little more clearly?

been designed to accurately assess the diagnostic accuracy of the pelvic examination against a biopsy gold standard. None of the studies have biopsied a representative cohort of women regardless of pelvic examination findings; nor have they followed women for a sufficient period of time to determine if interval cancers plausibly missed by a pelvic examination but present at that time arise. Thus the negative predictive value and the false and true negative value of the pelvic examination is not known. We also do not believe that other screening tests, such as TVUS, or CA-125 should be used as a gold standard because similar issues arise. No studies have biopsied women with normal TVUS or CA-125 results. The screening trial while, while providing sufficient follow-up to assess for development of ovarian cancer and ovarian cancer death is unlikely to provide sufficient information to allow these studies to be considered “gold standard”. At 

best we could make some comments on the operating characteristics of pelvic examination versus other tests sometimes used to assess for 

ovarian cancer.In the ovarian cancer studies, patients were followed for 1 year.There is some uncertainty around the value of identifying BV so we decided to leave it in the report.We have clarified the harms sections.We have added information on the likelihood of return visits.“k” is used to indicate the number of studies; “n” indicates the number of patientsWe have removed this comment.We have removed this paragraph.We have modified the text to clarify these statements.
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sion in the more conventional/article type format would be better. 

 think you would do it with bullet points or a separate section titled 

e you are just repeating the results. I know this is going to be 

s is a really important part of the document. Also, somewhere, I would 

xam and opportunity costs. Also, I think more discussion of absence 

gain, where is the avoiding the exam, missing birth control stuff that 

rranted. I think an article such as this will get lots of attention so 

 discussion will be good. 

alities such as....

pport the statement that the sensitivity and specificity of the exam are 

my fund of knowledge but am interested in where they get this data. I 

ed on your review of not finding this info.

e first is as mentioned above, I think you can develop the logic much 

work that it is highly unlikely that the pelvic exam would work. The 

ut sensitivity. Was there no info on sensitivity and spec from PLCO?

he best of our knowledge, this is the first systematic review to include 

.....” 

The discussion was re-written and now includes a section on costs.This is correct.One screening study is still underway. From PLCO there was no information for pelvic exam, only for TVUS and CA-125.We have modified this sentence.

e name of the nominating office to “the VHA National Center for 

vention”

eviations for American Society for Clinical Pathology and American 

al Pathology should be, respectively, ASCP and ASCCP. 

uld include reference for USPSTF recommendation

r noting that the pelvic examination for cervical cancer screening 

 portion of the exam; inspection of the external genitalia and the 

ot indicated for cervical cancer screening. 

o Centers (for Disease Control and Prevention)

Thank you. All these comments are addressed in the final version.
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 the evidence for routine pelvic examination is well scoped and 

ack more than 60 years. The authors have included important 

2, the suggestion that “fear of the exam” seems a bit overstated 

ps it is better to say simply that discomfort with the internal 

ce. As currently written, the introduction reads as though the 

assumptions going into the evidence review. Alternatively, consider 

omen might avoid health care because of the pelvic exam.

omatic women and the outcomes of pelvic examination could be 

, as it is important evidence of “yield” from routine assessment above 

with swab and urine samples.

hould be given to the decision to drop the pelvic examination arm 

ad the discussion of the results on page 32 (line 27). The information 

what buried, when it can be read as strong evidence that the pelvic 

with respect to this outcome. Even the ultrasound and CA125 arms 

e and specific for detecting ovarian cancer, and pelvic examination 

much so that it was dropped from the trial. Instead of discussing this 

ate that the guidelines of professional organizations were made 

ct, the evidence of no benefit from the PLCO trial drives many of 

on my own research, screening for ovarian cancer is a main reason 

 – since this is such a strong motivation for screening, a more 

rials should be given. 

d Sensitivity of PE for BV, it would be helpful to point out in the 

(69%) means pragmatically – relative to other screening tests, does 

 values (especially when considering they are based on a population 

c).

s the importance of age and parity for women’s experiences of the 

cuss possible life stage differences in pelvic exam experiences 

ou consider. Is more discussion, for example, of adolescents’ 

ossible?

er gender preference data reviewed is relevant to the KQs as scoped. 

ght make sense in the discussion on improving the pelvic examination 

harms or benefits data related to provider gender, I do not think it does 

or points:

or the BRFSS Survey online – it is listed as NR in your table (Watson

he ages at which yearly screening is recommended to highlight the 

 this issue. 

primary studies rather than the Westhoff article – hers is a very 

nce you are conducting an SER, it should be founded in original 

hat you say one study but then cite 2 studies. Where the estimates 

 is a direct quote from our Paper – you can probably remove the 

uanced conclusions. 

Thank you. We have modified the introduction and discussion sections as noted.We have clarified the information about the sensitivity and specificity of PE for BV.We have added information about age to the discussion although the focus of our literature search was on adult women so we can only comment on studies that stratified outcome reporting by age.We have removed the provider gender preference data as suggested.For the BRFSS Survey data, the response rates varied by state as noted in Watson-Johnson 2012. We calculated a weighted average response rate for the 11 states and 1 territory administering the SV module: 52.2%. However, since the analysis in the Watson-Johnson Paper is based on 88.2% of respondents and we focus on the women respondents, an exact response rate cannot be determined. We have added ages at which yearly screening is recommended.Thank you. We have modified the statement that was in quotes..
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and Clark C, BJOG 1992;99:329-332, Benign ovarian cysts in 

 This international comparison provides indirect evidence that 

he U.S. lead to an increased rate of surgery for asymptomatic ovarian 

downstaging of ovarian cancer diagnosis). Possibly relevant as a 

Thank you for the suggested reference. We have added this reference to the report.

dations on how this report can be revised to more directly address or assist implementation needs. applies to bimanual exam, not Paps

ments/addendum.

e of the clinical communication challenges that could emerge – our 

believe many of their patients expect the exam and are reassured 

especially for women who have become accustomed to the usual 

nce, tools, and support to communicate the reasons for a major 

patients may feel underserved, and clinicians may not adopt new 

ptions it could breed. Perhaps the report should acknowledge the 

s well as the need for research in this area. There are also important 

e delivery patterns with a change in the annual gynecologic exam 

sarily see ob/gyns as frequently.

lvic examination experience seems a little out of place in its current 

side of the scope of the review, but if to be included, it might go into a 

 discussion – not in the section discussing implications of the review 

Thank you. We incorporated these suggestions in the final version.The paragraph on improving the pelvic examination experience has been omitted.
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STF RECOMMENDATIONS FOR SCREENING FOR SEXUALLY TRANSMIT

N WOMEN

ulation Recommendation Timing of Intervention Method of Screening Gradeb

-pregnant women age 

en at increased risk

Perform Screening Not specified NAAT A

e ≤ 24 and older 

ncreased risk

Perform screening First prenatal visit NAAT B

hether or not they are 

 increased risk

Do not perform screening C

en (pregnant and non

ed risk Perform screening Pregnant: First prenatal visit and, if applicable, during third trimester

Non-pregnant: Not specified

Vaginal culture ORNAAT ORNucleic acid hybridization testing

B

Do not perform screening D

t at increased risk Insufficient evidence for or 

against screening

I

tic population Do not perform screening D

Perform screening First prenatal visit HBsAg testing A

nant women Do not perform screening D

scents and adults Do not perform screening D

 years; younger and 

ased risk

Perform screening One time screening of all persons 

and possibly annually (highest risk) or every 3-5 years (increased risk)

Repeatedly reactive immunoassay followed by Western blot or immunofluorescent assayOR rapid testing followed by conventional testing

A

cluding those who 

 are untreated and 

 unknown

Perform screening During pregnancy, including women 

who present in labor 

Repeatedly reactive immunoassay followed by Western blot or immunofluorescent assayOR rapid testing followed by conventional testing

A

d risk Perform Screening Not specified VDRL or RPR followed by

FTA-ABS or TP-PA

A

Perform Screening During Pregnancy VDRL or RPR followed by

FTA-ABS or TP-PA

A

ased risk Do not perform screening D

e time of publication, many of these recommendations are being updated; bGrade of USPSTF recommendation

vices Task Force; NAAT = nucleic acid amplification testing; VDRL =venereal disease research laboratory; FTA-ABS = fluorescent treponemal antibody absorption 

e agglutination assay; RPR = rapid plasma regain; HBsAg = Hepatitis B surface antigen