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Background Type 2 diabetes mellitus (T2DM) is a leading cause of morbidity and mortality globally, with adverse health consequences largely related to hyperglycemia. Despite clinical practice guideline recommendations, effective pharmacotherapy, and interventions to support patients and providers, up to 60% of patients diagnosed with T2DM are estimated to have hemoglobin A1c (HbA1c) levels above the recommended targets owing to multilevel barriers hindering optimal glycemic control. Objective The aim of this study is to compare changes in HbA1c levels among patients with suboptimally controlled T2DM who were offered the opportunity to use an intermittently viewed continuous glucose monitor and receive personalized low-carbohydrate nutrition counseling ( Methods This was a 12-month, pragmatic, randomized quality improvement program. All adult patients with T2DM who received primary care at a university-affiliated primary care clinic (N=1584) were randomized to either the UC or the enhanced care (EC) group. Within each program arm, we identified individuals with HbA1c >7.5% (58 mmol/mol) who were medically eligible for tighter glycemic control, and we defined these subgroups as UC–high risk (UC-HR) or EC-HR. UC-HR participants (n=197) received routine primary care. EC-HR participants (n=185) were invited to use an intermittently viewed continuous glucose monitor and receive low-carbohydrate nutrition counseling. The primary outcome was mean change in HbA1c levels from baseline to 12 months using an intention-to-treat difference-in-differences analysis comparing EC-HR with UC-HR groups. We conducted follow-up semistructured interviews to understand EC-HR participant experiences with the intervention. Results HbA1c decreased by 0.41% (4.5 mmol/mol; P=.04) more from baseline to 12 months among participants in the EC-HR group than among those in UC-HR; however, only 61 (32.9%) of 185 EC-HR participants engaged in the program. Among the EC-HR participants who wore continuous glucose monitors (61/185, 32.9%), HbA1c was 1.1% lower at 12 months compared with baseline (P Conclusions Among patients with suboptimally controlled T2DM, a combined approach that includes continuous glucose monitoring and low-carbohydrate nutrition counseling can improve glycemic control compared with the standard of care.

BACKGROUND: The intestinal microbiome is an important determinant of inflammatory balance in the colon that may affect response to dietary agents. OBJECTIVE: This is a secondary analysis of a clinical trial, the Fish Oil Study, to determine whether interindividual differences in colonic bacteria are associated with variability in the reduction of colonic prostaglandin E(2) (PGE(2)) concentrations after personalized supplementation with ω-3 (n–3) fatty acids. METHODS: Forty-seven healthy adults (17 men, 30 women, ages 26–75 y) provided biopsy samples of colonic mucosa and luminal stool brushings before and after personalized ω-3 fatty acid supplementation that was based on blood fatty acid responses. Samples were analyzed using 16S ribosomal RNA sequencing. The data analyses focused on changes in bacterial community diversity. Linear regression was used to evaluate factors that predict a reduction in colonic PGE(2). RESULTS: At baseline, increased bacterial diversity, as measured by the Shannon and Inverse Simpson indexes in both biopsy and luminal brushing samples, was positively correlated with dietary fiber intakes and negatively correlated with fat intakes. Dietary supplementation with ω-3 fatty acids increased the Yue and Clayton community dis-similarity index between the microbiome in luminal brushings and colon biopsy samples post-supplementation (P = 0.015). In addition, there was a small group of individuals with relatively high Prevotella abundance who were resistant to the anti-inflammatory effects of ω-3 fatty acid supplementation. In linear regression analyses, increases in diversity of the bacteria in the luminal brushing samples, but not in the biopsy samples, were significant predictors of lower colonic PGE(2) concentrations post-supplementation in models that included baseline PGE(2), baseline body mass index, and changes in colonic eicosapentaenoic acid–to–arachidonic acid ratios. The changes in bacterial diversity contributed to 6–8% of the interindividual variance in change in colonic PGE(2) (P = 0.001). CONCLUSIONS: Dietary supplementation with ω-3 fatty acids had little effect on intestinal bacteria in healthy humans; however, an increase in diversity in the luminal brushings significantly predicted reductions in colonic PGE(2). This trial was registered at www.clinicaltrials.gov as NCT 01860352.

PURPOSE The objective of this study was to review randomized controlled trials (RCT), which included a wearable activity tracker in an intervention to promote physical activity among cardiac rehabilitation (CR) participants, and to conduct a meta-analysis for the outcomes of step counts and aerobic capacity (V˙o2max). METHODS Eight databases were searched for RCTs that included an activity tracker, enrolled adults eligible for CR, and reported outcomes of step count or aerobic capacity. Mean differences were calculated for outcomes in the meta-analyses. RESULTS Nineteen RCTs with 2429 participants were included in the systematic review and 10 RCTs with 891 participants were included in the meta-analysis. Meta-analysis of three RCTs using a pedometer or accelerometer demonstrated a significant increase in daily step count compared with controls (n = 211, 2587 steps/d [95% CI, 916-5257]; I2 = 74.6% and P = .002). Meta-analysis of three RCTs using a pedometer or accelerometer intervention demonstrated a significant increase in V˙o2max compared with controls (n = 260, 2.6 mL/min/kg [95% CI, 1.6-3.6]; I2 = 0.0% and P < .0001). Meta-analysis of four RCTs using a heart rate monitor demonstrated a significant increase in V˙o2max compared with controls (n = 420, 1.4 mL/min/kg [95% CI, 0.4-2.3]; I2 = 0.0% and P = .006). CONCLUSIONS Use of activity trackers among CR participants was associated with significant increases in daily step count and aerobic capacity when compared with controls. However, study size was small and variability in intervention supports the need for larger trials to assess use of activity trackers in CR.

The overall goal of this study was to determine whether Aquamin®, a calcium-, magnesium-, trace element-rich, red algae-derived natural product, would alter the expression of proteins involved in growth-regulation and differentiation in colon. Thirty healthy human subjects (at risk for colorectal cancer) were enrolled in a three-arm, 90-day interventional trial. Aquamin® was compared to calcium alone and placebo. Before and after the interventional period, colonic biopsies were obtained. Biopsies were evaluated by immunohistology for expression of Ki67 (proliferation marker) and for CK20 and p21 (differentiation markers). Tandem mass tag-mass spectrometry-based detection was used to assess levels of multiple proteins. As compared to placebo or calcium, Aquamin® reduced the level of Ki67 expression and slightly increased CK20 expression. Increased p21 expression was observed with both calcium and Aquamin®. In proteomic screen, Aquamin® treatment resulted in many more proteins being upregulated (including pro-apoptotic, cytokeratins, cell–cell adhesion molecules, and components of the basement membrane) or downregulated (proliferation and nucleic acid metabolism) than placebo. Calcium alone also altered the expression of many of the same proteins but not to the same extent as Aquamin®. We conclude that daily Aquamin® ingestion alters protein expression profile in the colon that could be beneficial to colonic health.

Background: Health-related quality of life (HRQoL) for adults with chronic and acute illnesses informs health and economic policy for pandemic recovery. Our primary aim was to compare HRQoL of 3 illness groups of outpatient adults: those with diabetes, those who survived a hospitalization for COVID-19, and those who had a respiratory virus not COVID-19. The secondary aim was to compare the group domain summary scores to the referent general population. Methods: We identified the 3 groups from the electronic medical record and invited them to complete the SF-36 survey. Analysis of variance and post hoc testing was used for univariate analyses followed by linear regression. Results: One hundred thirty-two adults completed the survey. The groups differed least for physical functioning and most for emotional/mental health. The hospitalized group had the greatest limitation in role due to emotional issues. All groups had significantly lower social functioning scores than the general population. Linear regression showed lower HRQoL domain score in role limitations due to emotional issues adjusted for age, race, and gender for the hospitalized group. Conclusion: SF-36 scores show the decrease in HRQoL that outpatient adults have suffered, mostly in the emotional domain, regardless of illness group during the COVID-19 pandemic.

Study Objectives In a randomized controlled noninferiority trial, we compared face-to-face and telemedicine delivery (via the AASM SleepTM platform) of cognitive-behavioral therapy (CBT) for insomnia for improving insomnia/sleep and daytime functioning at posttreatment and 3-month follow-up. A secondary objective compared the modalities on treatment credibility, satisfaction, and therapeutic alliance. Methods A total of 65 adults with chronic insomnia (46 women, 47.2 ± 16.3 years of age) were randomized to 6 sessions of CBT for insomnia delivered individually via AASM SleepTM (n = 33, CBT-TM) or face-to-face (n = 32, CBT-F2F). Participants completed sleep diaries, the Insomnia Severity Index (ISI), and daytime functioning measures at pretreatment, posttreatment, and 3-month follow-up. Treatment credibility, satisfaction, and therapeutic alliance were compared between treatment modalities. The ISI was the primary noninferiority outcome. Results Based on a noninferiority margin of four points on the ISI and, after adjusting for confounders, CBT-TM was noninferior to CBT-F2F at posttreatment (β = 0.54, SE = 1.10, 95% CI = 1.64 to 2.72) and follow-up (β = 0.34, SE = 1.10, 95% CI = 1.83 to 2.53). Daytime functioning measures, except the physical composite scale of the SF-12, were significantly improved at posttreatment and follow-up, with no difference between treatment formats. CBT-TM sessions were, on average, nearly 10 min shorter, yet participant ratings of therapeutic alliance were similar to CBT-F2F. Conclusions Telemedicine delivery of CBT for insomnia is not inferior to face-to-face for insomnia severity and yields similar improvements on other sleep and daytime functioning outcomes. Further, telemedicine allows for more efficient treatment delivery while not compromising therapeutic alliance. Clinical Trial Registration Number NCT03293745

Sexually transmitted infections (STIs) are an increasingly critical and costly health problem for American childbearing women. Pregnant women who misuse substances are more likely to engage in risky sexual behavior that leads to STIs. Substance use and risky sex during pregnancy are both associated with numerous negative consequences for the woman and the developing fetus.A two-group, randomized controlled trial.Recruitment of 50 pregnant women (30% Latina; 24.4 years old [SD = 5.31]) with an average of 13 weeks gestation (SD = 4.5 weeks) was conducted at a prenatal clinic in a large inner-city hospital. Recruitment took place between 2015 and 2016, and data analysis took place in 2016.A computer-delivered, single-session brief motivational intervention plus booster session addressing both substance use and STI risk.To assess participants' perceptions of the intervention and to examine the preliminary efficacy in reduction of substance use and risky sex at 4-month follow-up assessment.There were consistently very high ratings of acceptability of the intervention, ranging between 6.3 and 6.8 on a 1-7 scale. At the 4-month follow-up, participants in the intervention arm reported a significantly larger reduction (54%) in any marijuana or alcohol use compared with participants in the control group (16%) (p = 0.015) based on two-group clustered logistic regression using a generalized estimating equations approach. There was a higher reduction in condomless vaginal sex at follow-up in the health checkup for expectant moms (HCEM) arm than control (27% vs. 5%), although this was not significant (p = 0.127).The results of this pilot study are encouraging with respect to the acceptability and preliminary efficacy of an intervention in reducing alcohol/marijuana use and condomless sex during pregnancy, supporting the next step of testing the intervention in a larger sample.

Female sterilization accounts for 50% of all contraceptive use in the U.S. The extent to which U.S. women with physical and/or sensory disabilities have undergone female sterilization is unknown.Our primary objective was to determine the prevalence of sterilization for women with physical/sensory disabilities, and compare this to the prevalence for women without disabilities. We also compared use of long-acting reversible contraceptive (LARC) methods between women with and without disabilities.We conducted a secondary analysis of data from the National Survey of Family Growth 2011-2013, a population-based survey of U.S. women aged 15-44. Bivariate comparisons between women with and without disabilities by female sterilization and LARC use were conducted using chi-square tests. Using logistic regression, we estimated the odds of female sterilization based upon disability status.Women with physical/sensory disabilities accounted for 9.3% of the total sample (N = 4966). Among women with disabilities only, 28.2% had undergone female sterilization, representing 1.2 million women nationally. LARC use was lower among women with disabilities than those without disabilities (5.4%, 9.3%, respectively, p 0.01). After adjusting for age, race/ethnicity, education, insurance, marital status, parity, and self-reported health, women with disabilities had higher odds of sterilization (OR 1.36, 95% CI 1.03, 1.79).The odds of female sterilization is higher among women with physical/sensory disabilities than those without disabilities. Future research is necessary to understand factors contributing to this finding, including possible underutilization of LARC methods.

Introduction Employee wellness programs show mixed effectiveness results. This study examined the impact of an insurer's lifestyle modification program on healthcare costs of obese individuals. Methods This nonrandomized comparative effectiveness study evaluated changes in healthcare costs for participants in two incentivized programs, an Internet-mediated pedometer-based walking program (WalkingSpree, n =7,594) and an in-person weight-loss program (Weight Watchers, n =5,764). The primary outcome was the change in total healthcare costs from the baseline year to the year after program participation. Data were collected from 2009 to 2011 and the analysis was done in 2014–2015. Results After 1 year, unadjusted mean costs decreased in both programs, with larger decreases for Weight Watchers participants than WalkingSpree participants (–$1,055.39 vs –$577.10, p =0.019). This difference was driven by higher rates of women in Weight Watchers, higher baseline total costs among women, and a greater decrease in costs for women in Weight Watchers (–$1,037.60 vs –$388.50, p =0.014). After adjustment for baseline costs, there were no differences by program or gender. Conclusions Comparable cost reductions in both programs suggest that employers may want to offer more than one choice of incentivized wellness program with monitoring to meet the diverse needs of employees.

Sexually transmitted infections (STIs) are at a record high in the United States, and STI risk is a critical and costly public health concern for childbearing women. STIs can lead to a number of serious health risks including premature birth, low birth weight, ectopic pregnancy, and fetal death. Similarly, there has been a dramatic increase in substance use during pregnancy, leading to complications during pregnancy and poorer birth outcomes. Women who misuse substances are disproportionately more likely to engage in risky sexual behaviors that can result in STIs. The proposed study will test whether the Health Check-Up for Expectant Moms (HCEM), a computer-delivered brief intervention that simultaneously targets STI risk and alcohol/illicit drug use during pregnancy, reduces antenatal and postpartum risk more than an attention, time, and information matched control condition among pregnant women seeking prenatal care. The study is a two-group, randomized controlled trial in which a diverse sample of 250 pregnant women will be recruited from prenatal care clinics and assigned to either (a) a computer-delivered, single-session brief intervention plus two booster sessions); or (b) a computer-delivered control condition. Follow-up assessments will occur at 2 and 6 months from baseline, and at 6 weeks postpartum. Our objective measures include STI incidence and birth outcomes. The results of this trial will fill a critical gap and provide much-needed data on the efficacy, costs, and resource utilization of a practical computer-delivered, brief motivational intervention tailored to reach high-risk women during pregnancy and extending impact to postpartum.

Aquamin is a calcium-, magnesium-, and multiple trace element–rich natural product with colon polyp prevention efficacy based on preclinical studies. The goal of this study was to determine the effects of Aquamin on colonic microbial community and attendant metabolomic profile. Thirty healthy human participants were enrolled in a 90-day trial in which Aquamin (delivering 800 mg of calcium per day) was compared with calcium alone or placebo. Before and after the intervention, colonic biopsies and stool specimens were obtained. All 30 participants completed the study without serious adverse event or change in liver and renal function markers. Compared with pretreatment values, intervention with Aquamin led to a reduction in total bacterial DNA (P = 0.0001) and a shift in the microbial community measured by thetaYC (θYC; P = 0.0087). Treatment with calcium also produced a decline in total bacteria, but smaller than seen with Aquamin, whereas no reduction was observed with placebo in the colon. In parallel with microbial changes, a reduction in total bile acid levels (P = 0.0375) and a slight increase in the level of the short-chain fatty acid (SCFA) acetate in stool specimens (P < 0.0001) from Aquamin-treated participants were noted. No change in bile acids or SCFAs was observed with calcium or placebo. We conclude that Aquamin is safe and tolerable in healthy human participants and may produce beneficial alterations in the colonic microbial community and the attendant metabolomic profile. Because the number of participants was small, the findings should be considered preliminary.

This study evaluated whether mRNA expression of major genes regulating formation of prostaglandin (PG)E(2) in the colon and colonic fatty acid concentrations are associated with the reduction in colonic mucosal PGE(2) after dietary supplementation with omega-3 (ω-3) fatty acids. Supplementation with ω-3 fatty acids was done for 12 weeks using personalized dosing that was expected to reduce colonic PGE(2) by 50%. In stepwise linear regression models, the ω-3 fatty acid dose and subject BMI explained 16.1% of the inter-individual variability in the fold change of colonic PGE(2) post-supplementation. Increases in mRNA gene expression after supplementation were, however, modest and were not associated with changes in PGE(2). When baseline expression of PTGS1, PTGS2 and HPGD genes was included in the linear regression model containing dose and BMI, only PTGS2, the gene coding for the inducible form cyclooxygenase, was a significant predictor. Higher relative expression of PTGS2 predicted greater decreases in colonic PGE(2), accounting for an additional 13.6% of the inter-individual variance. In the final step of the regression model, greater decreases in total colonic fatty acid concentrations predicted greater decreases in colonic PGE(2), contributing to an additional 18.7% of the variance. Overall, baseline BMI, baseline expression of PTGS2 and changes in colonic total fatty acids together accounted for 48% of the inter-individual variability in the change in colonic PGE(2). This is consistent with biochemical data showing that fatty acids which are not substrates for cyclooxygenases can activate cyclooxygenase-2 allosterically. Further clinical trials are needed to elucidate the factors that regulate the fatty acid milieu of the human colon and how this interacts with key lipid metabolizing enzymes. Given the central role of PGE(2) in colon carcinogenesis, these pathways may also impact on colon cancer prevention by other dietary and pharmacological approaches.

Vulvodynia has been considered to be a chronic disorder. We sought to estimate the probability of and risk factors for remission, relapse, and persistence among women screening positive for vulvodynia.Survey-based assessment in a longitudinal population-based study of women (the Woman to Woman Health Study) who screened positive for vulvodynia and completed at least four follow-up surveys. Outcome measures included remission without relapse, relapse (after remission), and persistence of a positive vulvodynia screen. Multinomial regression was used to assess factors associated with outcomes.Of 441 women screening positive for vulvodynia during the study, 239 completed 4 additional surveys. Of these, 23 (9.6%) had consistently positive vulvodynia screens, 121 (50.6%) remitted without relapse, and 95 (39.7%) relapsed following remission. Overall, factors associated with both relapse and persistence (compared with remission alone) included increased severity of pain ever (p0.001) or after intercourse (p = 0.03), longer duration of symptoms (p ≤ 0.001), and screening positive for fibromyalgia (p0.001). Factors associated with persistence (but not relapse) included more severe symptoms with intercourse (p = 0.001) and pain with oral sex (p = 0.003) or partner touch (p = 0.04). Factors associated with relapse (but not persistence) included having provoked pain (p = 0.001) or screening positive for interstitial cystitis (p = 0.05) at first positive vulvodynia screen. Demographic characteristics, age at pain onset, and whether vulvodynia was primary or secondary did not predict outcome.Remission of vulvodynia symptoms is common with approximately half of remitters experiencing a relapse within 6-30 months. Persistence without remission is the exception rather than the rule. Pain history and comorbid conditions were associated with the more severe outcomes of relapse and/or persistence compared with those who remitted only. These findings provide further support that vulvodynia is heterogeneous and often occurs in an episodic pattern.

Objective The Remission Evaluation and Mood Inventory Tool (REMIT) is a practical 5-item self-report measure of key positive mood states associated with recovering from depression, as distinct from depressive symptoms per se. The study goal was to identify a clinically useful threshold for interpreting REMIT responses in the context of mild to moderate depressive symptoms. Methods This was a secondary analysis of a cross-sectional dataset initially used to develop and validate the REMIT. Primary care patients being treated for depressive symptoms of either mild or moderate severity ( n = 247 and 240, respectively) rated their perceived degree of depression remission prior to completing the Patient Health Questionnaire-8 (PHQ-8) and the REMIT. We summed the totals of the latter two measures to form the PHQ + REMIT index. Results Receiver Operating Characteristics analysis indicated that the PHQ + REMIT threshold ≥13 was associated with good sensitivity (92%) and acceptable specificity (43%) to the absence of patient-perceived remission. In contrast, the PHQ had only 21% specificity at this sensitivity level. Area under the curve was 0.815 (95% C.I.: 0.765–0.865), which was significantly greater than that of the PHQ-8 alone (area under the curve = 0.745, 95% C.I.: 0.691–0.805, p(diff) = 0.0002). Threshold performance was unaffected by adjustment for demographic characteristics and variation in remission percentage. Compared with standard symptom-based classification, using the REMIT reclassified 27% of mildly symptomatic patients as remitted. Conclusions Using the REMIT with patients who have mild to moderate depressive symptoms improves the assessment of patient-perceived remission, which is indicated by a summed PHQ + REMIT index of less than 13. Longitudinal research is needed to test whether this broadened patient-centered approach to assessing remission improves clinical decision making and long-term outcomes.

Objective The aim of the study was to assess the association between cytokines/neurokines after in vitro stimulation with Candida antigen or lipopolysaccharide (LPS) in blood samples among women with and without vulvodynia. Materials and methods Women with vulvodynia and asymptomatic controls at three offices at the University of Michigan were examined clinically and completed a comprehensive survey in this cross-sectional study. Cytokine/neurokine levels were determined on blood samples using established ELISA protocols. Analysis of 48 cases and 42 ethnically matched controls included descriptive statistics (median, minimal, and maximal levels of cytokines/neurokines), overall and in cases and controls. Because of left-censored measurements, interval censored survival analysis was used to assess the association between case/control status and pain characteristics with cytokine/neurokine levels. Results Participants ranged in age from 19 to 60 years. Levels of IL1β, IL1-RA, TNFα, IL-6, and IL-8 increased substantially after LPS stimulation, whereas no response was seen on IFNγ or nerve growth factor (NGF). Each increased after Candida antigen stimulation, although responses to Candida antigen stimulation of IL1β, IL-6, and TNFα were less robust than after LPS. Only NGF was significantly increased in vulvodynia cases compared with controls (Exp β (95% CI) = 2.08 [1.08-3.98]) after 24-hour Candida antigen stimulation and persisted when controlled for age, use of oral contraceptives, or history of Candida vulvovaginitis. No association between cytokine/neurokine levels and pain characteristics was found. Conclusions Compared with that of control women, whole blood from women with vulvodynia demonstrates an enhanced production of NGF, but not of a set of inflammation-related cytokines, in response to Candida antigen stimulation.

Background Continuing use of analog film and digital chest radiography for screening and surveillance for pneumoconiosis and tuberculosis in lower and middle income countries raises questions of equivalence of disease detection. This study compared analog to digital images for intra-rater agreement across formats and prevalence of changes related to silicosis and tuberculosis among South African gold miners using the International Labour Organization classification system. Methods Miners with diverse radiological presentations of silicosis and tuberculosis were recruited. Digital and film chest images on each subject were classified by four expert readers. Results Readings of film and soft copy digital images showed no significant differences in prevalence of tuberculosis or silicosis, and intra-rater agreement across formats was fair to good. Hard copy images yielded higher prevalences. Conclusion Film and digital soft copy images show consistent prevalence of findings, and generally fair to good intra-rater agreement for findings related to silicosis and tuberculosis.

Background Deaf American Sign Language (ASL) users comprise a linguistic minority population with poor health care access due to communication barriers and low health literacy. Potentially, these health care barriers could increase Emergency Department (ED) use. Objective To compare ED use between deaf and non-deaf patients. Method A retrospective cohort from medical records. The sample was derived from 400 randomly selected charts (200 deaf ASL users and 200 hearing English speakers) from an outpatient primary care health center with a high volume of deaf patients. Abstracted data included patient demographics, insurance, health behavior, and ED use in the past 36 months. Results Deaf patients were more likely to be never smokers and be insured through Medicaid. In an adjusted analysis, deaf individuals were significantly more likely to use the ED (odds ratio [OR], 1.97; 95% confidence interval [CI], 1.11–3.51) over the prior 36 months. Conclusion Deaf American Sign Language users appear to be at greater odds for elevated ED utilization when compared to the general hearing population. Efforts to further understand the drivers for increased ED utilization among deaf ASL users are much needed.

Background Despite established guidelines for regular walking as a first line therapy for adults with peripheral arterial disease (PAD), most patients do not walk routinely. This paper presents the design specifications for a randomized clinical trial to examine the effectiveness of an internet-based walking program compared to a telephone intervention, or the combination (internet-based with telephone counseling) for promotion of regular walking in patients with PAD. Methods Sedentary adults with documented lower extremity PAD are being recruited from the University of Michigan Health System and the surrounding area. Participants are randomized to one of four arms in a 2 × 2 factorial design: 1) telephone counseling to promote walking, 2) an internet-based walking program with tailored step-count goals, 3) the combination of telephone counseling with the internet-based walking program, or 4) waitlist control. Participants receive a 4-month intervention phase, after which all participants are followed for an additional 8 months to assess long-term adherence to regular walking. Outcomes are assessed at baseline, 4 and 12 months. The primary outcome is walking distance assessed through a standardized treadmill protocol. Additional outcomes include change in step-counts measured with a commercial activity tracker, pain-free walking distance, and changes in health-related quality of life from baseline to follow-up. Conclusion Finding effective and feasible programs to promote walking among PAD patients is warranted. This study will add to current evidence regarding use of internet based programs with and without telephone counseling to promote regular walking in this population.

This clinical trial developed a personalized dosing model for reducing prostaglandin E2 (PGE2) in colonic mucosa using ω-3 fatty acid supplementation. The model utilized serum eicosapentaenoic acid (EPA, ω-3):arachidonic acid (AA, ω-6) ratios as biomarkers of colonic mucosal PGE2 concentration. Normal human volunteers were given low and high ω-3 fatty acid test doses for 2 weeks. This established a slope and intercept of the line for dose versus serum EPA:AA ratio in each individual. The slope and intercept was utilized to calculate a personalized target dose that was given for 12 weeks. This target dose was calculated on the basis of a model, initially derived from lean rodents, showing a log-linear relationship between serum EPA:AA ratios and colonic mucosal PGE2 reduction. Bayesian methods allowed addition of human data to the rodent model as the trial progressed. The dosing model aimed to achieve a serum EPA:AA ratio that is associated with a 50% reduction in colonic PGE2. Mean colonic mucosal PGE2 concentrations were 6.55 ng/mg protein (SD, 5.78) before any supplementation and 3.59 ng/mg protein (SD, 3.29) after 12 weeks of target dosing. In secondary analyses, the decreases in PGE2 were significantly attenuated in overweight and obese participants. This occurred despite a higher target dose for the obese versus normal weight participants, as generated by the pharmacodynamic predictive model. Large decreases also were observed in 12-hydroxyicosatetraenoic acids, and PGE3 increased substantially. Future biomarker-driven dosing models for cancer prevention therefore should consider energy balance as well as overall eicosanoid homeostasis in normal tissue.

Perinatal loss is often a traumatic outcome for families. While there are limited data about depressive outcomes in small populations, information about depression and posttraumatic stress disorder among large racially and economically diverse populations is sparse.We collaborated with the Michigan Department of Community Health to conduct a longitudinal survey of bereaved mothers with stillbirth or infant death under 28 days of life and live-birth (control) mothers in Michigan. The study assessed 9-month mental health outcomes including self-reported symptoms of depression and posttraumatic stress disorder along with information about demographics, pregnancy and loss experience, social support, and past and present mental health and treatment.Of 1400 women contacted by the State of Michigan, 609 completed surveys and were eligible to participate for a 44% response rate (377 bereaved mothers and 232 control mothers with live births). In multivariable analysis, bereaved women had nearly 4-fold higher odds of having a positive screen for depression and 7-fold higher odds of a positive screen for post-traumatic stress disorder after controlling for demographic and personal risk variables. A minority of screen-positive women were receiving any type of psychiatric treatment.This is the largest epidemiologically based study to date to measure the psychological impact of perinatal loss. Nine months after a loss, bereaved women showed high levels of distress with limited rates of treatment. Symptoms need to be monitored over time for persisting disorder and further research should identify women at highest risk for poor outcomes.

Diet-related disease is disproportionately concentrated in low-income communities where fruit and vegetable consumption is far below guidelines. To address financial barriers, Double Up Food Bucks (DUFB)-a statewide healthy food incentive-matches Supplemental Nutrition Assistance Program (SNAP) funds spent at farmers markets. However, incentive use is limited. This study examined the impact of a brief waiting room-based intervention about DUFB on program utilization and produce consumption.Longitudinal, repeated measures, quasi-experimental trial.SNAP-enrolled adults at a health center in a low-income, racially and ethnically diverse area of Southeast Michigan.Participants received a brief explanation of DUFB, written program materials, a map highlighting market locations and hours, and an initial $10 market voucher. DUFB use and produce consumption were measured through four surveys over 5 months (August 2014-January 2015).Outcome measures included DUFB use and fruit and vegetable consumption (analyses conducted in 2015-2016).A total of 302 eligible adults were identified, and 177 (59%) enrolled. One hundred twenty-seven (72%) completed all surveys. At baseline, 57% of participants reported shopping at a farmers market within the last year; 18% had previously used DUFB. By the end of the DUFB season, participants were significantly more likely to report DUFB use than at baseline (AOR=19.2, 95% CI=10.3, 35.5, p0.001), with 69% of participants reporting use of DUFB at least once, and 34% reporting use of DUFB three or more times. Adjusted fruit and vegetable consumption increased from baseline by 0.65 servings/day (95% CI=0.37, 0.93, p0.001) at 3 months, and remained 0.62 servings/day (95% CI=0.32, 0.92, p0.001) higher than baseline 2 months post-DUFB season.A brief clinic-based intervention was associated with a nearly fourfold increase in uptake of a SNAP incentive program, as well as clinically and statistically significant increases in produce consumption. Results suggested sustained behavior change even once the financial incentive was no longer available. Providing information about healthy food incentives is a low-cost, easily implemented intervention that may increase produce consumption among low-income patients.

To assess incidence rates of and risk factors for vulvodynia.We conducted a longitudinal population-based study of women in southeast Michigan (Woman-to-Woman Health Study) using a validated survey-based screening test for vulvodynia that was repeated at 6-month intervals over 30 months. Unadjusted incidence rates were determined using Poisson models. Demographic and symptom-related risk factors for incidence were assessed using discrete time survival analysis.Women who screened negative for vulvodynia at baseline and were followed through at least one additional survey (n=1,786) were assessed for onset of vulvodynia. The incidence rate was 4.2 cases per 100 person-years, and rates per 100 person-years were greater in women who were younger (7.6 cases per 100 person-years at age 20 years, compared with 3.3 cases per 100 person-years at age 60 years), Hispanic (9.5 cases per 100 person-years), married, or living as married (4.9 cases per 100 person-years); had reported symptoms of vulvar pain but did not meet vulvodynia criteria on the initial survey (11.5 cases per 100 person-years); or had reported past symptoms suggesting a history of vulvodynia (7.5 cases per 100 person-years). Increased risk of new-onset vulvodynia also included baseline sleep disturbance, chronic pain in general, specific comorbid pain disorders, and specific comorbid psychological disorders.The incidence rates of vulvodynia differ by age, ethnicity, and marital status. Onset is more likely among women with previous symptoms of vulvodynia or those with intermediate symptoms not meeting criteria for vulvodynia and among those with pre-existing sleep, psychological, and comorbid pain disorders. This suggests vulvodynia is an episodic condition with a potentially identifiable prodromal phase.II.

This study aimed to assess whether the domains identified by items on the Sexual Functioning Questionnaire (SFQ) apply to women with vulvodynia.Forty-one women with vulvodynia and 43 asymptomatic controls, between the ages 18 and 70 years, were assessed with a physician evaluation and a written survey that included the SFQ.Women with vulvodynia had a higher likelihood of female sexual dysfunction than did controls as indicated by 5 of the seven individual SFQ domains (desire, arousal-lubrication, pain, enjoyment, and partner domains, p.05). Scored on individual items relating to pain or penetrative sex differed more by vulvodynia presence than did items related to arousal and emotions. Compared with published SFQ psychometrics, factor analysis among women with vulvodynia demonstrated similar factor loadings in 6 of the 7 domains of the SFQ (desire, arousal-sensation, arousal-lubrication, orgasm, partner, and pain), but the enjoyment domain intermingled substantially with these other domains.The SFQ factor structure is generally valid among women with vulvodynia. However, vulvodynia may impact responses to individual items on questions about pain and/or penetration, which may potentially result in erroneous interpretations.

Little is known about the effect of preventive diets on colonic nutrient concentrations. This study randomized 120 persons at increased risk of colon cancer to a Mediterranean versus a Healthy Eating diet for six months. The former targeted increases in whole grains, fruits, vegetables, monounsaturated, and n3 fats. The Healthy Eating diet was based on Healthy People 2010 recommendations. At baseline, dietary fat and carotenoid intakes were poorly associated (Spearman ρ < 0.4) with serum and colon concentrations. Strong associations were observed between serum and colon measurements of β-cryptoxanthin (ρ = 0.58; P < 0.001), α-carotene (ρ = 0.48; P < 0.001), and β-carotene (ρ = 0.45; P < 0.001). After six months, the Healthy Eating intervention increased serum lutein, β-, and α-carotene significantly (P < 0.05). In the Mediterranean arm, the significant increases were in serum lutein, β-cryptoxanthin, β-carotene, monounsaturated, and n3 fats. A significant group-by-time interaction (P = 0.03) was obtained for monounsaturated fats. Colonic increases in carotenoids and n3 fats were significant only in Healthy Eating arm, whereas the group-by-time interaction was significant for β-carotene (P = 0.02) and α-carotene (P = 0.03). Changes in colon concentrations were not significantly associated with reported dietary changes. Changes in colon and serum concentrations were strongly associated for β-cryptoxanthin (ρ = 0.56; P < 0.001) and α-carotene (ρ = 0.40; P < 0.001). The associations between colonic and serum concentrations suggest the potential use of using serum concentration as a target in dietary interventions aimed at reducing colon cancer risk. Cancer Prev Res; 6(6); 558–65. ©2013 AACR.

Although women with vulvodynia typically have increased vulvar sensitivity, data on characteristics associated with the degree of vulvar sensitivity are lacking. We measured vulvar sensitivity using cotton swab test and vulvodolorimeter among a subset of 335 women, aged younger than 70 years, in the longitudinal Woman to Woman Health Study. Comparing the vulvodynia screening results from their online/paper survey to that at the time of the examination, 42 women had ongoing vulvodynia, 66 had a recent remission, 22 control participants had a recent onset of vulvodynia, and 205 control participants remained asymptomatic. Vulvar sensitivity was greater in each vulvodynia group compared with the control group (P .001), and was associated with younger age at first onset of pain (P = .025), pain after intercourse (P = .008), describing the pain as a "pressure," "burning," or "irritating" (P = .015, P = .005, and P = .006, respectively), with increased severity of pain ever (P = .012), and with subsequent persistent or relapsing vulvodynia (P .001 for each). A score of1 for the cotton swab summary score best differentiated case from control participants (sensitivity 71.9%; specificity 72.0%). Although 13.8% of women with vulvodynia had no increased sensitivity on cotton swab testing, they did not differ in most clinical characteristics or clinical course from those with increased vulvar sensitivity.This study showed that women with vulvodynia have more vulvar sensitivity than control women, but the spectrum of sensitivity is broad. Furthermore, those with and without vulvar sensitivity did not differ in most vulvar pain characteristics or in prognosis, suggesting a positive swab test is not required to substantiate the diagnosis.

OBJECTIVE: To assess differences in vulvar and peripheral sensitivity between women with and without vulvodynia. METHODS: Women with vulvodynia (n = 41) and age-matched controls (n = 43) seen in the outpatient setting were evaluated via surveys, clinical examination, and multimodal sensory testing (pressure, heat, cold, vibration, and electrical stimulation). The relationships between sensitivity to various sensory modalities and case/control status, as well as by vulvodynia subgroups, were assessed using logistic regression. RESULTS: Women with vulvodynia were more sensitive to pressure and to electrical stimuli than were control women at the vulva (median, 22 vs 230 g and 0.495 vs 0.769 mA, respectively; P < 0.001 for each) and at the thumb (median, 2500 vs 4250 g and 0.578 vs 0.764 mA, respectively; P = 0.006 for pressure, P < 0.001 for electrical stimulation). Heat, cold, and vibration detection thresholds did not differ significantly between these groups (P > 0.025). Those reporting spontaneous pain versus provoked pain had greater pressure sensitivity to the thumb (median, 1850 vs 2690 g; P = 0.020) and greater electrical sensitivity at the introitus (0.450 vs 0.608 mA; P = 0.011), and those with primary versus secondary vulvodynia had substantially greater pressure sensitivity to the thumb (median, 2438 vs 3125 g, P = 0.004). However, having localized versus generalized vulvodynia was not associated with differences in pressure or electrical sensitivity. CONCLUSIONS: Sensitivities to pressure and electrical stimuli are greater among vulvodynia cases than among controls and support 2 previously defined subgroups-those reporting spontaneous pain versus those whose pain only occurred when provoked, and those with primary versus secondary vulvodynia.

CONTEXT Women with disabilities experience a higher rate of adverse pregnancy outcomes than women without disabilities. Preventing or delaying pregnancy when that is the best choice for a woman is a critical strategy to reducing pregnancy-related disparities, yet little is known about current contraceptive use among women with disabilities. METHODS A cohort of 545 reproductive-age women with physical disabilities (i.e., difficulty walking, climbing, dressing or bathing) or sensory disabilities (i.e., difficulty with vision or hearing) was identified from among participants in the 2011–2013 National Survey of Family Growth. Those at risk for unplanned pregnancy were categorized by whether they were using highly effective reversible contraceptive methods (IUD, implant), moderately effective ones (pill, patch, ring, injectable), less effective ones (condoms, withdrawal, spermicides, diaphragm, natural family planning) or no method. Multinomial regression was conducted to examine the association between disability and type of contraceptive used. RESULTS Some 39% of women with disabilities were at risk of unplanned pregnancy, and 27% of those at risk were not using contraceptives. The presence of disability was associated with decreased odds of using highly effective methods or moderately effective methods, rather than less effective ones (odds ratio, 0.6 for each), but had no association with using no method. CONCLUSION There is a significant need to reduce contraceptive disparities related to physical or sensory disabilities. Future research should explore the extent to which contraceptive use differs by type and severity of disability, as well as identify contextual factors that contribute to any identified differences.

To estimate the relationship among the presence of vulvodynia, fibromyalgia, interstitial cystitis, and irritable bowel syndrome.Validated questionnaire-based screening tests for the four pain conditions were completed by women with and without vulvodynia who were participating in the Michigan Woman to Woman Health Study, a longitudinal population-based survey in southeastern Michigan. Weighted population-based estimates of the prevalence and characteristics of participants with these chronic comorbid pain conditions were calculated using regression analyses.Of 1,940 women who completed the survey containing all four screening tests, 1,890 (97.4%) answered all screening questions and were included. The prevalences of the screening-based diagnoses ranged from 7.5% (95% confidence interval [CI] 6.2-9.0) for interstitial cystitis, 8.7% (95% CI 7.3-10.4) for vulvodynia, 9.4% (95% CI 8.1-11.0) for irritable bowel syndrome, to 11.8% (95% CI 10.1-13.7) for fibromyalgia with 27.1% screening positive for multiple conditions. The presence of vulvodynia was associated with the presence of each of the other comorbid pain conditions (P.001, odds ratio 2.3-3.3). Demographic risk factors for each condition varied. Increasing age was not associated with greater numbers of comorbid conditions, and only low socioeconomic status was associated with having multiple comorbid conditions concurrently.Chronic pain conditions are common, and a subgroup of women with vulvodynia is more likely than those without vulvodynia to have one or more of the three other chronic pain conditions evaluated.

Objective The aims of the study were to define the heterogeneity of vulvodynia by determining data-driven subgroups within the vulvodynia diagnosis using exploratory cluster analysis and to characterize the subgroups identified. Materials and methods Included were participants in the longitudinal population-based study of vulvodynia in southeast Michigan who screened positive for vulvodynia at least once during the study. A cluster analysis using variables reflecting vulvar pain characteristics and comorbid pain conditions was conducted. Variables reflecting best separation of clusters were used to assign participants to subgroup categories. Demographic, psychiatric, general health, and other vulvar pain characteristics were summarized for each subgroup, followed by multinomial regression and pairwise comparisons of subgroups on these factors. Results Of 441 women screening positive for vulvodynia during the course of the study, 393 were eligible on the basis of data requirements. Cluster analysis suggested that best subgroup separation was based on the following 2 variables: (1) presence or absence of spontaneous vulvar pain and (2) presence or absence of other comorbid pain conditions. Subgroups did not differ by age or ethnicity. The subgroup having spontaneous pain and other comorbid conditions demonstrated greatest morbidity in general health measures, psychiatric disorders, and other vulvar pain measures. Primary versus secondary vulvodynia did not vary between subgroups and did not assist in subgroup separation in the cluster analysis. Discussion Subgroups based on exploratory cluster analysis demonstrated that presence of spontaneous pain and the presence of comorbid pain conditions resulted in best separation of groups. Presence of both spontaneous pain and other comorbid pain conditions identified the group with greatest morbidity.

Little is known about Millennial nursing students’ attitudes toward computer games and new media in nursing education and whether these attitudes differ between undergraduates and graduates. This study elicited nursing students’ experience with computer games and new media, their attitudes toward various instructional styles and methods, and the role of computer games and new media technologies in nursing education. We e-mailed all nursing students enrolled in two universities to invite their participation in an anonymous cross-sectional online survey. The survey collected demographic data and participants’ experience with and attitudes toward video gaming and multi-player online health care simulations. We used descriptive statistics and logistic regression to compare the differences between undergraduates and graduates. Two hundred eighteen nursing students participated. Many of the nursing students support using new media technologies in nursing education. Nurse educators should identify areas suitable for new media integration and further evaluate the effectiveness of these technologies.

Context The Mountain Ok (Mt Ok) people of Telefomin, who live at the interior of Papua New Guinea (PNG), were documented over 25 years ago to be one of the shortest populations on record, with average adult height below the fifth percentile (US). Serum Growth Hormone was detectable, Insulin-like Growth Factor-1 and serum indicators of protein nutritional status fell within the normal range, suggesting that these were not primary factors for their relative short stature. Objective Since the Telefolmin people have experienced recent socioeconomic changes, they were re-evaluated in 2008, to examine height, weight, and body mass index (BMI), for insight into relative contributions of environment and other factors that modulate stature in children and adults. Study Design and Setting Cross-sectional anthropometric data were collected from 474 individuals at Telefomin in 2008, and compared with anthropometric data from 342 individuals measured in 1983. Results The height of Telefolmin subjects, below the fifth percentile in 1983, remained below the fifth percentile in 2008. Weight and BMI of peripubertal and adult age groups increased from 1983 to 2008. Male and female heights at peripubertal ages were significantly greater in 2008. Nevertheless, final adult height did not change significantly over the 25 years. Conclusions Recent socioeconomic changes appear to contribute to increased weight, BMI, and stature at younger ages in the Mt Ok at Telefomin. In contrast, unchanging adult stature may reflect a delay in the impact of socioeconomic changes, or genetic influences that modulate responsiveness to other growth regulators. Am. J. Hum. Biol., 2011. © 2010 Wiley-Liss, Inc.

Objective. Central pain augmentation resulting from enhanced excitatory and/or decreased inhibitory neurotransmission is a proposed mechanism underlying the pathophysiology of functional pain syndromes such as fibromyalgia (FM). Multiple functional magnetic resonance imaging studies implicate the insula as a region of heightened neuronal activity in this condition. Since glutamate (Glu) is a major cortical excitatory neurotransmitter that functions in pain neurotransmission, we undertook this study to test our hypothesis that increased levels of insular Glu would be present in FM patients and that the concentration of this molecule would be correlated with pain report. Methods. Nineteen FM patients and 14 age- and sex-matched pain-free controls underwent pressure pain testing and a proton magnetic resonance spectroscopy session in which the right anterior insula and right posterior insula were examined at rest. Results. Compared with healthy controls, FM patients had significantly higher levels of Glu (mean SD 8.09 0.72 arbitrary institutional units versus 6.86 1.29 arbitrary institutional units; P 0.009) and combined glutamine and Glu (i.e., Glx) (mean SD 12.38 0.94 arbitrary institutional units versus 10.59 1.48 arbitrary institutional units; P 0.001) within the right posterior insula. No significant differences between groups were detected in any of the other major metabolites within this region (P > 0.05 for all comparisons), and no group differences were detected for any metabolite within the right anterior insula (P > 0.11 for all comparisons). Within the right posterior insula, higher levels of Glu and Glx were associated with lower pressure pain thresholds across both groups for medium pain (for Glu, r 0.43, P 0.012; for Glx, r 0.50, P 0.003). Conclusion. Enhanced glutamatergic neurotransmission resulting from higher concentrations of Glu within the posterior insula may play a role in the pathophysiology of FM and other central pain augmentation syndromes.

A Greek-Mediterranean dietary pattern has two distinct aspects that differ relative to average intakes in the United States: a high intake of monounsaturated fats and a high intake of fruit and vegetables. The purpose of the study was to develop and test an exchange list Greek-Mediterranean diet that could be used in future clinical trials of breast cancer prevention. A total of 69 women, ages 25 to 59 years, were randomized to either continue their own usual diet or follow an intervention diet for 6 months during 2004 through 2005. Intervention goals were to decrease usual fat intakes by about half and to replace those fats with olive oil and other high–monounsaturated fatty acid foods; increase fruit and vegetable intakes to 7 to 9 servings/day, depending on energy intake; and consume at least one serving per day each of culinary herbs and allium vegetables. Registered dietitians provided exchange goals and individualized telephone counseling, and diets were self-selected using a Mediterranean exchange list developed specifically for this study. Changes in diet were assessed by 7-day food records. Results demonstrated that counseling using the Mediterranean exchange list was effective for large dietary changes relative to the nonintervention group. Repeated measures analysis of variance indicated a statistically significant 48% increase in dietary monounsaturated fat with no appreciable change in total fat intake, and a significant increase in fruit and vegetable intake from 4.0 to 8.6 servings/day (P < 0.05).

To estimate the incidence and remission rates of vulvodynia over a 2-year period.A 2-year follow-up survey was sent to the University of Michigan Women's Health Registry members who had participated in a previously reported, validated survey. Changes in clinical status, incidence, and remission rates for vulvodynia were estimated, as were factors associated with new onset or remission of symptoms, using univariable and multivariable analyses.Of 1,037 women enrolled in the initial study, 744 women (71.7%) completed an online or written follow-up survey between September 2006 and March 2007. Of the 372 asymptomatic women controls at initial enrollment, 13 (3.5%, 95% confidence interval 1.6-5.4%) had developed vulvodynia during the 2-year follow-up period; nine (2.2%) of these had ongoing symptoms. Of 45 women with vulvodynia at initial enrollment, 10 (22.2%, 95% confidence interval 10.1-34.4%) indicated their symptoms had resolved. Factors at enrollment that were associated with incidence of vulvodynia were younger age and history of pain after intercourse. Remission was more common in women who did not have pain after intercourse and in those who reported less severe pain at enrollment.Based on 2-year follow-up, each year approximately one in 50 women develop symptoms of vulvodynia, and one in 10 women with vulvodynia report remission of symptoms.

BACKGROUND AND PURPOSE: Widespread pain sensitivity in patients with fibromyalgia (FM) suggests a central nervous system (CNS)-processing problem. Therefore, it is conceivable that metabolic alterations exist in pain-processing brain regions of people with FM compared with healthy controls (HC) and that such metabolic data could correlate with clinical symptoms. The purpose of this study was to test these hypotheses using proton MR spectroscopy ( 1 H-MR spectroscopy). Materials and METHODS: There were 21 patients with FM and 27 HC who underwent conventional structural MR imaging and additional 2D-chemical shift imaging (CSI) MR-spectroscopy sequences. For the 2D-CSI spectroscopy, larger volumes of interest (VOIs) were centered at the level of the basal ganglia and the supraventricular white matter. Within these larger areas, 16 smaller voxels were placed in a number of regions previously implicated in pain processing. N -acetylaspartate (NAA)/creatine(Cr), choline (Cho)/Cr and NAA/Cho ratios were calculated for each voxel. Subjects underwent clinical and experimental pain assessment. RESULTS: Mean metabolite ratios and ratio variability for each region were analyzed by using repeated-measures analysis of variance (ANOVA). Correlations between clinical symptoms and metabolite ratios were assessed. Cho/Cr variability in the right dorsolateral prefrontal cortex (DLPFC) was significantly different in the 2 groups; a significant correlation between Cho/Cr in this location and clinical pain was present in the FM group. Evoked pain threshold correlated significantly with NAA/Cho ratios in the left insula and left basal ganglia. CONCLUSION: Our data suggest that there are baseline differences in the variability of brain metabolite relative concentrations between patients with FM and HC, especially in the right DLPFC. Furthermore, there are significant correlations between metabolite ratios and clinical and experimental pain parameters in patients with FM.

PURPOSE Cross-sectional studies show that individuals who walk more tend to be thinner than those who walk less. This does not mean, however, that the associa- tion between higher step counts and lower weight is causal or that encouraging sedentary individuals to increase step counts helps them lose weight. METHODS In this meta-analysis, we searched 6 electronic databases and contacted pedometer experts to identify pedometer-based walking studies without a dietary intervention that reported weight change as an outcome. We included randomized controlled trials and prospective cohort studies published after January 1, 1995, in either English or Japanese, with 5 or more adult participants and at least 1 cohort enrolled in a pedometer-based walking intervention lasting at least 4 weeks. RESULTS Nine studies met the study inclusion criteria. Cohort sample size ranged from 15 to 106, for a total of 307 participants, 73% of whom were women and 27% of whom were men. The duration of the intervention ranged from 4 weeks to 1 year, with a median duration of 16 weeks. The pooled estimate of mean weight change from baseline using a fi xed-effects model and combining data from all 9 cohorts was -1.27 kg (95% confi dence interval, -1.85 to -0.70 kg). Longer intervention duration was associated with greater weight change. On average, participants lost 0.05 kg per week during the interventions. CONCLUSION Pedometer-based walking programs result in a modest amount of weight loss. Longer programs lead to more weight loss than shorter programs.

Background. Because cervical intraepithelial neoplasia (CIN, or dysplasia) is associated with behavioral factors, health education is an important part of the care of patients at risk for this disease. Smoking, which is strongly associated with CIN and cancers, is particularly important because smoking cessation, even after the onset of CIN, improves outcomes. This study is part of an effort to identify effective ways to convey information about the association between smoking and CIN to at-risk women.Methods. We created 8 images to systematically incorporate a range of artistic approaches to inform viewers about the relationship between smoking and CIN. College women smokers were recruited to participate. Participants rated the images on the extent to which they attracted attention and motivated smoking cessation.Results. Significant differences were identified in the response of this population to visual images differing in content and style. Informative images were more compelling than those that were emotive.conclusions. Further exploration is warranted to improve our understanding of how visual forms of health education can impact smoking cessation by those at risk for cervical cancer.

Cervical cancer is a well-established smoking-related illness, but many at-risk women are unaware of this link.The authors designed this study to (1) investigate the relationship of smoking behavior with the history of abnormal Pap test results, sexual history, and perceived risk of cervical cancer and (2) determine whether self-classified smoking status (and hence perceived risk) corresponds with actual smoking behavior in a college student population. PARTICIPANTS AND METHOD SUMMARY: College women students (N = 135) completed a survey assessing smoking history, health history, sexual risk behavior, and risk awareness.Relative to those who had not smoked in the past month, current smokers (n = 36, or 27% of the total sample) perceived themselves to be at higher risk for developing cervical cancer, but did not demonstrate increased awareness of specific cervical cancer risk factors, including smoking. Twenty-eight percent (10 of 36) of past-month smokers did not define themselves as current smokers.The authors conclude that anti-smoking and health-related messages targeting smokers may misfire for individuals who do not define themselves as smokers but are nonetheless at risk for smoking-related consequences and escalating use.

Communication and language barriers isolate Deaf American Sign Language (ASL) users from mass media, healthcare messages, and health care communication, which when coupled with social marginalization, places them at a high risk for inadequate health literacy. Our objectives were to translate, adapt, and develop an accessible health literacy instrument in ASL and to assess the prevalence and correlates of inadequate health literacy among Deaf ASL users and hearing English speakers using a cross-sectional design. A total of 405 participants (166 Deaf and 239 hearing) were enrolled in the study. The Newest Vital Sign was adapted, translated, and developed into an ASL version of the NVS (ASL-NVS). Forty-eight percent of Deaf participants had inadequate health literacy, and Deaf individuals were 6.9 times more likely than hearing participants to have inadequate health literacy. The new ASL-NVS, available on a self-administered computer platform, demonstrated good correlation with reading literacy. The prevalence of Deaf ASL users with inadequate health literacy is substantial, warranting further interventions and research.

This randomized trial evaluated the effects of intervention with either a Healthy Eating or a Mediterranean diet on colon biomarkers in 120 healthy individuals at increased colon cancer risk. The hypothesis was that eicosanoids and markers of proliferation would be favorably affected by the Mediterranean diet. Colon epithelial biopsy tissues and blood samples were obtained at baseline and after six months of intervention. Colonic eicosanoid concentrations were evaluated by HPLC-MS-MS, and measures of epithelial proliferation and nuclear morphology were evaluated by image analysis of biopsy sections. There was little change in pro-inflammatory eicosanoids and in plasma cytokine concentrations with either dietary intervention. There was, however, a 50% increase in colonic prostaglandin E3 (PGE3), which is formed from eicosapentanoic acid, in the Mediterranean arm. Unlike PGE2, PGE3, was not significantly affected by regular use of non-steroidal anti-inflammatory drugs at baseline, and normal weight subjects had significantly higher colon PGE3 than overweight or obese subjects. Increased proliferation in the colon at baseline, by Ki67 labeling, was associated with morphological features that defined smaller nuclei in the epithelial cells, lower colon leukotriene concentrations and higher plasma cytokine concentrations. Dietary intervention had little effect on measures of epithelial proliferation or of nuclear morphology. The increase in PGE3 with a Mediterranean diet indicates that in normal colon, diet might affect protective pathways to a greater extent than pro-inflammatory and proliferative pathways. Hence, biomarkers from cancer models might not be relevant in a true prevention setting.

Breast cancer is a major cause of morbidity, mortality, and medical expenditures among women in Canada. Essiac (Resperin Canada Limited, Waterloo, Ontario, Canada), a blend of at least four herbs (burdock root [Arctium lappa], Indian rhubarb [Rheum palmatum], sheep sorrel [Rumex acetosella], and the inner bark of slippery elm [Ulmus fulva or U. rubra]), has become one of the more popular herbal remedies for breast-cancer treatment, secondary prevention, improving quality of life, and controlling negative side-effects of conventional breast-cancer treatment.Our primary objective was to determine the difference in health-related quality of life (HR-QOL), as assessed by the Functional Assessment of Cancer Therapy Breast Cancer Version, between women who are new Essiac users (since breast cancer diagnosis) and those who have never used Essiac. Secondary endpoints included differences in depression, anxiety, fatigue, rate of adverse events, and prevalence of complications or benefits associated with Essiac during standard breast-cancer treatment. Additionally, we described the pattern of use of Essiac in this cohort of women.We performed a retrospective cohort study in 510 women, randomly chosen from the Ontario Cancer Tumour Registry, with a diagnosis of primary breast cancer in 2003.With the exception changes in a Physical well-being subscale and a relationship with doctor subscale, Essiac did not have a significant effect on HR-QOL or mood states. Even for Physical well-being and relationship with doctor, Essiac seemed to have a negative effect, with Essiac users doing worse than the non-Essiac users. This might be attributed to the fact that the group of users comprised younger women with more advanced stages of breast cancer, and both of these subgroups of patients have been shown to be at a significantly increased risk for negative mood states and/or a decreased sense of well-being. The women were taking low doses (total daily dose 43.6 +/- 30.8 mL) of Essiac that corresponded to the label directions found on most Essiac products. Friends were the most common source of information, and most women were taking Essiac to boost their immune systems or increase their chances of survival. Only 2 women reported minor adverse events, whereas numerous women reported beneficial effects of Essiac.Essiac does not appear to improve HR-QOL or mood states. Future studies are needed to determine whether other clinical outcomes, such as cancer reoccurrence, are affected by Essiac.

Previous studies have identified stress system dysregulation in fibromyalgia (FM) patients; such dysregulation may be involved in the generation and/or maintenance of pain and other symptoms. Corticotropin-releasing factor (CRF) is the principal known central nervous system mediator of the stress response; however, to date no studies have examined cerebrospinal fluid (CSF) CRF levels in patients with FM. The relationship between CSF CRF level, heart rate variability (HRV), and pain, fatigue, and depressive symptoms was examined in patients with FM. Among participants (n = 26), CSF CRF levels were associated with sensory pain symptoms (r = 0.574, p = 0.003) and affective pain symptoms (r = 0.497, p = 0.011), but not fatigue symptoms. Increased HRV was also strongly associated with increased CSF CRF and FM pain. In multivariate analyses adjusting for age, sex, and depressive symptoms, the association between CSF CRF and sensory pain symptoms (t = 2.54, p = 0.027) persisted. Women with FM who reported a history of physical or sexual abuse had lower CSF CRF levels than women who did not report such a history. CSF CRF levels are associated with both pain symptoms and variation in autonomic function in FM. Differences in CSF CRF levels among women with and without a self-reported history of physical or sexual abuse suggest that subgroups of FM patients may exist with different neurobiological characteristics. Further studies are needed to better understand the nature of the association between CSF CRF and pain symptoms in FM.

Evoked pain measures such as tender point count and dolorimetry are often used to determine tenderness in studies of fibromyalgia (FM). However, these measures frequently do not improve in clinical trials and are known to be influenced by factors other than pain such as distress and expectancy. The purpose of this investigation was to determine whether evoked pain paradigms that present pressure stimuli in a random fashion (eg, Multiple Random Staircase [MRS]) would track with clinical pain improvement in patients with FM better than traditional measures. Sixty-five subjects enrolled in a randomized clinical trial of acupuncture were observed longitudinally. Clinical pain was measured on a 101-point numerical rating scale (NRS) and the Short Form McGill Pain Questionnaire (SF-MPQ), whereas evoked pressure sensitivity was assessed via manual tender point count, dolorimetry, and MRS methods. Improvements in clinical pain and evoked pain were assessed irrespective of group assignment. Improvement was seen in clinical pain during the course of the trial as measured by both NRS ( P = .032) and SF-MPQ ( P = .001). The MRS was the only evoked pain measure to improve correspondingly with treatment (MRS, P = .001; tender point count and dolorimeter, P > .05). MRS change scores were correlated with changes in NRS pain ratings ( P = .003); however, this association was not stronger than tender point or dolorimetry correlations with clinical pain improvement ( P > .05). Pain sensitivity as assessed by random paradigms was associated with improvements in clinical FM pain. Sophisticated pain testing paradigms might be responsive to change in clinical trials. Perspective Trials in fibromyalgia often use both clinical and experimental methods of pain assessment; however, these two outcomes are often poorly correlated. We explore the relationship between changes in clinical and experimental pain within FM patients. Pressure pain testing that applies stimuli in a random order is associated with improvements in clinical pain, but this association was not stronger than other experimental techniques.

This study examines the impact of Family Healthware™ on communication behaviors; specifically, communication with family members and health care providers about family health history.A total of 3786 participants were enrolled in the Family Healthware™ Impact Trial (FHITr) in the United States from 2005-7. The trial employed a two-arm cluster-randomized design, with primary care practices serving as the unit of randomization. Using generalized estimating equations (GEE), analyses focused on communication behaviors at 6month follow-up, adjusting for age, site and practice clustering.A significant interaction was observed between study arm and baseline communication status for the family communication outcomes (p's.01), indicating that intervention had effects of different magnitude between those already communicating at baseline and those who were not. Among participants who were not communicating at baseline, intervention participants had higher odds of communicating with family members about family history risk (OR=1.24, p=0.042) and actively collecting family history information at follow-up (OR=2.67, p=0.026). Family Healthware™ did not have a significant effect on family communication among those already communicating at baseline, or on provider communication, regardless of baseline communication status. Greater communication was observed among those at increased familial risk for a greater number of diseases.Family Healthware™ prompted more communication about family history with family members, among those who were not previously communicating. Efforts are needed to identify approaches to encourage greater sharing of family history information, particularly with health care providers.

PURPOSE Statins reduce the risk of mortality and coronary artery disease in individuals at high cardiovascular risk. Using nationally representative data, we examined the relationships between statin use and cardiovascular risk, diagnosis of hyperlipidemia, and other risk factors. METHODS We analyzed data from the 2010 Medical Expenditure Panel Survey, a nationally representative survey of the US civilian noninstitutionalized population. The study sample had a total of 16,712 individuals aged 30 to 79 years. Those who reported filling at least 2 statin prescriptions were classified as statin users. We created multiple logistic regression models for statin use as the dependent variable, with cardiovascular risk factors and sociodemographic factors as independent variables. RESULTS Overall, 58.2% (95% CI, 54.6%–61.7%) of individuals with coronary artery disease and 52.0% (95% CI, 49.4%–54.6%) of individuals with diabetes aged older than 40 years were statin users. After adjusting for cardiovascular risk factors and sociodemographic factors, the probability of being on a statin was significantly higher among individuals with both hyperlipidemia and coronary artery disease, at 0.44 (95% CI, 0.40–0.48), or hyperlipidemia only, at 0.32 (95% CI, 0.30–0.33), than among those with coronary artery disease only, at 0.11 (95% CI, 0.07–0.15). A similar pattern was seen in people with diabetes. CONCLUSIONS In this nationally representative sample, many people at high risk for cardiovascular events, including those with coronary artery disease, diabetes, or both, were not receiving statins despite evidence that these agents reduce adverse events. This undertreatment appears to be related to placing too much emphasis on hyperlipidemia and not enough on cardiovascular risk. Recently released guidelines from the American College of Cardiology and the American Heart Association offer an opportunity to improve statin use by focusing on cardiovascular risk instead of lipid levels.

Colorectal cancer (CRC) remains a significant cause of mortality. Inhibitors of cyclooxygenase (COX) and thus prostaglandin E2, are promising CRC preventives, but have significant toxicities. Ginger has been shown to inhibit COX, to decrease the incidence and multiplicity of adenomas, and decrease PGE2 concentrations in subjects at normal risk for CRC. This study was conducted to determine the effects of 2.0 g/d of ginger given orally on the levels of PGE2, leukotriene B4 (LTB4), 13-hydroxy-octadecadienoic acids, and 5-, 12-, & 15-hydroxy-eicosatetraenoic acid, in the colonic mucosa of subjects at increased risk for CRC. We randomized 20 subjects to 2.0 g/d ginger or placebo for 28 d. At baseline and Day 28, a flexible sigmoidoscopy was used to obtain colon biopsies. A liquid chromatography mass spectrometry method was used to determine eicosanoid levels in the biopsies, and levels were expressed per amount of protein or free arachidonic acid (AA). There was a significant decrease in AA between baseline and Day 28 (P = 0.05) and significant increase in LTB4 (P = 0.04) when normalized to protein, in subjects treated with ginger versus placebo. No other changes in eicosanoids were observed. There was no difference between the groups in total adverse events (AE; P = 0.06). Ginger lacks the ability to decrease eicosanoid levels in people at increased risk for CRC. Ginger did appear to be both tolerable and safe; and could have chemopreventive effects through other mechanisms. Further investigation should focus on other markers of CRC risk in those at increased CRC risk.

Fetal deaths account for nearly one percent of all births in the United States. The cost of hospital care associated with fetal deaths may be substantial. However, there is very limited data on the economic burden of fetal death. We conducted a retrospective medical chart review of stillbirths at three large hospitals in Michigan over a ten-year period and identified medical complications, hospital costs, and length of stay for these deliveries. Mothers with stillbirth were matched with mothers of the same age who delivered a live-born infant at the same hospital during the same year. Our final sample was comprised of 533 stillbirths and 1,053 matched live births. Average hospital cost for stillbirth was $7,495 (±7,015) and the average length of stay was 2.8 days (±2.8). Having a serious maternal medical complication was associated with higher costs and longer length of stay among women with stillbirth. Early stillbirths between 20 and 28 weeks gestational age, epidural/spinal/general anesthesia, and cesarean delivery were also associated with longer length of stay. Average hospital costs for women with stillbirth were more than $750 higher than women with live births but length of stay was not significantly different between the two. This study suggests that stillbirths were associated with substantial maternal hospital costs. Future research examining the economic impact of stillbirths beyond labor and delivery such as increased costs associated with additional testing and care in subsequent pregnancies will help better understand the overall economic impact of stillbirths.

Elevated tissue levels of prostaglandin E2, produced by cyclooxygenase (COX), are an early event in colorectal cancer (CRC). Data suggest the efficacy of nonsteroidal anti-inflammatory drugs, such as cancer preventives, in the inhibition of COX activity; however, side effects of nonsteroidal anti-inflammatory pose unacceptable limitations. Ginger has been reported to have anti-inflammatory activities with significant CRC preventive potential. We investigated whether consumption of 2.0 g ginger daily regulated the level of two key enzymes that control prostaglandin E2 production, COX-1 and NAD(+)-dependent 15-hydroxyprostaglandin dehydrogenase (15-PGDH). Thirty participants at normal and 20 participants at increased risk for CRC were randomized and given 2.0 g/day ginger or placebo for 28 days. Flexible sigmoidoscopy was used to obtain colon biopsies at baseline and the end of the study. Tissue levels of COX-1 and 15-PGDH were assessed using western blotting. After ginger consumption, participants at increased risk for CRC had a significantly reduced colonic COX-1 protein level (23.8±41%) compared with the placebo group (18.9±52%; P=0.03). Protein levels of 15-PGDH in the colon were unchanged. In participants who were at normal risk for CRC, neither protein levels of COX-1 nor 15-PGDH in the colon were altered by ginger consumption. Ginger significantly lowered COX-1 protein expression in participants at increased risk for CRC but not in those at normal risk for CRC. Ginger did not alter 15-PGDH protein expression in either increased or normal-risk participants. Further investigation, in larger studies with a longer ginger intervention, is needed to examine the ability of ginger to impact tissue levels of prostaglandin.

Objective To assess whether the risk of vulvodynia is associated with previous use of oral contraceptives (OCs). Design Longitudinal population-based study. Setting Four counties in south-east Michigan, USA. Population A population-based sample of women, aged 18 years and older, enrolled using random-digit dialling. Methods Enrolled women completed surveys that included information on demographic characteristics, health status, current symptoms, past and present OC use, and a validated screen for vulvodynia. The temporal relationship between OC use and subsequent symptoms of vulvodynia was assessed using Cox regression, with OC exposure modelled as a time-varying covariate. Main outcome measure Vulvodynia, as determined by validated screen. Results Women aged

To estimate the effects of ginger on apoptosis, proliferation, and differentiation in the normal-appearing colonic mucosa, we randomized 20 people at increased risk for colorectal cancer to 2.0 g of ginger or placebo daily for 28 days in a pilot trial. Overall expression and distributions of Bax, Bcl-2, p21, hTERT, and MIB-1 (Ki-67) in colorectal crypts in rectal mucosa biopsies were measured using automated immunohistochemistry and quantitative image analysis. Relative to placebo, Bax expression in the ginger group decreased 15.6% (P = 0.78) in the whole crypts, 6.6% (P = 0.95) in the upper 40% (differentiation zone) of crypts, and 21.7% (P = 0.67) in the lower 60% (proliferative zone) of crypts; however, there was a 19% increase (P = 0.14) in Bax expression in the upper 40% relative to the whole crypt. While p21 and Bcl-2 expression remained relatively unchanged, hTERT expression in the whole crypts decreased by 41.2% (P = 0.05); the estimated treatment effect on hTERT expression was larger in the upper 40% of crypts (−47.9%; P = 0.04). In the ginger group, MIB-1 expression decreased in the whole crypts, upper 40% of crypts, and lower 60% of crypts by 16.9% (P = 0.39), 46.8% (P = 0.39), and 15.3% (P = 0.41), respectively. These pilot study results suggest that ginger may reduce proliferation in the normal-appearing colorectal epithelium and increase apoptosis and differentiation relative to proliferation—especially in the differentiation zone of the crypts and support a larger study to further investigate these results. Cancer Prev Res; 6(4); 271–81. ©2012 AACR.