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Medicare claims are frequently used to study Clostridioides difficile infection (CDI) epidemiology. However, they lack specimen collection and diagnosis dates to assign location of onset. Algorithms to classify CDI onset location using claims data have been published, but the degree of misclassification is unknown.
Methods:
We linked patients with laboratory-confirmed CDI reported to four Emerging Infections Program (EIP) sites from 2016–2021 to Medicare beneficiaries with fee-for-service Part A/B coverage. We calculated sensitivity of ICD-10-CM codes in claims within ±28 days of EIP specimen collection. CDI was categorized as hospital, long-term care facility, or community-onset using three different Medicare claims-based algorithms based on claim type, ICD-10-CM code position, duration of hospitalization, and ICD-10-CM diagnosis code presence-on-admission indicators. We assessed concordance of EIP case classifications, based on chart review and specimen collection date, with claims case classifications using Cohen’s kappa statistic.
Results:
Of 12,671 CDI cases eligible for linkage, 9,032 (71%) were linked to a single, unique Medicare beneficiary. Compared to EIP, sensitivity of CDI ICD-10-CM codes was 81%; codes were more likely to be present for hospitalized patients (93.0%) than those who were not (56.2%). Concordance between EIP and Medicare claims algorithms ranged from 68% to 75%, depending on the algorithm used (κ = 0.56–0.66).
Conclusion:
ICD-10-CM codes in Medicare claims data had high sensitivity compared to laboratory-confirmed CDI reported to EIP. Claims-based epidemiologic classification algorithms had moderate concordance with EIP classification of onset location. Misclassification of CDI onset location using Medicare algorithms may bias findings of claims-based CDI studies.
With wide-field phased array feed technology, the Australian Square Kilometre Array Pathfinder (ASKAP) is ideally suited to search for seemingly rare radio transient sources that are difficult to discover previous-generation narrow-field telescopes. The Commensal Real-time ASKAP Fast Transient (CRAFT) Survey Science Project has developed instrumentation to continuously search for fast radio transients (duration $\lesssim$ 1 s) with ASKAP, with a particular focus on finding and localising fast radio bursts (FRBs). Since 2018, the CRAFT survey has been searching for FRBs and other fast transients by incoherently adding the intensities received by individual ASKAP antennas, and then correcting for the impact of frequency dispersion on these short-duration signals in the resultant incoherent sum (ICS) in real time. This low-latency detection enables the triggering of voltage buffers, which facilitates the localisation of the transient source and the study of spectro-polarimetric properties at high time resolution. Here we report the sample of 43 FRBs discovered in this CRAFT/ICS survey to date. This includes 22 FRBs that had not previously been reported: 16 FRBs localised by ASKAP to $\lesssim 1$ arcsec and 6 FRBs localised to $\sim 10$ arcmin. Of the new arcsecond-localised FRBs, we have identified and characterised host galaxies (and measured redshifts) for 11. The median of all 30 measured host redshifts from the survey to date is $z=0.23$. We summarise results from the searches, in particular those contributing to our understanding of the burst progenitors and emission mechanisms, and on the use of bursts as probes of intervening media. We conclude by foreshadowing future FRB surveys with ASKAP using a coherent detection system that is currently being commissioned. This will increase the burst detection rate by a factor of approximately ten and also the distance to which ASKAP can localise FRBs.
An estimated 129000 cases of Lyme borreliosis (LB) are reported annually in Europe. In 2022, we conducted a representative web-based survey of 28034 persons aged 18–65 years old in 20 European countries to describe tick and LB risk exposures and perceptions. Nearly all respondents (95.0%) were aware of ticks (range, 90.4% in the UK to 98.8% in Estonia). Among those aware of ticks, most (85.1%) were also aware of LB (range, 70.3% in Switzerland to 97.0% in Lithuania). Overall, 8.3% of respondents reported a past LB diagnosis (range, 3.0% in Romania to 13.8% in Sweden). Respondents spent a weekly median of 7 (interquartile range [IQR] 3–14) hours in green spaces at home and 9 (IQR 4–16) hours away from home during April–November. The most common tick prevention measures always or often used were checking for ticks (44.8%) and wearing protective clothing (40.2%). This large multicountry survey provided needed data that can be used to design targeted LB prevention programmes in Europe.
One reason given for declining levels of trust in politicians and institutions is the incidence of scandals involving voters' representatives. Politicians implicated in scandals, especially financial scandals, typically see their constituents' support for them decrease. It has been suggested that these specific negative judgements about a representative's misconduct spill over onto diffuse political trust in the system as a whole. We argue that the 2009 Parliamentary expenses scandal in the United Kingdom is a strong test of these scandal spillover effects in a non-experimental context. Yet, using a multilevel analysis of survey and representative implication data, we find no evidence for these effects. This is despite voters being aware of their MP's scandal implication, and this awareness affecting voters' support for their own MP. We conclude that voters' judgements about their constituency representatives are unlikely to affect their diffuse political trust.
Medicines routinely funded for use in Wales undergo health technology appraisal by the All Wales Medicines Strategy Group (AWMSG) or the National Institute for Health and Care Excellence (NICE). This includes pediatric license extensions (PLE) notwithstanding any existing advice in adults. A review of the PLE process was conducted with the aim of providing faster access to children’s medicines in Wales.
Methods
Data were collected for PLE appraisals of medicines previously approved for adults by the AWMSG or NICE that subsequently went through the original PLE process between January 2010 and December 2020, or a simplified PLE process between January 2021 and March 2023. Data were analyzed using descriptive statistics and a two-tailed t-test (unequal variance) to test the null hypothesis that the difference between the two means was zero. An alpha of less than 0.05 was considered significant. Feedback was obtained from relevant stakeholders including the Association of the British Pharmaceutical Industry (Wales) and the Royal College of Paediatrics and Child Health.
Results
The AWMSG issued positive recommendations for all PLE appraisals included in the data collected, and these were endorsed by the Welsh Government. Appraisals that went through the original PLE process (n=56) took a mean 229.8 days (standard deviation 55.6), whereas those that went through the simplified PLE process (n=15) took a mean 102.6 days (standard deviation 48.1; p < 0.0001). The rapid access to children’s medicines was welcomed by the Association of the British Pharmaceutical Industry and the Royal College of Paediatrics and Child Health.
Conclusions
Review of the 2020 and 2023 PLE processes facilitated faster access to clinically effective and cost-effective medicines for children in Wales. In March 2023, the AWMSG and the Welsh Government reviewed these results and agreed that because all PLE medicines were approved for use within Wales irrespective of the process used, the AWMSG would no longer be required to routinely appraise PLEs.
Stigma of mental health conditions hinders recovery and well-being. The Honest, Open, Proud (HOP) program shows promise in reducing stigma but there is uncertainty about the feasibility of a randomized trial to evaluate a peer-delivered, individual adaptation of HOP for psychosis (Let's Talk).
Methods
A multi-site, Prospective Randomized Open Blinded Evaluation (PROBE) design, feasibility randomised controlled trial (RCT) comparing the peer-delivered intervention (Let's Talk) to treatment as usual (TAU). Follow-up was 2.5 and 6 months. Randomization was via a web-based system, with permuted blocks of random size. Up to 10 sessions of the intervention over 10 weeks were offered. The primary outcome was feasibility data (recruitment, retention, intervention attendance). Primary outcomes were analyzed by intention to treat. Safety outcomes were reported by as treated status. The study was prospectively registered: https://doi.org/10.1186/ISRCTN17197043.
Results
149 patients were referred to the study and 70 were recruited. 35 were randomly assigned to intervention + TAU and 35 to TAU. Recruitment was 93% of the target sample size. Retention rate was high (81% at 2.5 months primary endpoint), and intervention attendance rate was high (83%). 21% of 33 patients in Let's talk + TAU had an adverse event and 16% of 37 patients in TAU. One serious adverse event (pre-randomization) was partially related and expected.
Conclusions
This is the first trial to show that it is feasible and safe to conduct a RCT of HOP adapted for people with psychosis and individual delivery. An adequately powered trial is required to provide robust evidence.
Translational science rarely addresses the needs of rural communities, perpetuating health inequities. Furthermore, policy and resource allocation reflect this dynamic. Through a partnership between a rural community and a community engagement program, the Rural Health Initiative (RHI) was developed with the goal of building capacity for community-driven translational research in rural settings.
Methods:
We describe the process of forming the RHI and selection of a community health priority to motivate the translational research agenda in this particular rural setting. We used a mixed methods approach utilizing literature review, community survey data, and qualitative evaluation of community meeting discussions. Consensus on a final health priority was built through voting and comparison of voting responses across the three RHI counties through Fisher’s Exact test.
Results:
Four priority topics were identified through literature search, community needs assessment, state/national trend data, and community experts. Priority ranking from a community forum and survey selected the final health priority topic. Healthcare access was selected by all three counties in the RHI community as the most critical health priority to address.
Conclusions:
This program highlights the importance of and methods for community involvement in directing the research conducted in their community. Additionally, through this project, guidance was developed to define the role of community engagement programs supporting work led by communities.
In response to the COVID-19 pandemic, we rapidly implemented a plasma coordination center, within two months, to support transfusion for two outpatient randomized controlled trials. The center design was based on an investigational drug services model and a Food and Drug Administration-compliant database to manage blood product inventory and trial safety.
Methods:
A core investigational team adapted a cloud-based platform to randomize patient assignments and track inventory distribution of control plasma and high-titer COVID-19 convalescent plasma of different blood groups from 29 donor collection centers directly to blood banks serving 26 transfusion sites.
Results:
We performed 1,351 transfusions in 16 months. The transparency of the digital inventory at each site was critical to facilitate qualification, randomization, and overnight shipments of blood group-compatible plasma for transfusions into trial participants. While inventory challenges were heightened with COVID-19 convalescent plasma, the cloud-based system, and the flexible approach of the plasma coordination center staff across the blood bank network enabled decentralized procurement and distribution of investigational products to maintain inventory thresholds and overcome local supply chain restraints at the sites.
Conclusion:
The rapid creation of a plasma coordination center for outpatient transfusions is infrequent in the academic setting. Distributing more than 3,100 plasma units to blood banks charged with managing investigational inventory across the U.S. in a decentralized manner posed operational and regulatory challenges while providing opportunities for the plasma coordination center to contribute to research of global importance. This program can serve as a template in subsequent public health emergencies.
Imagery-focused therapies within cognitive behavioural therapy are growing in interest and use for people with delusions.
Aims:
This review aimed to examine the outcomes of imagery-focused interventions in people with delusions.
Method:
PsycINFO, PubMed, MEDLINE, Web of Science, EMBASE and CINAHL were systematically searched for studies that included a clinical population with psychosis and delusions who experienced mental imagery. The review was informed by the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines and quality appraisal of all included papers was completed using the Crowe Critical Appraisal Tool. Information from included texts was extracted and collated in Excel, which informed the narrative synthesis of results.
Results:
Of 2,736 studies identified, eight were eligible for inclusion and rated for quality with an average score of 70.63%. These studies largely supported their aims in reducing levels of distress and intrusiveness of imagery. Four of the eight studies used case series designs, two were randomised controlled trials, and two reported single case studies. It appears that interventions targeting mental imagery were acceptable and well tolerated within a population of people experiencing psychosis and delusions.
Conclusions:
Some therapeutic improvement was reported, although the studies consisted of mainly small sample sizes. Clinical implications include that people with a diagnosis of psychosis can engage with imagery-focused therapeutic interventions with limited adverse events. Future research is needed to tackle existing weaknesses of design and explore the outcomes of imagery interventions within this population in larger samples, under more rigorous methodologies.
Background: Medicare claims are frequently used to study Clostridioides difficile infection (CDI) epidemiology. Categorizing CDI based on location of onset and potential exposure is critical in understanding transmission patterns and prevention strategies. While claims data are well-suited for identifying prior healthcare utilization exposures, they lack specimen collection and diagnosis dates to assign likely location of onset. Algorithms to classify CDI onset and healthcare association using claims data have been published, but the degree of misclassification is unknown. Methods: We linked patients with laboratory-confirmed CDI reported to four Emerging Infections Program (EIP) sites from 2016-2020 to Medicare beneficiaries using residence, birth date, sex, and hospitalization and/or healthcare exposure dates. Uniquely linked patients with fee-for-service Medicare A/B coverage and complete EIP case report forms were included. Patients with a claims CDI diagnosis code within ±28 days of a positive CDI test reported to EIP were categorized as hospital-onset (HO), long-term care facility onset (LTCFO), or community-onset (CO, either healthcare facility-associated [COHCFA] or community-associated [CA]) using a previously published algorithm based on claim type, ICD-10-CM code position, and duration of hospitalization (if applicable). EIP classifies CDI into these categories using positive specimen collection date and other information from chart review (e.g. admit/discharge dates). We assessed concordance of EIP and claims case classifications using Cohen’s kappa. Results: Of 10,002 eligible EIP-identified CDI cases, 7,064 were linked to a unique beneficiary; 3,451 met Medicare A/B fee-for-service coverage inclusion criteria. Of these, 650 (19%) did not have a claims diagnosis code ±28 days of the EIP specimen collection date (Table); 48% (313/650) of those without a claims diagnosis code were categorized by EIP as CA CDI. Among those with a CDI diagnosis code, concurrence of claims-based and EIP CDI classification was 68% (κ=0.56). Concurrence was highest for HO and lowest for COHCFA CDI. A substantial number of EIP-classified CO CDIs (30%, Figure) were misclassified as HO using the claims-based algorithm; half of these had a primary ICD-10 diagnosis code of sepsis (226/454; 50%). Conclusions: Evidence of CDI in claims data was found for 81% of EIP-reported CDI cases. Medicare classification algorithms concurred with the EIP classification in 68% of cases. Discordance was most common for community-onset CDI patients, many of whom were hospitalized with a primary diagnosis of sepsis. Misclassification of CO-CDI as HO may bias findings of claims-based CDI studies.
The 2014 US National Strategy for Combating Antibiotic-Resistant Bacteria (CARB) aimed to reduce inappropriate inpatient antibiotic use by 20% for monitored conditions, such as community-acquired pneumonia (CAP), by 2020. We evaluated annual trends in length of therapy (LOT) in adults hospitalized with uncomplicated CAP from 2013 through 2020.
Methods:
We conducted a retrospective cohort study among adults with a primary diagnosis of bacterial or unspecified pneumonia using International Classification of Diseases Ninth and Tenth Revision codes in MarketScan and the Centers for Medicare & Medicaid Services databases. We included patients with length of stay (LOS) of 2–10 days, discharged home with self-care, and not rehospitalized in the 3 days following discharge. We estimated inpatient LOT based on LOS from the PINC AI Healthcare Database. The total LOT was calculated by summing estimated inpatient LOT and actual postdischarge LOT. We examined trends from 2013 to 2020 in patients with total LOT >7 days, which was considered an indicator of likely excessive LOT.
Results:
There were 44,976 and 400,928 uncomplicated CAP hospitalizations among patients aged 18–64 years and ≥65 years, respectively. From 2013 to 2020, the proportion of patients with total LOT >7 days decreased by 25% (68% to 51%) among patients aged 18–64 years and by 27% (68%–50%) among patients aged ≥65 years.
Conclusions:
Although likely excessive LOT for uncomplicated CAP patients decreased since 2013, the proportion of patients treated with LOT >7 days still exceeded 50% in 2020. Antibiotic stewardship programs should continue to pursue interventions to reduce likely excessive LOT for common infections.
Empowering the Participant Voice (EPV) is an NCATS-funded six-CTSA collaboration to develop, demonstrate, and disseminate a low-cost infrastructure for collecting timely feedback from research participants, fostering trust, and providing data for improving clinical translational research. EPV leverages the validated Research Participant Perception Survey (RPPS) and the popular REDCap electronic data-capture platform. This report describes the development of infrastructure designed to overcome identified institutional barriers to routinely collecting participant feedback using RPPS and demonstration use cases. Sites engaged local stakeholders iteratively, incorporating feedback about anticipated value and potential concerns into project design. The team defined common standards and operations, developed software, and produced a detailed planning and implementation Guide. By May 2023, 2,575 participants diverse in age, race, ethnicity, and sex had responded to approximately 13,850 survey invitations (18.6%); 29% of responses included free-text comments. EPV infrastructure enabled sites to routinely access local and multi-site research participant experience data on an interactive analytics dashboard. The EPV learning collaborative continues to test initiatives to improve survey reach and optimize infrastructure and process. Broad uptake of EPV will expand the evidence base, enable hypothesis generation, and drive research-on-research locally and nationally to enhance the clinical research enterprise.
This study investigated the effects of Lacticaseibacillus rhamnosus HN001 supplementation on the architecture and gene expression in small intestinal tissues of piglets used as an animal model for infant humans. Twenty-four 10-d-old entire male piglets (4·3 (sd 0·59) kg body weight) were fed an infant formula (IF) (control) or IF supplemented with 1·3 × 105 (low dose) or 7·9 × 106 (high dose) colony-forming units HN001 per ml of reconstituted formula (n 8 piglets/treatment). After 24 d, piglets were euthanised. Samples were collected to analyse the histology and gene expression (RNAseq and qPCR) in the jejunal and ileal tissues, blood cytokine concentrations, and blood and faecal calprotectin concentrations. HN001 consumption altered (false discovery rate < 0·05) gene expression (RNAseq) in jejunal tissues but not in ileal tissues. The number of ileal goblet cells and crypt surface area increased quadratically (P < 0·05) as dietary HN001 levels increased, but no increase was observed in the jejunal tissues. Similarly, blood plasma concentrations of IL-10 and calprotectin increased linearly (P < 0·05) as dietary HN001 levels increased. In conclusion, supplementation of IF with HN001 affected the architecture and gene expression of small intestine tissue, blood cytokine concentration and frequencies, and blood calprotectin concentrations, indicating that HN001 modulated small intestinal tissue maturation and immunity in the piglet model.
Religious believers are often commanded to love like God. On classical accounts, God seems a poor model for human beings: an immutable and impassable being seems incapable of the kind of episodic emotion (sympathy, empathy) that seems required for the best sorts of human love. Models more conducive to human love, on the other hand, are often rejected because they seem to limit God's power and glory. This Element looks first at God and then divine love within the Abrahamic traditions—Islam, Christianity and Judaism. It will then turn to love and the problem of hell, which is argued as primarily a problem for Christians. The author discusses the kind of love each tradition asks of humans and wonders, given recent work in the relevant cognitive and social sciences, if such love is even humanly possible. This title is also available as Open Access on Cambridge Core.
Background: The 2014 US National Strategy for Combating Antibiotic-Resistant Bacteria aimed to reduce inappropriate inpatient antibiotic use by 20% for monitored conditions, such as community-acquired pneumonia (CAP), by 2020. Clinical guidelines recommend treating uncomplicated CAP with a minimum of 5 days of antibiotic therapy. Total length of therapy (LOT) >7 days or >3 days after clinical improvement is rarely necessary. In a previous study estimating LOT in uncomplicated CAP patients, 71% of patients ≥65 years exceeded recommended duration of antibiotics in 2012–2013 (Yi et al, 2018). We evaluated annual trends in LOT in adults ≥65 years hospitalized with uncomplicated CAP from 2013 to 2020. Methods: We conducted a retrospective cohort study among patients in the CMS database with a primary diagnosis of bacterial or unspecified pneumonia using International Classification of Diseases 9th and 10th Revision codes, length of stay (LOS) of 2–10 days, discharged home with self-care, and not rehospitalized in the 3 days following discharge. Discharge home was used as a surrogate for clinical improvement. Because inpatient LOT is not available in CMS data, we used linear regression to model inpatient LOT as a function of LOS using data on CAP patients ≥65 years from the PINC AI healthcare database. Postdischarge LOT was based on prescriptions filled following discharge. Total LOT was calculated by summing estimated inpatient LOT and actual postdischarge LOT (Fig. 1). Total LOT >7 days and postdischarge LOT >3 days were considered indicators of likely excessive LOT. We reported trends in the proportion of patients with likely excessive LOT during the study period. Results: From 2013 through 2020, there were 400,928 uncomplicated CAP hospitalizations among patients aged ≥65 years. Patients were more likely to be female (55%), and they had a median age of 76 years and a median LOS of 3 days. The median total LOT decreased from 9.5 days in 2013 to 7.7 days in 2020. The proportion of patients with total LOT >7 days decreased from 68% in 2013 to 50% in 2020 (% change, −27%); the proportion with postdischarge LOT >3 days decreased from 73% in 2013 to 62% in 2020 (% change, −16%) (Fig. 2). Conclusions: Likely excessive total LOT for adults ≥65 years hospitalized with uncomplicated CAP decreased by 27% in 2020, a considerable improvement from 2013. However, the high proportion of patients with likely excessive postdischarge LOT in 2020 (62%) demonstrates the need for antibiotic stewardship to optimize prescribing at hospital discharge.
OBJECTIVES/GOALS: Supported by the State of Alabama, the Alabama Genomic Health Initiative (AGHI) is aimed at preventing and treating common conditions with a genetic basis. This joint UAB Medicine-HudsonAlpha Institute for Biotechnology effort provides genomic testing, interpretation, and counseling free of charge to residents in each of Alabama’s 67 counties. METHODS/STUDY POPULATION: Launched in 2017, as a state-wide population cohort, AGHI (1.0) enrolled 6,331 Alabamians and returned individual risk of disease(s) related to the ACMG SF v2.0 medically actionable genes. In 2021, the cohort was expanded to include a primary care cohort. AGHI (2.0) has enrolled 750 primary care patients, returning individual risk of disease(s) related to the ACMG SF v3.1 gene list and pre-emptive pharmacogenetics (PGx) to guide medication therapy. Genotyping is done on the Illumina Global Diversity Array with Sanger sequencing to confirm likely pathogenic / pathogenic variants in medically actionable genes and CYP2D6 copy number variants using Taqman assays, resulting in a CLIA-grade report. Disease risk results are returned by genetic counselors and Pharmacogenetics results are returned by Pharmacists. RESULTS/ANTICIPATED RESULTS: We have engaged a statewide community (>7000 participants), returning 94 disease risk genetic reports and 500 PGx reports. Disease risk reports include increased predisposition to cancers (n=38), cardiac diseases (n=33), metabolic (n=12), other (n=11). 100% of participants harbor an actionable PGx variant, 70% are on medication with PGx guidance, 48% harbor PGx variants and are taking medications affected. In 10% of participants, pharmacists sent an active alert to the provider to consider/ recommend alternative medication. Most commonly impacted medications included antidepressants, NSAIDS, proton-pump inhibitors and tramadol. To enable the EMR integration of genomic information, we have developed an automated transfer of reports into the EMR with Genetics Reports and PGx reports viewable in Cerner. DISCUSSION/SIGNIFICANCE: We share our experience on pre-emptive implementation of genetic risk and pharmacogenetic actionability at a population and clinic level. Both patients and providers are actively engaged, providing feedback to refine the return of results. Real time alerts with guidance at the time of prescription are needed to ensure future actionability and value.
Gaps in the implementation of effective interventions impact nearly all cancer prevention and control strategies in the US including Massachusetts. To close these implementation gaps, evidence-based interventions must be rapidly and equitably implemented in settings serving racially, ethnically, socioeconomically, and geographically diverse populations. This paper provides a brief overview of The Implementation Science Center for Cancer Control Equity (ISCCCE) and describes how we have operationalized our commitment to a robust community-engaged center that aims to close these gaps. We describe how ISCCCE is organized and how the principles of community-engaged research are embedded across the center. Principles of community engagement have been operationalized across all components of ISCCCE. We have intentionally integrated these principles throughout all structures and processes and have developed evaluation strategies to assess whether the quality of our partnerships reflects the principles. ISCCCE is a comprehensive community-engaged infrastructure for studying efficient, pragmatic, and equity-focused implementation and adaptation strategies for cancer prevention in historically and currently disadvantaged communities with built-in methods to evaluate the quality of community engagement. This engaged research center is designed to maximize the impact and relevance of implementation research on cancer control in community health centers.