The GOAL-Hem journey: Shared decision making and patient-centred outcomes.

INTRODUCTION: GOAL-Hem is a novel, haemophilia-specific, patient-centred outcome measure (PCOM) based on goal attainment scaling, allowing people with haemophilia (PwH) to set and monitor the attainment of individualized goals for treatment. AIM: To provide a thorough overview of the creation, validation, and development of GOAL-Hem. METHODS: Clinician workshops were held to develop a haemophilia-specific goal menu. Qualitative data from semistructured interviews with PwH and their caregivers guided further revisions to the goal menu (i.e., goal domains and descriptors). A feasibility study was performed including a 12-week, prospective, noninterventional evaluation involving clinicians and PwH at four US haemophilia treatment centres. Finally, the Patient Voice Study gathered feedback from PwH and their caregivers via an online survey, interviews, and a focus group. RESULTS: The feasibility study validated GOAL-Hem with successful outcomes in construct/content validity and responsiveness, including a large effect in patient- and clinician-rated goal attainments. The Patient Voice Study led to significant refinement of GOAL-Hem goals and descriptors, resulting in a more straightforward and relatable menu for PwH and their caregivers. Overall, GOAL-Hem captured qualitative data in areas important to PwH and employed quantitative methods to evaluate meaningful changes in those areas. The individualized tool was well equipped to handle the complex and chronic nature of haemophilia and was endorsed by PwH, their caregivers, and clinicians. CONCLUSION: The GOAL-Hem development journey may serve as a roadmap for other PCOMs in a variety of settings, including clinical studies, haemophilia treatment centres for care planning, and as a tool to gather real-world evidence.

Cognitive Distraction at Mealtime Decreases Amount Consumed in Healthy Young Adults: A Randomized Crossover Exploratory Study.

BACKGROUND: Environmental distractions have been shown to affect eating patterns. OBJECTIVE: The purpose of this study was to determine the effects of a cognitive distraction on amount, preference, and memory of food consumed and perceptions of fullness, hunger, and enjoyment of food in a healthy young-adult population. METHODS: A randomized controlled crossover study of 119 healthy adults (20.2 ± 1.4 y; 57% women; 48% white) assigned participants to begin under either the distracted (DIS, n = 55) or control (CON, n = 64) conditions. DIS participants consumed a meal of quiche while completing a Rapid Visual Information Processing (RVIP) for 15 min. CON participants ate without any task assignment. After a 30-min rest period, participants were offered a snack and given 5 min to eat ad libitum. Participants completed a survey assessing fullness, hunger, and enjoyment of the meal using 100 mm visual analogue scales. One week later, participants completed the opposite condition. Data were analyzed using ANOVA. RESULTS: Those in DIS consumed 13 g less of the meal (P < 0.001), even when comparing by initial condition (P < 0.001) and adjusting for sex (P < 0.001). A carryover effect of initial condition was found (P < 0.001), such that participants first assigned to DIS condition consumed less (95.2 ± 61.7 g) when distracted compared to all other condition combinations (127-133 g). Those in DIS had decreased accuracy for both memory of quiche received (absolute difference, 1.1 ± 1.6 compared with 0.7 ± 1.2 for CON, P < 0.001) and memory of quiche consumed (0.8 ± 1.1 for DIS compared with 0.7 ± 1.2 for CON, P = 0.007). CONCLUSIONS: When distracted, healthy young adults consumed significantly less food and their memory of the meal was dampened. These findings underscore the potential importance of cognitive distraction in affecting food intake. This trial was registered at clinicaltrials.gov as NCT04078607.

Fresh- and lean-pork intake in relation to functional limitations among US older adults, 2005-2016.

BACKGROUND: Pork consumption, in particular fresh/lean-pork consumption, provides protein and other essential micronutrients that older adults need daily and may hold the potential to prevent functional limitations resulting from sub-optimal nutrition. AIM: Assess fresh/lean-pork intake in relation to functional limitations among older adults in the USA. METHODS: Individual-level data came from the National Health and Nutrition Examination Survey (NHANES) 2005-2016 waves. Nineteen validated questions assessed five functional limitation domains: activities of daily living (ADLs); instrumental activities of daily living (IADLs); leisure and social activities (LSAs); lower extremity mobility (LEM); and general physical activities (GPAs). Logistic regressions were performed to examine pork, fresh-pork and fresh lean-pork intake in relation to functional limitations among NHANES older adults (n = 6135). RESULTS: Approximately 21, 18 and 16% of older adults consumed pork, fresh pork and fresh lean pork, respectively. An increase in pork consumption by 1 oz-equivalent/day was associated with a reduced odds of ADLs by 12%, IADLs by 10% and any functional limitation by 7%. An increase in fresh-pork consumption by 1 oz-equivalent/day was associated with a reduced odds of ADLs by 13%, IADLs by 10%, GPAs by 8%, and any functional limitation by 8%. Similar effects were found for fresh lean-pork consumption on ADLs, IADLs, GPAs and any functional limitation. CONCLUSION: This study found some preliminary evidence linking fresh/lean-pork consumption to a reduced risk of functional limitations. Future studies with longitudinal/experimental designs are warranted to examine the influence of fresh/lean-pork consumption on functional limitations.

College students' interpretations of food security questions: results from cognitive interviews.

BACKGROUND: Food insecurity (FI) - the lack of sufficient access to food to maintain a healthy lifestyle - among college (i.e. post-secondary or higher education institution) students has become a prominent issue in the U.S. However, it is not clear if high rates of FI among students are due to the modern experience in higher education institutions or due to underlying issues in common surveying methods. To understand if there were underlying content validity issues, the present study had two primary research questions: 1) How do students interpret the U.S. Department of Agriculture (USDA) Food Security Survey Module (FSSM) questionnaire items, and 2) How do responses of students experiencing FI compare with the theorized experiences and coping responses? METHODS: Thirty-three undergraduate students, aged 18- to 24-years old and fluent in English were recruited from a single 4-year university. During a 60-min session, participants completed the 10-item Adult FSSM and then were cognitively interviewed about their responses using the think-aloud method. Interview transcripts were analysed by two researchers using a collaborative process and basic interpretative approach. RESULTS: Students were on average 19.5 years old (± 1.2 years), the majority were in their freshman or sophomore (i.e., first or second) year, and 67% (n = 22) experienced FI. Results indicated that students' interpretations of key terms - such as "money for more," "balanced meals," and "real hunger" - diverge from expectations. Furthermore, students categorized as food insecure reported experiences and responses to FI that varied from theoretical dimensions of the process. CONCLUSIONS: Though limited by sample size and representativeness, the present results indicate that the content validity of the FSSM may be compromised in this population and the managed process of FI may present differently among college students. Further psychometric research on modifications to the FSSM or with new FI assessment tools should be conducted with college students.

Exploring the association of urban or rural county status and environmental, nutrition- and lifestyle-related resources with the efficacy of SNAP-Ed (Supplemental Nutrition Assistance Program-Education) to improve food security.

OBJECTIVE: To investigate the association of policy, systems and environmental factors with improvement in household food security among low-income Indiana households with children after a Supplemental Nutrition Assistance Program-Education (SNAP-Ed) direct nutrition education intervention. DESIGN: Household food security scores measured by the eighteen-item US Household Food Security Survey Module in a longitudinal randomized and controlled SNAP-Ed intervention study conducted from August 2013 to April 2015 were the response variable. Metrics to quantify environmental factors including classification of urban or rural county status; the number of SNAP-authorized stores, food pantries and recreational facilities; average fair market housing rental price; and natural amenity rank were collected from government websites and data sets covering the years 2012-2016 and used as covariates in mixed multiple linear regression modelling. SETTING: Thirty-seven Indiana counties, USA, 2012-2016. SUBJECTS: SNAP-Ed eligible adults from households with children (n 328). RESULTS: None of the environmental factors investigated were significantly associated with changes in household food security in this exploratory study. CONCLUSIONS: SNAP-Ed improves food security regardless of urban or rural location or the environmental factors investigated. Expansion of SNAP-Ed in rural areas may support food access among the low-income population and reduce the prevalence of food insecurity in rural compared with urban areas. Further investigation into policy, systems and environmental factors of the Social Ecological Model are warranted to better understand their relationship with direct SNAP-Ed and their impact on diet-related behaviours and food security.

Wasted food: A qualitative study of U.S. young adults' perceptions, beliefs and behaviors.

U.S. consumers, namely young adults, are one of the largest sources of preventable food waste. However, the antecedents of wasted food among young adults in the U.S. are unknown. This study aimed to explore the perceptions, beliefs and behaviors related to wasted food among 18- to 24-year-old adults. Fifty-eight individuals (63.8% female) with an average age of 20.2 y (±1.6) who lived in a residence where they had control over some food purchases (excluding co-op or other communal housing, and living with parents) participated in 75-min focus groups during spring of 2016. Thirty participants lived in residence halls at a university and the remaining 28 lived in off-campus dwellings. Focus group transcriptions were analyzed for themes by two investigators using a constant-comparative approach. Inductive thematic analyses provided insights that were broadly categorized into: 1) awareness and knowledge of wasted food, 2) factors that influence food waste behaviors, and 3) suggested interventions to reduce wasted food. Results provide evidence of heterogeneity in perceptions, beliefs, and behaviors related to wasted food based on dwelling type. Insights from the current study may be used to inform observational or intervention work focused on reducing wasted food by young adults.

Influence of seasoning on vegetable selection, liking and intent to purchase.

Low vegetable intake continues to be a health concern, and strategies to increase vegetable intake have resulted in only small increases. One strategy that has received less attention is the use of seasonings. This study's objective was to determine the impact of seasoning on vegetable selection, liking, and intent to purchase. We conducted a 3-week study in a public café on a university campus. Customers buying a main dish could select a vegetable side (seasoned [SS] or steamed [ST]) at no cost. Based on café data and power analysis (alpha 0.05, 80% power), 2 days per vegetable pair were conducted with carrot, broccoli, and green bean pairs randomized 3 days/week 1 and 3, with normal service week 2. Selection was greater for SS vs ST, n = 335 vs. 143 for all 3 vegetables combined; n = 97 vs 47 for carrots; n = 114 vs. 55 for broccoli; n = 124 vs. 41 for green beans (p < 0.001 Chi-Square). Liking responses were similar for SS vs ST and were high for all vegetables. Response distribution was not significantly different for SS vs ST vegetables when people were asked if they would purchase the vegetable that they selected. More customers chose the 'somewhat likely' and 'very likely' (n = 353) than the 'not likely' and 'definitely would not' (n = 121) purchase responses. Regression showed that people who did not often consume a vegetable with lunch while dining out were 1.59 times more likely to select the SS vegetables over the ST (p = 0.007). Given a choice, consumers were more likely to select a seasoned vegetable. With low vegetable consumption as a predictor of seasoned vegetable choice, offering seasoned vegetables may increase intake in those with poor vegetable intake in a café setting.

Effects of nutrition education on weight gain prevention: a randomized controlled trial.

BACKGROUND: Body weight (BW) reduction through energy restriction is ineffective at impacting the obesity epidemic. Shifting from an obesity treatment to weight gain prevention focus may be more effective in decreasing the burden of adult obesity. METHODS: This was a 1-year randomized controlled trial of weight gain prevention in healthy premenopausal women, aged 18-45 y, with a body mass index (BMI) of >18.5 kg/m(2). Eighty-seven women were randomized to a weight gain prevention intervention delivered by a registered dietitian (RDG) or counselor (CSG), or to a control (CON) group. Eighty-one women (mean ± SD, age: 31.4 ± 8.1 y; BW: 76.1 ± 19.0 kg; BMI: 27.9 ± 6.8 kg/m(2)) completed baseline testing and were included in intention-to-treat analyses; anthropometric, blood pressure, dietary intake and physical activity measurements and biochemical markers of health were measured every three months. Data were analyzed using repeated measures ANCOVA, with significance at P < 0.01. RESULTS: Sixty-two percent of women met the weight gain prevention criteria (BW change within ±3 %) after one year; this did not differ by group assignment. Body fat % was lower in the RDG versus CSG and CON groups at all intervals (P < 0.001). Systolic blood pressure increased from month 6 to 9 and decreased from month 6 to 12 in the CON group (P < 0.001), with a significant group x time interaction (P < 0.01). Estimated carbohydrate intake (%) was higher in the RDG vs. CON group at month 9 (P < 0.01); fat intake (%) was lower in the RDG vs. CON group and CSG vs. CON group at months 3 and 9, respectively (P < 0.01). Estimated fruit intake (svgs/d) was higher in the RDG vs. CON group at months 3, 6, 9 and 12 (P < 0.01), and non-meat protein sources (svgs/d) was higher in the RDG vs. CSG and CON groups at month 3 (P < 0.001). Estimated energy, macronutrient and food group intakes did not change over time. CONCLUSIONS: A majority of all participants maintained BW over one year and were able to do so regardless of whether they received nutrition education. Additional studies that include a variety of clinical outcomes are needed to evaluate further aspects of nutrition education on weight gain prevention and health status over the long term.

Increase in cognitive eating restraint predicts weight loss and change in other anthropometric measurements in overweight/obese premenopausal women.

In modern societies characterized by food abundance, dietary restraint may serve as a factor in the successful control of weight or facilitation of weight loss. This secondary analysis of data examined whether changes in cognitive eating restraint (CER) and disinhibition predicted weight loss in a sample of 60 overweight/obese premenopausal women [mean ± SD, age = 35.9 ± 5.8 y; weight = 84.4 ± 13.1 kg; body mass index (BMI) = 31.0 ± 4.3 kg/m(2)]. Changes in weight, BMI, waist circumference, hip circumference, waist-to-hip ratio and body fat percentage (BF%) were examined in relation to changes in CER, disinhibition and hunger as measured by the Eating Inventory questionnaire at baseline and week 18 of an 18-week dietary intervention. Multivariate linear regression analysis was used to identify predictors of weight loss and changes in other anthropometric variables from baseline to study completion. Increase in CER was found to be the most robust predictor of reduction in weight (P < 0.0001), BMI (P < 0.0001), waist circumference (P < 0.001), hip circumference (P < 0.0001) and BF% (P < 0.0001). Effect of increase in CER on change in BMI, hip circumference and BF% was moderated by increase in disinhibition (all P < 0.05). Results suggest that strategies that target CER and disinhibition should be emphasized in programs proposed to treat and prevent obesity.

Insulin resistance and adipose-derived hormones in young men with untreated obstructive sleep apnea.

PURPOSE: Obstructive sleep apnea (OSA) increases the risk for insulin resistance (IR). The mechanisms that link the two are not clear and are frequently confounded by obesity. OSA is associated with alterations in adipose-derived hormones (adipokines) that increase IR; however, previous studies have focused on middle-aged and older adults. The objective of this study was to determine if IR and alterations in adipokines exist in young men with OSA, independent of obesity. METHODS: Subjects were assigned into the following groups based on body mass index and presence of OSA: obese with OSA (OSA, n = 12), obese without OSA (NOSA, n = 18), and normal weight without OSA (CON, n = 15). Fasting blood was obtained for batch analysis of biomarkers of IR. The homeostasis model assessment (HOMA) method was used to assess IR. RESULTS: HOMA and leptin were higher in the OSA group than the CON group. There were no differences in insulin, tumor necrosis factor alpha (TNF-α), and interleukin-6 (IL-6) between the OSA and NOSA groups. Adiponectin was lower in the OSA group vs. NOSA and CON; however, when controlled for central abdominal fat (CAF), the difference was nullified. When controlled for total body adiposity, however, CAF was 24 % higher in the subjects with OSA vs. subjects without OSA. CONCLUSIONS: These findings suggest that excess CAF in young men with OSA may contribute to risk for type 2 diabetes indirectly by a degree that would otherwise not be reached through obesity, although further research is needed.

Prevalence and Determinants of Undiagnosed Liver Steatosis and Fibrosis in a Nationally Representative Sample of US Adults.

Background Chronic liver diseases account for approximately 1.9 million deaths globally every year and negatively affect health-related quality of life. Early detection of liver disease may enable timely treatment, potentially improving patient outcomes. This study aimed to determine the prevalence and determinants of liver steatosis and fibrosis in US adults with no previously diagnosed liver condition. Methods We conducted an observational, nationally representative, cross-sectional study using data from the National Health and Nutrition Examination Survey (NHANES) conducted from January 2017 to March 2020. Study participants were 7,391 adults aged 21 and older with no history of diagnosed liver disorders who underwent vibration-controlled transient elastography (VCTE) to determine liver steatosis and fibrosis. Controlled attenuation parameter (CAP) values between 248 and 267 dB/m were classified as mild steatosis, and those over 267 dB/m as advanced steatosis. Liver stiffness measurement (LSM) values between 7.65 and 13 kPa were classified as moderate/severe fibrosis, and those over 13 kPa as cirrhosis. Covariates included age, sex, race, body mass index (BMI), diabetes mellitus, kidney disease, smoking history, alcohol intake, alanine aminotransferase (ALT), aspartate aminotransferase (AST), physical activity, sedentary time, and sleep time. The associations of subject characteristics with liver CAP and LSM were evaluated using survey multivariable linear regression. Shapley Additive Explanations values determined the relative importance of each attribute in the model. The discriminative performance of classification models was assessed using the area under the receiver operating characteristic (AUROC) curve. Results The population prevalence of liver steatosis was 57.2% (10.2% mild; 47.0% advanced). The relative importance of covariates in predicting liver CAP was 63.1% for BMI, 10.7% for ALT, and less than 10% for the other covariates. The prevalence of significant fibrosis was 11.4% (8.3% moderate/severe fibrosis; 3.1% cirrhosis). The relative importance of covariates in predicting LSM was 67.3% for BMI and less than 10% for the other covariates. BMI alone demonstrated acceptable discriminative performance in classifying varying severities of steatosis and fibrosis (AUROC range 72%-78%) at cutoffs between 28 and 33 kg/m2. Conclusions Undiagnosed chronic liver disease based on VCTE findings is highly prevalent among US adults, particularly in obese individuals. Efforts to increase awareness about liver disease and to reconsider existing BMI thresholds for liver disease screening may be warranted.

Fat and muscle indices assessed by pQCT: relationships with physical activity and type 2 diabetes risk.

The aim of this study was to compare and determine the repeatability of foreleg and forearm muscle and fat indices evaluated by the peripheral quantitative computed tomography (pQCT). Effects of habitual physical activity and associated health risk of type 2 diabetes were examined within the interrelations of intermuscular adipose tissue (IMAT) and muscle density. Eighty-two premenopausal women (mean age ± standard deviation: 38.6 ± 4.7 yr) underwent dual-energy X-ray absorptiometry scans and pQCT of foreleg and forearm scans to assess muscle and fat parameters. Physical activity status was based on 4-d self-reported log and pedometer step counts. Fat and muscle distribution between the foreleg and forearm were similar and highly correlated to total body adiposity. The pQCT device reliably measured muscle density in the foreleg and forearm; coefficients of variation were 0.8% and 2.1%, which was therefore used to reflect IMAT status. Muscle density was positively related to physical activity and negatively associated with markers of fat distribution and risk for type 2 diabetes. The pQCT is a novel, noninvasive tool to assess IMAT and muscle density in the foreleg and forearm. Additional research is necessary to understand the biology of IMAT and its relations with physical activity and potentially, with risks for cardiometabolic disease.

Effect of donepezil on emergence of apathy in mild to moderate Alzheimer's disease.

OBJECTIVE: To determine whether donepezil treatment (10 mg/day over 24 weeks) is associated with delayed emergence of apathy in patients with mild to moderate Alzheimer's disease (AD) and to explore relationships between donepezil's effects on apathy and other Neuropsychiatric Inventory (NPI)-measured behavioural symptoms. METHODS: Two randomised, double-blind, parallel-group, placebo-controlled studies that met prespecified criteria and were sufficiently similar to allow data pooling were derived from all donepezil AD clinical trials. Patients scoring from 10 to 26 on baseline Mini-Mental Status Examination were included. A clinical milestone for apathy and other NPI items was defined as the first emergence of a composite score (frequency × severity) ≥ 3. Differences in time to event (i.e. milestone) between donepezil- and placebo-treated groups were assessed using the Kaplan-Meier method and log-rank test. Shift tables were constructed to evaluate clinical milestone status for apathy and other NPI items at baseline and endpoint, and were analysed using the Cochran-Mantel-Haenszel (CMH) test, stratified by baseline status. RESULTS: Of all NPI items, apathy had the highest proportion of subjects scoring ≥ 3 at baseline. Donepezil was superior to placebo on both apathy milestone analyses (time-to-event log-rank test and shift table CMH test, p = 0.01). Aberrant motor behaviour demonstrated similar benefit. CONCLUSIONS: Donepezil treatment appears to have resulted in a significant reduction over 6 months of the emergence of apathy in patients with AD. These data suggest that a prospective clinical trial in patients with early AD that includes apathy as a primary outcome measure may be warranted.

Using Process Evaluation Results to Compare Peer and Adult Leader Delivery of the PAWS (Peer-Education about Weight Steadiness) Club Program.

To date, there is limited published literature on process evaluation of adolescent health promotion programs. In this paper, we describe the methods and results of PAWS Club process evaluation over 2 years of implementation to compare the effectiveness of delivery by peer and adult leaders. PAWS (Peer-education About Weight Steadiness) Club was a 12-week healthy lifestyle program, delivered to 6th and 7th graders by peer and adult educators, using cluster randomized controlled design. Peer educators were 8th graders in the program schools and adult educators were staff/teachers in the program schools. Trained university students filled out fidelity logs at each session led by peer and adult educators to assess program delivery. The fidelity logs included questions to collect information about the number of participants, duration of the session, percent of activities completed, and if lessons started on time, lesson objectives were clearly stated, lesson objectives were emphasized, demonstrations were visible to participants, all activities were completed, the leader was familiar with lessons, the leader maintained an appropriate pace, the leader kept participants on track, and the leader asked if participants had any questions. Adult educators had a higher mean performance for all questions compared to peer leaders. Significant differences were observed for emphasizing lesson objectives (p = 0.005), making demonstrations visible to participants (p = 0.031), being familiar with the lesson plan (p = 0.000), maintaining an appropriate pace (p = 0.000), keeping participants on track (p = 0.000), and asking if participants had any questions (p = 0.000). Significance was set at p < 0.05. Findings from the current study have implications for designing and conducting a process evaluation of complex healthy lifestyle programs with adolescents in schools. Additional training of peer educators may be needed to enhance program delivery.

Donepezil for treatment of cognitive dysfunction in children with Down syndrome aged 10-17.

The objective of this 10-week, randomized, double-blind, placebo-controlled multicenter study was to assess the efficacy and safety of donepezil for the treatment of cognitive dysfunction exhibited by children with Down syndrome (DS). Intervention comprised donepezil (2.5-10 mg/day) in children (aged 10-17 years) with DS of mild-to-moderate severity. The primary measures were the Vineland-II Adaptive Behavior Scales (VABS-II) Parent/Caregiver Rating Form (PCRF) the sum of nine subdomain standardized scores and standard safety measures. Secondary measures included the VABS-II/PCRF scores on the following domains and their respective individual subdomains: Communication (receptive, expressive, and written); Daily Living Skills (personal, domestic, and community); Socialization (interpersonal relationships, play and leisure time, and coping skills), and scores on the Test of Verbal Expression and Reasoning, a subject-performance-based measure of expressive language. At baseline, 129 participants were assigned treatment with donepezil or placebo. During the double-blind phase, VABS II/PCRF sum of the nine subdomain standardized scores, called v-scores, improved significantly from baseline in both groups (P < 0.0001), with no significant between-group differences. This trial failed to demonstrate any benefit for donepezil versus placebo in children and adolescents with DS, although donepezil appeared to be well tolerated.

Food Insecurity among College Students Differs by Questionnaire Modality: An Exploratory Study.

Objectives: Literature suggests that college (ie, post-secondary) students experience food insecurity (FI) at alarming rates. However, the commonly used FI questionnaires have undergone limited evaluations for accuracy in this sub-population. The objective of this exploratory study was to evaluate if FI estimates among college students differ by survey distribution modality. Methods: A test-retest study was conducted from October to December 2017. A random sample of undergraduate students (N = 343) participated in an online survey. After completing the survey, a random sample of these students (N = 66; 29%) completed the same items in paper-and-pencil format. Responses were compared with percent agreement and kappa (κ) coefficients. Results: Students were less likely to affirm each item on paper-and-pencil questionnaires. Percent agreement ranged from 71.2% to 96.9% across items, and κ coefficients ranged from poor to fair. FI prevalence differed by 15% between online and paper-and-pencil assessments (40.9% and 25.8%, respectively). Percent agreement for FI categorization was 75.8% and κ=0.47. Conclusions: Differing survey modalities resulted in varying FI classifications in a sample of under-graduate students. Though limited by size and representativeness, this supports the need for further testing of FI surveys, as accurate FI estimates are essential to serving college students.

Food Insecurity among College Students in the United States: A Scoping Review.

Reports of college students experiencing food insecurity (FI), defined as inadequate access, availability, adequacy, and stability of food, have sparked national calls for alleviation and prevention policies. However, there are a wide variety of FI rates reported across studies and even among recent literature reviews. The current scoping review aimed to develop a weighted estimated prevalence of FI among US students using a comprehensive search approach. In addition, study characteristics that may be related to the high variability in reported FI prevalence were explored. To address these aims, the peer-reviewed and gray literature on US college student FI was systematically searched to identify 12,044 nonduplicated records. A total of 51 study samples, across 62 records, met inclusion criteria and were included in the current review. The quality of the included studies was moderate, with an average rate of 6.4 on a scale of 0-10. Convenience (45%) and census (30%) sampling approaches were common; only 4 study samples were based on representative sampling strategies. FI estimates ranged from 10% to 75%. It was common for very low security to be as prevalent as, or more prevalent than, low food security. The surveying protocols used in the studies were related to the FI estimates. The USDA Short Form Food Security Survey Module (FSSM; 50%) and the USDA Adult FSSM (40%) prevalence estimates were larger than for the full USDA Household FSSM (13%). When these surveys referenced a 12-mo period, FI estimates were 31%. This was a lower FI estimate than surveys using reference periods of 9 mo or shorter (47%). The results indicate that FI is a pressing issue among college students, but the variation in prevalence produced by differing surveys suggests that students may be misclassified with current surveying methods. Psychometric testing of these surveys when used with college students is warranted.

Isokinetic resistance training increases tibial bending stiffness in young women.

Bone mineral content (BMC) and bone mineral density (BMD) are common but imperfect surrogate measures of bone strength. The mechanical response tissue analyzer is a device that measures long bone bending stiffness (EI), which strongly predicts bone breaking strength. We hypothesized that isokinetic resistance training of the knee flexor and extensor muscles would increase tibial EI, BMC, and BMD in young women. Fifty-two women, aged 18-26 years, performed concentric (CON, n = 30) or eccentric (ECC, n = 22) isokinetic resistance training with the nondominant leg three times per week for 20 weeks. Before and after the training period, subjects were tested for CON and ECC peak torque of the knee flexor and extensor muscles with isokinetic dynamometry, tibial BMC and BMD using dual-energy X-ray absorptiometry, and tibial EI using mechanical response tissue analysis. Both training groups increased CON (15-21%) and ECC (17-31%) peak torque vs. the untrained leg. Tibial EI increased in the entire cohort (26%) and in each training group (CON 34%, ECC 16%) vs. the untrained tibia. Tibial BMC and BMD increased in the trained and untrained tibiae, with no significant differences between limbs. No differential tibial EI or bone mineral outcomes were observed between the CON and ECC training groups. In summary, CON and ECC isokinetic resistance training increased tibial EI, but not BMC or BMD, in young women.

The efficacy, safety, and tolerability of donepezil for the treatment of young adults with Down syndrome.

The objective of our study was to assess the efficacy and safety of donepezil in young adults with Down syndrome (DS) but no evidence of Alzheimer disease (AD). A 12-week, randomized, double-blind, placebo-controlled study with a 12-week, open-label extension was conducted. The intervention consisted of donepezil (5-10 mg/day) in young adults (aged 18-35 years) with DS, but no AD. The primary measure was the Severe Impairment Battery (SIB) test and secondary measures were the Vineland Adaptive Behavior Scales (VABS), the Rivermead Behavioral Memory Test for Children, and the Clinical Evaluation of Language Fundamentals, Third Edition. At baseline, 123 subjects were randomly assigned treatment with donepezil or placebo. During the double-blind phase, SIB scores improved significantly from baseline in both groups, with no significant between-group differences. During the open-label phase, SIB scores in the original donepezil group remained stable; the original placebo group showed an improvement similar to that seen in the double-blind phase. VABS scores improved for donepezil, but not placebo, during the double-blind phase (observed cases, P = 0.03; last observation carried forward, P = 0.07). Post hoc responder analyses were significant for donepezil using three of five response definitions (P < or = 0.045). Adverse event rates were comparable to AD studies. In this first large-scale, multicenter trial of a pharmacological agent for DS, donepezil appears safe. Efficacy interpretation was limited for the primary measure due to apparent learning/practice and ceiling effects. Outcomes in post hoc analyses suggested efficacy in some, but not all subjects, consistent with phenotypic variability of DS. Additional studies are required to confirm potential benefits of donepezil in this population.

A brief instrument to assess treatment response in the patient with advanced Alzheimer disease.

The availability of effective treatments for severe Alzheimer disease (AD) has accentuated the need for brief, simple tools to evaluate treatment response in busy clinical settings for patients with advanced dementia. To develop such a tool, data on 875 patients from 4 double-blind-randomized studies of donepezil in severe AD [Mini-Mental State Examination (MMSE) 0 to 12 inclusive] were pooled and analyzed to identify Severe Impairment Battery (SIB) items, which are sensitive to change over time. Eight of the 51 SIB items were chosen based on effect sizes and relative ease of administration. The resulting SIB-8 was then applied to a validation data set (not used to generate the short form) to characterize its usefulness. The items, Month, Months of Year, Write Name, Sentence, Fluency, Confrontational Naming-Spoon, Using Spoon-Photograph, and Digit Span, were sensitive to change with treatment (P<0.0001) and easy to administer. Baseline SIB-8 scores were correlated with baseline MMSE and full-scale SIB scores, and provided a good distribution of scores in patients at the lower end of the MMSE. The SIB-8 is a brief (< or =3 min) assessment for patients with severe AD that is sensitive to change and able to detect treatment response.