The impact of lifestyle intervention on sedentary time in individuals at high risk of diabetes.

AIMS/HYPOTHESIS: The Diabetes Prevention Program (DPP) lifestyle intervention successfully achieved its goal of increasing leisure physical activity levels. This current study examines whether the lifestyle intervention also changed time spent being sedentary and the impact of sedentary time on diabetes development in this cohort. METHODS: 3,232 DPP participants provided baseline data. Sedentary behaviour was assessed via an interviewer-administered questionnaire and reported as time spent watching television specifically (or combined with sitting at work). Mean change in sedentary time was examined using repeated measures ANCOVA. The relationship between sedentary time and diabetes incidence was determined using Cox proportional hazards models. RESULTS: During the DPP follow-up (mean: 3.2 years), sedentary time declined more in the lifestyle than the metformin or placebo participants (p < 0.05). For the lifestyle group, the decrease in reported mean television watching time (22 [95% CI 26, 17] min/day) was greater than in the metformin or placebo groups (p < 0.001). Combining all participants together, there was a significantly increased risk of developing diabetes with increased television watching (3.4% per hour spent watching television), after controlling for age, sex, treatment arm and leisure physical activity (p < 0.01), which was attenuated when time-dependent weight was added to the model. CONCLUSIONS/INTERPRETATION: In the DPP, the lifestyle intervention was effective at reducing sedentary time, which was not a primary goal. In addition, in all treatment arms, individuals with lower levels of sedentary time had a lower risk of developing diabetes. Future lifestyle intervention programmes should emphasise reducing television watching and other sedentary behaviours in addition to increasing physical activity. TRIAL REGISTRATION: ClinicalTrials.gov NCT00004992.

Comparative effectiveness of weight-loss interventions in clinical practice.

BACKGROUND: Obesity and its cardiovascular complications are extremely common medical problems, but evidence on how to accomplish weight loss in clinical practice is sparse. METHODS: We conducted a randomized, controlled trial to examine the effects of two behavioral weight-loss interventions in 415 obese patients with at least one cardiovascular risk factor. Participants were recruited from six primary care practices; 63.6% were women, 41.0% were black, and the mean age was 54.0 years. One intervention provided patients with weight-loss support remotely--through the telephone, a study-specific Web site, and e-mail. The other intervention provided in-person support during group and individual sessions, along with the three remote means of support. There was also a control group in which weight loss was self-directed. Outcomes were compared between each intervention group and the control group and between the two intervention groups. For both interventions, primary care providers reinforced participation at routinely scheduled visits. The trial duration was 24 months. RESULTS: At baseline, the mean body-mass index (the weight in kilograms divided by the square of the height in meters) for all participants was 36.6, and the mean weight was 103.8 kg. At 24 months, the mean change in weight from baseline was -0.8 kg in the control group, -4.6 kg in the group receiving remote support only (P<0.001 for the comparison with the control group), and -5.1 kg in the group receiving in-person support (P<0.001 for the comparison with the control group). The percentage of participants who lost 5% or more of their initial weight was 18.8% in the control group, 38.2% in the group receiving remote support only, and 41.4% in the group receiving in-person support. The change in weight from baseline did not differ significantly between the two intervention groups. CONCLUSIONS: In two behavioral interventions, one delivered with in-person support and the other delivered remotely, without face-to-face contact between participants and weight-loss coaches, obese patients achieved and sustained clinically significant weight loss over a period of 24 months. (Funded by the National Heart, Lung, and Blood Institute and others; ClinicalTrials.gov number, NCT00783315.).

Atomoxetine treatment of attention-deficit/hyperactivity disorder in young adults with assessment of functional outcomes: a randomized, double-blind, placebo-controlled clinical trial.

BACKGROUND: Attention-deficit/hyperactivity disorder (ADHD) is associated with significant impairment in multiple functional domains. This trial evaluated efficacy in ADHD symptoms and functional outcomes in young adults treated with atomoxetine. METHODS: Young adults (18-30 years old) with ADHD were randomized to 12 weeks of double-blind treatment with atomoxetine (n = 220) or placebo (n = 225). The primary efficacy measure of ADHD symptom change was Conners' Adult ADHD Rating Scale (CAARS): Investigator-Rated: Screening Version Total ADHD Symptoms score with adult prompts. Secondary outcomes scales included the Adult ADHD Quality of Life-29, Clinical Global Impression-ADHD-Severity, Patient Global Impression-Improvement, CAARS Self-Report, Behavior Rating Inventory of Executive Function-Adult Version Self-Report, and assessments of depression, anxiety, sleepiness, driving behaviors, social adaptation, and substance use. RESULTS: Atomoxetine was superior to placebo on CAARS: Investigator-Rated: Screening Version (atomoxetine [least-squares mean ± SE, -13.6 ± 0.8] vs placebo [-9.3 ± 0.8], 95% confidence interval [-6.35 to -2.37], P < 0.001), Clinical Global Impression-ADHD-Severity (atomoxetine [-1.1 ± 0.1] vs placebo [-0.7 ± 0.1], 95% confidence interval [-0.63 to -0.24], P < 0.001), and CAARS Self-Report (atomoxetine [-11.9 ± 0.8] vs placebo [-7.8 ± 0.7], 95% confidence interval [-5.94 to -2.15], P < 0.001) but not on Patient Global Impression-Improvement. In addition, atomoxetine was superior to placebo on Adult ADHD Quality of Life-29 and Behavior Rating Inventory of Executive Function-Adult Version Self-Report. Additional assessments failed to detect significant differences (P ≥ 0.05) between atomoxetine and placebo. The adverse event profile was similar to that observed in other atomoxetine studies. Nausea, decreased appetite, insomnia, dry mouth, irritability, dizziness, and dyspepsia were reported significantly more often with atomoxetine than with placebo. CONCLUSIONS: Atomoxetine reduced ADHD symptoms and improved quality of life and executive functioning deficits in young adults compared with placebo. Atomoxetine was also generally well tolerated.

Impact of lifestyle intervention and metformin on health-related quality of life: the diabetes prevention program randomized trial.

BACKGROUND: Adults at high risk for diabetes may have reduced health-related quality of life (HRQoL). OBJECTIVE: To assess changes in HRQoL after interventions aimed at diabetes risk reduction. DESIGN, SETTING, AND PARTICIPANTS: A randomized clinical trial, the Diabetes Prevention Program, was conducted in 27 centers in the United States, in 3,234 non-diabetic persons with elevated fasting and post-load plasma glucose, mean age 51 years, mean BMI 34 Kg/m(2); 68 % women, and 45 % members of minority groups. INTERVENTIONS: Intensive lifestyle (ILS) program with the goals of at least 7 % weight loss and 150 min of physical activity per week, metformin (MET) 850 mg twice daily, or placebo (PLB). MEASUREMENTS: HRQoL using the 36-Item Short-Form (SF-36) health survey to evaluate health utility index (SF-6D), physical component summaries (PCS) and mental component summaries (MCS). A minimally important difference (MID) was met when the mean of HRQoL scores between groups differed by at least 3 %. RESULTS: After a mean follow-up of 3.2 years, there were significant improvements in the SF-6D (+0.008, p=0.04) and PCS (+1.57, p<0.0001) scores in ILS but not in MET participants (+0.002 and +0.15, respectively, p=0.6) compared to the PLB group. ILS participants showed improvements in general health (+3.2, p<0.001), physical function (+3.6, p<0.001), bodily pain (+1.9, p=0.01), and vitality (+2.1, p=0.01) domain scores. Treatment effects remained significant after adjusting sequentially for baseline demographic factors, and for medical and psychological comorbidities. Increased physical activity and weight reduction mediated these ILS treatment effects. Participants who experienced weight gain had significant worsening on the same HRQoL specific domains when compared to those that had treatment-related (ILS or MET) weight loss. No benefits with ILS or MET were observed in the MCS score. CONCLUSION: Overweight/obese adults at high risk for diabetes show small improvement in most physical HRQoL and vitality scores through the weight loss and increased physical activity achieved with an ILS intervention.

Psychometric properties of an instrument for assessing the experience of patients treated with inhaled insulin: the inhaled insulin treatment questionnaire (IITQ).

BACKGROUND: Along with general measures of treatment satisfaction, treatment-specific and device-specific treatment satisfaction should be assessed in clinical trials, because these latter measures may be more strongly correlated with clinical outcomes. METHODS: Study participants were 1076 adults (type 1 = 509, type 2 = 567) in clinical trials of Technosphere Insulin(R), who completed the SF-36 health-related quality of life questionnaire and the Inhaled Insulin Treatment Questionnaire (IITQ), a new instrument assessing diabetes worries, perceptions of insulin therapy, treatment satisfaction, treatment preference, and inhaler performance. The IITQ was administered twice prior to treatment initiation in the clinical trials, 1-2 weeks apart, and several times during the trials. Inhaler performance was assessed at follow-up visits, after participants had used the device. RESULTS: IITQ subscales had acceptable reliability (alpha = 0.68-0.87, median 0.83) and test-retest correlations (intra-class correlation coefficient = 0.67-0.90, median 0.82); floor effects (0.2-2.8%) and ceiling effects (0-9.3%) were minimal. Reliabilities for inhaler performance measures were acceptable (alpha = 0.73-0.90, median 0.85); there were no floor effects (0.0%) and ceiling effects (4.9-39.0%) were moderate. There were several modest associations between IITQ scores and measures of health status. Diabetes worries were lower for participants who had better mental health (type 2) and for those with higher BMI; perceptions of insulin therapy were more favorable for participants who had better physical and mental health; treatment satisfaction was higher for patients who had lower BMI (type 2), lower A1c levels, and better physical health (type 2); treatment preference was higher for patients with lower BMI (type 2) and better mental health (type 1). CONCLUSIONS -: Preliminary findings suggest that the IITQ is a comprehensive, reliable measure of the experience of patients treated with inhaled insulin.

Patient-reported outcomes and diabetes technology: a systematic review of the literature.

BACKGROUND: Advanced diabetes technology should have benefits not only in terms of clinical outcomes, but also in terms of patient-reported outcomes. OBJECTIVE: The objective of this paper is to review the methodology and findings of studies that assessed the effects of diabetes technologies such as continuous subcutaneous insulin infusion (CSII), continuous glucose monitoring (CGM), and integrated CSII/CGM on patientreported outcomes. DATA: The existing literature in pediatric and adult patients is limited, so there is no conclusive evidence that use of CSII, CGM, or integrated CSII/CGM systems produce improved patient-reported outcomes, but most studies provide evidence that these technologies yield some patient-reported outcomes advantages, and few indicate any disadvantages. CONCLUSION: We expect that more robust studies in the future will provide further evidence regarding the impact of these technologies for patient-reported outcomes, including general health-related quality-of-life, diabetesspecific quality-of-life, treatment satisfaction, and treatment preference.

Permanent grounding of a USAF pilot following photorefractive keratectomy.

INTRODUCTION: Photorefractive keratectomy (PRK) has been extensively studied in the literature and its potential application in aircrew has not gone unnoticed. Complication rates following corneal refractive surgery (CRS), including PRK and laser in-situ keratomileusis (LASIK), remain low, with most patients achieving improved uncorrected visual acuity and reduced spectacle dependence. Overall, predictability, low complication rates, high rate of success, stability, and safety have all been cited as instrumental in the adoption of PRK in aviators. Consequently, the U.S. Air Force (USAF) approved PRK for aviators in August 2000. However, quality of vision outcomes following CRS remain a concern given the unique visual performance requirements in military aircrew, especially in austere operational environments. CASE REPORT: This paper will present a recent case of steroid-induced ocular hypertension that is believed to have precipitated non-arteritic anterior ischemic optic neuropathy (NA-AION) associated with reduced visual performance following PRK that resulted in the first permanent grounding of a USAF pilot following CRS. DISCUSSION: CRS has radically widened the aircrew applicant pool and has decreased spectacle dependence in war-fighters. Despite the low-risk profile of modern CRS, this case demonstrates the potential for poor outcomes from such elective surgery. Understanding these rare, but potentially devastating complications and the unique aeromedical risk factors in aircrew is paramount when considering elective vision-enhancing surgery.

Patient-reported outcomes for an integrated real-time continuous glucose monitoring/insulin pump system.

BACKGROUND: A 16-week, two-site study evaluated outcomes for a new device (the Paradigm 722 System, Medtronic MiniMed, Northridge, CA) that combines a "smart" continuous subcutaneous insulin infusion (CSII) pump with real-time (RT) continuous glucose monitoring (CGM) and CareLinktrade mark data management software (DMS). METHODS: CSII-naive adults with type 1 diabetes in suboptimal control (mean glycosylated hemoglobin [A1C] = 8.6%) were randomized to the control arm, consisting of multiple daily injections (MDI) and self-monitoring of blood glucose (SMBG), or the study arm (CSII with RT-CGM as an adjunct to SMBG). Participants (n = 28) completed the validated Insulin Delivery System Rating Questionnaire (IDSRQ) and the parallel Blood Glucose (BG) Monitoring System Rating Questionnaire (BGMSRQ) at study start and end. Participants in the study arm (n = 14) also completed newly developed User Acceptance Questionnaires (UAQs) for CSII, RT-CGM, and DMS at study end. RESULTS: A1C reduction from study start to end was significant (P < 0.05) in both arms (-1.7% for study arm;-1.0% for control arm); there was no significant change in weight in either arm. The IDSRQ showed significantly (P < 0.05) greater benefit for the study arm in convenience, acceptability of BG monitoring requirements, BG control efficacy, diabetes worries, and interpersonal hassles, as well as higher overall satisfaction/preference. The BGMSRQ showed significantly (P < 0.05) greater benefit for the study arm in the BG monitoring system's ability to help manage glycemic control and less interest in changing to another BG monitoring system. The Study Arm UAQs showed positive ratings of system features. CONCLUSIONS: Several patient-reported outcomes were significantly more positive in the study arm than the control arm; none was significantly more positive in the control arm. The features of the integrated RT-CGM/CSII system were frequently used and highly rated by participants, with high user satisfaction.

Atomoxetine treatment in adults with attention-deficit/hyperactivity disorder and comorbid social anxiety disorder.

BACKGROUND: To evaluate the effect of atomoxetine (ATX) on attention-deficit/hyperactivity disorder (ADHD) and comorbid social anxiety disorder in adults. METHODS: Randomized, double-blind, placebo-controlled, conducted in adults with ADHD and social anxiety disorder. Patients received 40-100 mg ATX (n=224) or placebo (n=218) for 14 weeks following a 2-week placebo lead-in period. Efficacy measures included the Conners' Adult ADHD Rating Scale: Investigator-Rated: Screening Version (CAARS:Inv:SV), Liebowitz Social Anxiety Scale (LSAS), Clinical Global Impression-Overall-Severity (CGI-O-S), State-Trait Anxiety Inventory (STAI), Social Adjustment Scale-Self Report (SAS), and Adult ADHD Quality of Life Scale-29 (AAQoL). Safety and tolerability were also assessed. RESULTS: ATX mean change (-8.7+/-10.0) from baseline (29.6+/-10.4) on CAARS:Inv:SV Total ADHD Symptoms score was significantly greater than placebo mean change (-5.6+/-10.2) from baseline (31.2+/-9.4; P<.001). ATX mean change (-22.9+/-25.3) from baseline (85.3+/-23.6) on LSAS Total score was significant compared to placebo mean change (-14.4+/-20.3) from baseline (82.1+/-21.3; P<.001). The visit-wise analysis revealed greater improvement on the CAARS:Inv:SV Total ADHD Symptoms score and LSAS Total score for ATX at every time point throughout the study (P values

Psychometric properties of an instrument for assessing treatment satisfaction associated with pramlintide use.

BACKGROUND: The clinical benefits of any new treatment depend substantially on patient acceptance and treatment satisfaction, because only well-accepted treatments will be widely used. Thus, it is important to understand how patients experience a new treatment. OBJECTIVE: This study assessed the psychometric properties of a questionnaire (PRAM-TSQ) designed to measure treatment satisfaction in patients using pramlintide (an analog of amylin, a glucoregulatory hormone co-secreted with insulin), which is designed to improve glucose control. METHODS: Patients with diabetes completed the 14-item PRAM-TSQ at the end of 2 separate placebo-controlled, double-blind, randomized clinical trials in which they added active or placebo pramlintide to their established insulin regimen. Factor analysis was used to assess item clustering for the PRAM-TSQ, and the Cronbach's alpha measure of inter-item agreement was used to assess scale reliability. PRAM-TSQ validity was assessed by comparing scores between treatment arms, and effect sizes were measured by the eta statistic. Validity was also assessed by associations (Pearson correlations) between the PRAM-TSQ and clinical study outcomes (end of study values and during study changes in clinical measures: postprandial glucose [PPG], A1C, weight, and insulin requirements). RESULTS: Scaling revealed 4 PRAM-TSQ components: Global Benefits, Specific Benefits, Absence of Side Effects, Treatment Preference. The total composite PRAM-TSQ had good reliability in both studies (type 1 alpha = .93; type 2 alpha = .94); subscale reliabilities ranged from .65 to 94. Composite scores differed for pramlintide-treated and placebo-treated patients (type 1 P < .01; type 2 P < .05), and were associated with lower PPG, weight, and insulin requirements (all P < .05). Results were similar for PRAM-TSQ subscales assessing Global Benefits and Treatment Preference; Specific Benefits subscale scores were associated with lower PPG and weight (all P < .05). CONCLUSIONS: The PRAM-TSQ shows evidence of being a valid, reliable instrument for assessing treatment satisfaction in patients using pramlintide. The subscales are comprehensive and sensitive to the known potential effects of pramlintide treatment. Diabetes educators can use patient responses to the PRAM-TSQ to facilitate treatment adherence by reminding patients of treatment benefits they experience and by helping patients overcome negative effects they report.

Access to diabetes self-management education: results of national surveys of patients, educators, and physicians.

PURPOSE: To examine factors related to access to diabetes self-management education (DSME), including services delivered and sought; patient, physician, and program barriers to access; educator outreach and expansion efforts; and perceptions of alternative DSME delivery strategies. METHODS: Internet surveys were completed by 1169 adults with diabetes (661 with prior DSME, 508 with no prior DSME) from a national community survey panel, 1871 educators who were AADE members, and 629 physicians (212 diabetes specialists, 417 primary care practitioners) from a national physician survey panel. RESULTS: Physicians want patients to receive more self-management support, but some report that patients are told to do things with which the physician does not agree. Provider (physician and educator)-delivered DSME is more highly regarded among those who have received it than among those who have not received it. Physicians generally have positive perceptions of provider-delivered DSME, and educators see physicians as key to encouraging DSME use in patients. Some physicians are concerned about losing patients sent to DSME, and 11% of patients report changing physicians as a result of DSME. Most DSME programs have grown recently as a result of recruiting efforts and adding new programs/services; most programs plan more such efforts. Patients prefer traditional DSME sources/settings and are moderately accepting of media sources. CONCLUSIONS: Additional efforts are required to guarantee that all people with diabetes receive the DSME they need. This will require increased referral by physicians, increased follow-through by patients, and increased availability of DSME in forms that make it appealing to patients and physicians.

The Impact of Case Management on Reducing Readmission for Patients Diagnosed With Heart Failure and Diabetes.

PURPOSE OF THE STUDY: To determine the impact of integrated case management services versus treatment as usual (TAU) for patients diagnosed with diabetes and concomitant heart failure. PRIMARY SETTING: This medical chart review was conducted at a single-site facility. The retrospective study design can be implemented at other facilities with a similar landscape. METHODS: A retrospective, descriptive, comparative analysis of integrated case management services compared with TAU from a medical chart review of 68 patients from September 1, 2015, through July 31, 2017. A medical chart review was conducted to generate the study sample for data collection and analysis. The data were organized, cleaned, and prepared and then analyzed. The data were analyzed using SPSS and verified with SAS and R. Applied were descriptive statistics and statistical tests-t test, χ test, Mann-Whitney U test, and Logistic Regression. RESULTS: For the integrated case management group, there were 18.4% who readmitted whereas 81.6% did not. For the TAU group, there were 52.6% who readmitted and 47.4% who did not. The association between readmission and case management was χ (1, n = 68) = 6.372, p = .012. NURSING IMPLICATIONS: Integrated case management services were statistically significant in reducing readmission for the sample. Demographics tested in this study were not significant predictors for readmission. Extending length of stay for patients who are not medically ready for discharge should be considered because there is a cost difference, as there is evidence of readmission reduction. Policy and procedural amendments can be obtained from this study.

Diabetes distress and its association with clinical outcomes in patients with type 2 diabetes treated with pramlintide as an adjunct to insulin therapy.

OBJECTIVE: This study was designed to assess diabetes-related distress and its association with clinical outcomes in patients with type 2 diabetes using basal insulin who were treated with pramlintide. METHODS: In a 16-week, double-blind, placebo-controlled study 211 patients using insulin glargine with or without oral antidiabetes agents were randomized to addition of pramlintide or placebo. Clinical outcomes (change in A1C, postprandial glucose, daily basal insulin dose, and weight) and during-trial hypoglycemia were assessed, along with the Diabetes Distress Scale (DDS). The DDS assesses overall diabetes distress and four subdomains: regimen distress (RD), emotional burden (EB), interpersonal distress (ID), and physician-related distress (PD). Hierarchical, stepwise multiple regression was used to assess the association of clinical outcomes and during-trial hypoglycemia with DDS score changes during the study. RESULTS: Pramlintide use was associated with a significant reduction in total DDS and RD, but only among those above the median of distress at baseline. Across treatment groups, reduction in basal insulin dose was linked to a drop in total DDS, RD, EB, and ID, reduction in postprandial glucose was associated with reduced total DDS and ID, and reduction in A1C was associated with reduced EB and RD. PD was not associated with hypoglycemia or any clinical outcome. Reduction in weight and incidence of hypoglycemia were not associated with any DDS measure. CONCLUSIONS: Pramlintide use reduced diabetes-related distress among those with high levels of distress at baseline, and better clinical outcomes were associated with improvements in several domains of diabetes-related distress. Efforts should be made to enhance these potential benefits of treatment.

Access to diabetes self-management education.

PURPOSE: The purpose of this study is to explore issues related to access to diabetes self-management education (DSME), including supply and demand, educator outreach and expansion efforts, patient and physician barriers to access, and acceptability of alternative DSME delivery strategies. METHODS: Telephone focus groups were conducted with 17 diabetes educators, 18 primary care physicians who treat adults with diabetes, and 14 adults with type 1 or type 2 diabetes (8 in a group for those who had received diabetes education and 6 in a group for those who had not). RESULTS: DSME programs develop new services to attract additional patients but do little outreach, and budget struggles are common. Some physicians establish good relationships with DSME programs, but others are critical of the available programs and experience conflicts over the role of educators vis-à-vis that of the physician. Physicians do not refer all patients to DSME and are perceived by educators and patients as not providing enough encouragement to attend DSME. Patients generally have positive experiences with DSME but do not discuss these experiences with their physicians. Patients are receptive to alternative strategies for DSME delivery (community settings, electronic media), but physicians are concerned about meeting standards, and educators want to make sure that they are available to support alternative education strategies. CONCLUSIONS: Future advocacy efforts should seek implementation of policies to guarantee that all people with diabetes can receive the DSME they need.

Utilizing debates as an instructional tool for dental students.

Debates have been used as an instructional tool since 1999 in the Program in Dental Hygiene and are currently used by the School of Dental Medicine at the University of Pittsburgh. The debate format is designed to present a thought-provoking and uncomplicated teaching tool that uses key elements of adult education, such as emphasis on self-learning and its process. The objective of this article is to demonstrate the use of debates as an instructional tool for dental hygiene and dental students. A debate format is presented in detail. Post-debate small discussion groups and a questionnaire were used to explore dental student experiences with using debates as an instructional tool. Dental students indicated that their experiences with the debate format had positive pedagogical benefits. Students reported that their interest in the given topic was heightened and knowledge was improved or reinforced. The debates also appeared to help students organize their thoughts on the presented topics. The debates were reported to be engaging and were received with enthusiasm by the students. Students reported that the debates enhanced their ability to organize and reinforce their thoughts on issues they may confront as dental professionals.

Exploring dental students' perceptions of cultural competence and social responsibility.

The improvement of basic cultural competency skills and the creation of a greater community-minded spirit among dental students are important parts of dental education. The purpose of our study was to assess changes in dental students' attitudes and beliefs about community service and changes in cultural competencies after participation in a two-year program of non-dental community service (Student Community Outreach Program and Education, SCOPE). During 2003-07, two identical twenty-eight-item surveys were administered to SCOPE participants/completers. In the first, students reported on their attitudes after program completion. In the second, students reported retrospectively on their attitudes prior to starting the program. One hundred twenty-six post- and pre-intervention surveys were matched and assessed for changes in student attitudes after program participation. Based on factor analysis, four distinct scales were identified: 1) community service, 2) cultural competence, 3) communication, and 4) treatment perspective. Over time, statistically significant changes (p<.05) in student attitudes and beliefs were found for scales 1 (p=.017), 2 (p=.001), and 3 (borderline significance, p=.057). Scale 4 showed no significant difference (p=.108). These scales indicate main focus areas to help guide future dentists in acquiring relevant sociocultural competencies and enabling community-minded attitudes. Overall, this study provides support for the addition of a non-dental community service-learning program into the preclinical curriculum.

Effect of adjunctive pramlintide treatment on treatment satisfaction in patients with type 1 diabetes.

OBJECTIVE: To assess the effect of adjunctive pramlintide treatment on treatment satisfaction in patients with type 1 diabetes treated with intensive insulin regimens. RESEARCH DESIGN AND METHODS: Intensively treated (multiple daily injection [MDI] or continuous subcutaneous insulin infusion [CSII] pump therapy) patients with type 1 diabetes completed a study-specific treatment satisfaction questionnaire following 29 weeks of either placebo (n = 136) or pramlintide (n = 130) treatment in a double-blind, noninferiority pramlintide dose titration trial. End points included patient reported outcomes, their relationship to insulin treatment regimen, A1C, weight, and insulin use. RESULTS: Pramlintide-treated patients reported greater treatment satisfaction in most questionnaire responses. Treatment satisfaction was similar for pramlintide-treated patients regardless of intensive insulin regimens (MDI versus CSII). Mean A1C was reduced to a similar degree in both pramlintide- (-0.39 +/- 0.07%) and placebo-treated (-0.45 +/- 0.07%) patients. However, pramlintide treatment was associated with reductions in mean body weight (-1.50 +/- 0.33 kg; P < 0.0001) and mealtime insulin use (-19.05 +/- 5.17%; P < 0.005) over 29 weeks, while placebo treatment resulted in weight gain (1.28 +/- 0.25 kg) and a smaller reduction in mealtime insulin use (-2.20 +/- 3.33%). CONCLUSIONS: Despite similar reductions in A1C, pramlintide treatment resulted in greater treatment satisfaction compared with placebo treatment. This was independent of insulin delivery method.

Atomoxetine treatment for pediatric patients with attention-deficit/hyperactivity disorder with comorbid anxiety disorder.

OBJECTIVE: Research suggests 25% to 35% of children with attention-deficit/hyperactivity disorder (ADHD) have comorbid anxiety disorders. This double-blind study compared atomoxetine with placebo for treating pediatric ADHD with comorbid anxiety, as measured by the ADHD Rating Scale-IV-Parent Version: Investigator Administered and Scored (ADHDRS-IV-PI) and the Pediatric Anxiety Rating Scale (PARS). METHOD: Patients (ages 8-17 years) meeting DSM-IV criteria for ADHD and generalized anxiety disorder, separation anxiety disorder, and/or social phobia were randomized to 12 weeks of atomoxetine (n = 87) or placebo (n = 89). ADHDRS-IV-PI and PARS total scores were analyzed using analysis of covariance last observation carried forward and repeated-measures analyses. RESULTS: Sixty-six patients in each group completed the study. Mean ADHDRS-IV-PI total score improved significantly for atomoxetine (n = 55; -10.5, SD 10.6) relative to placebo (n = 58; -1.4, SD 8.3; p < .001). Mean PARS total score also improved significantly for atomoxetine (n = 55; -5.5, SD 4.8) relative to placebo (n = 58; -3.2, SD 5.0; p = .011). CONCLUSIONS: Atomoxetine was efficacious in reducing ADHD symptoms in patients who have ADHD with comorbid anxiety and was well tolerated. There was also a significant reduction in independently assessed anxiety symptoms using both clinician-rated and self-rated measures, which merits further investigation. Results support consideration of atomoxetine for the treatment of ADHD in youths who have ADHD with comorbid anxiety disorder. CLINICAL TRIAL REGISTRATION INFORMATION: The LYBP study, on which this article is based, was not registered at clinicaltrials.gov because the last patient visit occurred before July 1, 2005. Results, however, are publicly posted at lillytrials.com and clinicalstudyresults.org. The unique study ID at both sites is 6477a.

US nurses' perceptions of their role in diabetes care: results of the cross-national Diabetes Attitudes Wishes and Needs (DAWN) study.

PURPOSE: The purpose of this study was to examine nurse and physician perceptions of nurse involvement and roles in diabetes care. METHODS: The study used a cross-sectional design with face-to-face or telephone interviews of diabetes health care professionals in 13 countries from Asia, Australia, Europe, and North America. This article focuses on the data from US health care providers. The US sample included 51 generalist nurses, 50 diabetes specialist nurses, 166 generalist physicians, and 50 diabetes specialist physicians. RESULTS: Nurses and physicians agreed that nurses should take a larger role in managing diabetes. Most common differences identified between nurses and physicians were that nurses provide better education, spend more time with patients, were better listeners, and knew their patients better than physicians. All nurses had a high perceived need for better understanding of psychosocial issues and were more likely than physicians to suggest helping patients to take responsibility for their care. Nurses more than physicians also said better communication was needed. Generalist nurses report that they act as intermediaries and facilitate patient appointment keeping. Specialist nurses talk to patients about self-management, teach medication management, have a higher level of involvement in medication prescribing, and are more willing to take on additional responsibilities than generalist nurses. CONCLUSIONS: There is an increased need for more involvement by nurses, particularly specialist nurses, in diabetes care.