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A direct comparison of the American College of Radiology (ACR), Scottish Intercollegiate Guidelines Network (SIGN), United States Preventive Services Task Force (USPSTF), and University of Michigan Health System (UMHS) recommendations for the screening of ovarian cancer is provided in the tables below.
The guidelines differ somewhat in scope. In addition to addressing the screening of ovarian cancer, the SIGN guideline also addresses risk assessment, diagnosis and treatment. UMHS is broader in scope as well, and provides screening recommendations for breast, cervical, colon and prostate cancer. The discussion of ovarian cancer is found in the cervical cancer screening section of the UMHS original guideline document. These topics, however, are beyond the scope of this synthesis.
The tables below provide a side-by-side comparison of key attributes of each guideline, including specific interventions and practices that are addressed. The language used in these tables, particularly that which is used in Tables 4, 5 and 6, is in most cases taken verbatim from the original guidelines:
A summary discussion of the areas of agreement and differences among the guidelines is presented following the content comparison tables.
Abbreviations:
| TABLE 1: COMPARISON OF INTERVENTIONS AND PRACTICES CONSIDERED ("  " indicates topic is addressed) |
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| ACR (2005) | SIGN (2003) | USPSTF (2004) | UMHS (2004) | |
| Screening | ||||
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General Population |
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High-Risk Groups |
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| TABLE 3: COMPARISON OF METHODOLOGY | ||
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| Methods Used to Collect/Select the Evidence | ||
| ACR (2005) |
Searches of Electronic Databases Described Process: The guideline developer performed literature searches of peer-reviewed medical journals, and the major applicable articles were identified and collected. Number of Source Documents: The total number of source documents identified as the result of the literature search is not known. Number of References: 18 |
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| SIGN (2003) |
Searches of Electronic Databases Described Process: Literature searches were initially conducted in Medline, Embase, Cinahl, Cancerlit, and the Cochrane Library using the year range 1993 to 2001. The literature search was updated with new material during the course of the guideline development process. Key Web sites on the Internet were also used, such as the National Guidelines Clearinghouse. These searches were supplemented by the reference lists of relevant papers and group members' own files. The Medline version of the main search strategies can be found on the Scottish Intercollegiate Guidelines Network (SIGN) Web site. Number of Source Documents: Not stated Number of References: 182 |
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| USPSTF (2004) |
Hand-searches of Published Literature (Primary Sources) Searches of Electronic Databases Note from the National Guideline Clearinghouse (NGC): A systematic evidence review was prepared by the Oregon Health & Science University Evidence-based Practice Center (EPC) for the Agency for Healthcare Research and Quality (AHRQ) for use by the U.S. Preventive Services Task Force (USPSTF) Evidence Review:
Electronic copies: Available from the U.S. Preventive Services Task Force (USPSTF) Web site. Described Process: Search Strategy In conjunction with a medical librarian, EPC staff conducted literature searches using MEDLINE (January 1995-December 2002) and the Cochrane Controlled Trials Register, yielding 685 abstracts. Additional articles were obtained by reviewing reference lists of pertinent studies, reviews, and editorials. EPC staff also reviewed results of a systematic review on screening for ovarian cancer by the Health Technology Assessment (HTA) program in the United Kingdom. Inclusion and Exclusion Criteria Studies were included if they addressed the key questions for the target population of asymptomatic women. Studies were excluded if the population was selected according to prior test results. Papers related to genetic testing were also excluded because they are beyond the scope of screening recommendations for the general population. Number of Source Documents: Not stated Number of References: 23 |
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| UMHS (2004) |
Searches of Electronic Databases Described Process: The literature searches for this project were conducted prospectively on Medline for literature published since 1/1/95. A search was performed using the major key words adults, humans, English, plus the terms described below for each topic. (The specific key words associated with a term are detailed in parentheses following the first time a term is used.) The searches were conducted in components each keyed to a specific causal link in a formal problem structure. The searches were supplemented with very recent clinical trials known to expert members of the panel. Negative trials were specifically sought. The searches were single cycle. Breast cancer screening. The additional search terms (with specific key words in parentheses) were: breast cancer (breast neoplasms, mammary neoplasms, experimental mammary neoplasms, breast AND cancer), preventive services (preventive health services, diagnostic services, mass screening, genetic screening, mass chest x-ray, multiphasic screening, neonatal screening, mobile health units, early intervention/education, health education, health fairs, patient education, prevention and control), diagnosis (sensitivity and specificity, predictive value of test, false negative reactions, false positive reactions, likelihood functions), guidelines (clinical protocols, physician's practice patterns, algorithms, outcome and process assessment [health care], consensus development conferences, NIH consensus development conferences, guideline, practice guidelines), research studies (clinical trials - phase IV, randomized clinical trials, controlled clinical trials, multicenter studies, cohort studies). Cervical cancer screening. The additional search terms were: cervical cancer (cervical neoplasms, cervical intraepithelial neoplasms, cervix dysplasia), preventive services, diagnosis, guidelines, research studies. Colon cancer screening. The additional search terms (with specific key words in parentheses) were: gastrointestinal cancer (gastrointestinal neoplasms, intestinal neoplasms, stomach neoplasms), preventive services, diagnosis, guidelines, research studies. Prostate cancer screening. The additional search terms were: prostate cancer (prostatic neoplasms), preventive services, diagnosis, guidelines, research studies. Number of Source Documents: Not stated Number of References: 4 |
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| Methods Used to Assess the Quality and Strength of the Evidence | ||
| ACR (2005) |
Weighting According to a Rating Scheme (Scheme Not Given) |
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| SIGN (2003) |
Weighting According to a Rating Scheme (Scheme Given - Refer to Table 6) |
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| USPSTF (2004) |
Weighting According to a Rating Scheme (Scheme Given - Refer to Table 6) |
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| UMHS (2004) |
Weighting According to a Rating Scheme (Scheme Given - Refer to Table 6) |
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| Methods Used to Analyze the Evidence | ||
| ACR (2005) |
Systematic Review with Evidence Tables Described Process: One or two topic leaders within a panel assume the responsibility of developing an evidence table for each clinical condition, based on analysis of the current literature. These tables serve as a basis for developing a narrative specific to each clinical condition. |
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| SIGN (2003) |
Review of Published Meta-Analyses Described Process: The Scottish Intercollegiate Guidelines Network (SIGN) carries out comprehensive systematic reviews of the literature using customized search strategies applied to a number of electronic databases and the Internet. This is often an iterative process whereby the guideline development group will carry out a search for existing guidelines and systematic reviews in the first instance and, after the results of this search have been evaluated, the questions driving the search may be redefined and focused before proceeding to identify lower levels of evidence. Once papers have been selected as potential sources of evidence, the methodology used in each study is assessed to ensure its validity. Scottish Intercollegiate Guidelines Network has developed checklists to aid guideline developers to critically evaluate the methodology of different types of study design. The result of this assessment will affect the level of evidence allocated to the paper, which in turn will influence the grade of recommendation it supports. Additional details can be found in the companion document titled "An Introduction to the SIGN Methodology for the Development of Evidence-based Clinical Guidelines" (Edinburgh [UK]: Scottish Intercollegiate Guidelines Network. [SIGN publication; no. 50]). Available from the SIGN Web site. |
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| USPSTF (2004) |
Systematic Review with Evidence Tables |
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| UMHS (2004) |
Systematic Review Described Process: Not stated |
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| Methods Used to Formulate the Recommendations | ||
| ACR (2005) |
Expert Consensus (Delphi) Described Process: Since data available from existing scientific studies are usually insufficient for meta-analysis, broad-based consensus techniques are needed to reach agreement in the formulation of the Appropriateness Criteria. The American College of Radiology (ACR) Appropriateness Criteria panels use a modified Delphi technique to arrive at consensus. Serial surveys are conducted by distributing questionnaires to consolidate expert opinions within each panel. These questionnaires are distributed to the participants along with the evidence table and narrative as developed by the topic leader(s). Questionnaires are completed by the participants in their own professional setting without influence of the other members. Voting is conducted using a scoring system from 1-9, indicating the least to the most appropriate imaging examination or therapeutic procedure. The survey results are collected, tabulated in anonymous fashion, and redistributed after each round. A maximum of three rounds is conducted and opinions are unified to the highest degree possible. Eighty percent agreement is considered a consensus. This modified Delphi technique enables individual, unbiased expression, is economical, easy to understand, and relatively simple to conduct. If consensus cannot be reached by this Delphi technique, the panel is convened and group consensus techniques are utilized. The strengths and weaknesses of each test or procedure are discussed and consensus reached whenever possible. If "No consensus" appears in the rating column, reasons for this decision are added to the comment sections. |
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| SIGN (2003) |
Expert Consensus (Refer to Table 6 for rating scheme) Described Process: The process for synthesising the evidence base to form graded guideline recommendations is illustrated in the companion document titled "An Introduction to the SIGN Methodology for the Development of Evidence-based Clinical Guidelines." (Edinburgh [UK]: Scottish Intercollegiate Guidelines Network. [SIGN publication; no. 50], available from the SIGN Web site. Evidence tables should be compiled, summarizing all the validated studies identified from the systematic literature review relating to each key question. These evidence tables form an important part of the guideline development record and ensure that the basis of the guideline development group's recommendations is transparent. In order to address how the guideline developer was able to arrive at their recommendations given the evidence they had to base them on, SIGN has introduced the concept of considered judgement. Under the heading of considered judgement, guideline development groups are expected to summarise their view of the total body of evidence covered by each evidence table. This summary view is expected to cover the following aspects:
Guideline development groups are provided with a pro forma in which to record the main points from their considered judgement. Once they have considered these issues, the groups are asked to summarise their view of the evidence and assign a level of evidence to it, before going on to derive a graded recommendation. The assignment of a level of evidence should involve all those on a particular guideline development group or subgroup involved with reviewing the evidence in relation to each specific question. The allocation of the associated grade of recommendation should involve participation of all members of the guideline development group. Where the guideline development group is unable to agree on a unanimous recommendation, the difference of opinion should be formally recorded and the reason for dissent noted. The recommendation grading system is intended to place greater weight on the quality of the evidence supporting each recommendation, and to emphasize that the body of evidence should be considered as a whole, and not rely on a single study to support each recommendation. It is also intended to allow more weight to be given to recommendations supported by good quality observational studies where randomised controlled trials (RCTs) are not available for practical or ethical reasons. Through the considered judgement process guideline developers are also able to downgrade a recommendation where they think the evidence is not generalisable, not directly applicable to the target population, or for other reasons is perceived as being weaker than a simple evaluation of the methodology would suggest. On occasion, there is an important practical point that the guideline developer may wish to emphasise but for which there is not, nor is there likely to be, any research evidence. This will typically be where some aspect of treatment is regarded as such sound clinical practice that nobody is likely to question it. These are marked in the guideline as "good practice points." It must be emphasized that these are not an alternative to evidence-based recommendations, and should only be used where there is no alternative means of highlighting the issue. |
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| USPSTF (2004) |
Balance Sheets Described Process: When the overall quality of the evidence is judged to be good or fair, the U.S. Preventive Services Task Force (USPSTF) proceeds to consider the magnitude of net benefit to be expected from implementation of the preventive service. Determining net benefit requires assessing both the magnitude of benefits and the magnitude of harms and weighing the two. The USPSTF classifies benefits, harms, and net benefits on a 4-point scale: "substantial," "moderate," "small," and "zero/negative." "Outcomes tables" (similar to "balance sheets") are the USPSTF's standard resource for estimating the magnitude of benefit. These tables, prepared by the topic teams for use at USPSTF meetings, compare the condition-specific outcomes expected for a hypothetical primary care population with and without use of the preventive service. These comparisons may be extended to consider only people of specified age or risk groups or other aspects of implementation. Thus, outcomes tables allow the USPSTF to examine directly how the preventive service affects benefits for various groups. When evidence on harms is available, the topic teams assess its quality in a manner like that for benefits and include adverse events in the outcomes tables. When few harms data are available, the USPSTF does not assume that harms are small or nonexistent. It recognizes a responsibility to consider which harms are likely and judge their potential frequency and the severity that might ensue from implementing the service. It uses whatever evidence exists to construct a general confidence interval on the 4-point scale (e.g., substantial, moderate, small, and zero/negative). Value judgments are involved in using the information in an outcomes table to rate either benefits or harms on the USPSTF's 4-point scale. Value judgments are also needed to weigh benefits against harms to arrive at a rating of net benefit. In making its determinations of net benefit, the USPSTF strives to consider what it believes are the general values of most people. It does this with greater confidence for certain outcomes (e.g., death) about which there is little disagreement about undesirability, but it recognizes that the degree of risk people are willing to accept to avert other outcomes (e.g., cataracts) can vary considerably. When the USPSTF perceives that preferences among individuals vary greatly, and that these variations are sufficient to make a trade-off of benefits and harms a "close-call," then it will often assign a C recommendation (see the "Recommendation Rating Scheme" field). This recommendation indicates the decision is likely to be sensitive to individual patient preferences. The USPSTF uses its assessment of the evidence and magnitude of net benefit to make recommendations. The general principles the USPSTF follows in making recommendations are outlined in Table 5 of the companion document cited below. The USPSTF liaisons on the topic team compose the first drafts of the recommendations and rationale statements, which the full panel then reviews and edits. Recommendations are based on formal voting procedures that include explicit rules for determining the views of the majority. From: Harris RP, Helfand M, Woolf SH, Lohr KN, Mulrow, CD, Teutsch SM, Atkins D. Current methods of the U.S. Preventive Services Task Force: a review of the process. Methods Work Group, Third U.S. Preventive Services Task Force. Am J Prev Med 2001 Apr;20(3S):21-35. |
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| UMHS (2004) |
Expert Consensus Described Process: Consideration of benefits, harms, costs, and patient preferences. |
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| Outcomes | ||
| ACR (2005) |
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| SIGN (2003) |
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| USPSTF (2004) |
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| UMHS (2004) |
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| Financial Disclosures/Conflicts of Interest | ||
| ACR (2005) |
Not stated |
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| SIGN (2003) |
All members of the Scottish Intercollegiate Guidelines Network (SIGN) guideline development groups are required to complete a declaration of interests, both personal and non-personal. A personal interest involves payment to the individual concerned (e.g., consultancies or other fee-paid work commissioned by or shareholdings in the pharmaceutical industry); a non-personal interest involves payment which benefits any group, unit or department for which the individual is responsible (e.g., endowed fellowships or other pharmaceutical industry support). Details of the declarations of interest of any guideline development group member(s) are available from the Scottish Intercollegiate Guidelines Network executive. |
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| USPSTF (2004) |
The U.S. Preventive Services Task Force (USPSTF) has an explicit policy concerning conflict of interest. All members and Evidence-based Practice Center (EPC) staff disclose at each meeting if they have an important financial conflict for each topic being discussed. Task Force members and EPC staff with conflicts can participate in discussions about evidence, but members abstain from voting on recommendations about the topic in question. From: Harris RP, Helfand M, Woolf SH, Lohr KN, Mulrow, CD, Teutsch SM, Atkins D. Current methods of the U.S. Preventive Services Task Force: a review of the process. Methods Work Group, Third U.S. Preventive Services Task Force. Am J Prev Med 2001 Apr;20(3S):21-35. |
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| UMHS (2004) |
The University of Michigan Health System endorses the Guidelines of the Association of American Medical Colleges and the Standards of the Accreditation Council for Continuing Medical Education that the individuals who present educational activities disclose significant relationships with commercial companies whose products or services are discussed. Disclosure of a relationship is not intended to suggest bias in the information presented, but is made to provide readers with information that might be of potential importance to their evaluation of the information. |
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| TABLE 4: COMPARISON OF RECOMMENDATIONS FOR THE DIAGNOSIS AND TREATMENT OF CELIAC DISEASE | |
|---|---|
| Screening Recommendations | |
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ACR |
Appropriateness Criteria Scale: 1-9. 1 = Least appropriate. 9 = Most appropriate Variant 1: Premenopausal or postmenopausal female: low risk. Radiologic Procedure and Appropriateness Rating
Variant 2: Premenopausal female: high risk.
Variant 3: Postmenopausal female: high risk.
Variant 4: Premenopausal female with no mass detected by US: low risk.
Variant 5: Premenopausal female with no mass detected by US: high risk.
Variant 6: Postmenopausal female with no mass detected by US: low risk.
Variant 7: Postmenopausal female with no mass detected by US: high risk.
Current screening tests for detecting ovarian cancer include physical examination, tumor markers (e.g., CA 125) and imaging methods such as US: transabdominal (TAS) and transvaginal (TVS) with color Doppler and power Doppler imaging, CT, and MRI. The pelvic examination, which can detect a variety of gynecological disorders, is not sensitive or specific for detecting ovarian cancer. In general, ovarian malignancies have disseminated by the time they are palpable. CA 125 alone does not have a sufficiently high sensitivity to be recommended for routine ovarian cancer screening. However, CA 125 levels exceeding 65 U/mL are predictive of malignancy in 75% of postmenopausal women with pelvic masses. The primary usefulness of CA 125 is in the management of patients with documented ovarian cancer. Other tumor markers such as NB/70K, a marker for epithelial mucinous adenocarcinomas of the ovary, may increase the sensitivity of the CA 125 marker when used concurrently. Data have confirmed that US is a more accurate method of distinguishing normal from abnormal ovaries, especially in the postmenopausal female. By placing a high frequency transducer closer to the adnexa, TVS increases resolution and improves the ability to detect abnormalities of the ovary. Combining TVS with color flow Doppler imaging technique has been shown by many authors to further enhance the detection of early stage ovarian cancer. The neovascularity identified in malignant masses can also be seen in the formation of the corpus luteum. Therefore, to avoid unnecessary surgery, screening for premenopausal women should be done during days 1 to 12 of the menstrual cycle. In postmenopausal women, low resistance blood vessels are not seen within normal ovaries and when present are considered abnormal. The absence of intraluminal flow or high impedance flow in an ovary can potentially exclude malignancy. However, morphologic characteristics remain the most important criteria in differentiating a normal from an abnormal ovary. Pelvic CT is not indicated for screening due to its inability to image small lesions, poor soft tissue discrimination in the pelvis, high cost and need for contrast material. The cost of MRI, in addition to the lack of resolution in the pelvis precludes its use in screening for small ovarian abnormalities. In postmenopausal women, surgical evaluation may be recommended when the ovarian volume is enlarged (>8 cc) with an elevated CA 125 or a normal CA 125 with abnormal morphologic characteristics of the ovary (i.e., complex or solid mass). If an ovarian simple cyst measures > 5 cm in diameter or < 5 cm with an elevated CA 125 and/or low impedance flow, surgical intervention may be considered. Since there is a low prevalence of the disease in the general population, there are no statistically significant data to show that screening reduces mortality. Additionally, a screening test with high sensitivity is needed. Therefore, routine screening for ovarian cancer cannot be recommended. |
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SIGN |
At present the value of general population screening remains uncertain and cannot be recommended. Results from the current UK Collaborative Trial of Ovarian Cancer Screening (UKCTOCS) are not expected until 2011. Screening in the high risk population is discussed below. Screening in High Risk Groups D - Screening for ovarian cancer in high risk groups should only be offered in the context of a research study designed to gather data on:
D - Screening programmes for women at increased risk of ovarian cancer should include mechanisms for providing emotional and psychological support. NGC Note: Refer to the original guideline document for a discussion of methods to identify high risk groups. |
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USPSTF |
The U.S. Preventive Services Task Force (USPSTF) recommends against routine screening for ovarian cancer. D recommendation. The USPSTF found fair evidence that screening with serum CA-125 level or transvaginal ultrasound can detect ovarian cancer at an earlier stage than it can be detected in the absence of screening; however, the USPSTF found fair evidence that earlier detection would likely have a small effect, at best, on mortality from ovarian cancer. Because of the low prevalence of ovarian cancer and the invasive nature of diagnostic testing after a positive screening test, there is fair evidence that screening could likely lead to important harms. The USPSTF concluded that the potential harms outweigh the potential benefits. Clinical Considerations
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UMHS |
Role of a screening pelvic exam alone. The incidence and frequency of ovarian cancer in the general population is relatively low. Although ovarian tumors are occasionally detected on pelvic examination, they are usually at an advanced stage and associated with a poor prognosis. Screening for ovarian cancer with a CA 125 or ultrasound is not recommended for asymptomatic women. The predictive value of either test alone (less than 3 percent) yields an unacceptably high rate of false positive results. Currently no North American expert groups recommend routine screening for ovarian cancer. |
| SELECTED SUPPORTING REFERENCES Note from NGC: Bolded references are cited in more than one guideline. Refer to the original guideline documents for a complete listing of supporting references. |
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| ACR (2005) |
Adonakis GL, Paraskevardis E, Tsiga S, et al. A combined approach for the early detection of ovarian cancer in asymptomatic women. Eur J Obstet, Gynecol Reprod Biol 1996; 65(2):221-225. Bourne TH, Whitehead MI, Campbell S, et al. Ultrasound screening for familial ovarian cancer. Gynecol Oncol 1991; 43(2):92-97. Campbell S, Bhan V, Royston P, et al. Transabdominal ultrasound screening for early ovarian cancer. BMJ 1989; 299(6712):1363-1367. Dorum A, Kustensen GB, Ateler VM, et al. Early detection of familial ovarian cancer. Eur J Cancer 1996; 32A(10):1645-1651. Fleischer AC, McKee MS, Gordon AN, et al. Transvaginal sonography of postmenopausal ovaries with pathologic correlation. J Ultrasound Med 1990; 9(11):637-644. Fung MF, Bryson P, Johnson M, et al. Screening postmenopausal women for ovarian cancer. Journal Obstet Gynaecol Can 2004; 26(8):717-728. Hakama M, Stenmman UH, Javisalo J, et al. CA125 as a screening test for ovarian cancer. J Med Screen 1996; 3(1):40-42. Jacobs I, Davies AP, Bridges J, et al. Prevalence screening for ovarian cancer in postmenopausal women by CA 125 measurement and ultrasonography. BMJ 1993; 306(6884):1030-1034. Jacobs IJ, Menon U. Progress and challenges in screening for early detection of ovarian cancer. Mol Cell Proteomics 2004; 3(4);355-366. Jacobs IJ, Skates S, Davies AP, et al. Risk of diagnosis of ovarian cancer after raised serum CA125 concentration: a prospective cohort study. BMJ 1996; 313(7069):1355-1358. Karlan BY, Platt LD. The current status of ultrasound and color Doppler imaging in screening for ovarian cancer. Gynecol Oncol 1994; 55(3 Pt 2):S28-S33. Levine D, Gosink BB, Wolf SI, et al. Simple adnexal cysts: the natural history in postmenopausal women. Radiology 1992; 184(3):665-659. Rampone B, Rampone A, Tirabasso S, et al. Ovarian cancer screening by TV color Doppler ultrasonography. Minerva Ginecol 2001; 53(1 Suppl 1):125-128. Tailor A, Bourne TH, Campbell S, et al. Results from an ultrasound-based familial ovarian cancer screening clinic: a 10-year observational study. Ultrasound Obstet Gynecol 2003; 21(4):78-385. Taylor KJ, Schwartz PE. Screening for early ovarian cancer. Radiology 1994; 192(1):1-10. Van Nagell JR Jr., DePriest PD, Puls LE, et al. Ovarian cancer screening in asymptomatic postmenopausal women by transvaginal sonography. Cancer 1991; 68(3):458-462. Weiner Z, Beck D, Shteiner M, et al. Screening for ovarian cancer in women with breast cancer with transvaginal sonography and color flow imaging. J Utrasound Med 1993; 12(7):387-393. |
| SIGN (2003) |
Audrain J, Schwartz MD, Leman C, Hughes C, Peshkin BN, Biesecker B. Psychological distress in women seeking genetic counseling for breast-ovarian cancer risk: the contributions of personality and appraisal. Ann Behav Med 1998;19(4):370-7. Cull A, Fry A, Rush R, Steel CM. Cancer risk perceptions and distress among women attending a familial ovarian cancer clinic. Br J Cancer 2001;84(5):594-9. Erlick Robinson G, Rosen BP, Bradley LN, Rockert WG, Carr ML, Cole DE, et al. Psychological impact of screening for familial ovarian cancer: reactions to initial assessment. Gynecol Oncol 1997:65(2);197-205. Fry A, Busby-Earle C, Rush R, Cull A. Prophylactic oophorectomy versus screening: psychosocial outcomes in women at increased risk of ovarian cancer. Psycho-Oncology 2001;10(3):231-41. Hallowell N. A qualitative study of the information needs of high-risk women undergoing prophylactic oophorectomy. Psycho-Oncology 2000;9(6):486-95. Karlan BY, Baldwin RL, Lopez-Luevanos E, Raffel LJ, Barbuto D, Narod S, et al. Peritoneal serous papillary carcinoma, a phenotypic variant of familial ovarian cancer: implications for ovarian cancer screening. Am J Obstet Gynecol 1999;180(4):917-28. Kauff ND, Satagopan JM, Robson ME, Scheuer L, Hensley M, Hudis CA et al. Risk-reducing salpingo-oophorectomy in women with a BRCA1 or BRCA2 mutation. N Engl J Med 2002;346(21):1609-15. Moller, P, Borg A, Heimdal K, Apold J, Vallon-Christersson J, Hovig E, et al. The BRCA1 syndrome and other inherited breast or breast-ovarian cancers in a Norwegian prospective series. Eur J cancer 2001;37(8):1027-32. NHS Executive. Guidance on commissioning cancer services: improving outcomes in gynaecological cancer: the research evidence. London: The Executive; 1999. Pernet AL, Wardle J, Bourne TH, Whitehead MI, Campbell S, Collins WP. A qualitative evaluation of the experience of surgery after false positive results in screening for familial ovarian cancer. Psycho-oncology 1991;1:217-33. Rebbeck TR, Lynch HT, Neuhausen SL, Narod SA, Van't Veer L, Garber Je, et al. Prophylactic oophorectomy in carriers of BRCA1 or BRCA2 mutations. N Engl J Med 2002;346(21):1616-22. Taylor L, Schwarz H. Identification of a soluble OX40 isoform: development of a specific and quantitative immunoassay. J Immunol Methods 2001;255(1-2):67-72. Wagner TM, Moslinger R, Langbauer G, Ahner R, Fleischmann E, Auterith A, et al. Attitude towards prophylactic surgery and effects of genetic counseling in families with BRCA mutations. Austrian Hereditary Breast and Ovarian Cancer Group. Br J Cancer 2000;82(7):1249-53. Wardle FJ, Collins W, Pernet AL, Whitehead MI, Bourne TH, Campbell S. Psychological impact of screening for familial ovarian cancer. J Natl Cancer Inst 1993;85(8):653-7. Wardle J, Pernet A, Collins W, Bourne T. False positive results in ovarian cancer: one year followup of psychological status. Psychol Health 1994:10(1);33-40. |
| USPSTF (2004) |
Adonakis GL, Paraskevaidis E, Tsiga S, Seferiadis K, Lolis DE. A combined approach for the early detection of ovarian cancer in asymptomatic women. Eur J Obstet Gynecol Reprod Biol 1996;65(2):221-5. American Cancer Society. Can Ovarian Cancer Be Found Early? Available at: http://www.cancer.org/docroot/CRI/content/CRI_2_4_3X_Can_ovarian_cancer_be_found_early_33.asp?sitearea. Accessed April 2, 2003. American Cancer Society. Cancer Facts & Figures 2003. Available at: http://www.cancer.org/downloads/STT/CAFF2003PWSecured.pdf. Accessed April 2, 2003. American College of Obstetricians and Gynecologists. Committee Opinion No. 280. The role of the generalist obstetrician-gynecologist in the early detection of ovarian cancer. Gynecol Oncol 2002;87(3):237-9. Bell R, Petticrew M, Luengo S, Sheldon TA. Screening for ovarian cancer: a systematic review. Health Technology Assessment (Winchester, England). 1998;2(2):i-iv, 1-84. Ford D, Easton DF. The genetics of breast and ovarian cancer. Br J Cancer 1995;72(4):805-12. Gladstone CQ. Screening for ovarian cancer. In: Canadian Task Force on the Periodic Health Examination. Canadian Guide to Clinical Preventive Health Care. Ottawa: Health Canada, 1994;870-81. Gohagan JK, Prorok PC, Hayes RB, Kramer BS, Prostate LC, Ovarian Cancer Screening Trial Project Team. The Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial of the National Cancer Institute: history, organization, and status. Control Clin Trials 2000;21(6 Suppl):251S-272S. Jacobs I, Davies AP, Bridges J, et al. Prevalence screening for ovarian cancer in postmenopausal women by CA 125 measurement and ultrasonography. BMJ 1993;306(6884):1030-4. Jacobs I, Stabile I, Bridges J, et al. Multimodal approach to screening for ovarian cancer. Lancet 1988;1(8580):268-71. Jacobs IJ, Skates SJ, MacDonald N, et al. Screening for ovarian cancer: a pilot randomised controlled trial. Lancet 1999;353(9160):1207-10. Jacobs IJ. European randomized trial of ovarian cancer screening (protocol). London: Wolfson Institute of Preventive Medicine, Department of Environmental and Preventive Medicine; 1995. Kerlikowske K, Brown JS, Grady DG. Should women with familial ovarian cancer undergo prophylactic oophorectomy? Obstet Gynecol 1992;80(4):700-7. Kurjak A, Shalan H, Kupesic S, et al. An attempt to screen asymptomatic women for ovarian and endometrial cancer with transvaginal color and pulsed Doppler sonography. J Ultrasound Med 1994;13(4):295-301. Lacey JV Jr, Mink PJ, Lubin JH, et al. Menopausal hormone replacement therapy and risk of ovarian cancer. JAMA 2002;288(3):334-41. Nelson HD, Westhoff C, Piepert J, Berg A. Screening for Ovarian Cancer: Brief Evidence Update. May 25, 2004. Available at: www.ahrq.gov/clinic/3rduspstf/ovariancan/ovcanup.htm. Prorok PC, Andriole GL, Bresalier RS, et al. Design of the Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial. Control Clin Trials 2000;21(6 Suppl):273S-309S. Rodriguez C, Patel A, Calle E, Jacob E, Thun M. Estrogen replacement therapy and ovarian cancer mortality in a large prospective study of US women. JAMA 2001;285(11):1460-5. Sato S, Yokoyama Y, Sakamoto T, Futagami M, Saito Y. Usefulness of mass screening for ovarian carcinoma using transvaginal ultrasonography. Cancer 2000;89(3):582-8. U.S. Preventive Services Task Force. Guide to Clinical Preventive Services, 2nd ed. Washington, DC: Office of Disease Prevention and Health Promotion; 1996. van Nagell JR Jr, DePriest PD, Reedy MB, et al. The efficacy of transvaginal sonographic screening in asymptomatic women at risk for ovarian cancer. Gynecol Oncol 2000;77(3):350-6. Vuento MH, Pirhonen JP, Makinen JI, Laippala PJ, Gronroos M, Salmi TA. Evaluation of ovarian findings in asymptomatic postmenopausal women with color Doppler ultrasound. Cancer 1995;76(7):1214-8. Whittemore AS, Harris R, Itnyre J. Characteristics relating to ovarian cancer risk: collaborative analysis of 12 US case-control studies. II. Invasive epithelial ovarian cancers in white women. Collaborative Ovarian Cancer Group. Am J Epidemiol 1992;136(10):1184-1203. |
| UMHS (2004) |
Not stated |
| TABLE 5: BENEFITS AND HARMS | |
|---|---|
| Benefits | |
| ACR (2005) |
Selection of appropriate radiologic imaging procedures for screening of ovarian cancer |
| SIGN (2003) |
|
| USPSTF (2004) |
The U.S. Preventive Services Task Force (USPSTF) found fair evidence that screening with serum CA-125 level or transvaginal ultrasound can detect ovarian cancer at an earlier stage than it can be detected in the absence of screening; however, the USPSTF found fair evidence that earlier detection would likely have a small effect, at best, on mortality from ovarian cancer. Because of the low prevalence of ovarian cancer and the invasive nature of diagnostic testing after a positive screening test, there is fair evidence that screening could likely lead to important harms. The USPSTF concluded that the potential harms outweigh the potential benefits. |
| UMHS (2004) |
Not stated |
| Harms | |
| ACR (2005) |
Not stated |
| SIGN (2003) |
|
| USPSTF (2004) |
There is a significant potential for harms associated with screening for ovarian cancer, although there are few data to assess the magnitude of harms from screening, such as needless surgery or increased anxiety. |
| UMHS (2004) |
Not stated |
| TABLE 6: EVIDENCE RATING SCHEMES AND REFERENCES | |
|---|---|
| ACR (2005) |
The recommendations are based on analysis of the current literature and expert panel consensus. |
| SIGN (2003) |
Levels of Evidence 1++: High quality meta-analyses, systematic reviews of randomised controlled trials (RCTs), or RCTs with a very low risk of bias 1+: Well-conducted meta-analyses, systematic reviews of RCTs, or RCTs with a low risk of bias 1-: Meta-analyses, systematic reviews of RCTs, or RCTs with a high risk of bias 2++: High quality systematic reviews of case control or cohort or studies; high quality case control or cohort studies with a very low risk of confounding or bias and a high probability that the relationship is causal 2+: Well conducted case control or cohort studies with a low risk of confounding or bias and a moderate probability that the relationship is causal 2-: Case control or cohort studies with a high risk of confounding or bias and a significant risk that the relationship is not causal 3: Non-analytic studies, e.g. case reports, case series 4: Expert opinion Grade of Recommendation The grade of recommendation relates to the strength of the evidence on which the recommendation is based. It does not reflect the clinical importance of the recommendation. A: At least one meta-analysis, systematic review of randomised controlled trials (RCTs), or RCT rated as 1++ and directly applicable to the target population; or A body of evidence consisting principally of studies rated as 1+, directly applicable to the target population, and demonstrating overall consistency of results B: A body of evidence including studies rated as 2++, directly applicable to the target population, and demonstrating overall consistency of results; or Extrapolated evidence from studies rated as 1++ or 1+ C: A body of evidence including studies rated as 2+, directly applicable to the target population and demonstrating overall consistency of results; or Extrapolated evidence from studies rated as 2++ D: Evidence level 3 or 4; or Extrapolated evidence from studies rated as 2+ Good Practice Point: Recommended best practice based on the clinical experience of the guideline development group |
| USPSTF (2004) |
Definitions: Strength of Recommendations The USPSTF grades its recommendations according to one of five classifications (A, B, C, D, I) reflecting the strength of evidence and magnitude of net benefit (benefits minus harms): A The USPSTF strongly recommends that clinicians provide [the service] to eligible patients. The USPSTF found good evidence that [the service] improves important health outcomes and concludes that benefits substantially outweigh harms. B The USPSTF recommends that clinicians provide [this service] to eligible patients. The USPSTF found at least fair evidence that [the service] improves important health outcomes and concludes that benefits outweigh harms. C The USPSTF makes no recommendation for or against routine provision of [the service]. The USPSTF found at least fair evidence that [the service] can improve health outcomes but concludes that the balance of benefits and harms is too close to justify a general recommendation. D The USPSTF recommends against routinely providing [the service] to asymptomatic patients. The USPSTF found at least fair evidence that [the service] is ineffective or that harms outweigh benefits. I The USPSTF concludes that the evidence is insufficient to recommend for or against routinely providing [the service]. Evidence that the [service] is effective is lacking, of poor quality, or conflicting and the balance of benefits and harms cannot be determined. Strength of Evidence The USPSTF grades the quality of the overall evidence for a service on a 3-point scale (good, fair, poor): Good Evidence includes consistent results from well-designed, well-conducted studies in representative populations that directly assess effects on health outcomes. Fair Evidence is sufficient to determine effects on health outcomes, but the strength of the evidence is limited by the number, quality, or consistency of the individual studies, generalizability to routine practice, or indirect nature of the evidence on health outcomes. Poor Evidence is insufficient to assess the effects on health outcomes because of limited number or power of studies, important flaws in their design or conduct, gaps in the chain of evidence, or lack of information on important health outcomes. |
| UMHS (2004) |
Definitions: Levels of Evidence
|
The American College of Radiology (ACR), Scottish Intercollegiate Guidelines Network (SIGN), United States Preventive Services Task Force (USPSTF), and University of Michigan Health System (UMHS) present recommendations for the screening of ovarian cancer and provide explicit reasoning behind their judgments.
The guidelines differ somewhat in scope. In addition to addressing the screening of ovarian cancer, the SIGN guideline also addresses its diagnosis and treatment. UMHS is broad in scope as well, and provides screening recommendations for breast, cervical, colon and prostate cancer. The discussion of ovarian cancer is found in the cervical cancer screening section of the UMHS guideline.
To collect and select the evidence, all four guideline groups performed searches of electronic databases, with SIGN, USPSTF and UMHS providing the names of the databases searched, the date range over which they searched, and the search strategy. USPSTF also performed hand-searches of published literature (primary and secondary sources). USPSTF based their guideline statements on a separately-prepared, systematic evidence review that included applying quality criteria to published studies to select those suitable for evidence review and guideline formulation (see "Availability of Companion Documents" in the NGC summary of this guideline).
With regard to methods used to analyze the evidence, ACR , SIGN, and USPSTF performed a systematic review with evidence tables. Note that these are available on demand from SIGN and are not published in the guideline. UMHS performed a systematic review, and SIGN also performed a review of published meta-analyses. All four groups used expert consensus to formulate their recommendations, while USPSTF also used balance sheets. SIGN, USPSTF and UMHS rank the level of evidence supporting each major recommendation, and SIGN and USPSTF also grade the strength of the recommendations.
SIGN and USPSTF provide their guidance through explicit graded recommendation statements (note that only 1 recommendation is provided by USPSTF in this particular guideline), supplemented by narrative discussion. In the narrative discussion they link the supporting evidence directly to their recommendation statement(s). ACR provides its appropriateness criteria ratings, followed by a discussion with in-text references directing the reader to the corresponding resource in the reference list. Like SIGN and USPSTF, UMHS also provides its guidance in the form of recommendation statements for which the supporting evidence is graded, followed by narrative discussion. They do not, however, provide in-text references to supporting evidence. Instead, they provide a list of annotated references used to support major recommendations.
All four guideline groups provide reference lists (18 for ACR, 182 for SIGN, 23 for USPSTF, 4 for UMHS).
| Screening and Prevention of Ovarian Cancer: Comparison of Key Recommendations Between the ACR, SIGN, USPSTF and UMHS Guidelines | |
|---|---|
| ACR (2005) |
|
| SIGN (2003) |
|
| USPSTF (2004) |
|
| UMHS (2004) |
|
All four guideline groups found that there is insufficient evidence to support a recommendation for routine screening of the general population for ovarian cancer, citing reasons such as its low prevalence (ACR, UMHS and USPSTF), a lack of evidence that screening reduces mortality (ACR, USPSTF), evidence that harms of screening outweigh potential benefits (USPSTF), and a high rate of false-positive screening results (USPSTF, UMHS). SIGN states that the value of general population screening remains uncertain and cannot be recommended. They add that results from the current UK Collaborative Trial of Ovarian Cancer Screening (UKCTOCS) are not expected until 2011. Note that while ACR, SIGN and UMHS note that there is insufficient evidence to recommend screening, USPSTF goes a step further and recommends against screening, concluding that the potential harms of genetic screening do, in fact, outweigh the potential benefits.
ACR differs from the other groups in that it stratifies its recommendations for individual radiologic interventions by menopausal status, risk level, and presence of an ultrasound-detected mass, and further rates the appropriateness of each radiologic procedure on a level of 1 (least appropriate) to 9 (most appropriate). In line with their conclusion that there is insufficient evidence to recommend screening the general public for ovarian cancer, they accord an appropriateness rating of "2" to all of the radiological procedures for low-risk populations. They assign an appropriateness rating of "8" to a gynecological evaluation not completely directed for ovarian cancer but for a variety of reasons.
Two of the guideline groups, ACR and SIGN, address screening in high-risk groups, with SIGN recommending that screening in this population be offered only in the context of a research study designed to gather data. ACR provides higher appropriateness ratings for radiologic interventions in high-risk populations than for low-risk.
There are no significant areas of difference between the guideline groups.
There is general agreement across the ACR, SIGN, USPSTF and UMHS guidelines concerning the lack of evidence to recommend screening for ovarian cancer in the general public. SIGN notes that screening in high-risk populations should only be conducted in the context of a research study to gather data. ACR assigns Appropriateness Criteria to radiologic procedures for both low-risk and high-risk populations, and assigns higher ratings to interventions for high-risk populations.
This Synthesis was prepared by ECRI on October 2, 2007. It was reviewed by SIGN on October 10, 2007, UMHS on October 25, 2007, and ACR on November 2, 2007.
Internet citation: National Guideline Clearinghouse (NGC). Guideline synthesis: Screening for ovarian cancer. In: National Guideline Clearinghouse (NGC) [website]. Rockville (MD): 2007 Nov. [cited YYYY Mon DD]. Available: http://www.guideline.gov.
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© 1998-2009 National Guideline Clearinghouse
Date Modified: 1/12/2009
