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Background From 2015 to 2020, the Centers for Disease Control and Prevention’s Colorectal Cancer Control Program (CRCCP) supported 30 awardees in partnering with primary care clinics to implement evidence-based interventions (EBIs) and supporting activities (SAs) to increase colorectal cancer (CRC) screening. This study identified factors that facilitated early implementation and sustainability within partner clinics. Methods We conducted longitudinal qualitative case studies of four CRCCP awardees and four of their partner clinics. We used the Consolidated Framework for Implementation Research (CFIR) to frame understanding of factors related to implementation and sustainability. A total of 41 semi-structured interviews were conducted with key staff and stakeholders exploring implementation practices and facilitators to sustainability. Qualitative thematic analysis of interview transcripts identified emerging themes across awardees and clinics. Results Qualitative themes related to six CFIR inner setting constructs—structural characteristics, readiness for implementation, networks and communication, culture, and implementation climate—were identified. Themes related to early implementation included conducting readiness assessments to tailor implementation, providing moderate funding to clinics, identifying clinic champions, and coordinating EBIs and SAs with existing clinic practices. Themes related to sustainability included the importance of ongoing electronic health record (EHR) support, clinic leadership support, team-based care, and EBI and SA integration with clinic policies, workflows, and procedures. Implications Findings help to inform future scale-up of and decision-making within CRC screening programs and other chronic disease prevention programs implementing EBIs and SAs within primary care clinics and also highlight factors that maximize sustainability within these programs.

COVID-19 caused significant declines in colorectal cancer (CRC) screening. Health systems and clinics, faced with a new rapidly spreading infectious disease, adapted to maintain patient safety and address the effects of the pandemic on healthcare delivery. This study aimed to understand how CDC-funded Colorectal Cancer Control Program recipients and their partner health systems and clinics may have modified evidence-based intervention (EBI) implementation to promote CRC screening during the COVID-19 pandemic; to identify barriers and facilitators to implementing modifications; and to extract lessons that can be applied to support CRC screening, chronic disease management, and clinic resilience in the face of future public health crises. Nine recipients were selected to reflect the diversity inherent among all CRCCP recipients. Recipient and clinic partner staff answered unique sets of pre-interview questions to inform tailoring of interview guides that were developed using constructs from the Framework for Reporting Adaptations and Modifications to Evidence-based Implementation Strategies (FRAME-IS) and Consolidated Framework for Implementation Research (CFIR). The study team then interviewed recipient, health system, and clinic partner staff incorporating pre-interview responses to focus each conversation. We employed a rapid qualitative analysis approach then conducted virtual focus groups with recipient representatives to validate emergent themes. Three modifications that emerged from thematic analysis include: (1) offering mailed fecal immunochemical test (FIT) kits for CRC screening with mail or drop off return; (2) increasing the use of patient education and engagement strategies; and (3) increasing the use of or improving automated patient messaging systems. With improved tracking and automated reminder systems, mailed FIT kits paired with tailored patient education and clear instructions for completing the test could help primary care clinics catch up on the backlog of missed screenings during COVID-19. Future research can assess the effectiveness and cost-effectiveness of offering mailed FIT kits on maintaining or improving CRC screening, especially among people who are medically underserved.

Many in the U.S. are not up to date with cancer screening. This systematic review examined the effectiveness of interventions engaging community health workers to increase breast, cervical, and colorectal cancer screening.Authors identified relevant publications from previous Community Guide systematic reviews of interventions to increase cancer screening (1966 through 2013) and from an update search (January 2014-November 2021). Studies written in English and published in peer-reviewed journals were included if they assessed interventions implemented in high-income countries; reported screening for breast, cervical, or colorectal cancer; and engaged community health workers to implement part or all of the interventions. Community health workers needed to come from or have close knowledge of the intervention community.The review included 76 studies. Interventions engaging community health workers increased screening use for breast (median increase=11.5 percentage points, interquartile interval=5.5‒23.5), cervical (median increase=12.8 percentage points, interquartile interval=6.4‒21.0), and colorectal cancers (median increase=10.5 percentage points, interquartile interval=4.5‒17.5). Interventions were effective whether community health workers worked alone or as part of a team. Interventions increased cancer screening independent of race or ethnicity, income, or insurance status.Interventions engaging community health workers are recommended by the Community Preventive Services Task Force to increase cancer screening. These interventions are typically implemented in communities where people are underserved to improve health and can enhance health equity. Further training and financial support for community health workers should be considered to increase cancer screening uptake.

Early during the COVID-19 pandemic, nearly two thirds of unpaid caregivers of adults reported adverse mental or behavioral health symptoms, compared with approximately one third of noncaregivers† (1). In addition, 27% of parents of children aged

Evidence-based interventions, including provider assessment and feedback, provider reminders, patient reminders, and reduction of structural barriers, improve colorectal cancer screening rates. Assessing primary care clinics' readiness to implement these interventions can help clinics use strengths, identify barriers, and plan for success. However, clinics may lack tools to assess readiness and use findings to plan for successful implementation. To address this need, we developed the Field Guide for Assessing Readiness to Implement Evidence-Based Cancer Screening Interventions (Field Guide) for the Centers for Disease Control and Prevention's (CDC's) Colorectal Cancer Control Program (CRCCP). We conducted a literature review of evidence and existing tools to measure implementation readiness, reviewed readiness tools from selected CRCCP award recipients (n = 35), and conducted semi-structured interviews with key informants (n = 8). We sought feedback from CDC staff and recipients to inform the final document. The Field Guide, which is publicly available online, outlines 4 assessment phases: 1) convene team members and determine assessment activities, 2) design and administer the readiness assessment, 3) evaluate assessment data, and 4) develop an implementation plan. Assessment activities and tools are included to facilitate completion of each phase. The Field Guide integrates implementation science and practical experience into a relevant tool to bolster clinic capacity for implementation, increase potential for intervention sustainability, and improve colorectal cancer screening rates, with a focus on patients served in safety net clinic settings. Although this tool was developed for use in primary care clinics for cancer screening, the Field Guide may have broader application for clinics and their partners for other chronic diseases.

Background In 2015, the Centers for Disease Control and Prevention funded the Colorectal Cancer Control Program (CRCCP), which partners with health systems and primary care clinics to increase CRC screening uptake. We interviewed CRCCP stakeholders to explore factors that support an integrated implementation of evidence-based interventions and supporting activities to promote CRC screening with other screening and chronic disease management activities in primary care clinics. Methods Using the Consolidated Framework for Implementation Research, we conducted a literature review and identified constructs to guide data collection and analysis. We purposively selected four CRCCP awardees that demonstrated ongoing engagement with clinic partner sites, willingness to collaborate with CDC and other stakeholders, and availability of high-quality data. We gathered background information on the selected program sites and conducted primary data collection interviews with program staff and partners. We used NVivo QSR 11.0 to systematically pilot-code interview data, achieving a Kappa coefficient of 0.8 or higher, and then implemented a stepwise process to identify site-specific and cross-cutting emergent themes. Results Programs reported that they support clinic partners’ integrated implementation by providing coordinated application processes and braided funding streams, and by funding partner organizations to provide technical assistance to support efficient implementation of evidence-based interventions and supporting activities into existing clinic workflows. These actions, in turn, support clinics in implementing evidence-based interventions and supporting activities that promote both CRC screening and other chronic disease screening and management. Discussion The selected CRCCP programs and their partners implement activities to support the integration of evidence-based interventions and supporting activities with other clinic efforts. These integrated efforts support increased efficiency of clinic workflow, improved coordination of patient care, increased uptake of screening and improved patient outcomes. Conclusions The findings provide insights into how public health programs can support primary care clinics in integrating interventions and activities into existing workflows to support efficient, coordinated delivery of quality patient-centered care.

Women from racial and ethnic minority groups face a disproportionate burden of cervical and breast cancers in the United States. The Coronavirus Disease 2019 (COVID-19) pandemic might exacerbate these disparities as supply and demand for screening services are reduced. The National Breast and Cervical Cancer Early Detection Program (NBCCEDP) provides cancer screening services to women with low income and inadequate health insurance. We examined COVID-19's impact on NBCCEDP screening services during January-June 2020. We found the total number of NBCCEDP-funded breast and cervical cancer screening tests declined by 87% and 84%, respectively, during April 2020 compared with the previous 5-year averages for that month. The extent of declines varied by geography, race/ethnicity, and rurality. In April 2020, screening test volume declined most severely in Health and Human Services Region 2 - New York (96% for breast, 95% for cervical cancer screening) compared to the previous 5-year averages. The greatest declines were among American Indian/Alaskan Native women for breast cancer screening (98%) and Asian Pacific Islander women for cervical cancer screening (92%). Test volume began to recover in May and, by June 2020, NBCCEDP breast and cervical cancer screening test volume was 39% and 40% below the 5-year average for that month, respectively. However, breast cancer screening remained over 50% below the 5-year average among women in rural areas. NBCCEDP programs reported assisting health care providers resume screening.

Introduction: In the United States, disparities in cancer screening, morbidity, and mortality are well documented, and often are related to race/ethnicity and socioeconomic indicators including income, education, and healthcare access. Public health approaches that address social determinants of health have the greatest potential public health benefit, and can positively impact health disparities. As public health interventions, community health workers (CHWs), and patient navigators (PNs) work to address disparities and improve cancer outcomes through education, connecting patients to and navigating them through the healthcare system, supporting patient adherence to screening and diagnostic services, and providing social support and linkages to financial and community resources. Clinical settings, such as federally qualified health centers (FQHCs) are mandated to provide care to medically underserved communities, and thus are also valuable in the effort to address health disparities. We conducted a systematic literature review to identify studies of cancer-related CHW/PN interventions in FQHCs, and to describe the components and characteristics of those interventions in order to guide future intervention development and evaluation. Method: We searched five databases for peer-reviewed CHW/PN intervention studies conducted in partnership with FQHCs with a focus on cancer, carried out in the United States, and published in English between January 1990 and December 2013. Results: We identified 24 articles, all reporting positive outcomes of CHW/PNs interventions in FQHCs. CHW/PN interventions most commonly promoted breast, cervical, or colorectal cancer screening and/or referral for diagnostic resolution. Studies were supported largely through federal funding. Partnerships with academic institutions and community-based organizations provided support and helped develop capacity among FQHC clinic leadership and community members. Discussion: Both the FQHC system and CHW/PNs were borne from the need to address persistent, complex health disparities among medically underserved communities. Our findings support the effectiveness of CHW/PN programs to improve completion and timeliness of breast, cervical, and colorectal cancer screening in FQHCs, and highlight intervention components useful to design and sustainability.

Few data are available on patient navigators (PNs) across diverse roles and organizational settings that could inform optimization of patient navigation models for cancer prevention. The National Breast and Cervical Cancer Early Detection Program (NBCCEDP) and the Colorectal Cancer and Control Program (CRCCP) are two federally-funded screening programs that support clinical- and community-based PNs who serve low-income and un- or underinsured populations across the United States. An online survey assessing PN characteristics, delivered activities, and patient barriers to screening was completed by 437 of 1002 identified PNs (44%). Responding PNs were racially and ethnically diverse, had varied professional backgrounds and practice-settings, worked with diverse populations, and were located within rural and urban/suburban locations across the U.S. More PNs reported working to promote screening for breast/cervical cancers (BCC, 94%) compared to colorectal cancer (CRC, 39%). BCC and CRC PNs reported similar frequencies of individual- (e.g., knowledge, motivation, fear) and community-level patient barriers (e.g., beliefs about healthcare and screening). Despite reporting significant patient structural barriers (e.g., transportation, work and clinic hours), most BCC and CRC PNs delivered individual-level navigation activities (e.g., education, appointment reminders). PN training to identify and champion timely and patient-centered adjustments to organizational policies, practices, and norms of the NBCCEDP, CRCCP, and partner organizations may be beneficial. More research is needed to determine whether multilevel interventions that support this approach could reduce structural barriers and increase screening and diagnostic follow-up among the marginalized communities served by these two important cancer-screening programs.

The Centers for Disease Control and Prevention conducted a systematic screening and assessment process to identify promising practices implemented by grantees of the National Breast and Cervical Cancer Early Detection Program and its partners that were appropriate for rigorous evaluation.The systematic screening and assessment (SSA) process was conducted from September 2010 through March 2012 and included five steps: (1) nominations of promising practices; (2) a first rating by subject matter experts; (3) field-based evaluability assessments; (4) a second rating by experts; and (5) use of results. Nominations were sought in three program areas including health education and promotion, quality assurance and quality improvement, and case management/patient navigation.A total of 98 practices were nominated of which 54 % were eligible for the first review by the experts. Fifteen practices were selected for evaluability assessment with ten forwarded for the second review by the experts. Three practices were ultimately recommended for rigorous evaluation, and one evaluation was conducted. Most nominated practices were based on evidence-based strategies rather than representing new, innovative activities. Issues were identified through the process including inconsistent implementation and lack of implementation fidelity.While the SSA was successful in identifying several programs for evaluation, the process also revealed important shortcomings in program implementation. Training and technical assistance could help address these issues and support improved programming.

INTRODUCTION: Screening for colorectal cancer (CRC) is effective in reducing CRC burden. Primary care clinics have an important role in increasing screening. We investigated associations between clinic-level CRC screening rates of the clinics serving low income, medically underserved population, and clinic-level screening interventions, clinic characteristics and community contexts. METHODS: Using data (2015–16) from the Centers for Disease Control and Prevention's (CDC) Colorectal Cancer Control Program, we linked clinic-level data with county-level contextual data from external sources. Analysis variables included clinic-level CRC screening rates, four different evidence-based interventions (EBIs) intended to increase screening, clinic characteristics, and clinic contexts. In the analysis (2018), we used weighted ordinary least square multiple regression analyses to associate EBIs and other covariates with clinic-level screening rates. RESULTS: Clinics (N = 581) had an average screening rate of 36.3% (weighted. Client reminders had the highest association (5.6 percentage points) with screening rates followed by reducing structural barriers (4.9 percentage points), provider assessment and feedback (3.2 percentage points), and provider reminders (< 1 percentage point). Increases in the number of EBIs was associated with steady increases in the screening rate (5.4 percentage points greater for one EBI). Screening rates were 16.4 percentage points higher in clinics with 4 EBIs vs. no EBI. Clinic characteristics, contexts (e.g. physician density), and context-EBI interactions were also associated with clinic screening rates. CONCLUSIONS: These results may help clinics, especially those serving low income, medically underserved populations, select individual or combinations of EBIs suitable to their contexts while considering costs.

This evidence review addresses whether type 2 diabetes genomic risk panels improve health outcomes (e.g., reduce rates of developing type 2 diabetes) in low- or high-risk adults; two clinical scenarios promulgated by commercial companies offering such testing. Evidence for the analytic validity of available genomic profiles was inadequate. Clinical validity ranged from inadequate to convincing for 30 variants identified on five type 2 diabetes genomic panels and by genome-wide association studies. Eight common variants were identified for general population use; evidence credibility based on published criteria was strong for two variants, moderate for two variants, and weak for four variants. TCF7L2 had the largest per-allele odds ratio of 1.39 (95% confidence interval 1.33–1.46). Models combining the best four, best eight, and all 30 variants used summary effect sizes, reported genotype frequencies, and assumed independent effects. Areas under the curve were 0.547, 0.551, and 0.570, respectively. In high-risk populations, per-allele odds ratios for TCF7L2 alone were similar to those of the general population. TCF7L2, in combination with other variants, yielded minimal improvement in risk reclassification. Evidence on TCF7L2 clinical validity was adequate. Three studies addressed the clinical utility of intervention effectiveness, stratified by TCF7L2 genotype; none found significant interactions. Clinical utility evidence was inadequate. In addition to analytic validity and clinical utility knowledge gaps, additional gaps were identified regarding how to inform, produce, and evaluate models combining multiple variants.

Context Screening reduces mortality from breast, cervical, and colorectal cancers. The Guide to Community Preventive Services previously conducted systematic reviews on the effectiveness of 11 interventions to increase screening for these cancers. This article presents results of updated systematic reviews for nine of these interventions. Evidence acquisition Five databases were searched for studies published during January 2004-October 2008. Studies had to (1) be a primary investigation of one or more intervention category; (2) be conducted in a country with a high-income economy; (3) provide information on at least one cancer screening outcome of interest; and (4) include screening use prior to intervention implementation or a concurrent group unexposed to the intervention category of interest. Forty-five studies were included in the reviews. Evidence synthesis Recommendations were added for one-on-one education to increase screening with fecal occult blood testing (FOBT) and group education to increase mammography screening. Strength of evidence for client reminder interventions to increase FOBT screening was upgraded from sufficient to strong. Previous findings and recommendations for reducing out-of-pocket costs (breast cancer screening); provider assessment and feedback (breast, cervical, and FOBT screening); one-on-one education and client reminders (breast and cervical cancer screening); and reducing structural barriers (breast cancer and FOBT screening) were reaffirmed or unchanged. Evidence remains insufficient to determine effectiveness for the remaining screening tests and intervention categories. Conclusions Findings indicate new and reaffirmed interventions effective in promoting recommended cancer screening, including colorectal cancer screening. Findings can be used in community and healthcare settings to promote recommended care. Important research gaps also are described.

Purpose Postdoctoral pharmacy industry fellowship programs and the employment of fellowship graduates are described. Methods A list of postgraduate industry fellowships was gathered from the 2009 ASHP Midyear Clinical Meeting. Data regarding program characteristics were collected using the Personnel Placement Service database and program-specific brochures. After data compilation, a standardized survey was sent in January 2010 via e-mail to the point of contact for all programs to confirm the accuracy of the program’s characteristics. Only academically affiliated industry fellowship programs were analyzed. Retrospective data were collected regarding the first position of employment for all fellows who graduated from the program between 2005 and 2009 and the position of those same individuals at the time of survey completion. Results Surveys were sent to 64 postgraduate industry fellowship programs affiliated with a school of pharmacy, 56 (87.5%) of whom responded. The departmental breakdown for positions offered ( n = 75) across all academically affiliated industry fellowship programs (including nonresponders) was as follows: medical affairs (38.7%, n = 29), clinical research (32.0%, n = 24), regulatory affairs (9.3%, n = 7), commercial (8.0%, n = 6), health economics and outcomes research (8.0%, n = 6), and pharmacovigilance (4.0%, n = 3). Data from fellows during years 1–5 after completion of the industry fellowship indicated that 90.5% of former fellows remained in the industry ( n = 238). Conclusion The postgraduate industry fellowship programs surveyed indicated that the majority of fellowship graduates continued to hold positions in industry after program completion. The majority of industry fellowships and subsequent job placements occurred in the areas of medical affairs, clinical research, and regulatory affairs.

Eur J Clin Invest 2011; 41 (9): 1010–1035 Summary Points • The rapid and continuing progress in gene discovery for complex diseases is fuelling interest in the potential application of genetic risk models for clinical and public health practice. • The number of studies assessing the predictive ability is steadily increasing, but they vary widely in completeness of reporting and apparent quality. • Transparent reporting of the strengths and weaknesses of these studies is important to facilitate the accumulation of evidence on genetic risk prediction. • A multidisciplinary workshop sponsored by the Human Genome Epidemiology Network developed a checklist of 25 items recommended for strengthening the reporting of Genetic RIsk Prediction Studies (GRIPS), building on the principles established by prior reporting guidelines. • These recommendations aim to enhance the transparency, quality and completeness of study reporting and thereby to improve the synthesis and application of information from multiple studies that might differ in design, conduct or analysis.

Most major medical organizations recommend routine screening for breast, cervical, and colorectal cancers. Screening can lead to early detection of these cancers, resulting in reduced mortality. Yet, not all people who should be screened are screened regularly or, in some cases, ever. This report presents results of systematic reviews of effectiveness, applicability, economic efficiency, barriers to implementation, and other harms or benefits of provider reminder/recall interventions to increase screening for breast, cervical, and colorectal cancers. These interventions involve using systems to inform healthcare providers when individual clients are due (reminder) or overdue (recall) for specific cancer screening tests. Evidence in this review of studies published from 1986 through 2004 indicates that reminder/recall systems can effectively increase screening with mammography, Pap, fecal occult blood tests, and flexible sigmoidoscopy. Additional research is needed to determine if provider reminder/recall systems are effective in increasing colorectal cancer screening by colonoscopy. Specific areas for further research are also suggested.

Most major medical organizations recommend routine screening for breast, cervical, and colorectal cancers. Screening can lead to early detection of these cancers, resulting in reduced mortality. Yet not all people who should be screened are screened, either regularly or, in some cases, ever. This report presents the results of systematic reviews of effectiveness, applicability, economic efficiency, barriers to implementation, and other harms or benefits of interventions designed to increase screening for breast, cervical, and colorectal cancers by increasing community demand for these services. Evidence from these reviews indicates that screening for breast cancer (mammography) and cervical cancer (Pap test) has been effectively increased by use of client reminders, small media, and one-on-one education. Screening for colorectal cancer by fecal occult blood test has been increased effectively by use of client reminders and small media. Additional research is needed to determine whether client incentives, group education, and mass media are effective in increasing use of any of the three screening tests; whether one-on-one education increases screening for colorectal cancer; and whether any demand-enhancing interventions are effective in increasing the use of other colorectal cancer screening procedures (i.e., flexible sigmoidoscopy, colonoscopy, double contrast barium enema). Specific areas for further research are also suggested in this report.

Most major medical organizations recommend routine screening for breast, cervical, and colorectal cancers. Screening can lead to early detection of these cancers, resulting in reduced mortality. Yet not all people who should be screened are screened, either regularly or, in some cases, ever. This report presents the results of systematic reviews of effectiveness, applicability, economic efficiency, barriers to implementation, and other harms or benefits of interventions designed to increase screening for breast, cervical, and colorectal cancers by increasing community demand for these services. Evidence from these reviews indicates that screening for breast cancer (mammography) and cervical cancer (Pap test) has been effectively increased by use of client reminders, small media, and one-on-one education. Screening for colorectal cancer by fecal occult blood test has been increased effectively by use of client reminders and small media. Additional research is needed to determine whether client incentives, group education, and mass media are effective in increasing use of any of the three screening tests; whether one-on-one education increases screening for colorectal cancer; and whether any demand-enhancing interventions are effective in increasing the use of other colorectal cancer screening procedures (i.e., flexible sigmoidoscopy, colonoscopy, double contrast barium enema). Specific areas for further research are also suggested in this report. (Am J Prev Med 2008;35(1S):S34-S55) © 2008 American Journal of Preventive Medicine

Context The National Breast and Cervical Cancer Early Detection Program (NBCCEDP) provides cancer screening to low-income, un-, and underinsured women through more than 11 000 primary care clinics. The program is well-positioned to work with health systems to implement evidence-based interventions (EBIs) to increase screening among all women. Objective To collect baseline data on EBI use, evaluation of EBIs, and related training needs among NBCCEDP grantees. Design The Centers for Disease Control and Prevention conducted a Web-based survey in late 2013 among NBCCEDP grantees for the period July 2012 to June 2013. This was the first systematic assessment of EBIs among NBCCEDP grantees. Setting The Centers for Disease Control and Prevention's NBCCEDP. Participants Primarily program directors/coordinators for all 67 NBCCEDP grantees. Main outcome measures Data captured were used to assess implementation of 5 EBIs, their evaluation, and related training needs. Frequencies and proportions were determined. Cluster analysis identified grantees with similar patterns of EBI use for NBCCEDP clients and providers. Results On average, 4.1 of 5 EBIs were implemented per grantee for NBCCEDP clients and providers. Four clusters were identified including "high overall EBI users," "high provider EBI users," "high EBI users with no provider assessment and feedback," and "high client EBI users." Only 1.8 EBIs were implemented, on average, with non-NBCCEDP clients and providers. Fewer than half (n = 32, 47.8%) of grantees conducted process or outcome evaluation of 1 or more EBIs. Overall, 47.6% of grantees reported high or medium training needs for client-oriented EBIs and 54.3% for provider-oriented EBIs. Conclusions The NBCCEDP grantees are implementing EBIs extensively with clients and providers. Increased EBI use among non-NBCCEDP clients/providers is needed to extend the NBCCEDP's reach and impact. Grantee training and technical assistance is necessary across EBIs. In addition, grantees' use of process and outcome evaluation of EBI implementation must be increased to inform effective program implementation.

Individuals with Lynch syndrome, sometimes referred to as hereditary non-polyposis colorectal cancer (HNPCC), have an increased risk of developing colorectal cancer (CRC) as well as other cancers. The increased risk is due to inherited mutations in mismatch repair (MMR) genes, which reduce the ability of cells to repair DNA damage. Screening for Lynch syndrome in individuals newly diagnosed with colorectal cancer has been proposed as part of a strategy that combines tests and interventions to reduce the risk of colorectal cancer in the relatives of the colorectal cancer patients with Lynch Syndrome. Abstract Individuals with Lynch syndrome, sometimes referred to as hereditary non-polyposis colorectal cancer (HNPCC), have an increased risk of developing colorectal cancer (CRC) as well as other cancers. The increased risk is due to inherited mutations in mismatch repair (MMR) genes, which reduce the ability of cells to repair DNA damage. Screening for Lynch syndrome in individuals newly diagnosed with colorectal cancer has been proposed as part of a strategy that combines tests and interventions to reduce the risk of colorectal cancer in the relatives of the colorectal cancer patients with Lynch Syndrome. Abstract Individuals with Lynch syndrome, sometimes referred to as hereditary non-polyposis colorectal cancer (HNPCC), have an increased risk of developing colorectal cancer (CRC) as well as other cancers. The increased risk is due to inherited mutations in mismatch repair (MMR) genes, which reduce the ability of cells to repair DNA damage. Screening for Lynch syndrome in individuals newly diagnosed with colorectal cancer has been proposed as part of a strategy that combines tests and interventions to reduce the risk of colorectal cancer in the relatives of the colorectal cancer patients with Lynch Syndrome.

Purpose: The development of health-related genomic tests is decentralized and dynamic, involving government, academic, and commercial entities. Consequently, it is not easy to determine which tests are in development, currently available, or discontinued. We developed and assessed the usefulness of a systematic approach to identifying new genomic tests on the Internet. Methods: We devised targeted queries of Web pages, newspaper articles, and blogs (Google Alerts) to identify new genomic tests. We finalized search and review procedures during a pilot phase that ended in March 2010. Queries continue to run daily and are compiled weekly; selected data are indexed in an online database, the Genomic Applications in Practice and Prevention Finder. Results: After the pilot phase, our scan detected approximately two to three new genomic tests per week. Nearly two thirds of all tests (122/188, 65%) were related to cancer; only 6% were related to hereditary disorders. Although 88 (47%) of the tests, including 2 marketed directly to consumers, were commercially available, only 12 (6%) claimed United States Food and Drug Administration licensure. Conclusion: Systematic surveillance of the Internet provides information about genomic tests that can be used in combination with other resources to evaluate genomic tests. The Genomic Applications in Practice and Prevention Finder makes this information accessible to a wide group of stakeholders.

The rapid and continuing progress in gene discovery for complex diseases is fuelling interest in the potential application of genetic risk models for clinical and public health practice. The number of studies assessing the predictive ability is steadily increasing, but they vary widely in completeness of reporting and apparent quality. Transparent reporting of the strengths and weaknesses of these studies is important to facilitate the accumulation of evidence on genetic risk prediction. A multidisciplinary workshop sponsored by the Human Genome Epidemiology Network developed a checklist of 25 items recommended for strengthening the reporting of Genetic RIsk Prediction Studies (GRIPS), building on the principles established by prior reporting guidelines. These recommendations aim to enhance the transparency, quality and completeness of study reporting and thereby to improve the synthesis and application of information from multiple studies that might differ in design, conduct or analysis. © 2011 The Authors. European Journal of Clinical Investigation © 2011 Stichting European Society for Clinical Investigation Journal Foundation.

To address the key question of whether using available "cardiogenomic profiles" leads to improved health outcomes (e. g., reduction in rates of myocardial infarction and stroke) and whether these profiles help in making medical or personal decisions. Methods: A targeted evidence-based review based on published Evaluation of Genomic Applications in Practice and Prevention methodologies. Results: No study addressed the overarching question directly. Evidence for the analytic validity of genomic profiles was inadequate for most genes (scale: convincing, adequate, and inadequate), but based on gray data, the analytic sensitivity and specificity might be adequate. For the 29 candidate genes (58 separate associations reviewed), the credibility of evidence for clinical validity was weak (34 associations) to moderate (23 associations), based on limited evidence, potential biases, and/or variability between included studies. The association of 9p21 variants with heart disease had strong credibility with odds ratios of 0.80 (95% confidence interval: 0.77-0.82) and 1.25 (95% confidence interval: 1.21-1.30), respectively, for individuals with no, or two, at-risk alleles versus those with one at-risk allele. Using a multiplicative model, we combined information from 24 markers predicting heart disease and from 13 markers for stroke. The areas under the curves (64.7% and 55.2%, respectively), and overall screening performance (detection rates of 24% and 14% at a 10% false-positive rate, respectively) do not warrant use as stand-alone tests. Conclusion: Even if genomic markers were independent of traditional risk factors, reports indicate that cardiovascular disease risk reclassification would be small. Improvement in health could occur with earlier initiation or higher adherence to medical or behavioral interventions, but no prospective studies documented such improvements (clinical utility). Genet Med 2010:12(12):772-784.

Most major medical organizations recommend routine screening for breast, cervical, and colorectal cancers. Screening can lead to early detection of these cancers, resulting in reduced mortality. Yet, not all people who should be screened are screened regularly or, in some cases, ever. This report presents results of systematic reviews of effectiveness, applicability, economic efficiency, barriers to implementation, and other harms or benefits of provider reminder/recall interventions to increase screening for breast, cervical, and colorectal cancers. These interventions involve using systems to inform healthcare providers when individual clients are due (reminder) or overdue (recall) for specific cancer screening tests. Evidence in this review of studies published from 1986 through 2004 indicates that reminder/recall systems can effectively increase screening with mammography, Pap, fecal occult blood tests, and flexible sigmoidoscopy. Additional research is needed to determine if provider reminder/recall systems are effective in increasing colorectal cancer screening by colonoscopy. Specific areas for further research are also suggested.

1. Clarifying how to define the clinical disorder—Lynch syndrome. In this supplementary review, Lynch syndrome refers to individuals with a predisposition to CRC and certain other malignancies as a result of a germline mismatch repair (MMR) gene mutation—including those with an existing cancer and those who have not yet developed cancer. This definition allows planned analyses of clinical validity and utility to be more straightforward. Several recent editorials and publications recommend that the ambiguous term HNPCC be abandoned and that this clarified definition of Lynch syndrome should be used instead. 2. Removing family history from consideration as a preliminary test. A previous evidence review showed that screening performance of both the Amsterdam and the Bethesda criteria to identify individuals with Lynch syndrome were highly heterogeneous, possibly due to differences among the populations tested. In a general population, Amsterdam criteria are associated with relatively low sensitivity (28‐45%), but high specificity (99%), whereas Bethesda criteria are associated with higher sensitivity (73‐91%), but at the cost of lower specificity (82‐77%). Neither provides the necessary high sensitivity/specificity in a reliable and consistent manner. There are also gaps in knowledge relating to the time required to

Most major medical organizations recommend routine screening for breast, cervical, and colorectal cancers. Screening can lead to early detection of these cancers, resulting in reduced mortality. Yet not all people who should be screened are screened, either regularly or, in some cases, ever. This report presents the results of systematic reviews of effectiveness, applicability, economic efficiency, barriers to implementation, and other harms or benefits of interventions designed to increase screening for breast, cervical, and colorectal cancers by increasing community demand for these services. Evidence from these reviews indicates that screening for breast cancer (mammography) and cervical cancer (Pap test) has been effectively increased by use of client reminders, small media, and one-on-one education. Screening for colorectal cancer by fecal occult blood test has been increased effectively by use of client reminders and small media. Additional research is needed to determine whether client incentives, group education, and mass media are effective in increasing use of any of the three screening tests; whether one-on-one education increases screening for colorectal cancer; and whether any demand-enhancing interventions are effective in increasing the use of other colorectal cancer screening procedures (i.e., flexible sigmoidoscopy, colonoscopy, double contrast barium enema). Specific areas for further research are also suggested in this report.

Most major medical organizations recommend routine screening for breast, cervical, and colorectal cancers. Screening can lead to early detection of these cancers, resulting in reduced mortality. Yet not all people who should be screened are screened, either regularly or, in some cases, ever. This report presents the results of systematic reviews of effectiveness, applicability, economic efficiency, barriers to implementation, and other harms or benefits of interventions designed to increase screening for breast, cervical, and colorectal cancers by increasing community access to these services. Evidence from these reviews indicates that screening for breast cancer (by mammography) has been increased effectively by reducing structural barriers and by reducing out-of pocket client costs, and that screening for colorectal cancer (by fecal occult blood test) has been increased effectively by reducing structural barriers. Additional research is needed to determine whether screening for cervical cancer (by Pap test) can be increased by reducing structural barriers and by reducing out-of-pocket costs, whether screening for colorectal cancer (fecal occult blood test) can be increased by reducing out-of-pocket costs, and whether these interventions are effective in increasing the use of other colorectal cancer screening procedures (i.e., flexible sigmoidoscopy, colonoscopy, double contrast barium enema). Specific areas for further research are also suggested in this report.

Colorectal cancer is the third most common cancer and the second leading cause of cancer-related deaths in the United States. Screening has been shown to be effective in reducing colorectal cancer incidence and mortality. Colonoscopy, sigmoidoscopy, and fecal occult blood tests are all recommended screening tests that have widespread availability. Nevertheless, many people do not receive the evidence-based recommended screening for colorectal cancer. Additional stool-based methods have been developed that offer more options for colorectal cancer screening, including a variety of fecal DNA tests. The only fecal DNA test that is currently available commercially in the United States is ColoSure(TM), which is marketed as a non-invasive test that detects an epigenetic marker (methylated vimentin) associated with colorectal cancer and pre-cancerous adenomas. We examined the published literature on the analytic validity, clinical validity, and clinical utility of ColoSure and we briefly summarized the current colorectal cancer screening guidelines regarding fecal DNA testing. We also addressed the public health implications of the test and contextual issues surrounding the integration of fecal DNA testing into current colorectal cancer screening strategies. The primary goal was to provide a basic overview of ColoSure and identify gaps in knowledge and evidence that affect the recommendation and adoption of the test in colorectal cancer screening strategies.