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Abstract: Background: Although health literacy has been a public health priority area for more than a decade, the relationship between health literacy and dietary quality has not been thoroughly explored. Objective: To evaluate health literacy skills in relation to Healthy Eating Index (HEI) scores and sugar-sweetened beverage (SSB) consumption while accounting for demographic variables. Design: Cross-sectional survey. Participants/setting: A community-based proportional sample of adults residing in the rural Lower Mississippi Delta. Methods: Instruments included a validated 158-item regional food frequency questionnaire and the Newest Vital Sign (scores range 0 to 6) to assess health literacy. Statistical analyses performed: Descriptive statistics, analysis of variance, and multivariate linear regression. Results: Of 376 participants, the majority were African American (67.6%), without a college degree (71.5%), and household income level <$20,000/year (55.0%). Most participants (73.9%) scored in the two lowest health literacy categories. The multivariate linear regression model to predict total HEI scores was significant (R 2=0.24; F=18.8; P<0.01), such that every 1-point increase in health literacy was associated with a 1.21-point increase in HEI scores, while controlling for all other variables. Other significant predictors of HEI scores included age, sex, and Supplemental Nutrition Assistance Program participation. Health literacy also significantly predicted SSB consumption (R 2=0.15; F=6.3; P<0.01) while accounting for demographic variables. Every 1 point in health literacy scores was associated with 34 fewer kilocalories per day from SSBs. Age was the only significant covariate in the SSB model. Conclusions: Although health literacy has been linked to numerous poor health outcomes, to our knowledge this is the first investigation to establish a relationship between health literacy and HEI scores and SSB consumption. Our study suggests that understanding the causes and consequences of limited health literacy is an important factor in promoting compliance to the Dietary Guidelines for Americans. [Copyright &y& Elsevier]

Objective: To explore cultural perceptions of the MyPyramid key messages and identify factors that may impact adoption of these recommendations. Methods: Systematic content analysis of transcripts from in-depth, structured interviews with 23 adults, primarily African American females, residing in the Lower Mississippi Delta. Results: When asked to identify good reasons to follow the MyPyramid key messages, nonspecific references to improved health were most prevalent (11 = 130); however, participants also acknowledged the importance of getting vitamins and nutrients (n = 81), and the impact food choices have on health conditions (n = 77) and organ systems (n = 65). Individual-level factors (11 = 211), such as dislike for food items and tradition or customs, far outnumbered environmental-level factors (n = 48), such as cost and availability, as perceived reasons preventing community members from adhering to the key messages. The most frequently mentioned suggestion for helping community members eat according to the MyPyramid were to raise awareness (n = 93), provide information (n = 65), and improve the taste of or provide opportunity to taste (11 = 49). Conclusions and Implications: This study captured participants' cultural perspectives of the MyPyramid key messages. Results indicate that both social marketing campaigns and intervention efforts focused on individual-level factors are needed to promote the MyPyramid in this disadvantaged Delta region. [ABSTRACT FROM AUTHOR]

Abstract: Objective: To determine if measures of diet quality differ between food insecure and food secure adults in a rural high-risk population. Design: Random digit dialing telephone survey of a cross-section of the population designed to collect data on food intake, household demographics, and food security status. Setting: A representative sample of adults who live in 36 counties in the Lower Mississippi Delta region of Arkansas, Louisiana, and Mississippi. Subjects: One thousand six hundred seven adults, both white and African American. Main outcome measures: Food security status and diet quality, as defined by adherence to the Healthy Eating Index and Dietary Reference Intakes by determinations from self-reported food intake (1 day intake). Statistical analyses: Regression analysis, t tests, Wald statistic, and beta tests were employed. Results: Food secure adults scored higher on Healthy Eating Index than food insecure adults (P=0.0001), but the regression model showed no differences when multiple factors were included. Food secure individuals consistently achieved higher percentages of the Dietary Reference Intakes (specifically Estimated Average Requirements and Adequate Intakes) than food insecure individuals, with the greatest differences seen for vitamin A (P<0.0001), copper (P=0.0009), and zinc (P=0.0022) and very little difference for vitamins C (P=0.68) and E (P=0.32). Both populations consumed diets extremely low in fiber. Conclusions: Food insecurity is associated with lower quality diets in this population. It is acknowledged that serious limitations are associated with the use of one 24-hour recall and for comparison between food intake and assessment of food security. These findings still suggest a pressing need for nutrition interventions to improve dietary intake in these at-risk impoverished individuals. [Copyright &y& Elsevier]

Introduction: Here we examine the relationship between achieving different levels of disease activity with tofacitinib (an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis), long-term structural progression, and patient-reported physical function.Methods: This was a post hoc analysis of two 24-month, phase III randomized controlled trials in methotrexate (MTX)-naïve (ORAL Start [NCT01039688]) or MTX-inadequate responder (IR) patients (ORAL Scan [NCT00847613]) receiving tofacitinib 5 or 10 mg twice daily as either monotherapy or with background MTX. The modified total Sharp score (mTSS) and Health Assessment Questionnaire-Disability Index (HAQ-DI) were analyzed at month 24 according to disease activity at month 6 defined by the Clinical Disease Activity Index (CDAI) or the Disease Activity Score in 28 joints, C-reactive protein (DAS28CRP).Results: Mean changes from baseline in mTSS at month 24 were less in patients with CDAI remission at month 6 than in those with CDAI moderate/high disease activity (MDA/HDA) at month 6. A DAS28CRP of < 1.9 most closely approximated CDAI remission (≤ 2.8). Tofacitinib appeared to inhibit joint damage in the presence of persistent inflammation compared with MTX. More patients receiving tofacitinib or MTX with CDAI remission or low disease activity (LDA) at month 6 reported normative HAQ-DI scores (< 0.5) at month 24 than did those with CDAI MDA/HDA.Conclusion: Regardless of treatment, in both MTX-naïve and MTX-IR patients, remission or LDA at month 6 was associated with successful long-term outcomes: inhibition of structural progression and normative HAQ-DI scores. Long-term outcomes were similar when patients achieved CDAI remission or a DAS28CRP of < 1.9, confirming that this is an appropriate cut-off for remission with DAS28CRP. Tofacitinib potentially inhibits joint damage even with persistent inflammation.Funding: Pfizer Inc.Trial registration: Clinicaltrials.gov identifiers: NCT01039688 and NCT00847613. [ABSTRACT FROM AUTHOR]

Objective: To examine socio-environmental, behavioral, and predisposing, reinforcing, and enabling (PRE) factors contributing to post-migration dietary behavior change among a sample of traditional Hispanic males. Design: In this descriptive study, semistructured interviews, a group interview, and photovoice, followed by group interviews, were used to examine dietary change and contributing factors. The behavioral, environmental, organizational, and educational assessment phases of the PRECEDE-PROCEED model guided the organization of dietary contributing factors for development of a nutrition intervention. Setting: The southern region of Mississippi. Participants: Traditional Hispanic males (n = 19) were identified from 35 Hispanic males who participated in a larger study. The traditional Hispanic males were identified by the Acculturation Rating Scale for Mexican Americans-II and the Marginality Scale. Analysis: Using the Grounded Theory approach to data analysis, themes and core categories relating to dietary behavior were identified and defined during the analysis process. The constant comparison method was used to identify key themes among coders. Results: Cultural gender role and living structure, as socio-environmental factors, influenced the PRE dietary factors. Conclusions and Implications: Multiple factors influence dietary behavior in the target population. The identified socio-environmental factors underlie the PRE factors and, therefore, must first be addressed in nutrition interventions. [ABSTRACT FROM AUTHOR]

The majority of adult diets in the United States, particularly the South, are of poor quality, putting these individuals at increased risk for chronic diseases. In this study, simulation modeling was used to determine the effects of substituting familiar, more healthful foods and beverages for less healthy ones on diet quality and total energy intake in Lower Mississippi Delta (LMD) adults. Dietary data collected in 2000 for 1689 LMD adults who participated in the Foods of Our Delta Study were analyzed. The Healthy Eating Index-2005 (HEI-2005) was used to measure diet quality. The effects of substituting targeted foods and beverages with more healthful items on diet quality were simulated by replacing the targeted items' nutrient profile with their replacements' profile. For the single food and beverage groups, 100% replacement of grain desserts with juice-packed fruit cocktail and sugar-sweetened beverages with water resulted in the largest improvements in diet quality (4.0 and 3.8 points, respectively) and greatest decreases in total energy intake (98 and 215 kcal/d, respectively). The 100% substitution of all food and beverage groups combined resulted in a 12.0-point increase in HEI-2005 score and a decrease of 785 kcal/d in total energy intake. Community interventions designed to improve the diet of LMD adults through the use of familiar, healthy food and beverage substitutions have the potential to improve diet quality and decrease energy intake of this health disparate population. [ABSTRACT FROM AUTHOR]

Parents and preschool teachers play a key role in shaping children's dietary behaviors. Knowledge of nutrition and healthy dietary choices is a key component to improve dietary habits and reduce the prevalence of obesity and associated co-morbidities. Using valid and reliable instruments is necessary for accurate assessment of knowledge to tailor interventions and measure effectiveness specific to the population of interest. The objectives of this paper are to (1) identify potential gaps in the baseline nutrition knowledge among parents and teachers using a previously validated questionnaire prior to a preschool obesity prevention intervention; and (2) assess the instrument's reliability and construct validity for a low socioeconomic status population using a post hoc Rasch analysis. Participants included 177 parents and 75 teachers who participated in a Head Start intervention study. Knowledge scores, instrument reliability, and item fit and difficulty were assessed using a Rasch analysis; t-tests were used to determine differences in scores between parents and teachers. Parents answered 38% of questions correctly while teachers correctly answered 46% of the questions. Adequate item fit and reliability were indicated for Sections 1 and 2 of the Nutrition Knowledge Questionnaire (NKQ). Section 3 demonstrated less adequate reliability. The items were found to adequately and reliably define the unidimensional measures of the three components of knowledge represented in this instrument, providing evidence of construct validity. However, Rasch measures indicated the NKQ overall was difficult for participants. Recommendations for improving the instrument for nutrition education/intervention and research practice areas related to obesity and obesity-related conditions are addressed.

Objectives: Compare the risk of extended major adverse cardiovascular (CV) event (MACE) composite outcomes and component events in patients with rheumatoid arthritis (RA) treated with tofacitinib versus tumour necrosis factor inhibitors (TNFi) in Oral Rheumatoid Arthritis Trial (ORAL) Surveillance., Methods: Patients with RA aged ≥50 years and with ≥1 additional CV risk factor received tofacitinib 5 mg or 10 mg two times per day or TNFi. MACE (non-fatal myocardial infarction (MI), non-fatal stroke or CV death (MACE-3)) was extended by sequential addition of CV events (hospitalisation for unstable angina (MACE-4), coronary revascularisation (MACE-5), transient ischaemic attack (MACE-6), peripheral vascular disease (MACE-7)), heart failure (HF) hospitalisation (MACE-8) and venous thromboembolism (VTE; (MACE-8 plus VTE)). HRs (tofacitinib vs TNFi) were evaluated for MACE and individual components., Results: HRs for MACE-4 to MACE-8 with combined and individual tofacitinib doses versus TNFi were similar. Risk of MACE-8 plus VTE appeared similar with tofacitinib 5 mg two times per day versus TNFi (HR 1.12 (0.82 to 1.52)), but higher with tofacitinib 10 mg two times per day versus TNFi (HR 1.38 (1.02 to 1.85)). Risk of MI was higher with tofacitinib versus TNFi, but difference in risk of other individual CV events was not suggested. Across extended MACE definitions, risk appeared higher with tofacitinib versus TNFi in those with atherosclerotic CV disease or age ≥65 years., Conclusion: In ORAL Surveillance, risk of composite CV endpoints combining all ischaemic CV events and HF did not appear different with tofacitinib versus TNFi. The totality of CV risk was higher with tofacitinib 10 mg two times per day versus TNFi, driven by an increase in VTE., Trial Registration Number: NCT02092467., Competing Interests: Competing interests: MHB has acted as a consultant for AbbVie, Arxx therapeutics, Eli Lilly, Galapagos, Gilead Sciences, and Pfizer Inc with all funding paid to the University of Manchester; has received grant/research support paid to the University of Manchester from Gilead, Pfizer Inc and UCB; was a member of the Speakers’ Bureau for AbbVie and received honoraria from Boehringer Ingelheim, CESAS Medical, Galapagos, Medistream and Pfizer, all paid to the University of Manchester; and is supported by the National Institute for Health Research (NIHR) Manchester Biomedical Research Centre and is in receipt of an NIHR Senior Investigator award. DLB served as a member of the Steering Committee for ORAL Surveillance, with funding from Pfizer Inc paid to Brigham and Women’s Hospital; has served on Advisory Boards for Angiowave, Bayer, Boehringer Ingelheim, Cardax, CellProthera, Cereno Scientific, Elsevier Practice Update Cardiology, High Enroll, Janssen, Level Ex, McKinsey, Medscape Cardiology, Merck, MyoKardia, NirvaMed, Novo Nordisk, PhaseBio, PLx Pharma, Regado Biosciences, Stasys; Board of Directors: Angiowave (stock options), Boston VA Research Institute, Bristol Myers Squibb (stock), DRS.LINQ (stock options), High Enroll (stock), Society of Cardiovascular Patient Care, TobeSoft; Chair: Inaugural Chair, American Heart Association Quality Oversight Committee; Consultant: Broadview Ventures, Hims; Data Monitoring Committees: Acesion Pharma, Assistance Publique-Hôpitaux de Paris, Baim Institute for Clinical Research (formerly Harvard Clinical Research Institute, for the PORTICO trial, funded by St. Jude Medical, now Abbott), Boston Scientific (Chair, PEITHO trial), Cleveland Clinic (including for the ExCEED trial, funded by Edwards), Contego Medical (Chair, PERFORMANCE 2), Duke Clinical Research Institute, Mayo Clinic, Mount Sinai School of Medicine (for the ENVISAGE trial, funded by Daiichi Sankyo; for the ABILITY-DM trial, funded by Concept Medical), Novartis, Population Health Research Institute; Rutgers University (for the NIH-funded MINT Trial); Honoraria: American College of Cardiology (Senior Associate Editor, Clinical Trials and News, ACC.org; Chair, ACC Accreditation Oversight Committee), Arnold and Porter law firm (work related to Sanofi/Bristol-Myers Squibb clopidogrel litigation), Baim Institute for Clinical Research (formerly Harvard Clinical Research Institute; RE-DUAL PCI clinical trial steering committee funded by Boehringer Ingelheim; AEGIS-II executive committee funded by CSL Behring), Belvoir Publications (Editor in Chief, Harvard Heart Letter), Canadian Medical and Surgical Knowledge Translation Research Group (clinical trial steering committees), Cowen and Company, Duke Clinical Research Institute (clinical trial steering committees, including for the PRONOUNCE trial, funded by Ferring Pharmaceuticals), HMP Global (Editor in Chief, Journal of Invasive Cardiology), Journal of the American College of Cardiology (Guest Editor; Associate Editor), K2P (Co-Chair, interdisciplinary curriculum), Level Ex, Medtelligence/ReachMD (CME steering committees), MJH Life Sciences, Oakstone CME (Course Director, Comprehensive Review of Interventional Cardiology), Piper Sandler, Population Health Research Institute (for the COMPASS operations committee, publications committee, steering committee, and USA national co-leader, funded by Bayer), Slack Publications (Chief Medical Editor, Cardiology Today’s Intervention), Society of Cardiovascular Patient Care (Secretary/Treasurer), WebMD (CME steering committees), Wiley (steering committee); Other: Clinical Cardiology (Deputy Editor), NCDR-ACTION Registry Steering Committee (Chair), VA CART Research and Publications Committee (Chair); Patent: Sotagliflozin (named on a patent for sotagliflozin assigned to Brigham and Women's Hospital who assigned to Lexicon; neither I nor Brigham and Women's Hospital receive any income from this patent); Research Funding: Abbott, Acesion Pharma, Afimmune, Aker Biomarine, Amarin, Amgen, AstraZeneca, Bayer, Beren, Boehringer Ingelheim, Boston Scientific, Bristol-Myers Squibb, Cardax, CellProthera, Cereno Scientific, Chiesi, CinCor, Cleerly, CSL Behring, Eisai, Ethicon, Faraday Pharmaceuticals, Ferring Pharmaceuticals, Forest Laboratories, Fractyl, Garmin, HLS Therapeutics, Idorsia, Ironwood, Ischemix, Janssen, Javelin, Lexicon, Lilly, Medtronic, Merck, Moderna, MyoKardia, NirvaMed, Novartis, Novo Nordisk, Owkin, Pfizer, PhaseBio, PLx Pharma, Recardio, Regeneron, Reid Hoffman Foundation, Roche, Sanofi, Stasys, Synaptic, The Medicines Company, Youngene, 89Bio; Royalties: Elsevier (Editor, Braunwald’s Heart Disease); Site Co-Investigator: Abbott, Biotronik, Boston Scientific, CSI, Endotronix, St. Jude Medical (now Abbott), Philips, SpectraWAVE, Svelte, Vascular Solutions; Trustee: American College of Cardiology; Unfunded Research: FlowCo, Takeda. CC-S has acted as a consultant for AbbVie, Gilead Sciences, Pfizer Inc and Regeneron-Sanofi; and has received grant/research support from AbbVie, Bristol-Myers Squibb and Pfizer Inc. JTG has acted as a consultant for AbbVie, Bristol-Myers Squibb, Eli Lilly, Genentech, Gilead Sciences and UCB; and has received grant/research support from Pfizer Inc. TRM has been a consultant for Pfizer and served on the ORAL Surveillance Steering Committee; he has been a consultant for Horizon Therapeutics, Sanofi, Gilead, and UCB and has research support from Horizon. GGK is a shareholder of IQVIA, has received grant/research support from AbbVie, Acceleron, Amgen, Arena, AstraZeneca, Cytokinetics, Eli Lilly, Gilead Sciences, GlaxoSmithKline, Huya Bioscience International, Johnson & Johnson, Landos Biopharma, Merck, Momentum, Novartis, Otsuka, Pfizer Inc, Sanofi, UCB, and vTv Therapeutics, is an employee of the University of North Carolina at Chapel Hill. He served as a member of the Steering Committee for ORAL Surveillance, with funding from Pfizer Inc paid to the University of North Carolina at Chapel Hill. SY has acted as a consultant for Corbus, Janssen, Kezar Life Sciences and Pfizer Inc; and has received remuneration from Pfizer Inc for his services as a member of the Steering Committee for ORAL Surveillance. EN, KK, CAC, KM, and AY are employees and stockholders of Pfizer Inc. HJ is an employee of Syneos Health which was a paid contractor to Pfizer in connection with the development of this manuscript and data and statistical analysis., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY. Published by BMJ.)

Background: In patients with rheumatoid arthritis (RA), persistent inflammation and increasing disease activity are associated with increased risk of adverse events (AEs)., Objectives: To assess relationships between RA disease activity and AEs of interest in patients treated with tofacitinib or tumor necrosis factor inhibitors (TNFi)., Design: This was a post hoc analysis of a long-term, postauthorization safety endpoint trial of tofacitinib versus TNFi., Methods: In ORAL Surveillance, 4362 patients aged ⩾50 years with active RA despite methotrexate, and ⩾1 additional cardiovascular (CV) risk factor, were randomized 1:1:1 to tofacitinib 5 or 10 mg twice daily or TNFi for up to 72 months. Post hoc time-dependent multivariable Cox analysis evaluated the relationships between disease activity [Clinical Disease Activity Index (CDAI)], inflammation [C-reactive protein (CRP)], and AEs of interest. The AEs included major adverse CV events (MACE), malignancies excluding nonmelanoma skin cancer (NMSC), venous thromboembolism (VTE), serious infections, herpes zoster (HZ), nonserious infections excluding HZ (NSI), and death., Results: Across treatments, risk for NSI was higher when patients had CDAI-defined active disease versus remission; MACE and VTE risks trended higher, but did not reach significance. Hazard ratios for MACE, malignancies excluding NMSC, VTE, infections, and death rose by 2-9% for each 5-mg/L increment in serum CRP. The interaction terms evaluating the impact of treatment assignment on the relationship between disease activity and AEs were all p  > 0.05., Conclusion: In ORAL Surveillance, higher NSI risk was observed in the presence of active RA versus remission. The risk of MACE and VTE directionally increased in active disease versus remission, although statistical power was limited due to small event numbers in these categories. The relationship between active disease and AEs was not impacted by treatment with tofacitinib versus TNFi., Registration: NCT02092467., Competing Interests: GAK has received research grants from Pfizer Inc, has acted as a consultant for Janssen and Sanofi-Genzyme-Regeneron, and has participated in speakers’ bureau activities for Sanofi-Genzyme-Regeneron. ZS has acted as a consultant for AbbVie, Eli Lilly, Novartis, Pfizer Inc, Roche, and Sanofi, has acted as a paid instructor for AbbVie, Eli Lilly, Gedeon Richter, Novartis, Pfizer Inc, and Roche, and has participated in speakers’ bureau activities for AbbVie, Eli Lilly, Novartis, Pfizer Inc, Roche, and Sanofi. EB declares no competing interests. TRM has received research grants from Bristol Myers Squibb and Horizon, has acted as a consultant for Gilead Sciences, Horizon, Sanofi and UCB, and served on the Steering Committee for ORAL Surveillance for Pfizer Inc. DLB served as a member of the Steering Committee for ORAL Surveillance, with funding from Pfizer Inc paid to Brigham and Women’s Hospital. DLB has also served as an advisory board member for ANGIOWave, Bayer, Boehringer Ingelheim, Cardax, CellProthera, Cereno Scientific, Elsevier Practice Update Cardiology, High Enroll, Janssen, Level Ex, McKinsey, Medscape Cardiology, Merck, MyoKardia, NirvaMed, Novo Nordisk, PhaseBio, PLx Pharma, Regado Biosciences, and Stasys; has served on the Board of Directors for AngioWave (stock options), Boston VA Research Institute, Bristol Myers Squibb (stock), DRS.LINQ (stock options), High Enroll (stock), Society of Cardiovascular Patient Care, and TOBESOFT; has acted as the Inaugural Chair of the American Heart Association Quality Oversight Committee; has acted as a consultant for Broadview Ventures; has been a member of the Data Monitoring Committees for Acesion Pharma, Assistance Publique-Hôpitaux de Paris, Baim Institute for Clinical Research (formerly Harvard Clinical Research Institute, for the PORTICO trial, funded by St. Jude Medical, now Abbott), Boston Scientific (Chair, PEITHO trial), Cleveland Clinic (including for the ExCEED trial, funded by Edwards), Contego Medical (Chair, PERFORMANCE 2), Duke Clinical Research Institute, Mayo Clinic, Mount Sinai School of Medicine (for the ENVISAGE trial, funded by Daiichi Sankyo; for the ABILITY-DM trial, funded by Concept Medical), Novartis, Population Health Research Institute, and Rutgers University (for the NIH-funded MINT Trial); has received honoraria from the American College of Cardiology (Senior Associate Editor, Clinical Trials and News, ACC.org; Chair, ACC Accreditation Oversight Committee), Arnold and Porter law firm (work related to Sanofi/Bristol Myers Squibb clopidogrel litigation), Baim Institute for Clinical Research (formerly Harvard Clinical Research Institute; RE-DUAL PCI Clinical Trial Steering Committee funded by Boehringer Ingelheim; AEGIS-II Executive Committee funded by CSL Behring), Belvoir Publications (Editor in Chief, Harvard Heart Letter), Canadian Medical and Surgical Knowledge Translation Research Group (Clinical Trial Steering Committees), Cowen and Company, Duke Clinical Research Institute (Clinical Trial Steering Committees, including for the PRONOUNCE trial, funded by Ferring Pharmaceuticals), HMP Global (Editor in Chief, Journal of Invasive Cardiology), Journal of the American College of Cardiology (Guest Editor; Associate Editor), K2P (Co-Chair, interdisciplinary curriculum), Level Ex, Medtelligence/ReachMD (CME Steering Committees), MJH Life Sciences, Oakstone CME (Course Director, Comprehensive Review of Interventional Cardiology), Piper Sandler, Population Health Research Institute (for the COMPASS Operations Committee, Publications Committee, Steering Committee, and USA national co-leader, funded by Bayer), Slack Publications (Chief Medical Editor, Cardiology Today’s Intervention), Society of Cardiovascular Patient Care (Secretary/Treasurer), WebMD (CME Steering Committees), and Wiley (Steering Committee); has acted as Deputy Editor for Clinical Cardiology, Chaired the NCDR-ACTION Registry Steering Committee, and Chaired the VA CART Research and Publications Committee; has been named on a patent for sotagliflozin assigned to Brigham and Women’s Hospital, who assigned to Lexicon (neither DLB nor Brigham and Women’s Hospital receive any income from this patent); has received research funding from Abbott, Acesion Pharma, Afimmune, Aker BioMarine, Amarin, Amgen, AstraZeneca, Bayer, Beren, Boehringer Ingelheim, Boston Scientific, Bristol Myers Squibb, Cardax, CellProthera, Cereno Scientific, Chiesi, CinCor, CSL Behring, Eisai, Eli Lilly, Ethicon, Faraday Pharmaceuticals, Ferring Pharmaceuticals, Forest Laboratories, Fractyl, Garmin, HLS Therapeutics, Idorsia, Ironwood, Ischemix, Janssen, Javelin, Lexicon, Medtronic, Merck, Moderna, MyoKardia, NirvaMed, Novartis, Novo Nordisk, Owkin, Pfizer, PhaseBio, PLx Pharma, Recardio, Regeneron, Reid Hoffman Foundation, Roche, Sanofi, Stasys, Synaptic, The Medicines Company, Youngene, and 89Bio; has received royalties from Elsevier (Editor, Braunwald’s Heart Disease), has been a site co-investigator for Abbott, BIOTRONIK, Boston Scientific, CSI, Endotronix, St. Jude Medical (now Abbott), Philips, SpectraWAVE, Svelte, and Vascular Solutions; has been a trustee for the American College of Cardiology; and has worked on unfunded research for FlowCo and Takeda. GAS has acted as a consultant for Pfizer Inc, and was an employee of Syneos Health Inc at the time of the analysis, who were paid contractors to Pfizer Inc in the development of this manuscript and in providing statistical support. SRY has acted as a consultant for Corbus Pharmaceuticals, Kezar Life Sciences, and Pfizer Inc. SRY also acted as a member of the Steering Committee for ORAL Surveillance. CW, YC, SM, and MM are employees and shareholders of Pfizer Inc. CAC was an employee and shareholder of Pfizer Inc at the time of the analysis., (© The Author(s), 2023.)

Objectives: To evaluate malignancies and their associations with baseline risk factors and cardiovascular risk scores with tofacitinib versus tumour necrosis factor inhibitors (TNFi) in patients with rheumatoid arthritis (RA)., Methods: In an open-label, randomised controlled trial (ORAL Surveillance; NCT02092467), 4362 patients with RA aged ≥50 years with ≥1 additional cardiovascular risk factor received tofacitinib 5 (N=1455) or 10 mg two times per day (N=1456) or TNFi (N=1451). Incidence rates (IRs; patients with first events/100 patient-years) and HRs were calculated for adjudicated malignancies excluding non-melanoma skin cancer (NMSC), NMSC and subtypes. Post hoc analyses for malignancies excluding NMSC, lung cancer and NMSC included risk factors identified via simple/multivariable Cox models and IRs/HRs categorised by baseline risk factors, history of atherosclerotic cardiovascular disease (HxASCVD) and cardiovascular risk scores., Results: IRs for malignancies excluding NMSC and NMSC were higher with tofacitinib (combined and individual doses) versus TNFi. Risk of lung cancer (most common subtype with tofacitinib) was higher with tofacitinib 10 mg two times per day versus TNFi. In the overall study population, the risk of malignancies excluding NMSC was similar between both tofacitinib doses and TNFi until month 18 and diverged from month 18 onwards (HR (95% CIs) for combined tofacitinib doses: 0.93 (0.53 to 1.62) from baseline to month 18 vs 1.93 (1.22 to 3.06) from month 18 onwards, interaction p=0.0469). Cox analyses identified baseline risk factors across treatment groups for malignancies excluding NMSC, lung cancer and NMSC; interaction analyses generally did not show statistical evidence of interaction between treatment groups and risk factors. HxASCVD or increasing cardiovascular risk scores were associated with higher malignancy IRs across treatments., Conclusions: Risk of malignancies was increased with tofacitinib versus TNFi, and incidence was highest in patients with HxASCVD or increasing cardiovascular risk. This may be due to shared risk factors for cardiovascular risk and cancer., Trial Registration Numbers: NCT02092467, NCT01262118, NCT01484561, NCT00147498, NCT00413660, NCT00550446, NCT00603512, NCT00687193, NCT01164579, NCT00976599, NCT01059864, NCT01359150, NCT02147587, NCT00960440, NCT00847613, NCT00814307, NCT00856544, NCT00853385, NCT01039688, NCT02281552, NCT02187055, NCT02831855, NCT00413699, NCT00661661., Competing Interests: Competing interests: JRC has received research/grant support from Amgen, CorEvitas, Crescendo Bio and Pfizer; and is a consultant for AbbVie, Amgen, Bristol-Myers Squibb, CorEvitas, Eli Lilly, Janssen, Myriad, Pfizer, Roche/Genentech and UCB. KY has received research/grant support from Astellas Pharma, Eisai Pharma, Eli Lilly Japan KK, GlaxoSmithKline, Mitsubishi Tanabe Pharma, MSD, Pfizer and Teijin Pharma; is a consultant for AbbVie, Asahi Kasei Pharma, Astellas Pharma, Eli Lilly Japan KK, Gilead GK, Japan Tobacco and Pfizer; and is part of speakers’ bureau for AbbVie, Actelion Pharmaceuticals Japan, Asahi Kasei Pharma, Astellas Pharma, AYUMI Pharma Co., Boehringer Ingelheim Japan, Bristol-Myers Squibb, Chugai Pharma, Daiichi Sankyo, Eli Lilly Japan KK, Eisai Pharma, Gilead GK, GlaxoSmithKline, Hisamitsu Pharma Co., Janssen, Japan Tobacco, Mitsubishi Tanabe Pharma, MSD, Nippon Kayaku, Nippon Shinyaku, Ono Pharma, Otsuka Pharma, Pfizer, Sanofi and Takeda. Y-HC has received research/grant support from AbbVie, Agnitio Science & Technology, Astellas Pharma, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Chugai Pharma Taiwan, GlaxoSmithKline, Johnson & Johnson, MSD, National Yang-Ming University, Novartis, Pfizer, Roche, Sanofi, Taiwan Ministry of Science and Technology, Taiwan Department of Health and Welfare, Taichung Veterans General Hospital and UCB; and is a consultant for AbbVie, AstraZeneca, Astellas Pharma, Bristol-Myers Squibb, Chugai Pharma Taiwan, Inova Diagnostics, Eli Lilly, Johnson & Johnson, GlaxoSmithKline, MSD, Novartis, Roche, Sanofi, Thermo Fisher Scientific, UCB and United Biopharma. DLB served as a member of the Steering Committee for ORAL Surveillance, with funding from Pfizer paid to Brigham and Women’s Hospital. He is a member of the advisory board for: AngioWave, Bayer, Boehringer Ingelheim, Cardax, CellProthera, Cereno Scientific, Elsevier Practice Update Cardiology, High Enroll, Janssen, Level Ex, Medscape Cardiology, Merck, MyoKardia, NirvaMed, Novo Nordisk, PhaseBio, PLx Pharma, Regado Biosciences, Stasys; Board of Directors: AngioWave (stock options), Boston VA Research Institute, Bristol-Myers Squibb (stock), DRS.LINQ (stock options), High Enroll (stock), Society of Cardiovascular Patient Care, TobeSoft; Chair: Inaugural Chair, American Heart Association Quality Oversight Committee; Data Monitoring Committees: Acesion Pharma, Assistance Publique-Hôpitaux de Paris, Baim Institute for Clinical Research (formerly Harvard Clinical Research Institute, for the PORTICO trial, funded by St. Jude Medical, now Abbott), Boston Scientific (Chair, PEITHO trial), Cleveland Clinic (including for the ExCEED trial, funded by Edwards), Contego Medical (Chair, PERFORMANCE 2), Duke Clinical Research Institute, Mayo Clinic, Mount Sinai School of Medicine (for the ENVISAGE trial, funded by Daiichi Sankyo; for the ABILITY-DM trial, funded by Concept Medical), Novartis, Population Health Research Institute; Rutgers University (for the NIH-funded MINT Trial); Honoraria: American College of Cardiology (Senior Associate Editor, Clinical Trials and News, ACC.org; Chair, ACC Accreditation Oversight Committee), Arnold and Porter law firm (work related to Sanofi/Bristol-Myers Squibb clopidogrel litigation), Baim Institute for Clinical Research (formerly Harvard Clinical Research Institute; RE-DUAL PCI clinical trial steering committee funded by Boehringer Ingelheim; AEGIS-II executive committee funded by CSL Behring), Belvoir Publications (Editor in Chief, Harvard Heart Letter), Canadian Medical and Surgical Knowledge Translation Research Group (clinical trial steering committees), Cowen and Company, Duke Clinical Research Institute (clinical trial steering committees, including for the PRONOUNCE trial, funded by Ferring Pharmaceuticals), HMP Global (Editor in Chief, Journal of Invasive Cardiology), Journal of the American College of Cardiology (Guest Editor; Associate Editor), K2P (Co-Chair, interdisciplinary curriculum), Level Ex, Medtelligence/ReachMD (CME steering committees), MJH Life Sciences, Oakstone CME (Course Director, Comprehensive Review of Interventional Cardiology), Piper Sandler, Population Health Research Institute (for the COMPASS operations committee, publications committee, steering committee, and USA national co-leader, funded by Bayer), Slack Publications (Chief Medical Editor, Cardiology Today’s Intervention), Society of Cardiovascular Patient Care (Secretary/Treasurer), WebMD (CME steering committees), Wiley (steering committee); Other: Clinical Cardiology (Deputy Editor), NCDR-ACTION Registry Steering Committee (Chair), VA CART Research and Publications Committee (Chair); Patent: Sotagliflozin (named on a patent for sotagliflozin assigned to Brigham and Women's Hospital who assigned to Lexicon; DLB/Brigham and Women's Hospital do not receive any income from this patent); Research Funding: Abbott, Acesion Pharma, Afimmune, Aker Biomarine, Amarin, Amgen, AstraZeneca, Bayer, Beren, Boehringer Ingelheim, Boston Scientific, Bristol-Myers Squibb, Cardax, CellProthera, Cereno Scientific, Chiesi, CSL Behring, Eisai, Ethicon, Faraday Pharmaceuticals, Ferring Pharmaceuticals, Forest Laboratories, Fractyl, Garmin, HLS Therapeutics, Idorsia, Ironwood, Ischemix, Janssen, Javelin, Lexicon, Lilly, Medtronic, Merck, Moderna, MyoKardia, NirvaMed, Novartis, Novo Nordisk, Owkin, Pfizer, PhaseBio, PLx Pharma, Recardio, Regeneron, Reid Hoffman Foundation, Roche, Sanofi, Stasys, Synaptic, The Medicines Company, 89Bio; Royalties: Elsevier (Editor, Braunwald’s Heart Disease); Site Co-Investigator: Abbott, Biotronik, Boston Scientific, CSI, Endotronix, St. Jude Medical (now Abbott), Philips, SpectraWAVE, Svelte, Vascular Solutions; Trustee: American College of Cardiology; Unfunded Research: FlowCo, Takeda. LMG, NS, CW, JW, SM and IV are shareholders and employees of Pfizer. CAC was a shareholder and employee of Pfizer at the time of this analysis. JJG-R has received research/grant support from AbbVie, MSD, Pfizer and Roche; is a consultant for Pfizer; and is part of speakers’ bureau for AbbVie, Biogen, Bristol-Myers Squibb, Janssen, MSD, Pfizer and Roche., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objectives: Evaluate risk of major adverse cardiovascular events (MACE) with tofacitinib versus tumour necrosis factor inhibitors (TNFi) in patients with rheumatoid arthritis (RA) with or without a history of atherosclerotic cardiovascular disease (ASCVD) in ORAL Surveillance., Methods: Patients with RA aged ≥50 years with ≥1 additional CV risk factor received tofacitinib 5 mg or 10 mg two times per day or TNFi. Hazard rations (HRs) were evaluated for the overall population and by history of ASCVD (exploratory analysis)., Results: Risk of MACE, myocardial infarction and sudden cardiac death were increased with tofacitinib versus TNFi in ORAL Surveillance. In patients with history of ASCVD (14.7%; 640/4362), MACE incidence was higher with tofacitinib 5 mg two times per day (8.3%; 17/204) and 10 mg two times per day (7.7%; 17/222) versus TNFi (4.2%; 9/214). HR (combined tofacitinib doses vs TNFi) was 1.98 (95% confidence interval (CI) 0.95 to 4.14; interaction p values: 0.196 (for HR)/0.059 (for incidence rate difference)). In patients without history of ASCVD, MACE HRs for tofacitinib 5 mg two times per day (2.4%; 30/1251) and 10 mg two times per day (2.8%; 34/1234) versus TNFi (2.3%; 28/1237) were, respectively, 1.03 (0.62 to 1.73) and 1.25 (0.76 to 2.07)., Conclusions: This post hoc analysis observed higher MACE risk with tofacitinib versus TNFi in patients with RA and history of ASCVD. Among patients without history of ASCVD, all with prevalent CV risk factors, MACE risk did not appear different with tofacitinib 5 mg two times per day versus TNFi. Due to the exploratory nature of this analysis and low statistical power, we cannot exclude differential MACE risk for tofacitinib 5 mg two times per day versus TNFi among patients without history of ASCVD, but any absolute risk excess is likely low., Trial Registration Number: NCT02092467., Competing Interests: Competing interests: CCS has acted as a consultant for AbbVie, Gilead Sciences, Pfizer Inc and Regeneron-Sanofi, and has received grant/research support from AbbVie, Bristol-Myers Squibb and Pfizer Inc. MHB has acted as a consultant for AbbVie, Eli Lilly, Gilead Sciences, MSD, Pfizer Inc and Roche, has received grant/research support from Pfizer Inc, Roche and UCB, and is a member of the speakers’ bureau for AbbVie (paid to host institution). MHB is supported by the National Institute for Health and Care Research (NIHR) Manchester Biomedical Research Centre and is in receipt of an NIHR Senior Investigator award. The views expressed in this article are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health. MD has acted as a consultant for AbbVie, Bristol-Myers Squibb, Eli Lilly, Merck, Novartis, Pfizer Inc, Roche and UCB, and has received grant/research support from AbbVie, Bristol-Myers Squibb, Eli Lilly, Merck, Novartis, Pfizer Inc, Roche and UCB. DLB served as a member of the Steering Committee for ORAL Surveillance, with funding from Pfizer Inc paid to Brigham and Women’s Hospital. He is a member of the advisory board for AngioWave, Bayer, Boehringer Ingelheim, Cardax, CellProthera, Cereno Scientific, Elsevier Practice Update Cardiology, High Enroll, Janssen, Level Ex, Medscape Cardiology, Merck, MyoKardia, NirvaMed, Novo Nordisk, PhaseBio, PLx Pharma, Regado Biosciences, Stasys; serves on the Board of Directors for AngioWave (stock options), Boston VA Research Institute, Bristol Myers Squibb (stock), DRS.LINQ (stock options), High Enroll (stock), the Society of Cardiovascular Patient Care, and TobeSoft; is the Inaugural Chair for the American Heart Association Quality Oversight Committee; is on the Data Monitoring Committees for Acesion Pharma, Assistance Publique-Hôpitaux de Paris, Baim Institute for Clinical Research (formerly Harvard Clinical Research Institute), for the PORTICO trial, (funded by St. Jude Medical, now Abbott), Boston Scientific (Chair, PEITHO trial), Cleveland Clinic (including for the ExCEED trial, funded by Edwards), Contego Medical (Chair, PERFORMANCE 2), Duke Clinical Research Institute, the Mayo Clinic, Mount Sinai School of Medicine (for the ENVISAGE trial, funded by Daiichi Sankyo), for the ABILITY-DM trial (funded by Concept Medical), Novartis, the Population Health Research Institute, and Rutgers University (for the NIH-funded MINT trial); has received honoraria from the American College of Cardiology (Senior Associate Editor, Clinical Trials and News, ACC.org; Chair, ACC Accreditation Oversight Committee), Arnold and Porter law firm (work related to Sanofi/Bristol-Myers Squibb clopidogrel litigation), Baim Institute for Clinical Research (formerly Harvard Clinical Research Institute; the RE-DUAL PCI clinical trial steering committee funded by Boehringer Ingelheim; the AEGIS-II executive committee funded by CSL Behring), Belvoir Publications (Editor in Chief, Harvard Heart Letter), the Canadian Medical and Surgical Knowledge Translation Research Group (clinical trial steering committees), Cowen and Company, Duke Clinical Research Institute (clinical trial steering committees, including for the PRONOUNCE trial, funded by Ferring Pharmaceuticals), HMP Global (Editor in Chief, Journal of Invasive Cardiology), the Journal of the American College of Cardiology (Guest Editor; Associate Editor), K2P (Co-Chair, interdisciplinary curriculum), Level Ex, Medtelligence/ReachMD (CME steering committees), MJH Life Sciences, Oakstone CME (Course Director, Comprehensive Review of Interventional Cardiology), Piper Sandler, Population Health Research Institute (for the COMPASS operations committee, publications committee, steering committee and USA national co-leader, funded by Bayer), Slack Publications (Chief Medical Editor, Cardiology Today’s Intervention), the Society of Cardiovascular Patient Care (Secretary/Treasurer), WebMD (CME steering committees), and Wiley (steering committee); holds positions at Clinical Cardiology (Deputy Editor), the NCDR-ACTION Registry Steering Committee (Chair), and VA CART Research and Publications Committee (Chair); is named on a patent for sotagliflozin assigned to Brigham and Women's Hospital who assigned to Lexicon (neither DLB nor Brigham and Women's Hospital receive any income from this patent); has received research funding from Abbott, Acesion Pharma, Afimmune, Aker Biomarine, Amarin, Amgen, AstraZeneca, Bayer, Beren, Boehringer Ingelheim, Boston Scientific, Bristol-Myers Squibb, Cardax, CellProthera, Cereno Scientific, Chiesi, CSL Behring, Eisai, Ethicon, Faraday Pharmaceuticals, Ferring Pharmaceuticals, Forest Laboratories, Fractyl, Garmin, HLS Therapeutics, Idorsia, Ironwood, Ischemix, Janssen, Javelin, Lexicon, Lilly, Medtronic, Merck, Moderna, MyoKardia, NirvaMed, Novartis, Novo Nordisk, Owkin, Pfizer Inc, PhaseBio, PLx Pharma, Recardio, Regeneron, Reid Hoffman Foundation, Roche, Sanofi, Stasys, Synaptic, The Medicines Company and 89bio; has received royalties from Elsevier (Editor, Braunwald’s Heart Disease); is a site co-investigator for Abbott, Biotronik, Boston Scientific, CSI, Endotronix, St. Jude Medical (now Abbott), Phillips, SpectraWAVE, Svelte, and Vascular Solutions; is a trustee for the American College of Cardiology; and conducts unfunded research with FlowCo and Takeda.JTG has acted as a consultant for AbbVie, Bristol-Myers Squibb, Eli Lilly, Genentech, Gilead Sciences and UCB, and has received grant/research support from Pfizer Inc. SRY has acted as a consultant for Corbus and Pfizer Inc, and has received remuneration from Pfizer Inc for their services as a member of the Steering Committee for ORAL Surveillance. GGK is a shareholder of IQVIA, has received grant/research support from AbbVie, Acceleron, Amgen, Arena, AstraZeneca, Cytokinetics, Eli Lilly, Gilead Sciences, GlaxoSmithKline, Huya Bioscience International, Johnson & Johnson, Landos Biopharma, Merck, Momentum, Novartis, Otsuka, Pfizer Inc, Sanofi and vTv Therapeutics, is an employee of the University of North Carolina at Chapel Hill. He served as a member of the Steering Committee for ORAL Surveillance, with funding from Pfizer Inc paid to the University of North Carolina at Chapel Hill. IV, JW, CW, KK, SM, JLR, and AY are employees and stockholders of Pfizer Inc. CAC was an employee and stockholder of Pfizer Inc at the time of this analysis. ZS has acted as an advisor for AbbVie, Eli Lilly, Gedeon Richter, Novartis, Pfizer Inc and Roche, a consultant for AbbVie, Eli Lilly, Novartis, Pfizer Inc, Roche and Sanofi, has received grant/research support from Pfizer Inc and UCB, and is a member of the speakers’ bureau for AbbVie, Eli Lilly, MSD, Novartis, Pfizer Inc, Roche, Sanofi and UCB., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Preclinical data suggest that tofacitinib would protect bone health in patients with rheumatoid arthritis (RA)., Objective: To assess fracture risk in tofacitinib RA clinical trials., Design: Post hoc analysis., Methods: We analyzed pooled data of phase I/II/III and long-term extension studies (' P123LTE cohort'), pooled data of placebo-controlled portions of phase III studies ( phase III placebo-controlled cohort), and data from ORAL Surveillance [phase IIIb/IV randomized, open-label trial evaluating tofacitinib 5/10 mg twice daily (BID) vs tumor necrosis factor inhibitor (TNFi) in patients ⩾ 50 years with ⩾ 1 additional cardiovascular risk factor]., Results: In the phase III placebo-controlled cohort, incidence rates (IRs) [95% confidence interval (CI)] of fracture were 2.11 (1.09-3.68), 2.56 (1.23-4.71), and 4.43 (1.78-9.12) per 100 patient-years (PYs) for tofacitinib 5 mg BID, tofacitinib 10 mg BID, and placebo, respectively [tofacitinib 5 mg BID vs placebo: hazard ratio (HR) (95% CI) = 0.55(0.18-1.65); tofacitinib 10 mg BID vs placebo: HR (95% CI) = 0.72 (0.26-2.01)]. In P123LTE , IRs (95% CI) were 2.62 (2.29-2.99) and 2.26 (2.02-2.52) per 100 PY for average tofacitinib 5 and 10 mg BID, respectively. In ORAL Surveillance, IRs (95% CI) were 2.79 (2.34-3.30), 2.87 (2.40-3.40), and 2.27 (1.87-2.74) per 100 PY for tofacitinib 5 mg BID, tofacitinib 10 mg BID, and TNFi, respectively. In ORAL Surveillance, the risk of fracture was numerically higher than TNFi for tofacitinib 5 mg BID [HR (95% CI) = 1.23 (0.96-1.58)] and tofacitinib 10 mg BID [HR (95% CI) = 1.26 (0.97-1.62)]. In ORAL Surveillance, independent predictors of all and osteoporotic fractures with tofacitinib or TNFi included age ⩾ 65, female sex, history of fracture/osteoporosis, and baseline oral corticosteroid use., Conclusion: This post hoc analysis showed numerically lower fracture risk with tofacitinib versus placebo and numerically greater risk versus TNFi. We did not identify any tofacitinib-specific predictors of fractures, and predictors of fracture were generally aligned with prior literature in the general population and patients with RA. Patients with fracture risk factors should be adequately monitored and treated., Clinical Trial Registration: NCT00960440, NCT00847613, NCT00814307, NCT00856544, NCT00853385, NCT01039688, NCT02187055, NCT02831855, NCT00413699, NCT00147498, NCT00413660, NCT00550446, NCT00603512, NCT00687193, NCT00661661, NCT01164579, NCT00976599, NCT01059864, NCT01359150, NCT01262118, NCT01484561, NCT02281552, NCT02147587, NCT02092467., Competing Interests: The authors declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: KE Hansen has no conflicts to declare. GA has received fees from Theramex and Galapagos. MR has received fees from Amgen, AbbVie, BMS, Eli Lilly, Galapagos, Novartis, Pfizer, Sandoz, Theramex, and UCB. MM, EN, CW, and ZR are employees and stockholders of Pfizer Inc. CAC was an employee and stockholder of Pfizer Inc. at the time of this analysis. HJL is an employee and shareholder of CorEvitas., (© The Author(s), 2022.)

Objectives: To characterise infections in patients with rheumatoid arthritis (RA) in ORAL Surveillance., Methods: In this open-label, randomised controlled trial, patients with RA aged≥50 years with ≥1 additional cardiovascular risk factor received tofacitinib 5 or 10 mg two times per day or a tumour necrosis factor inhibitor (TNFi). Incidence rates (IRs; patients with first events/100 patient-years) and hazard ratios (HRs) were calculated for infections, overall and by age (50-<65 years; ≥65 years). Probabilities of infections were obtained (Kaplan-Meier estimates). Cox modelling identified infection risk factors., Results: IRs/HRs for all infections, serious infection events (SIEs) and non-serious infections (NSIs) were higher with tofacitinib (10>5 mg two times per day) versus TNFi. For SIEs, HR (95% CI) for tofacitinib 5 and 10 mg two times per day versus TNFi, respectively, were 1.17 (0.92 to 1.50) and 1.48 (1.17 to 1.87). Increased IRs/HRs for all infections and SIEs with tofacitinib 10 mg two times per day versus TNFi were more pronounced in patients aged≥65 vs 50-<65 years. SIE probability increased from month 18 and before month 6 with tofacitinib 5 and 10 mg two times per day versus TNFi, respectively. NSI probability increased before month 6 with both tofacitinib doses versus TNFi. Across treatments, the most predictive risk factors for SIEs were increasing age, baseline opioid use, history of chronic lung disease and time-dependent oral corticosteroid use, and, for NSIs, female sex, history of chronic lung disease/infections, past smoking and time-dependent Disease Activity Score in 28 joints, C-reactive protein., Conclusions: Infections were higher with tofacitinib versus TNFi. Findings may inform future treatment decisions., Trial Registration Number: NCT02092467., Competing Interests: Competing interests: A-RB has acted as a consultant for AbbVie, Akros, Alfasigma, Amgen, Biogen, Eli Lilly, MSD, Mylan, Novartis, Pfizer, Roche and UCB, has received speaker fees or honoraria from AbbVie, Alfasigma, Amgen, Angelini, AstraZeneca, Berlin-Chemie, Bristol-Myers Squibb, MSD, Novartis, Pfizer, Roche, Sandoz, Teva, UCB and Zentiva, and has been a principal investigator in studies sponsored by Akros, AstraZeneca, Bristol-Myers Squibb, GSK, MSD, Novartis, Pfizer, Roche and UCB. GC has received grants and/or research support from AbbVie, Amgen, Eli Lilly, Gema Pharma, Genzyme, Novartis, Pfizer and Sanofi-Genzyme, and has acted as a consultant for AbbVie, Amgen, Eli Lilly, Gema Pharma, Genzyme, Novartis, Pfizer and Sanofi-Genzyme. VP-R is an employee of Instituto Nacional de Ciencias Médicas y Nutrición and is a principal investigator in studies sponsored by Bristol-Myers Squibb and Pfizer.DLB is a member of the advisory board for: AngioWave, Bayer, Boehringer Ingelheim, Cardax, CellProthera, Cereno Scientific, Elsevier Practice Update Cardiology, High Enroll, Janssen, Level Ex, Medscape Cardiology, Merck, MyoKardia, NirvaMed, Novo Nordisk, PhaseBio, PLx Pharma, Regado Biosciences, Stasys; Board of Directors: AngioWave (stock options), Boston VA Research Institute, Bristol Myers Squibb (stock), DRS.LINQ (stock options), High Enroll (stock), Society of Cardiovascular Patient Care, TobeSoft; Chair: Inaugural Chair, American Heart Association Quality Oversight Committee; Data Monitoring Committees: Acesion Pharma, Assistance Publique-Hôpitaux de Paris, Baim Institute for Clinical Research (formerly Harvard Clinical Research Institute, for the PORTICO trial, funded by St. Jude Medical, now Abbott), Boston Scientific (Chair, PEITHO trial), Cleveland Clinic (including for the ExCEED trial, funded by Edwards), Contego Medical (Chair, PERFORMANCE 2), Duke Clinical Research Institute, Mayo Clinic, Mount Sinai School of Medicine (for the ENVISAGE trial, funded by Daiichi Sankyo; for the ABILITY-DM trial, funded by Concept Medical), Novartis, Population Health Research Institute; Rutgers University (for the NIH-funded MINT Trial); Honoraria: American College of Cardiology (Senior Associate Editor, Clinical Trials and News, ACC.org; Chair, ACC Accreditation Oversight Committee), Arnold and Porter law firm (work related to Sanofi/Bristol-Myers Squibb clopidogrel litigation), Baim Institute for Clinical Research (formerly Harvard Clinical Research Institute; RE-DUAL PCI clinical trial steering committee funded by Boehringer Ingelheim; AEGIS-II executive committee funded by CSL Behring), Belvoir Publications (Editor in Chief, Harvard Heart Letter), Canadian Medical and Surgical Knowledge Translation Research Group (clinical trial steering committees), Cowen and Company, Duke Clinical Research Institute (clinical trial steering committees, including for the PRONOUNCE trial, funded by Ferring Pharmaceuticals), HMP Global (Editor in Chief, Journal of Invasive Cardiology), Journal of the American College of Cardiology (Guest Editor; Associate Editor), K2P (Co-Chair, interdisciplinary curriculum), Level Ex, Medtelligence/ReachMD (CME steering committees), MJH Life Sciences, Oakstone CME (Course Director, Comprehensive Review of Interventional Cardiology), Piper Sandler, Population Health Research Institute (for the COMPASS operations committee, publications committee, steering committee and USA national co-leader, funded by Bayer), Slack Publications (Chief Medical Editor, Cardiology Today’s Intervention), Society of Cardiovascular Patient Care (Secretary/Treasurer), WebMD (CME steering committees), Wiley (steering committee); Other: Clinical Cardiology (Deputy Editor), NCDR-ACTION Registry Steering Committee (Chair), VA CART Research and Publications Committee (Chair); Patent: Sotagliflozin (named on a patent for sotagliflozin assigned to Brigham and Women's Hospital who assigned to Lexicon; DLB/Brigham and Women's Hospital do not receive any income from this patent); Research Funding: Abbott, Acesion Pharma, Afimmune, Aker Biomarine, Amarin, Amgen, AstraZeneca, Bayer, Beren, Boehringer Ingelheim, Boston Scientific, Bristol-Myers Squibb, Cardax, CellProthera, Cereno Scientific, Chiesi, CSL Behring, Eisai, Ethicon, Faraday Pharmaceuticals, Ferring Pharmaceuticals, Forest Laboratories, Fractyl, Garmin, HLS Therapeutics, Idorsia, Ironwood, Ischemix, Janssen, Javelin, Lexicon, Lilly, Medtronic, Merck, Moderna, MyoKardia, NirvaMed, Novartis, Novo Nordisk, Owkin, Pfizer, PhaseBio, PLx Pharma, Recardio, Regeneron, Reid Hoffman Foundation, Roche, Sanofi, Stasys, Synaptic, The Medicines Company, 89Bio; Royalties: Elsevier (Editor, Braunwald’s Heart Disease); Site Co-Investigator: Abbott, Biotronik, Boston Scientific, CSI, Endotronix, St. Jude Medical (now Abbott), Philips, SpectraWAVE, Svelte, Vascular Solutions; Trustee: American College of Cardiology; Unfunded Research: FlowCo, Takeda. He served as a member of the Steering Committee for ORAL Surveillance, with funding from Pfizer paid to Brigham and Women’s Hospital. CAC, DG and ABS are employees and stockholders of Pfizer. A-SC is an employee of Pfizer. GS is an employee of Syneos Health, who were paid contractors to Pfizer in the development of this manuscript. JEP has received grants and/or research support from Bristol-Myers Squibb, Roche, Seattle Genetics and UCB, and has acted as a consultant for AbbVie, Actelion, Amgen, Bayer, Bristol-Myers Squibb, Eli Lilly, Merck, Novartis, Pfizer, Roche, Sandoz, Sanofi and UCB. HS-K has acted as a consultant for, and been an advisor or review panel member for, AbbVie, Eli Lilly, Galapagos, MSD, Pfizer and UCB., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background and Objective: Abrocitinib is a Janus kinase 1-selective inhibitor for the treatment of moderate-to-severe atopic dermatitis. Abrocitinib is eliminated primarily by metabolism involving cytochrome P450 (CYP) enzymes. Abrocitinib pharmacologic activity is attributable to the unbound concentrations of the parent molecule and 2 active metabolites, which are substrates of organic anion transporter 3 (OAT3). The sum of potency-adjusted unbound exposures of abrocitinib and its 2 active metabolites is termed the abrocitinib active moiety. We evaluated effects of CYP inhibition, CYP induction, and OAT3 inhibition on the pharmacokinetics of abrocitinib, its metabolites, and active moiety., Methods: Three fixed-sequence, open-label, phase I studies in healthy adult volunteers examined the drug-drug interactions (DDIs) of oral abrocitinib with fluvoxamine and fluconazole, rifampin, and probenecid., Results: Co-administration of abrocitinib with fluvoxamine or fluconazole increased the area under the plasma concentration-time curve from time 0 to infinity (AUC inf ) of the unbound active moiety of abrocitinib by 91% and 155%, respectively. Co-administration with rifampin decreased the unbound active moiety AUC inf by 56%. The OAT3 inhibitor probenecid increased the AUC inf of the unbound active moiety by 66%., Conclusions: It is important to consider the effects of DDIs on the abrocitinib active moiety when making dosing recommendations. Co-administration of strong CYP2C19/2C9 inhibitors or CYP inducers impacted exposure to the abrocitinib active moiety. A dose reduction by half is recommended if abrocitinib is co-administered with strong CYP2C19 inhibitors, whereas co-administration with strong CYP2C19/2C9 inducers is not recommended. No dose adjustment is required when abrocitinib is administered with OAT3 inhibitors., Clinical Trials Registration Ids: NCT03634345, NCT03637790, NCT03937258., (© 2022. The Author(s).)

Objective: Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). We compared 5-year adverse event (AE) incidence rates (IRs) between patients initiating tofacitinib and those initiating new biological disease-modifying antirheumatic drugs (bDMARDs) within the United States (US) Corrona RA registry., Methods: IRs (number of first events/100 patient-years) of major adverse cardiovascular events (MACE), serious infection events (SIEs), herpes zoster (HZ), malignancies, and death were estimated among tofacitinib and bDMARD initiators, regardless of dose/schedule, between November 6, 2012 (US Food and Drug Administration tofacitinib approval), and July 31, 2018 (follow-up through January 31, 2019). Propensity score (PS) methods were used to control for nonrandom prescribing practices. Hazard ratios (HRs) were calculated to compare rates using multivariable-adjusted Cox regression. Different risk windows were used for acute (MACE, SIEs, HZ, and venous thromboembolic events [VTEs]) and long-term (malignancy and death) events. VTEs were assessed descriptively., Results: For MACE, SIEs, and HZ, 1999 (3152.1 patient-years) and 8358 (12 869.4 years) tofacitinib and bDMARD initiators were included, respectively; for malignancy/death, 1999 (4505.6 patient-years) and 6354 (16 670.8 patient-years) initiators were included, respectively. AE rates were similar across cohorts, except for HZ, which was significantly higher with tofacitinib versus bDMARDs (PS-trimmed adjusted HR 2.32; 95% confidence interval [CI] 1.43-3.75). There were 45 (zero serious) and 88 (five serious) HZ events with tofacitinib and bDMARDs, respectively. Sensitivity analyses demonstrated similar results. VTE IRs (95% CI) were 0.29 (0.13-0.54) and 0.33 (0.24-0.45) for tofacitinib and bDMARDs, respectively., Conclusion: In this registry analysis, both cohorts had similar MACE, SIE, malignancy, death, and VTE rates; HZ rates were higher for tofacitinib initaitors than for bDMARD initiators., (© 2021 The Authors. ACR Open Rheumatology published by Wiley Periodicals LLC on behalf of American College of Rheumatology.)

Objective: To describe the methodology of the Impact of a Preschool Obesity Prevention intervention enhanced with positive behavioral supports., Design: The social ecological model serves as the conceptual framework for this study, which has a within- and between-subjects design with an intervention group and a delayed intervention control group. This 3-year project will use formative methods to pretest materials in Year 1, collect data pre- and postintervention with a follow-up at 4 months in Years 2 and 3, and conduct summative and process evaluation in Year 3., Setting: Head Start centers in Southern and East-Central Mississippi counties., Participants: Three hundred parents with 3-year-old children enrolled in 9 Head Start centers (53 classrooms) and 75 Head Start teachers., Interventions: During Year 2, Hip Hop to Health Jr., Parent-Child Interaction Therapy, and Positive Behavior Interventions and Supports will be implemented., Main Outcome Measures: Primary outcomes include changes in parenting and teacher practices. Secondary outcomes include parent feeding styles as well as weight status and dietary intake. Variables will be measured using anthropometrics and validated surveys., Analysis: The primary analysis will be a multilevel 2 × 3 mixed ANOVA., (Copyright © 2020 Society for Nutrition Education and Behavior. Published by Elsevier Inc. All rights reserved.)

Objectives: Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). Here we present data from the completed Phase 3 randomised controlled trial (RCT) ORAL Scan (NCT00847613), which evaluated the impact of tofacitinib on patient-reported outcomes (PROs) through 24 months in patients with active RA and inadequate responses to methotrexate (MTX-IR)., Methods: Patients were randomised 4:4:1:1 to receive tofacitinib 5 or 10 mg twice daily (BID), or placebo advanced to tofacitinib 5 or 10 mg, plus background MTX. Patients receiving placebo advanced to tofacitinib at month 3 (non-responders) or month 6 (remaining patients). Mean changes from baseline in PROs, assessed at months 1-24, included Health Assessment Questionnaire-Disability Index, Patient Global Assessment of disease activity (visual analogue scale [VAS]), Patient Assessment of Arthritis Pain (VAS), health-related quality of life (Short Form-36 version 2), Functional Assessment of Chronic Illness Therapy-Fatigue and Medical Outcomes Study-Sleep., Results: Overall, 539/797 (67.6%) patients completed 24 months' treatment. At month 3, tofacitinib-treated patients reported signi cant (p<0.05) mean changes from baseline versus placebo across all PROs, and significantly more patients reported improvements ≥ minimum clinically important differences versus placebo. Improvements in PROs with tofacitinib were sustained to month 24. Following advancement to tofacitinib, placebo-treated patients generally reported changes of similar magnitude to tofacitinib-treated patients., Conclusions: Patients with RA and MTX-IR receiving tofacitinib 5 or 10 mg BID plus MTX reported significant and clinically meaningful improvements in PROs versus placebo at month 3, which were sustained through 24 months.

Barriers to health care access and utilization are likely to be perceived differently for receivers and providers of health care. This paper compares and contrasts perspectives of lay community members, volunteer community health advisors (CHA), and health care providers related to structural and interpersonal barriers to health care seeking and provision among African American adults experiencing health disparities in the rural Mississippi Delta. Sixty-four Delta residents (24 males, 40 females) participated in nine focus groups organized by role and gender. The constant comparative method was used to identify themes and subthemes from the focus group transcripts. Barriers were broadly categorized as structural and interpersonal with all groups noting structural barriers including poverty, lack of health insurance, and rurality. All groups identified common interpersonal barriers of gender socialization of African American males, and prevention being a low priority. Differences emerged in perceptions of interpersonal barriers between community members and healthcare providers. Community members and CHA fears of serious medical diagnosis, stigma, medical distrust, and racism emerged as factors inhibiting health care utilization. All groups were critical of insurance/regulatory constraints with providers viewing medical guidelines at times restricting their ability to provide quality treatment while community members and CHA viewed providers as receiving compensation for prescribing medications without regard to potential side-effects. These findings shed light on barriers perceived similarly and differently across these stakeholder groups, and offer directions for ongoing research, outreach, clinical work, and health care policy.

Objective: Tofacitinib is an oral JAK inhibitor for the treatment of rheumatoid arthritis (RA). The phase III, 24-month, placebo-controlled Oral Rheumatoid Arthritis (ORAL) Scan trial was undertaken to evaluate the efficacy, including inhibition of structural progression, and safety of tofacitinib in patients with active RA and an inadequate response to methotrexate (MTX). Month 24 data from the completed study are reported here., Methods: Patients were randomized 4:4:1:1 to receive tofacitinib 5 mg or 10 mg twice daily, or placebo, switched to tofacitinib 5 mg or 10 mg twice daily, with stable background MTX. Patients receiving placebo switched to tofacitinib at month 3 (nonresponders) or month 6 (remaining patients). Clinical efficacy, structural progression, and treatment-emergent adverse events were evaluated. Analyses were performed on the full analysis set with observed data or nonresponder imputation with no advancement penalty for clinical efficacy, and imputation by linear extrapolation for structural progression., Results: Overall, 797 patients were treated; 539 (67.6%) completed 24 months of treatment. Responses according to the American College of Rheumatology criteria for 20% improvement (ACR20), ACR50, and ACR70; the proportion of patients in whom remission or low disease activity was achieved according to the 4-variable Disease Activity Score in 28 joints using the erythrocyte sedimentation rate, Clinical Disease Activity Index, or Simplified Disease Activity Index; Boolean remission; and Health Assessment Questionnaire disability index scores were maintained from month 12 to 24 and were similar between tofacitinib dosages. Limited structural damage was observed at months 12 and 24. Safety events were similar in type and frequency for both tofacitinib dosages, and were consistent with those previously reported., Conclusion: Our findings indicate that clinical and radiographic treatment effects are sustained in months 12-24 in patients with RA receiving tofacitinib 5 mg or 10 mg twice daily plus MTX. The safety profile is consistent with that of other tofacitinib studies., (© 2019 Pfizer Inc. Arthritis & Rheumatology published by Wiley Periodicals, Inc. on behalf of American College of Rheumatology.)

Objective: This post-hoc, pooled analysis of Phase 3 studies of tofacitinib examined the safety of tofacitinib 5 and 10 mg twice daily (BID) when used as monotherapy versus combination therapy with conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) in patients with rheumatoid arthritis (RA)., Methods: Pooled data from six double-blind, randomized controlled Phase 3 studies of tofacitinib 5 and 10 mg BID in patients with RA were analyzed for safety and stratified by administration as monotherapy (ORAL Solo: NCT00814307 and ORAL Start: NCT01039688) or in combination with csDMARDs (ORAL Sync: NCT00856544, ORAL Standard: NCT00853385, ORAL Scan: NCT00847613, and ORAL Step: NCT00960440), and by glucocorticoid use at baseline. Safety assessments included incidence rates (IRs) for serious adverse events (SAEs), discontinuations due to AEs, serious infection events, and herpes zoster (HZ), and were evaluated throughout the duration of the Phase 3 studies., Results: In total, 3881 patients were included in the safety analysis (monotherapy studies: n = 1380; combination therapy studies: n = 2501). IRs for selected AEs of interest were generally numerically lower in patients who received tofacitinib 5 and 10 mg BID as monotherapy than as combination therapy (SAEs: IR [range] 6.21-6.72 versus IR 10.17-13.46; discontinuations due to AEs: IR 5.53-6.18 versus IR 10.80-11.01; serious infections: IR 1.57-1.66 versus IR 3.39-3.56; HZ: IR 1.95-2.93 versus IR 4.37-4.99, respectively), irrespective of tofacitinib dose or glucocorticoid use. There were too few patients and events within the placebo group to fully evaluate effect between combination therapy and monotherapy., Conclusions: Safety profiles were generally similar between patients receiving monotherapy and combination therapy; however, selected safety events of interest, including HZ and serious infections, showed lower IRs with non-overlapping 95% confidence intervals for tofacitinib all monotherapy versus combination therapy. Tofacitinib monotherapy may, therefore, have fewer safety events compared with combination therapy, and have a favorable risk-benefit profile in patients with active RA who are intolerant to csDMARDs., (Copyright © 2018. Published by Elsevier Inc.)

Background: Mississippi has the lowest rates of breastfeeding of all states at 6 months and at 1 year. Registered nurses working in the maternity setting can be influential in mothers' decision to breastfeed., Purpose: The purpose of this study was to examine registered nurses' knowledge and practice related to breastfeeding; and to identify facilitators and barriers to implementing the Ten Steps to Successful Breastfeeding in Mississippi hospitals., Methods: 302 Registered nurses working in hospital maternity/birthing settings in Mississippi completed a questionnaire. Breastfeeding knowledge and practices overall scores were categorized into: poor and good. Chi-square analysis and Spearman correlations were used to determine correlations among the variables., Results: Overall breastfeeding knowledge and practices of respondents was good. Only 4% earned a perfect score. Most believed they were effective (77%) in meeting the needs of new mothers. Significant positive associations were noted among knowledge and effectiveness, and other variables. Resistance to change and staffing shortages were the main barriers to implementing the Ten Steps; raising awareness about the importance of the Ten Steps and providing a lactation consultant were the main facilitators., Conclusion: More research is needed to understand reasons behind low breastfeeding rates in Mississippi.

Background: Improving the diet of communities experiencing health inequities can be challenging given that multiple dietary components are low in quality. Mississippi Communities for Healthy Living was designed to test the comparative effectiveness of nutrition education using a single- versus multiple-message approach to improve the diet of adult residents in the Lower Mississippi Delta., Method: The single-message approach targeted discretionary calories while the multiple-message approach also targeted vegetables, fruits, whole grains, and lean protein. Delta food frequency questionnaires were used to measure participants' diet, while the Healthy Eating Index-2005 (HEI-2005) was used to generate diet quality scores. Generalized linear mixed model regression was used to test for significant time, treatment, and time × treatment interaction effects in HEI-2005 component and total score changes., Results: The majority of participants in the single- and multiple-message arms ( n = 114 and 127, respectively) were female (88% and 96%, respectively), African American (90% and 98%, respectively), overweight or obese (92% and 87%, respectively), and 41 to 60 years of age (57% and 43%, respectively). Significant time effects were present for HEI-2005 total and component scores, with three exceptions-whole fruit, total grains, and saturated fat. Significant treatment effects were present for two components-total and whole fruit; scores were higher in the multiple-message approach arm as compared to the single-message approach arm across time points. No interaction effects were significant for any of the HEI-2005 scores., Conclusion: Focusing nutrition education on the discretionary calories component of the diet may be as effective as focusing on multiple components for improving diet quality.

Little is known about the effective dose of motivational interviewing for maintaining intervention-induced health outcome improvements. The purpose of this study was to compare effects of two doses of motivational interviewing for maintaining blood pressure improvements in a community-engaged lifestyle intervention conducted with African-Americans. Participants were tracked through a 12-month maintenance phase following a 6-month intervention targeting physical activity and diet. For the maintenance phase, participants were randomized to receive a low (4) or high (10) dose of motivational interviewing delivered via telephone by trained research staff. Generalized linear models were used to test for group differences in blood pressure. Blood pressure significantly increased during the maintenance phase. No differences were apparent between randomized groups. Results suggest that 10 or fewer motivational interviewing calls over a 12-month period may be insufficient to maintain post-intervention improvements in blood pressure. Further research is needed to determine optimal strategies for maintaining changes., (© The Author 2015. Published by Oxford University Press. All rights reserved. For permissions, please email: journals.permissions@oup.com.)

Objective: The purpose of the observational study was to determine whether interviewer race influences food frequency questionnaire (FFQ) reporting accuracy in a Deep South, largely African American cohort., Methods: A secondary analysis was conducted to investigate the influence of interviewer race on energy reporting of 319 African Americans who participated in the Mississippi Communities for Healthy Living intervention in May-June 2011, a community-based and USDA-funded project. Reported energy intake was compared to total energy expenditure to identify normal (ENR), under-(EUR) and over-reporters (EOR). Multivariate logistic regression models determined the relationship between race match and energy misreporting, accounting for confounding variables (educational level, health status perception, BMI, gender, and age) identified using chi-square/correlation analyses., Results: The sample included 278 African Americans with 165 EURs, 26 EORs, and 87 ENRs identified. Logistic regression analyses revealed that there was no relationship between race-matched participants and EUR or EOR; controlling factors, BMI and perceived health status were significant in the model., Conclusion: This study is the first to our knowledge to examine whether race influences dietary intake reporting which may influence assessment data used for comparison with health outcomes. This may have important implications for research conducted in health disparate populations, particularly rural, Southern populations.

Background: Intervention research in rural, health disparate communities presents unique challenges for study design, implementation, and evaluation. Challenges include 1) culturally appropriate intervention components, 2) participant recruitment and retention, 3) treatment cross-contamination, 4) intervention delivery and data collection, and 5) potential measurement reactivity., Purpose: The purposes of this paper are to 1) detail the methods of the MCHL study and 2) report baseline demographic characteristics of study participants. The secondary aim is to determine if study participants were engaging in behavior changes after enrollment and prior to intervention initiation., Methods: MCHL was developed using the RE-AIM planning and evaluation framework (reach, effectiveness, adoption, implementation, maintenance). Intervention components were based on Roger's diffusion of innovation attributes that promote adoption of a new innovation as well as on the psychosocial constructs of social support, self-efficacy and decisional balance. Rolling enrollment data collection was used to acquire sufficient sample size and a second data collection just prior to intervention implementation assessed measurement reactivity effects. Participant outcomes included diet quality, blood pressure, weight status, and quality of life. Cluster stratified assignment to one of two treatment arms was utilized to minimize cross contamination. Generalized linear models were used to compare enrollment measures between the two treatment arms while mixed model linear regression was used to test for changes in diet quality outcomes from enrollment to pre-intervention baseline., Results: There were no significant differences in participant demographic, anthropometric or clinical measures between the two treatment arms at enrollment. With the exception of total vegetables, none of the diet quality indicators were significantly different between enrollment and baseline timepoints., Conclusions: Conducting nutrition intervention research in a rural health disparate region requires flexibility in adapting the recruitment, retention, and data collection procedures while maintaining a high level of scientific rigor. Negligible research participation effects, such as measurement reactivity, were noted in this population. However, further research is needed to identify methods to successfully recruit and retain Caucasian females to participate in community-based nutrition interventions in this region., (Copyright © 2015 Elsevier Inc. All rights reserved.)

The objective of this secondary analysis was to evaluate the utility of several participant adherence indicators for predicting changes in clinical, anthropometric, dietary, fitness, and physical activity (PA) outcomes in a lifestyle intervention, HUB City Steps, conducted in a southern, African American cohort in 2010. HUB City Steps was a 6-month, community-engaged, multicomponent, noncontrolled intervention targeting hypertension risk factors. Descriptive indicators were constructed using two participant adherence measures, education session attendance (ESA) and weekly steps/day pedometer diary submission (PDS), separately and in combination. Analyses, based on data from 269 primarily African American adult participants, included bivariate tests of association and multivariable linear regression to determine significant relationships between seven adherence indicators and health outcome changes, including clinical, anthropometric, dietary, fitness, and PA measures. ESA indicators were significantly correlated with four health outcomes: body mass index (BMI), fat mass, low-density lipoprotein (LDL), and PA (-.29 ≤ r ≤ .23, p < .05). PDS indicators were significantly correlated with PA (r = .27, p < .001). Combination ESA/PDS indicators were significantly correlated with five health outcomes: BMI, percentage body fat (%BF), fat mass, LDL, and PA (r = -.26 to .29, p < .05). Results from the multivariate models indicated that the combination ESA/PDS indicators were the most significant predictors of changes for five outcomes--%BF, fat mass, LDL diastolic blood pressure (DBP), and PA--while ESA performed best for BMI only. For DBP, a one-unit increase in the continuous-categorical ESA/PDS indicator resulted in 0.3 mm Hg decrease. Implications for assessing participant adherence in community-based, multicomponent lifestyle intervention research are discussed., (© 2014 Society for Public Health Education.)

The effectiveness of community-based participatory research (CBPR) efforts to address the disproportionate burden of hypertension among African Americans remains largely untested. The objective of this 6-month, noncontrolled, pre-/post-experimental intervention was to examine the effectiveness of a CBPR intervention in achieving improvements in blood pressure, anthropometric measures, biological measures, and diet. Conducted in 2010, this multicomponent lifestyle intervention included motivational enhancement, social support provided by peer coaches, pedometer diary self-monitoring, and monthly nutrition and physical activity education sessions. Of 269 enrolled participants, 94% were African American and 85% were female. Statistical analysis included generalized linear mixed models using maximum likelihood estimation. From baseline to 6 months, blood pressure decreased significantly: mean (± standard deviation) systolic blood pressure decreased from 126.0 ± 19.1 to 119.6 ± 15.8 mm Hg, P=0.0002; mean diastolic blood pressure decreased from 83.2 ± 12.3 to 78.6 ± 11.1 mm Hg, P<0.0001). Sugar intake also decreased significantly as compared with baseline (by approximately 3 tsp; P<0.0001). Time differences were not apparent for any other measures. Results from this study suggest that CBPR efforts are a viable and effective strategy for implementing nonpharmacologic, multicomponent, lifestyle interventions that can help address the persistent racial and ethnic disparities in hypertension treatment and control. Outcome findings help fill gaps in the literature for effectively translating lifestyle interventions to reach and engage African-American communities to reduce the burden of hypertension., (Copyright © 2014 Academy of Nutrition and Dietetics. Published by Elsevier Inc. All rights reserved.)

Objective: Identification of prominent themes to be considered when planning a nutrition intervention using the Reach, Effectiveness, Adoption, Implementation, and Maintenance framework., Design: Qualitative formative research., Setting: Women's social and civic organizations in the Lower Mississippi Delta., Participants: Thirty-seven (5 white and 32 black) women with a college degree or higher., Phenomenon of Interest: Impact of dietary and contextual factors related to the Lower Mississippi Delta culture on intervention planning., Analysis: Case analysis strategy using question-by-question coding., Results: Major themes that emerged were "healthy eating focus" and "promoting a healthy lifestyle" when recruiting organizations (Reach); "positive health changes" as a result of the intervention (Effectiveness); "logistics: time commitment, location, and schedule" to initiate a program (Adoption); "expense of healthy foods" and "cooking and meal planning" as barriers to participation (Implementation); and "resources and training" and "motivation" as necessary for program continuation (Maintenance). The "health of the Delta" theme was found across all dimensions, which reflected participants' compassion for their community., Conclusions and Implications: Results were used to develop an implementation plan promoting optimal reach, effectiveness, adoption, implementation, and maintenance of a nutrition intervention. This research emphasizes the benefits of formative research using a systematic process at organizational and individual levels., (Copyright © 2014 Society for Nutrition Education and Behavior. Published by Elsevier Inc. All rights reserved.)

Objectives: To evaluate the efficacy and safety of atorvastatin versus placebo in modifying lipids in patients with rheumatoid arthritis (RA) receiving the oral Janus kinase inhibitor, tofacitinib., Methods: A randomised, placebo controlled, multicentre phase 2 study, open-label for tofacitinib and blinded for atorvastatin. Patients received tofacitinib 10 mg twice daily for 12 weeks; at week 6, patients were randomly assigned 1:1 to receive oral atorvastatin 10 mg once daily or placebo for 6 weeks. Main outcome measures were lipid moieties, American College of Rheumatology (ACR) response rates, disease activity score in 28 joint counts and safety., Results: 111 patients meeting ACR 1987 RA criteria with active disease were enrolled. Tofacitinib-induced elevation of mean total, low-density lipoprotein (LDL) and high-density lipoprotein-cholesterol, triglycerides and apolipoprotein A-1 concentrations were sustained in placebo recipients to week 12; atorvastatin added at week 6 significantly reduced tofacitinib-associated increases in total and LDL-cholesterol, triglycerides and apolipoprotein B to below week 0 levels. Co-administration of atorvastatin resulted in a significant reduction of LDL-cholesterol versus placebo (primary endpoint; p<0.0001); from week 6 to week 12 the least squares mean reduction was 35.3% with atorvastatin, versus 5.8% increase with placebo. ACR responses were observed with tofacitinib; numerically greater rates were seen with atorvastatin versus placebo. Adverse events were consistent with phase 3 studies., Conclusions: Tofacitinib-associated elevated total and LDL-cholesterol and triglycerides were rapidly and significantly reduced by atorvastatin. Further investigation is required to explore the significance of reductions in RA disease activity in patients receiving tofacitinib and atorvastatin. (Pfizer protocol A3921109).

Objective: To compare differences across food groups for food cost, energy, and nutrient profiles of 100 items from a cross-sectional survey of 225 stores in 18 counties across the Lower Mississippi Delta of Arkansas, Louisiana, and Mississippi., Methods: Energy, nutrient, and cost profiles for food items were calculated by using Naturally Nutrient Rich methodology and converting price per 100 g edible portion to price per serving. Foods were grouped into 6 food groups. Mean differences were compared with ANOVA., Results: Significant differences existed by food group for each measure. Energy density was highest for fats/oils/sweets, whereas nutrient density was highest for vegetables. Price per serving was lowest for fats/oils/sweets and highest for meats., Conclusions and Implications: Educational messages focusing on a complete diet should consider the role of food costs and provide specific recommendations for increasing nutrient-dense foods by replacing a portion of the meat serving at meals with culturally acceptable lower-cost nutrient-dense foods., (Copyright © 2012 Society for Nutrition Education and Behavior. Published by Elsevier Inc. All rights reserved.)

Critical thinking and problem solving skills are currently emphasis areas in the education of allied health professionals. Use of concept maps to teach these skills have been utilized primarily in nursing and medical education, but little has been published about their use in dietetics education. Therefore the purpose of this study was to evaluate the potential efficacy of concept mapping as a learning tool for nutrition assessment among dietetic interns and its acceptability by internship preceptors. Nineteen dietetic interns and 31 preceptors participated in a quasi-experimental pre-/post-design in which the concept mapping strategy was taught as a replacement for the traditional nutrition care plan. The pre-concept map mean score was significantly lower than the post-concept mean score (28.35 vs. 117.96; p=0.001) based on the Student t-test, thus indicating improved critical thinking skills as evidenced through concept mapping. Overall students' perceptions of concept mapping as a teaching-learning method were more positive than the preceptors' perceptions. In conclusion, internship preceptors and dietetic interns perceived concept mapping as effective in assisting interns to engage in critical thinking, to problem solve, and understand relationships among medical nutrition therapy concepts. However, preceptors had more negative attitudes toward concept mapping than the dietetic interns related to time and effort to complete and evaluate the concept map.

The objective of this study was to identify predictors of the use of multivitamin supplements (MVS) among Caucasian college females utilizing the Theory of Planned Behavior (TPB). Variables of the TPB and the self-reported use of multivitamin supplements were measured by two separate surveys within 1 week with a convenience sample of 96 Caucasian college student females. Two attitudinal beliefs and one control belief significantly predicted behavioral intention to use multivitamin. A belief that taking multivitamin supplements helps to feel and look good was the most important predictor of the use of multivitamin supplements. EDITORS' STRATEGIC IMPLICATIONS: Findings from this study, although in need of replication, suggest that prevention campaigns would be more successful if messages used to reach these females were consistent with perceived beliefs regarding benefits of using MVS. More broadly, TPB appears to offer a useful framework for understanding or predicting behavior based on psychological constructs theorized to influence behavior.

Background: A collaborative community--university--U.S. Department of Agriculture(USDA)/Agricultural Research Service (ARS) partnership developed and implemented a 6-month walking intervention whereby volunteer coaches were trained to lead community walking groups in a rural Mississippi Delta Community., Objective: Assess the feasibility of implementing community-based participatory research (CBPR), increase physical activity, and improve anthropometric and biological measures., Methods: This quasi-experimental design examined body mass index, percent body fat, waist circumference, blood pressure, blood glucose, lipid profile, self-reported walking, stages of change, social support, self-efficacy, and decisional balance at enrollment, 3 months, and 6 months. Participants were primarily African-American (99%) women (97%). Changes were evaluated using repeated measures analysis of variance (ANOVA) and Friedman's test., Results: Community members actively participated in assessing the problem, identifying the intervention, intervention planning, data collection, and evaluation. Of the 83 enrolled participants, 66 (80%) completed the intervention. Participants exhibited significant improvements in waist circumference (-1.4 inches), systolic blood pressure (-4.3 mmHg), and high-density lipoprotein (HDL) cholesterol (+7.9 mg/dL); (PA

Background: Members of a Lower Mississippi Delta community and university partners used the Comprehensive Participatory Planning and Evaluation (CPPE) model to assess nutrition and health problems and develop a menu of interventions., Objectives: We sought to identify and prioritize nutrition and physical activity problems in the community and to identify interventions to address the problems., Methods: Community members and university partners used the CPPE process to identify and prioritize nutrition and physical activity problems. The participants developed causal models to break down the identified problems to their root causes. They then developed a menu of interventions and criteria to rank the interventions., Results: The identified problems were intake of unhealthy foods, lack of nutrition education, and lack of adequate physical activity. The menu of interventions consisted of seven objectives to address poor nutrition and physical activity as well as a total of 19 interventions to meet these objectives., Conclusion: Directly involving community members in identifying health problems and solutions results in the development of interventions that are likely to have greater acceptability with the community.

Objective: To assess food supply adequacy within 3 food store types in the Lower Mississippi Delta., Design: Regional food store survey to determine availability and quality of 102 food items in 62 supermarkets, 77 small/medium stores, and 86 convenience stores., Setting: Lower Mississippi Delta region of the United States., Participants: 225 food stores in 18 counties., Main Outcome Measures: Percentage of Thrifty Food Plan (TFP) food items available and quality ratings of 6 food sections across store types., Results: On average, supermarkets carried 96% of the items that compose the TFP. Mean percentage of TFP carried in small/medium stores was 50%. Convenience stores carried 28% of the TFP items. Supermarkets had higher overall quality ratings and quality ratings for fresh and frozen foods compared to small/medium and convenience stores (P<.01)., Implications for Research and Practice: Although supermarkets carried a large percentage of items surveyed, the number of supermarkets in this region is limited. Community residents with limited transportation to reach supermarkets may experience limited food supply adequacy. Therefore, community-based nutrition interventions should include partnerships with small/medium food retailers while trying to impact residents' food choices within those stores.

Background: Public health officials recommend that women capable of becoming pregnant use folic acid-containing supplements (FAS) to prevent neural tube defects (NTD) in their newborn infants. However, the knowledge about NTD prevention and the prevalence of the use of FAS among women capable of becoming pregnant increased only modestly since the issuing of the recommendation in 1992. Since most commonly available multivitamin supplements (MVS) contain the recommended 400 gg of folic acid, finding out reasons why women take MVS and utilizing these factors in educational campaigns may contribute to increasing the use of FAS., Methods: The Theory of Planned Behavior variables and the self-reported use of MVS were measured by two separate surveys within one week. A preliminary open-ended questionnaire was utilized to elicit beliefs about MVS. A convenience sample of 100 African-American female college students, mean age 20.99 (SD=1.7) years, participated in this study., Results: Approximately 65% of variance in behavioral intention was explained by attitude, subjective norms, and perceived behavioral control (P<.001). Subjective norms had the greatest influence (3=0.348, P<.001), followed by PBC (3=0.336, P<.001), and attitude (1=0.228, P<.038). Behavioral intention significantly predicted the use of MVS accounting for =59.2% of variance., Conclusion: Consistent with the results of the present study, educational campaigns that target African-American female college students to encourage the use of MVS should focus on the impact of physicians, family, and peers.

Objective: The purpose of this study was to identify personal, behavioral, and environmental factors influencing fruit and vegetable consumption among 10- to 13-year-old low-income black American youth in the lower Mississippi Delta region. Social Cognitive Theory, along with other theoretical constructs, guided focus group questions and analysis., Design: A qualitative study using focus group methodology., Setting: Enrichment program of a sports summer camp for low-income youth., Participants: Forty-two adolescents (21 female, 21 male) participated in 6 focus groups., Main Outcome Measures: Personal, behavioral, and environmental influences on fruit and vegetable consumption., Analysis: Content analysis methods were used by 3 independent reviewers to identify themes within the focus group transcripts. Themes were summarized and then categorized into the 3 domains of Social Cognitive Theory., Results: The major themes were taste, availability, extended family influence, visual proof of the benefits of fruit and vegetable consumption, and the need for gender-specific behavioral skills., Conclusions and Implications: This formative research will aid in the development of a culturally relevant nutrition intervention for low-income black American adolescents in the lower Mississippi Delta region. The results indicate that this group is more likely to respond to interventions that use role models who can provide proof that fruit and vegetable consumption is related to improved health.

Context: Residents of the Lower Mississippi Delta of Arkansas, Louisiana, and Mississippi are at risk for food insecurity since a high proportion of the population live in households with incomes below the poverty level and have reduced access to food and decreased availability of a variety of foods. However, the magnitude of the problem is unknown because presently only nationwide and state estimates of food insecurity are available., Purpose: This study was conducted by the Lower-Mississippi Delta Nutrition Intervention Research Consortium to determine the prevalence of household food insecurity, identify high-risk subgroups in the Lower Delta, and compare to national data., Methods: A 2-stage stratified cluster sample representative of the population in 36 counties in the Lower Delta was selected using list-assisted random digit dialing telephone methodology. A cross-sectional telephone survey of 1662 households was conducted in 18 of the 36 counties using the US Food Security Survey Module., Findings: Twenty-one percent of Lower Delta households were food insecure, double the 2000 nationwide rate of 10.5%. Within the Lower Delta, groups with the highest rates of food insecurity were households with income below $15,000, black households, and households with children. The prevalence of hunger in Delta households with white children was 3.2% and in households with black children was 11.0%, compared to nationwide estimates of 0.3% and 1.6%., Conclusions: The Lower Mississippi Delta is characterized by a high prevalence of food insecurity and hunger. Future efforts to identify the household and community determinants of food insecurity to reduce its high prevalence are indicated.