Mammography Result Notification Letters: Are They Easy to Read and Understand?

Abstract

Background:

Federal law mandates that mammography centers notify women of their result in writing. The purpose of this study is to assess the readability and ease of use of the sample letters provided as a template for the notification letters centers send to patients.

Methods:

This is a cross-sectional analysis of the 43 mammography result notification template letters available from the American College of Radiology and two leading transcription software services. To assess readability, we used the Flesch-Kincaid grade level scale and the Lexile framework. To assess document suitability, we used the Suitability Assessment of Materials (SAM). Acceptable scores were based on established standards: ≤6th grade for the Flesch-Kincaid level, ≤900 for the Lexile analysis, and ≥40% on the SAM scale. Means, standard deviations (SDs), and ranges were calculated by diagnostic category, as indicated by BI-RADS level. The Kruskal-Wallis test was used to assess differences in readability and suitability by diagnostic category.

Results:

The Flesch Kincaid score ranged from 7.7 to 13.5, with a mean of 10.2. The Lexile score ranged from 880 to 1270, with a mean of 1113. The mean SAM score ranged from 16% to 36%, with a mean of 29%. Mean grade level, Lexile score, and SAM score did not vary significantly by diagnostic category. No single document had an acceptable suitability score, and only two had acceptable Lexile scores. Common deficiencies included use of the passive voice, vague wording, and technical jargon.

Conclusions:

The letters we analyzed were written at levels too difficult for many patients to understand. Future investigations should explore clearer ways of communicating mammography results.

Introduction

More than 54 million U.S. women undergo screening mammography over a 2-year period.¹ Most of these women will have a benign finding and will be advised to return in a year. About 1 in 10, however, will need to return for additional imaging, diagnostic evaluation, or short-term follow-up.² About 4% of these initially abnormal mammograms will be found to represent breast cancer.²

Delayed follow-up and lack of follow-up after an abnormal mammogram are common, especially in health systems serving low-income, ethnic minority women.^3

–8 These women are at higher risk of experiencing delays in breast cancer diagnosis^8
–10 and are more likely to present with advanced stage breast cancer¹¹ for reasons that may include differences in screening rates and tumor characteristics.^12,13 Many factors affect the likelihood that a woman will follow up after an abnormal mammogram,^3,14 including the successful communication of test results.⁷ Patient understanding of mammography results is important to enhance the likelihood of follow-up after an abnormal screening mammogram.^7,15,16 To reduce failures in the communication of mammography results, the 1998 Mammography Quality Standards Reauthorization Act (MQSRA) requires that all licensed mammography facilities mail each patient a written summary of her mammogram report “in terms easily understood by a lay person.”¹⁷ These letters may serve as an especially important vehicle for disseminating results to low-income women, many of whom lack reliable phone service¹⁸ or a regular primary care provider.^19,20 Despite the MQSRA's mandate, however, research suggests many women do not understand their mammogram results^21,22 or are not satisfied with the manner in which their results are communicated.²³

Women's health literacy may present a significant barrier to mammography follow-up. According to the U.S. Department of Education's National Assessment of Adult Literacy (NAAL), 43% of U.S. adults, or 93 million people, have limited (basic or below basic) prose literacy skills. People with this level of literacy lack the skills to understand moderately challenging reading materials.²⁴ The NAAL also concluded that 37% of the population, or 77 million people, have basic or below basic health literacy skills.²⁴ It is generally recommended that health materials be written at a 6th grade level or lower because 75% of U.S. adults can read at this level without significant problems.²⁵ Other studies have documented that informed consent documents^26,27 and many patient education materials, including cancer education materials, are written at a level that is unsuitable for much of the population.²⁸

It is possible that women with limited literacy may have particular difficulty understanding their mammography results and follow-up plan as presented in a typewritten letter. To our knowledge, no study has examined the letters mammography centers send to women to convey their results. It is important to determine if these letters are presented in a simple to understand format as a step toward ensuring appropriate follow-up for all women. The aim of this study was to assess the readability and ease of use of the sample mammography result notification letters provided to imaging centers as templates for the letters they send to patients. We hypothesized that these letters would be written at a level that is incompatible with limited literacy skills and that the letters' readability would differ by the diagnostic result each was trying to convey.

Materials and Methods

Data sources

In December 2008, we collected all publicly available, English-language templates for mammography result notification letters from the American College of Radiology (ACR), as well as all result notification letters available to users of two of the most commonly used tracking and reporting software services for mammography notification letters. Letters from the ACR (Source A) were obtained from their website (www.acr.org/accreditation/mammography/mammo_sample_letters.aspx). Letters from the software services (Sources B and C) were obtained by e-mail request from the companies. Both of the companies are recognized as industry leaders in the mammography tracking software market. Of note, one company (Source C) also provides additional sample letters that centers can use when patients do not appear for their scheduled appointment; these were excluded because they are not intended to serve as notification letters. Source A supplies a sample checklist with multiple result options that centers can hand patients at the time of their test. We also excluded this checklist from our analysis because it was not a letter conveying one specific result. The analysis was performed on the remaining 43 letters: 8 from Source A, 10 from Source B, and 25 from Source C.

We designated each letter by its diagnostic category, as specified by the Breast Imaging Reporting and Data System (BI-RADS), which is used by radiologists to report mammography results in a standardized way.²⁹ The letters were classified in the following categories: BI-RADS 0, BI-RADS 1–2, BI-RADS 3, BI-RADS 4–5, BI-RADS 6. BI-RADS 1 and 2 denote benign findings, and BI-RADS 4–5 indicate findings that are the most concerning and most in need of timely clinical follow-up. Definitions for the different BI-RADS categories are listed in Table 1.

Table 1.

Reading Level and Suitability Scores by Breast Imaging Reporting and Data System Category

	Number of letters	Flesch-Kincaid grade level score (Acceptable is ≤6)	Lexile score (Acceptable is ≤900)	Suitability score (Suitability Assessment of Materials) (Acceptable: ≥40%)
Diagnostic category of mammogram result	n (%)	Mean (SD, range)	Mean (SD, range)	Mean (SD, range)
BI-RADS 0	9 (21)	9.6	1101	30%
(need more views)		(1.1, 7.7–11.2)	(109, 940–1220)	(4.0%, 22%–36%)
BI-RADS 1–2	19 (44)	10.4	1144	29%
(normal, return in 1 year)		(1.3, 8.7–13.5)	(128, 880–1260)	(4.9%, 16%–36%)
BI-RADS 3	7 (16)	10.4	1073	27%
(probably benign, need 6-month follow-up)		(0.8, 8.8–11.2)	(90, 900–1160)	(4.1%, 19%–31%)
BI-RADS 4–5	5 (12)	10.3	1048	29%
(suspicious or highly suspicious, need biopsy)		(1.6, 8.7–12.5)	(74, 960–1150)	(2.6%, 25%–31%)
BI-RADS 6	3 (7)	9.8	1153	27%
(known malignancy, treatment as per MD)		(0.8, 8.9–10.5)	(132, 1010–1270)	(3.5%, 25%–31%)
Total group	43 (100)	10.2	1113	29%
		(1.2, 7.7–13.5)	(114, 880–1270)	(4.3%, 16%–36%)

SD, standard deviation.

Measures

Readability refers to the complexity of document text. To assess text readability, we used the Flesch-Kincaid grade level scale and the Lexile framework, both of which have been used in past studies assessing readability of health materials.^{26,30

–36} The Flesch-Kincaid calculates its results based on total words per sentence and syllables per word. It is featured in the standard Microsoft Word program. We considered a grade level score of ≤6th grade to be acceptable.²⁵ The Lexile framework evaluates a text based on the length of its sentences and on whether it uses words that are frequently encountered by readers.³⁷ The Lexile analyzer is available online (www.lexile.com) and assigns a score ranging from 0 to 2000. Lexile scores correspond to grade levels. We considered a score of 900 to be acceptable, as it corresponds to a 6th grade reading level.

Suitability refers to the layout and ease of use of a document. To assess document suitability, we used the Suitability Assessment of Materials (SAM),²⁵ a validated 17-item checklist that rates documents based on six categories: content clarity, literacy demand, graphics, layout and typography, learning stimulation, and cultural appropriateness. The SAM checklist is available through the Harvard School of Public Health's Health Literacy web page: www.hsph.harvard.edu/healthliteracy/doak.html. This tool has been used in past analyses of cancer education materials.^38,39 A document's content clarity is influenced by whether it has a clear purpose, focuses on knowledge necessary for desirable behavior, limits its scope to essential material, and includes a summary. Literacy demand is influenced by a document's reading level, whether it uses common words, provides context before presenting new information, uses such advance organizers as headers, and employs the active voice. Assessment of the graphic component is influenced by the type of graphics used, the inclusion of explanatory captions, and the relevance of illustrations. Layout and typography are influenced by the use of visual cuing devices, adequate white space, type size and font, and the inclusion of subheadings, so as to avoid what is referred to as chunking of information.

Learning stimulation is influenced by whether the document includes problems or questions that interact with the reader, models specific behavior, and makes behaviors seem feasible. Cultural appropriateness is influenced by whether culturally relevant images and examples are used. Each item is rated from 0 to 2 or as not applicable. A total score and total possible score (excluding the items marked “not applicable”) are then generated, and a percent score is calculated. A superior score is ≥70%; acceptable is 40%–69%; and 0–39% is not suitable. Before performing the analysis, the investigators reviewed the SAM criteria together and systematically evaluated different letters from a local mammography facility to ensure that their methods of analysis were consistent. Two of the investigators (E.N.M. and Y.D.T.) then independently completed a systematic SAM analysis on each letter, and mean scores were used for analysis. Any discrepancies between scores (defined as one investigator's score being in acceptable range and the other's not in acceptable range) were rescored by a third investigator (L.M.S.).

Analysis

Means, standard deviations (SD), and ranges were calculated for the Flesch-Kincaid score, the Lexile score, and the SAM by diagnostic category. The Kruskal-Wallis test was used to assess differences in document readability and suitability by diagnostic category, as indicated by BI-RADS level. Analyses were performed using STATA software version 9 (StataCorp., College Station, TX).

Results

Quantitative results

Table 1 shows the mean scores of the letters by diagnostic category. Mean grade level score (Flesch-Kincaid) is 10th grade (SD 1.2), and median is also 10th grade, with a distribution ranging from 7.7 to 13.5. None of the 43 letters is written at or below the 6th grade level. The mean Lexile score was 1113 (SD 114), with a median of 1140. Both the mean and median correspond to a 10th grade reading level. Only 3 of the 43 letters were at a level of ≤900. The distribution of Lexile scores ranged from 880 (approximate grade level, 5.8) to 1270 (approximate grade level, 12.8). Mean suitability score (SAM) was 29% (SD 4%), with a median of 30%. The mean suitability scores ranged from 16% to 36%. No letters fall in the acceptable range of ≥40%.

Mean grade level, Lexile score, and SAM score did not vary significantly by diagnostic category (p values for Kruskal Wallis test were 0.599, 0.210, and 0.254, respectively), and none were in an acceptable range (Table 1). Although mean grade level, Lexile score, and SAM score did vary significantly by diagnostic category (p<0.002 for all measures), none were in the acceptable range.

Suitability assessment of letters: Components

Content

The content scores ranged from 12.5% to 50%. Many of the letters do not make their purpose clear at the outset and include content unrelated to the individual woman's result and specific follow-up plan. For example, several letters feature a box listing the American Cancer Society Guidelines for breast cancer screening, including breast magnetic resonance imaging (MRI), with an explanation that it “is recommended for women with an approximately 20%–25% or greater lifetime risk of breast cancer, including women with a strong family history of breast and ovarian cancer and women who were treated for Hodgkin's disease.”

Literacy demand

The literacy demand scores ranged from 12.5% to 50%. Many of the letters include vague descriptions, use the passive voice, and employ technical jargon. None of the letters uses road signs, such as headings or bullet points, to alert the reader to the letter's main purpose or of the idea each paragraph is trying to convey.

Graphics

The scores ranged from 0 to 50%. Only one of the letters includes a picture, and it is of a woman doing a self-breast examination, which has no relevance to the result the letter is trying to convey.

Layout and typography

The scores ranged from 33% to 50%. The letters use adequate type size and font, and all include ample white space. They all contain large chunks of uninterrupted text, however.

Learning stimulation, motivation

The scores ranged from 0 to 50%. None of the letters provide interactive learning stimulation. Several do instruct the woman on desired behavior, stating, “If your physician has not contacted you to schedule these additional studies, please contact the office.” Specific details on how to do this are not provided, however.

Cultural appropriateness

The scores ranged from 0 to 25%. None of the letters target any particular racial or ethnic group.

Discussion

To our knowledge, no previous studies have examined mammography result notification letters. In this study, we examined widely available and commonly used templates for notifying women of the results of their screening mammograms. The letters in our analysis are written in a way that is not understandable by more than half of the U.S. population.²⁵ Additionally, our findings suggest that the design and scope of these letters may make them difficult for many women to use. Included in many letters is a large amount of information unrelated to timely follow-up. This extraneous information detracts from the letters' main message and could overwhelm readers who have limited literacy skills.

Our findings are consistent with past studies, which have found that many patient education materials are written at levels that are incompatible with the reading ability of much of the general public. These include patient-directed materials in the fields of oncology,³⁰ pediatrics,^40,41 orthopedics,⁴² and mental health,⁴³ among others.³⁵ Mammography result notification letters play a different role than general educational materials, however, in that their goal is to convey a specific result so that a woman understands how and when to follow up. Indeed, at the time Congress passed the 1998 MQSRA, Congressman David Dingell (D-MI, 15^th district) described it as “an important safeguard” that “ensures that patients have the information they need in a timely fashion so that they can take any additional steps warranted by the test.”⁴⁴

This study complements other research suggesting that the notification process for mammography results is ineffective for many women, despite the provisions of the MQSRA. Studies conducted since implementation of the law's notification requirement indicate that many women do not correctly understand their results. A telephone survey before and after the law's implementation found no significant improvement in the percentage of women correctly recollecting their result, with only 69.4% of those needing a surgical consultation or biopsy and 69.7% of those needing follow-up in 6 months correctly reporting their findings after the rule's implementation.²³ In another telephone survey of 970 San Francisco-area women with abnormal mammograms, nearly half of those with a suspicious abnormality did not understand that they had an abnormal result, and women notified in writing, and not by telephone or in person, were less likely to understand their result to be abnormal.²²

Research suggests that most women do not learn of their screening mammogram result at the time of their examination. One large national survey of community radiologists' verbal communication practices found that few (<6%) reported routinely telling patients of their result at the time of a screening examination, whether normal or abnormal.⁴⁵ Fewer than half (47%) of the radiologists reported that they routinely verbally tell patients of a normal diagnostic examination result, and a majority (77%) reported that they routinely tell patients immediately of an abnormal diagnostic examination result.

It is unknown how many mammography centers routinely telephone patients after the test to inform them of abnormal results. Federal law requires that mammography centers notify referring physicians of a patient's findings, and women may learn of their result from their primary care physician. However, more than 1 in 10 women in the United States lack a usual source of care,⁴⁶ and a substantial number of women may be difficult to reach by telephone. According to a Federal Communications Commission report, approximately 11% of low-income households lack phone service, including cell phone service.¹⁸

We do not know how many breast imaging centers use the letters that we analyzed. The ACR is the largest mammography accrediting body in the United States and lists more than 8000 accredited mammography facilities on its website.⁴⁷ It makes its sample letters freely available.⁴⁸ Source B has reported that its product is installed in 3700 facilities in the United States and Canada⁴⁹; Source C's website indicates that it is used by more than 2400 facilities.⁵⁰

Our study is limited by several biases common in studies of readability, including the sampling frame and measurement bias. We assessed only sample letters from national organizations. The template letters are all modifiable, however, and it is possible that the letters we examined differ from the actual letters that individual mammography centers mail to patients. We collected letters from two of the major national mammography software companies, but there are other companies that also provide their own template letters to centers. Our analysis was also limited to English-language documents. Neither the Flesch-Kincaid method nor the Lexile framework assess content. The SAM checklist that we used to evaluate the letters' design is intrinsically subjective and is influenced by the reviewer's cultural background; it is possible that other observers might score the letters differently. The investigators conducting the SAM analysis were not blinded to the research question. The inclusion of the cultural appropriateness section of the SAM is problematic, given that these letters are meant for the general population of women and are not tailored to a specific ethnic audience. Omitting this section of the SAM would not have changed our results significantly, however, given that none of the other sections had acceptable mean scores.

Despite these limitations, our findings suggest that mammography result notification letters may need to be redesigned and rewritten to accommodate low-literacy patients. Incorporating plain-language principles may make mammography notification letters more understandable to all women and potentially improve their role as a safeguard in the notification process, thus helping fulfill Congress' intent in passing the 1998 MQSRA. These principles are outlined on the NIH Plain Language Initiative website, which extols writing that is “clear and to the point” and contains many recommendations that we believe could help make mammography result notification letters more patient-friendly, including the use of common everyday words, the use of the active voice, and the use of personal pronouns, such as “we” and “you.”⁵¹ Mammography result letters are directed at a wide swath of the general public, and it is, therefore, important that these letters be designed in a way that will make them understandable to all women, including those with limited literacy. Incorporating aids for low-literacy readers can be done in a manner that is not insulting or condescending, as outlined on the National Cancer Institute's Clear and Simple website.⁵² Table 2 presents examples of problematic wording in the letters and our suggestions for clearer ways to express the same ideas.

Table 2.

Problematic Wording in Notification Letters and Suggestions for Improvement

Type of wording	Actual phrase in letter	Simpler way to express idea
Vague term	Your mammogram shows the need for further evaluation	You need to come back
	The area of concern	The part of the breast that we need to study more closely
Passive voice	The results of this procedure have been sent	We have mailed your results
	It is recommended	We recommend
Technical jargon	Healthcare provider	Doctor or nurse practitioner
	This procedure	Your mammogram
	Pathologic analysis	Lab studies

Even letters that are written clearly, however, might not reach some patients because of incorrect addresses, postal system problems, or other barriers. In a prospective cohort study of 1145 women in Connecticut, 12.5% reported they had not received their screening mammogram result.²¹ Although some letters may not reach their destination, it is possible that some women may lack the literacy skills to distinguish between billing and results communication, and others may choose not to open envelopes or attempt to understand the contents.

We did not examine other ways centers communicate with patients, including telephone messaging and direct person-to-person contact. Assessment of patient understanding of the notification letters and of the effect of the letters on patient follow-up were beyond the scope of this investigation.

Implications

Although there are many factors influencing follow-up after an abnormal mammogram, effective communication and adequate understanding of the result play a key role.^7,16 Past research suggests that women who report asking questions and receiving understandable next step information are more likely to receive timely follow-up.¹⁵ Voicing uncertainty about where to receive care¹⁴ and reporting not having been informed of one's results⁵³ have been associated with delay in follow-up and diagnosis. Difficult to read result notification letters are, therefore, a concern, given the prevalence of low health literacy and the important role letters play in communicating with women, particularly those of low income and who lack a specific primary care physician and reliable phone service.

The experience of receiving an abnormal mammogram result frequently triggers anxiety.^54,55 An effective letter must not unduly alarm women while effectively explaining how to follow up if needed. Women often overestimate their personal risk of breast cancer,⁵⁶ and any effective means of communicating mammogram results must bear in mind the wide prevalence of limited numeracy, or familiarity with mathematical concepts. According to the 2003 NAAL, more than half of the adult U.S. population has below basic or basic quantitative skills,²⁴ indicating that they are not proficient at performing numerical tasks and may have problems understanding risk and probability. Supplemental tools, such as icon-rich pictorials, photonovels, and virtual nurse agents, may enhance the letters' effectiveness.^57,58 Patient navigators are increasingly employed to ensure that women complete their follow-up.^59
–61 Future investigations should explore alternative means of notification and assess how best to communicate these important results.

Footnotes

Acknowledgments

We thank Dr. Olveen Carrasquillo, Ms. Yuliya Shneyderman, and Dr. Victoria Velasquez for their contributions to this article. E.N.M. is supported by an American Cancer Society Cancer Control Career Development Award (CCCDA-09-216-01) and by a grant from The Ford Foundation (grant 1095-0885).

Disclosure Statement

E.N.M. receives royalties from UpToDate. L.M.S. has received honoraria from Merck and from the Pfizer Medical Futures Forum. M.Y. has received honoraria from Naviscan. The other authors have no conflicts of interest to declare.

References

Centers for Disease Control and Prevention, Division of Cancer Prevention and Control. E-mail in response to inquiry. July 14, 2010.

National Cancer Institute Breast Cancer Surveillance Consortium. Abnormal interpretations for 2,264,089 screening mammography examinations from 2002–2006—Based on BCSC data as of 2009. www.breastscreening.cancer.gov/data/benchmarks/screening/2009/table3.html. 2010 September 29.

Jones

, Dailey

, Calvocoressi

et al.

Inadequate follow-up of abnormal screening mammograms: Findings from the race differences in screening mammography process study (United States)

Cancer Causes Control, 2005; 16:809–821.

Yabroff

, Washington

, Leader

, Neilson

, Mandelblatt

. Is the promise of cancer-screening programs being compromised? Quality of follow-up care after abnormal screening results. Med Care Res Rev, 2003; 60:294–331.

Burack

, Simon

, Stano

, George

, Coombs

. Follow-up among women with an abnormal mammogram in an HMO: Is it complete, timely and efficient? Am J Manag Care, 2000; 6:1102–1113.

Press

, Carrasquillo

, Sciacca

, Giardina

. Racial/ethnic disparities in time to follow-up after an abnormal mammogram. J Womens Health, 2008; 17:923–930.

Mojica

, Bastani

, Ponce

, Boscardin

. Latinas with abnormal breast findings: Patient predictors of timely diagnostic resolution. J Womens Health, 2007; 16:1468–1477.

Gorin

, Heck

, Cheng

, Smith

. Delays in breast cancer diagnosis and treatment by racial/ethnic group. Arch Intern Med, 2006; 166:2244–2252.

Kerlikowske

, Smith-Bindman

, Abraham

et al. Breast cancer yield for screening mammographic examinations with recommendation for short-interval follow-up. Radiology, 2005; 234:684–692.

10.

Weingart

, Saadeh

, Simchowitz

et al. Process of care failures in breast cancer diagnosis. J Gen Intern Med, 2009; 24:702–709.

11.

American Cancer Society. Breast cancer facts and figures, 2009–2010. Atlanta: American Cancer Society www.cancer.org/acs/groups/content/@nho/documents/document/f861009final90809pdf.pdf. 2010 September 29.

12.

Smith-Bindman , Miglioretti

, Lurie

et al.

Does utilization of screening mammography explain racial and ethnic differences in breast cancer?

Ann Intern Med, 2006; 144:544–553.

13.

. Socioeconomic disparities in breast cancer survival: Relation to stage at diagnosis, treatment and race. BMC Cancer, 2009; 9:364.

14.

Kaplan

, Crane

, Stewart

, Juarez-Reyes

. Factors affecting follow-up among low-income women with breast abnormalities. J Womens Health, 2004; 13:195–206.

15.

Kerner

, Yedidia

, Padgett

et al. Realizing the promise of breast cancer screening: Clinical follow-up after abnormal screening among black women. Prev Med, 2003; 37:92–101.

16.

Poon

, Haas

, Puopolo

et al. Communication factors in the follow-up of abnormal mammograms. J Gen Intern Med, 2004; 19:316–323.

17.

U.S. Public Law 105–248: Mammography Quality Standard Act October 9, 1998. history.nih.gov/research/downloads/PL105-248.pdf. 2010 September 30.

18.

Belinfante

. Telephone penetration by income by state. U.S. Federal Communications Commission. March 2008. hraunfoss.fcc.gov/edocs_public/attachmatch/DOC-280982A1.pdf. 2010 September 30.

19.

Gundelman

, Wagner

. Health care services utilization among Latinos and white non-Latinos: Results from a national survey. J Health Care Poor Underserved, 2000; 11:179–194.

20.

U.S. Agency for Health Care Research and Quality. Monitoring the health care safety net: Web conference. September 23–25, 2003. archive.ahrq.gov/news/ulp/safetynetaud/. 2010 September 30.

21.

Jones

, Reams

, Calvocoressi

, Dailey

, Kasl

, Liston

. Adequacy of communicating results from screening mammograms to African-American and white women. Am J Public Health, 2007; 97:531–538.

22.

Karliner

, Kaplan

, Juarbe

, Pasick

, Perez-Stable

. Poor patient comprehension of abnormal mammography results. J Gen Intern Med, 2005; 20:432–437.

23.

Priyanth

, Feinglass

, Dolan

, Haviley

, Venta

. Patient satisfaction with the communication of mammographic results before and after the mammography Quality Standards Reauthorization Act of 1998. Am J Radiol, 2002; 178:451–456.

24.

Kutner

, Greenberg

, Baer

. National Assessment of Adult Literacy. U.S. Department of Education National Center for Education Statistics. NCES Report, 2006470 December 2005.

25.

Doak

, Doak

. Teaching patients with low literacy skills. Philadelphia: JB Lippincott, 1996; 43–91.

26.

Paasche-Orlow

, Taylor

, Brancati

. Readability standards for informed consent as compared with actual readability. N Engl J Med, 2003; 348:721–726.

27.

Grossman

, Piantadosi

, Covahey

. Are informed consent forms that describe clinical oncology research protocols readable by most patients and their families? J Clin Oncol, 1994; 12:2211–2215.

28.

Cooley

, Moriarty

, Berger

, Selm-Orr

, Coyle

, Short

. Patient literacy and the readability of cancer educational materials. Oncol Nurses Forum, 1995; 22:1345–1351.

29.

National Cancer Institute. Dictionary of cancer terms. www.cancer.gov/dictionary/. 2010 September 30.

30.

Friedman

, Hoffman-Goetz

, Arocha

. Readability of cancer information on the internet. J Cancer Educ, 2004; 19:117–122.

31.

Wilson

, Kutner

, Levy

. Do health insurance plans perpetuate ambiguity about palliative care? J Palliative Med, 2008; 11:1182.

32.

Davis

, Wolf

, Bass

et al. Low literacy impairs comprehension of prescription drug warning labels. J Gen Intern Med, 2006; 21:847–851.

33.

Wolf

, Shekelle

, Choudhry

, Agnew-Blais

, Parker

, Shrank

. Variability in pharmacy interpretations of physician prescriptions. Med Care, 2009; 47:370–373.

34.

Alexander

. Readability of published dental educational materials. J Am Dent Assoc, 2000; 131:937–942.

35.

Estrada

, Hryniewicz

, Higgs

, Collins

, Byrd

. Anticoagulant patient information material is written at high readability levels. Stroke, 2000; 31:2966–2970.

36.

Cotugna

, Vickery

, Carpenter-Haefele

. Evaluation of literacy level of patient education pages in health-related journals. J Community Health, 2005; 30:213–219.

37.

Lennon

, Burdick

. White paper: The Lexile framework as an approach for reading measurement and success. Metametrics, Inc., April 2004. lexile.com/research/1/. 2010 October 20.

38.

Helitzer

, Hollis

, Lotner

, Oestreicher

. Health literacy demands of written health info material: An assessment of cervical cancer prevention materials. Cancer Control, 2009; 16:70–78.

39.

Weintraub

, Maliski

, Fink

, Choe

, Litwin

. Suitability of prostate cancer education materials: Applying a standardized assessment tool to currently available materials. Patient Educ Couns, 2004; 55:275–280.

40.

D'Alessandro

, Kingsley

, Johnson-West

. The readability of pediatric patient education materials on the world wide web. Arch Pediatr Adolesc Med, 2001; 155:807–812.

41.

Davis

, Mayeaux

, Fredrickson

, Bocchini

, Jackson

, Murphy

. Reading ability of parents compared with reading level of pediatric patient education materials. Pediatrics, 1994; 93:460–468.

42.

Sabharwal

, Badrudeen

, Unes Kunju

. Readability of online patient education materials from the AAOS web site. Clin Orthop Relat Res, 2008; 466:1245–1250.

43.

Adkins

, Singh

. Reading level and readability of patient education materials in mental health. J Child Fam Stud, 2001; 10:1–8.

44.

Dingell

. Remarks regarding the Mammography Quality Standards Reauthorization Act of 1998. Congressional Record—House of Representatives, 105th Congress. September 15, 1998Page H7749.frwebgate.access.gpo.gov/cgi-bin/getpage.cgi?position=all&page=H7749&dbname=1998_record. 2010 September 30.

45.

Carney

. An assessment of the likelihood, frequency, and content of verbal communication between radiologists and women receiving screening and diagnostic mammography. Acad Radiol, 2009; 16:1056–1063.

46.

U.S. Department of Health and Human Services, Health Resources and Services Administration. Maternal and Child Health Bureau. Women's health USA 2008. Rockville, MD: U.S. Department of Health and Human Services mchb.hrsa.gov/whusa08/. 2010 September 30.

47.

American College of Radiology. Accredited facility search. www.acr.org/accreditation/accreditedfacilitysearch.aspx. 2010 September 30.

48.

American College of Radiology. Breast imaging sample lay report letters. www.acr.org/accreditation/mammography/mammo_sample_letters.aspx. 2010 September 30.

49.

Source

. Company press release. 2010 September 15. Additional information available on request.

50.

Source

. Company information. 2010 September 15. Additional information available on request.

51.

Office of Communications and Public Liason, Office of the Director, National Institutes of Health. Clear communication: An NIH Health Literacy Initiative [updated July 20, 2010] www.nih.gov/clearcommunication/plainlanguage.htm. 2010 September 30.

52.

National Cancer Institute. Clear and simple: Developing effective print materials for low-literate readers[Updated February 27, 2003].www.cancer.gov/aboutnci/oc/clear-and-simple/page1. 2010 September 30.

53.

McCarthy

, Yood

, Boohaker

et al. Inadequate follow-up of abnormal mammograms. Am J Prev Med, 1996; 12:282–288.

54.

Brewer

, Salz

, Lillie

. Systematic review: The long-term effects of false-positive mammograms. Ann Intern Med, 2007; 146:502–510.

55.

Kahn

, Luce

M.F.

Understanding high-stakes consumer decisions: Mammography adherence following false alarm test results. Market Sci, 2003; 22:393–410.

56.

Black

, Nease

Jr , Tosteson

ANA

. Perceptions of breast cancer risk and screening effectiveness in women younger than 50 years of age. J Natl Cancer Inst, 1995; 87:720–731.

57.

Rudd

, Comings

. Learner developed materials: An empowering product. Health Educ Behav, 1994; 21:313–327.

58.

Bickmore

, Giorgino

. Health dialog systems for patients and consumers. J Biomed Informatics, 2006; 39:556–571.

59.

Battaglia

, Roloff

, Posner

, Freund

. Improving follow-up to abnormal breast cancer screening in an urban population: A patient navigation intervention. Cancer, 2007; 109,Suppl 2:359–367.

60.

Ell

, Vourlekis

, Lee

, Xie

. Patient navigation and care management following an abnormal mammogram: A randomized clinical trial. Prev Med, 2007; 44:26–33.

61.

Wells

, Battaglia

, Dudley

et al.

Patient navigation: State of the art or is it science?

Cancer, 2008; 113:1999–2010.