When describing harms and benefits to potential trial participants, participant information leaflets are inadequate.

BACKGROUND: Providing informed consent for trials requires providing trial participants with comprehensive information about the trial, including information about potential risks and benefits. It is required by the ethical principle of respecting patient autonomy. Our study examines the variation in the way information about potential trial benefits and harms is shared in participant information leaflets (PILs). METHODS: A total of 214 PILs and informed consent forms from clinical trials units (CTUs) and Clinical Research Facilities (CRFs) in Ireland and the UK were assessed by two authors independently, to check the extent to which they adhered to seven recently developed principles. Discrepancies were resolved by a third. RESULTS: Usage of the seven principles varied widely between PILs regardless of the intended recipient or trial type. None of the PILs used more than four principles, and some (4%) used none. Twenty-seven per cent of PILs presented information about all known potential harms, whereas 45% presented information on all known potential benefits. Some PILs did not provide any potential harms or potential benefits (8%). There was variation in the information contained in adult and children PILs and across disease areas. CONCLUSION: Significant variation exists in how potential trial benefits and harms are described to potential trial participants in PILs in our sample. Usage of the seven principles of good practice will promote consistency, ensure informed ethical decision-making and invoke trust and transparency. In the long term, a standardised PIL template is needed.

National Postpartum Permanent Contraception Practices and Perceived Barriers.

Single institution-level studies have demonstrated low postpartum permanent contraception fulfillment rates after vaginal birth. To explore the national scope of the problem, we collected cross-sectional survey data from faculty at 109 U.S. academic medical centers to elicit perceptions about postpartum permanent contraception practices after vaginal birth, including barriers to and changes in practice after the Dobbs v Jackson Women's Health Organization decision, a decision that eliminated the U.S. federal protection of the right to abortion. Of 68 respondent institutions, 65 (95.6%) offered postpartum permanent contraception. A large majority (87.3%) perceived there to be a problem with postpartum permanent contraception fulfillment at their institution. Respondents at institutions with postpartum permanent contraception fulfillment rates in the bottom quartile used main operating rooms (66.7% vs 25.0% respectively, P =.032) and reported institutional culture barriers (86.7% vs 50.0%, respectively, P =.054) more frequently than respondents in the top quartile. Our national data indicate that health care culture changes and the use of labor and delivery operating rooms could increase postpartum permanent contraception fulfillment.

How do trial teams plan for retention during the design stage of the trial? A scoping review.

BACKGROUND: Retention to trials is important to ensure the results of the trial are valid and reliable. The SPIRIT guidelines (18b) require "plans to promote participant retention and complete follow-up, including list of any outcome data to be collected for participants who discontinue or deviate from intervention protocols" be included in trial protocols. It is unknown how often protocols report this retention information. The purpose of our scoping review is to establish if, and how, trial teams report plans for retention during the design stage of the trial. MATERIALS AND METHODS: A scoping review with searches in key databases (PubMed, Scopus, EMBASE, CINAHL (EBSCO), and Web of Science from 2014 to 2019 inclusive) to identify randomised controlled trial protocols. We produced descriptive statistics on the characteristics of the trial protocols and also on those adhering to SPIRIT item 18b. A narrative synthesis of the retention strategies was also conducted. RESULTS: Eight-hundred and twenty-four protocols met our inclusion criteria. RCTs (n = 722) and pilot and feasibility trial protocols (n = 102) reported using the SPIRIT guidelines during protocol development 35% and 34.3% of the time respectively. Of these protocols, only 9.5% and 11.4% respectively reported all aspects of SPIRIT item 18b "plans to promote participant retention and to complete follow-up, including list of any outcome data for participants who discontinue or deviate from intervention protocols". Of the RCT protocols, 36.8% included proactive "plans to promote participant retention" regardless of whether they reported using SPIRIT guidelines or not. Most protocols planned "combined strategies" (48.1%). Of these, the joint most commonly reported were "reminders and data collection location and method" and "reminders and monetary incentives". The most popular individual retention strategy was "reminders" (14.7%) followed by "monetary incentives- conditional" (10.2%). Of the pilot and feasibility protocols, 40.2% included proactive "plans to promote participant retention" with the use of "combined strategies" being most frequent (46.3%). The use of "monetary incentives - conditional" (22%) was the most popular individual reported retention strategy. CONCLUSION: There is a lack of reporting of plans to promote participant retention in trial protocols. Proactive planning of retention strategies during the trial design stage is preferable to the reactive implementation of retention strategies. Prospective retention planning and clear communication in protocols may inform more suitable choice, costing and implementation of retention strategies and improve transparency in trial conduct.

Impaired cognitive and motor function are coincident with L-DOPA-induced dyskinesia in a model of Parkinson's disease.

Dopamine transmission has been implicated in motor and cognitive function. In Parkinson's disease (PD), dopamine replacement using the precursor drug L-DOPA is the predominant treatment approach, but long-term exposure leads to the onset of dyskinesias (LIDs). Chronic L-DOPA exposure has been associated with changes in gene expression and altered cortico-striatal plasticity. The aim of this research was to assess the functional consequence of long-term L-DOPA exposure on cognitive and motor function using a rodent model of PD. Across two independent experiments, we assessed the impact of chronic L-DOPA exposure, or a control D2R agonist, on motor and cognitive function in intact and in hemi parkinsonian rats, in the absence of drug. Abnormal involuntary movements associated with LID were measured and brain tissues were subsequently harvested for immunohistochemical analysis. Exposure to chronic L-DOPA, but not the D2R agonist, impaired motor and cognitive function, when animals were tested in the absence of drug. A meta-analysis of the two experiments allowed further dissociation of L-DOPA -treated rats into those that developed LIDs (dyskinetic) and those that did not develop LIDs (non-dyskinetic). This analysis revealed impaired cognitive and motor performance were evident only in dyskinetic, but not in non-dyskinetic, rats. These data reveal a functional consequence of the altered plasticity associated with LID onset and have implications for understanding symptom progression in the clinic.

Human Papillomavirus Inpatient Postpartum Vaccination: Clinical Guideline Implementation.

OBJECTIVE: The nine-valent human papillomavirus (9vHPV) vaccine is highly effective at preventing cervical cancer, yet U.S. vaccination rates remain low. The objective of this study was to evaluate integration of 9vHPV inpatient vaccination into routine postpartum care. METHODS: Obstetrics professionals at an academic urban referral center received an emailed protocol outlining a novel 9vHPV vaccination program of postpartum inpatients aged 26 years or younger. A retrospective evaluation from March 2021 to March 2022 was conducted to evaluate implementation. Characteristics of patients vaccinated before pregnancy compared with vaccine-eligible patients (none, unknown, or partially vaccinated status) were compared by the use of χ2, analysis of variance, and multivariable logistic regression. Similarly, analyses were performed comparing vaccine-eligible patients who did with those who did not receive an inpatient 9vHPV vaccination. RESULTS: Of 569 postpartum inpatients, 370 (65.0%) were already vaccinated, 70 (34.2%) were never vaccinated, 49 (24.6%) were partially vaccinated, and 80 (14.1%) had unknown status. Of vaccine-eligible patients, 46 (23.1%) received 9vHPV vaccination as an inpatient. In multivariable analysis, race and ethnicity, marital status, and primary language were significant predictors of vaccination before pregnancy. Among vaccine-eligible patients, inpatient vaccination recipients were primarily Hispanic, Spanish speaking, and publicly insured. In multivariable analysis of vaccine-eligible patients, receiving care from the certified nurse midwifery practice was the only independent predictor of vaccination (odds ratio 2.4, 95% CI 1.02-5.74, P=.04). CONCLUSION: Non-Hispanic White, Spanish-speaking, and married patients were disproportionally undervaccinated in our baseline population, but about one quarter of vaccine-eligible patients received 9vHPV vaccination postpartum. Inpatient postpartum 9vHPV vaccination may help narrow disparities in vaccination.

Omission of Pelvic Examination Before Gender-Affirming Hysterectomy and Vaginectomy.

Surgeons may be performing pelvic examinations on transgender patients before gender-affirming pelvic surgery (hysterectomy and vaginectomy) without a clinically significant indication. A retrospective cohort study was conducted at a single-institution academic referral center comparing 30-day perioperative outcomes of all 62 gender-affirming pelvic surgeries, including hysterectomy alone, hysterectomy with vaginectomy, and vaginectomy alone, between April 2018 and March 2022. More than half (53.2%, n=33) of the 62 patients did not have an in-office, preoperative, internal pelvic examination within 1 year of gender-affirming surgery. There were no significant differences in patient characteristics nor 30-day perioperative outcomes between the examined and examination-omitted groups, suggesting that omission of a preoperative pelvic examination is probably safe before gender-affirming hysterectomy and vaginectomy, minimizing barriers to gender-affirming surgical care.

The influence of music liking on episodic memory for rich spatiotemporal contexts.

It is thought that the presence of music influences episodic memory encoding. However, no studies have isolated the influence of music liking - the hedonic value listeners attribute to a musical stimulus - from that of the core affect induced by the presence of that music. In an online survey, participants rated musical excerpts in terms of how much they liked them, as well as in terms of felt valence, felt arousal and familiarity. These ratings were then used to inform the stimuli presented in an online episodic memory task which, across different scenarios, involved dragging cued objects to cued locations and then recalling details of what was moved, where they were moved to and the order of movements made. Our results showed an influence of liking and music-reward sensitivity on memory for what was moved, as well as a detrimental effect of arousing musical stimuli on memory for un-cued scenario details. Taken together, our study showcases the importance of episodic memory paradigms that involve rich spatiotemporal contexts and provides insights into how different aspects of episodic memory may be influenced by the presence of music.

How do trial teams plan for retention during the design stage of the trial? A scoping review protocol.

BACKGROUND: Retention remains a major challenge for many clinical trials. The SPIRIT guidelines state the following information on retention should be included in the trial protocol "Plans to promote participant retention and complete follow-up, including list of any outcome data to be collected for participants who discontinue or deviate from intervention protocols". This guidance shows the importance of planning retention methods and handling missing data as this can impact how the results of the trial are interpreted. The most recent Cochrane review of strategies to improve retention in clinical trials highlighted that some trials implemented multiple retention strategies and we questioned whether the use of multiple strategies was planned at the design stage and included in the protocol or are strategies implemented when retention becomes an issue within the trial. The purpose of our scoping review is to establish if and how trial teams prepare for retention at the design phase of clinical trials. METHODS AND ANALYSIS: We will follow the methodological framework and guidelines for scoping reviews outlined by the Joanna Briggs Institute. We will search MEDLINE/PubMed, Scopus, EMBASE, CINAHL (EBSCO), and Web of Science. A comprehensive search strategy for PubMed was developed in collaboration with an experienced research librarian. We will include protocols for phase 2, 3, and 4 RCTs as well as pilot and feasibility studies. The screening process will involve two reviewers. EM will independently screen all titles and abstracts. FS will screen 10% of the overall search output, and where necessary full protocol texts will be screened to determine eligibility. We will randomly sample eligible protocols to ensure the protocols represent a variety of trial and intervention types. Data will be extracted from each protocol and the results will be synthesised. The analysis will be qualitative using a narrative summary and descriptive statistics where appropriate. DISCUSSION: The scoping review will help trial methodologists better understand if retention strategies are planned for during the design stage of the trial contributing to the PRioRiTy II unanswered question "How should people who run trials plan for retention during their funding application and creation of the trial (protocol development)?".

How much is the lack of retention evidence costing trial teams in Ireland and the UK?

BACKGROUND: Evidence to support the use of many retention strategies in clinical trials is lacking. Despite this, trial teams still need to have some form of retention strategy in their trials to try and avoid high attrition rates. This study aimed to estimate how much this lack of retention evidence might be costing trials in Ireland and the UK. METHODS: We selected the top ten most routinely used retention strategies by Clinical Trial Units in the UK and made assumptions as to how each of these strategies was most likely to be implemented and the costs involved in doing this. We applied our costing model to a hypothetical trial scenario in both Ireland and the UK as well as to three published trial protocols. We developed the costing model and calculated the costs in Microsoft Excel. RESULTS: Retention strategies were often poorly specified, meaning we had to make assumptions about implementation and in some cases about the strategy itself. Based on our assumptions, some retention strategies can be extremely expensive; some of the costliest strategies included "data collection scheduled with routine care" (€900-€32,503.25), "a timeline of participant visits for sites"-with integrated participant reminder (€304.74-€14,803.70), and "routine site visits by CTU staff" and "investigator meetings face to face", both costing (€777.67-€14,753.48). Others such as "telephone reminders for questionnaire response" (€34.58-€568.62), "a timeline of participant visits for sites"-site reminder alone (€79.18-€112.23), and "targeted recruitment of sites/GPs" (€30-€1620) were less costly compared to the other strategies. DISCUSSION: The resources invested in the use of some retention strategies may outweigh known or imagined benefits on retention. Where benefits are currently unknown, evaluation should be a priority. CONCLUSION: More evaluation of the effectiveness and cost of trial retention strategies is needed to avoid widespread use of strategies that are both expensive and ineffective.

Yersinia enterocolitica in wild and peridomestic rodents within Great Britain, a prevalence study.

Yersinia enterocolitica is a human pathogen transmitted via the faecal-oral route among animals and humans and is a major foodborne public health hazard. This study explores the role of Y. enterocolitica transmission at the livestock-wildlife interface and investigates the potential role wild and peridomestic rodents play as a source of this zoonotic pathogen. The total of 342 faecal samples collected from the seven rodent species and one insectivore was examined using an optimized protocol to culture and identify Y. enterocolitica. Positive samples were also bioserotyped for grouping and determination of sample pathogenicity. Wildlife species sampled in this study were separated into two sample groups: randomly sampled (brown rats, house mice, wood mice, bank voles, field voles and the common shrew), as well as targeted sampling (red and grey squirrels). The overall prevalence of Y. enterocolitica in the randomly sampled population was 3.73%. Brown rats were chosen as sentinel species and tested to determine if location (pig farm vs non-pig farm) was a significant factor affecting Y. enterocolitica prevalence. In this study, location was not significant. All positive samples were found to be of biotype 1A, deemed non-pathogenic. Three of the samples were serotype 09, six were serotype 27 and five had an unidentifiable serotype. This study represents the first time Y. enterocolitica has been identified in these species of wildlife within mainland Britain. In addition, this study's findings are entirely novel and overall with regard to field voles and common shrews. However, the role of wild and peridomestic rodents in the transmission of pathogenic Y. enterocolitica remains unknown, as this study was unable to detect the presence of pathogenic Y. enterocolitica strains in these species.

Patient perceptions of the challenges of recruitment to a renal randomised trial registry: a pilot questionnaire-based study.

BACKGROUND: Randomised controlled trials (RCTs) are the gold standard for demonstrating the efficacy of new therapies. However, issues of external validity often affect result application to real-world settings. Using registries to conduct RCTs is a reasonably new practice, but is appealing because it combines the benefits of both observational studies and RCTs. There is limited literature on patient motivators, barriers, and consent to registries for conducting RCTs. The purpose of our study was to establish the factors that motivate and/or inhibit patients from joining a registry for RCTs and to determine what information matters to patients when making an enrolment decision to participate in such a registry. METHODS: We conducted a cross-sectional questionnaire-based study at a dialysis centre in Southwest Ireland representing a catchment patient population of approximately 430,000. Quantitative data were coded and analysed in SPSS (v16). Descriptive statistics were produced, and open-ended questions were analysed by thematic analysis. RESULTS: Eighty-seven patients completed the questionnaire. Reasons for participation in a registry included personal and altruistic benefits. Barriers to participation were time and travel requirements associated with registry participation, data safety concerns, risks, side effects, and concerns that registry participation would impact current treatment. Although 29.8% of patients expressed concern regarding their data being stored in a registry, 79.3% were still willing to consent to have their data uploaded and stored in a registry for conducting RCTs. It was important to patients to have their GP (general practitioner) involved in the decision to participate, despite little day-to-day contact with their GP for renal dialysis management. CONCLUSION: Challenges to recruitment to registries for RCTs exist, but addressing the identified concerns of potential participants may aid patients in making a more informed enrolment decision and may improve recruitment to registries, and by extension, to RCTs conducted using the registry.

Managing clinical trials during COVID-19: experience from a clinical research facility.

There is a dearth of literature on best practices for managing clinical trials, and little is understood on the role of the clinical trial manager. The COVID-19 pandemic has brought this into focus, and the continuance of clinical trials worldwide has been catapulted into a state of uncertainty as countries enter lockdown to manage the spread of the virus. Participant retention is an ongoing issue in clinical trials, and the concern is that in the current pandemic environment, attrition will be an issue which could potentially jeopardise trial completion. The current situation has necessitated timely problem solving by the trial manager to ensure trials remain open, and most importantly, that participant safety, paramount in clinical trials, is monitored. The purpose of our study is to highlight key issues arising in the management of clinical trials during a pandemic from first-hand experience in a clinical research facility managing both academic and commercial clinical trials. We offer some practical guidance on solution implementation.

Intimate Partner Violence Against Transgender Women: Prevalence and Correlates in Lima, Peru (2016-2018).

Limited data exists on intimate partner violence (IPV) among transgender women (TW), though global trends suggest IPV is associated with HIV risk in this population. We describe the prevalence of verbal, physical, and/or sexual violence as well as participant- and partner-level correlates of IPV among TW in Lima, Peru. Among 389 respondents, 15.2% reported IPV with one or more of their last three sexual partners: 9.2% verbal, 8.2% physical, and 2.3% sexual violence. Physical and verbal violence were more common with stable partners (aPR 3.46, 95% CI 1.17-10.25, aPR 2.46, 95% CI 1.14-5.28, respectively). Physical violence was associated with condomless receptive anal intercourse (cRAI) (aPR 2.22, 95% CI 1.19-4.13) and partner alcohol use (aPR 4.38, 95% CI 1.56-12.33) while verbal violence correlated with participant inebriation (aPR 4.86, 95% CI 1.63-14.46). Our results link IPV with stable partnerships, alcohol use, and cRAI, suggesting TW in Peru may benefit from multidimensional IPV prevention strategies to foster supportive relationships and reduce HIV transmission.

Detection of Seoul virus in wild brown rats (Rattus norvegicus) from pig farms in Northern England.

INTRODUCTION: Hantaviruses are maintained by mammalian hosts, such as rodents, and are shed in their excretions. Clinical disease can occur in humans from spillover infection. Brown rats (Rattus norvegicus) are the globally distributed reservoir host of Seoul virus (SEOV). Human cases of SEOV-associated haemorrhagic fever with renal syndrome (SEOV-HFRS)have been reported in Great Britain (GB) since 1977. METHODS: Brown rats (n=68) were trapped from a variety of peridomestic locations, with a focus on pig farms. Kidney and lung tissues were tested for viral RNA using a pan-hantavirus RT-PCR assay followed by Sanger sequencing and analysis. RESULTS: SEOV RNA was detected in 19 per cent (13/68, 95% CI 11 to 30) of rats and all sequences fell within SEOV lineage 9. Twelve sequences were highly similar to each other and to the previously reported GB Humber strain of SEOV (98 per cent). One rat SEOV sequence was more distant. The SEOV prevalence in rats from pig farms was significantly greater (p=0.047) than other sites sampled. No significant sex or age differences were observed among positive and negative rats. DISCUSSION: The results from this study suggest that SEOV could be widespread in wild rats in GB and therefore pose a potential risk to public health.

First detection of Hepatitis E virus (Orthohepevirus C) in wild brown rats (Rattus norvegicus) from Great Britain.

In the United Kingdom, there has been an increase in the number of hepatitis E virus (HEV) infections in people annually since 2010. Most of these are thought to be indigenously acquired Orthohepevirus A genotype 3 (HEV G3), which has been linked to pork production and consumption. However, the dominant subgroup circulating in British pigs differs from that which is found in people; therefore, an alternative, potentially zoonotic, source is suspected as a possible cause of these infections. Rodents, brown rats (Rattus norvegicus) in particular, have been shown to carry HEV, both the swine HEV G3 genotype and Orthohepevirus C, genotype C1 (rat HEV). To investigate the prevalence of HEV in British rodents, liver tissue was taken from 307 rodents collected from pig farms (n = 12) and other locations (n = 10). The RNA from these samples was extracted and tested using a pan-HEV nested RT-PCR. Limited histopathology was also performed. In this study, 8/61 (13%, 95% CI, 5-21) of brown rat livers were positive for HEV RNA. Sequencing of amplicons demonstrated all infections to be rat HEV with 87%-92% nucleotide identity to other rat HEV sequences circulating within Europe and China (224 nt ORF-1). Lesions and necrosis were observed histologically in 2/3 samples examined. No rat HEV RNA was detected in any other species, and no HEV G3 RNA was detected in any rodent in this study. This is the first reported detection of rat HEV in Great Britain. A human case of rat HEV infection has recently been reported in Asia, suggesting that rat HEV could pose a risk to public health.

Facilitators and Barriers to Supplemental Nutrition Assistance Program Incentive Use: Findings From a Clinic Intervention for Low-Income Patients.

INTRODUCTION: Healthy food incentives matching Supplemental Nutrition Assistance Program (SNAP) benefits spent on fruits and vegetables subsidize increased produce consumption among low-income individuals at risk for food insecurity and diet-related disease. Yet many eligible participants do not use these incentives, in part because of limited awareness. This study examined the acceptability and impact of a primary care-based informational intervention on facilitators and barriers to use of the statewide SNAP incentive program Double Up Food Bucks. METHODS: Focus groups (n=5) were conducted April-June 2015 among a purposive sample (n=26) of SNAP-enrolled adults from a Michigan health clinic serving low-income patients. All had participated in a waiting room-based informational intervention about Double Up Food Bucks; none had used Double Up Food Bucks before the intervention. Groups were stratified by Double Up Food Bucks use/non-use during the 6-month intervention period. Results were analyzed in 2016-2017 through an iterative content analysis process. RESULTS: Participants reported the waiting room intervention was acceptable and a key facilitator of first-time Double Up Food Bucks use. Motivators for Double Up Food Bucks use included (1) eating more healthfully, (2) stretching SNAP benefits, (3) higher-quality produce at markets, and (4) unique market environments. Remaining barriers included (1) lack of transportation, (2) limited market locations/hours, and (3) persistent confusion among a small number of participants regarding incentive use. CONCLUSIONS: Low-income patients who received an informational intervention about Double Up Food Bucks reported numerous benefits from participation. Yet barriers remained for a subset of patients. Improving geographic accessibility and ease of SNAP incentive redemption may further improve dietary quality and food security among vulnerable populations.

"Doubling Up" on Produce at Detroit Farmers Markets: Patterns and Correlates of Use of a Healthy Food Incentive.

INTRODUCTION: Federal food assistance programs such as the Supplemental Nutrition Assistance Program (SNAP) help address food insecurity, yet many participants still struggle to afford nutritionally adequate foods. The U.S. Department of Agriculture has committed $100 million to the expansion and evaluation of SNAP healthy food incentives, which match SNAP funds spent on produce. However, little is known about who uses SNAP incentives or how often they are used. This study examines patterns and correlates of use of the SNAP incentive Double Up Food Bucks at all eight participating Detroit farmers markets during 2012-2013. METHODS: SNAP/Double Up Food Bucks transactions from handwritten farmers market logs (n=21,541) were linked with state administrative SNAP enrollment data. Frequency of incentive use and characteristics of Double Up Food Bucks users relative to the overall Detroit SNAP-enrolled population were examined, as were market-level characteristics associated with program use. Negative binomial regression was used to estimate predictors of repeat transactions (analyses conducted 2015-2017). RESULTS: Although demographic characteristics of Double Up Food Bucks users reflected those of the overall Detroit SNAP-enrolled population, Double Up Food Bucks users were poorer and disproportionately female. One third of Double Up Food Bucks users had more than one transaction during the 2-year period. Repeat transactions were directly correlated with identifying as white (incidence rate ratio=2.34, 95% CI=2.11, 2.59, p<0.001), and inversely correlated with driving distance from market of first transaction (incidence rate ratio=0.98 per mile, 95% CI=0.98, 0.99, p<0.001). Rates of repeat transactions also varied significantly by market. CONCLUSIONS: Addressing barriers to initial use and return visits can help maximize the impact and reach of SNAP incentives among Americans at highest risk of diet-related disease.

Increasing Use of a Healthy Food Incentive: A Waiting Room Intervention Among Low-Income Patients.

INTRODUCTION: Diet-related disease is disproportionately concentrated in low-income communities where fruit and vegetable consumption is far below guidelines. To address financial barriers, Double Up Food Bucks (DUFB)-a statewide healthy food incentive-matches Supplemental Nutrition Assistance Program (SNAP) funds spent at farmers markets. However, incentive use is limited. This study examined the impact of a brief waiting room-based intervention about DUFB on program utilization and produce consumption. STUDY DESIGN: Longitudinal, repeated measures, quasi-experimental trial. SETTING/PARTICIPANTS: SNAP-enrolled adults at a health center in a low-income, racially and ethnically diverse area of Southeast Michigan. INTERVENTION: Participants received a brief explanation of DUFB, written program materials, a map highlighting market locations and hours, and an initial $10 market voucher. DUFB use and produce consumption were measured through four surveys over 5 months (August 2014-January 2015). MAIN OUTCOME MEASURES: Outcome measures included DUFB use and fruit and vegetable consumption (analyses conducted in 2015-2016). RESULTS: A total of 302 eligible adults were identified, and 177 (59%) enrolled. One hundred twenty-seven (72%) completed all surveys. At baseline, 57% of participants reported shopping at a farmers market within the last year; 18% had previously used DUFB. By the end of the DUFB season, participants were significantly more likely to report DUFB use than at baseline (AOR=19.2, 95% CI=10.3, 35.5, p<0.001), with 69% of participants reporting use of DUFB at least once, and 34% reporting use of DUFB three or more times. Adjusted fruit and vegetable consumption increased from baseline by 0.65 servings/day (95% CI=0.37, 0.93, p<0.001) at 3 months, and remained 0.62 servings/day (95% CI=0.32, 0.92, p<0.001) higher than baseline 2 months post-DUFB season. CONCLUSIONS: A brief clinic-based intervention was associated with a nearly fourfold increase in uptake of a SNAP incentive program, as well as clinically and statistically significant increases in produce consumption. Results suggested sustained behavior change even once the financial incentive was no longer available. Providing information about healthy food incentives is a low-cost, easily implemented intervention that may increase produce consumption among low-income patients.

Evaluation of approaches to monitor Staphylococcus aureus virulence factor expression during human disease.

Staphylococcus aureus is a versatile pathogen of medical significance, using multiple virulence factors to cause disease. A prophylactic S. aureus 4-antigen (SA4Ag) vaccine comprising capsular polysaccharide (types 5 and 8) conjugates, clumping factor A (ClfA) and manganese transporter C (MntC) is under development. This study was designed to characterize S. aureus isolates recovered from infected patients and also to investigate approaches for examining expression of S. aureus vaccine candidates and the host response during human infection. Confirmation of antigen expression in different disease states is important to support the inclusion of these antigens in a prophylactic vaccine. Hospitalized patients with diagnosed S. aureus wound (27) or bloodstream (24) infections were enrolled. Invasive and nasal carriage S. aureus isolates were recovered and characterized for genotypic diversity. S. aureus antigen expression was evaluated directly by real-time, quantitative, reverse-transcriptase PCR (qRT-PCR) analysis and indirectly by serology using a competitive Luminex immunoassay. Study isolates were genotypically diverse and all had the genes encoding the antigens present in the SA4Ag vaccine. S. aureus nasal carriage was detected in 55% of patients, and in those subjects 64% of the carriage isolates matched the invasive strain. In swab samples with detectable S. aureus triosephosphate isomerase housekeeping gene expression, RNA transcripts encoding the S. aureus virulence factors ClfA, MntC, and capsule polysaccharide were detected by qRT-PCR. Antigen expression was indirectly confirmed by increases in antibody titer during the course of infection from acute to convalescent phase. Demonstration of bacterial transcript expression together with immunological response to the SA4Ag antigens in a clinically relevant patient population provides support for inclusion of these antigens in a prophylactic vaccine.