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Chlorhexidine skin antisepsis is frequently recommended for most surgical procedures; however, it is unclear if these recommendations should apply to surgery involving traumatic contaminated wounds where povidone-iodine has previously been preferred. We aimed to compare the effect of aqueous 10% povidone-iodine versus aqueous 4% chlorhexidine gluconate on the risk of surgical site infection in patients who required surgery for an open fracture.We conducted a multiple-period, cluster-randomised, crossover trial (Aqueous-PREP) at 14 hospitals in Canada, Spain, and the USA. Eligible patients were adults aged 18 years or older with an open extremity fracture treated with a surgical fixation implant. For inclusion, the open fracture required formal surgical debridement within 72 h of the injury. Participating sites were randomly assigned (1:1) to use either aqueous 10% povidone-iodine or aqueous 4% chlorhexidine gluconate immediately before surgical incision; sites then alternated between the study interventions every 2 months. Participants, health-care providers, and study personnel were aware of the treatment assignment due to the colour of the solutions. The outcome adjudicators and data analysts were masked to treatment allocation. The primary outcome was surgical site infection, guided by the 2017 US Centers for Disease Control and Prevention National Healthcare Safety Network reporting criteria, which included superficial incisional infection within 30 days or deep incisional or organ space infection within 90 days of surgery. The primary analyses followed the intention-to-treat principle and included all participants in the groups to which they were randomly assigned. This study is registered with ClinicalTrials.gov, NCT03385304.Between April 8, 2018, and June 8, 2021, 3619 patients were assessed for eligibility and 1683 were enrolled and randomly assigned to povidone-iodine (n=847) or chlorhexidine gluconate (n=836). The trial's adjudication committee determined that 45 participants were ineligible, leaving 1638 participants in the primary analysis, with 828 in the povidone-iodine group and 810 in the chlorhexidine gluconate group (mean age 44·9 years [SD 18·0]; 629 [38%] were female and 1009 [62%] were male). Among 1571 participants in whom the primary outcome was known, a surgical site infection occurred in 59 (7%) of 787 participants in the povidone-iodine group and 58 (7%) of 784 in the chlorhexidine gluconate group (odds ratio 1·11, 95% CI 0·74 to 1·65; p=0·61; risk difference 0·6%, 95% CI -1·4 to 3·4).For patients who require surgical fixation of an open fracture, either aqueous 10% povidone-iodine or aqueous 4% chlorhexidine gluconate can be selected for skin antisepsis on the basis of solution availability, patient contraindications, or product cost. These findings might also have implications for antisepsis of other traumatic wounds.US Department of Defense, Canadian Institutes of Health Research, McMaster University Surgical Associates, PSI Foundation.

Despite advances in total knee arthroplasty (TKA) technology, up to 1 in 5 patients remain dissatisfied. This study sought to evaluate if sensor-guided knee balancing improves postoperative clinical outcomes and patient satisfaction compared to a conventional gap balancing technique.We undertook a prospective double-blind randomized controlled trial of patients presenting for elective primary TKA to determine a difference in TKA soft tissue balance between a standard gap balancing (tensiometer) approach compared to augmenting the balance using a sensor-guided device. The sensor-guided experimental group had adjustments made to achieve a balanced knee to within 15 pounds of intercompartmental pressure difference. Secondary outcomes included differences in clinical outcome scores at 6 months and 1 year postoperative, including the Oxford Knee Score and Knee Society Score and patient satisfaction.The sample comprised of 152 patients, 76 controls and 76 experimental sensor-guided cases. Within the control group, 36% (27/76) of knees were unbalanced based on an average coronal plane intercompartmental difference15 pounds, compared to only 5.3% (4/76) within the experimental group (P.0001). There were no significant differences in 1-year postoperative flexion, Knee Society Score, or Oxford scores. Overall, TKA patient satisfaction at 1 year was comparable, with 81% of controls and experimental cases reporting they were very satisfied (P = .992).Despite the use of the sensor-guided knee balancer device to provide additional quantitative feedback in the evaluation of the soft tissue envelope during TKA, we were unable to demonstrate improved clinical outcomes or patient satisfaction compared to our conventional gap balancing technique.

Three-dimensional printing (3DP) has become more frequently used in surgical specialties in recent years. These uses include pre-operative planning, patient-specific instrumentation (PSI), and patient-specific implant production. The purpose of this review was to understand the current uses of 3DP in orthopaedic surgery, the geographical and temporal trends of its use, and its impact on peri-operative outcomes One-hundred and eight studies (N = 2328) were included, published between 2012 and 2018, with over half based in China. The most commonly used material was titanium. Three-dimensional printing was most commonly reported in trauma (N = 41) and oncology (N = 22). Pre-operative planning was the most common use of 3DP (N = 63), followed by final implants (N = 32) and PSI (N = 22). Take-home message: Overall, 3DP is becoming more common in orthopaedic surgery, with wide range of uses, particularly in complex cases. 3DP may also confer some important peri-operative benefits. Cite this article: EFORT Open Rev 2020;5:430-441. DOI: 10.1302/2058-5241.5.190024

This is a technique guide for open anterior capsule reconstruction in unstable native hips due to Ehlers–Danlos syndrome. Ehlers–Danlos syndrome is a connective tissue disease that predisposes an individual to hypermobility of their soft tissues and recurrent subluxations and dislocations of their joints. This may lead to constant instability, guarding of the hip, and subsequent arthritic changes and poor quality of life. We demonstrate anterior capsule reconstruction of the hip using an Achilles tendon allograft performed through a direct anterior approach to the hip (Heuter's approach). This technique guide outlines in detail the surgical steps required to accomplish this reconstructive procedure. Furthermore, a narrated surgical video is provided that clearly depicts the anticipated result of the increased constrained provided to the hip from the anterior capsule reconstruction using an Achilles tendon allograft.

Author(s): Pogorzelski, David; Nguyen, Uyen; McKay, Paula; Thabane, Lehana; Camara, Megan; Ramsey, Lolita; Seymour, Rachel; Goodman, J Brett; McGee, Sheketha; Fraifogl, Joanne; Hudgins, Andrea; Tanner, Stephanie L; Bhandari, Mohit; Slobogean, Gerard P; Sprague, Sheila; PREP-IT Investigators Executive Committee:; Steering Committee; Adjudication Committee; Data and Safety Monitoring Committee; Research Methodology Core; Patient Centred Outcomes Core; Orthopaedic Surgery Core; Operating Room Core; Infectious Disease Core; Military Core; McMaster University Methods Center; University of Maryland School of Medicine Administrative Center; University of Maryland School of Pharmacy, The PATIENTS Program; PREP-IT Clinical Sites: Lead Clinical Site (Aqueous-PREP and PREPARE); Aqueous-PREP and PREPARE; Aqueous-PREP; PREPARE; PREP-IT Investigators Executive Committee | Abstract: IntroductionPragmatic trials in comparative effectiveness research assess the effects of different treatment, therapeutic, or healthcare options in clinical practice. They are characterized by broad eligibility criteria and large sample sizes, which can lead to an unmanageable number of participants, increasing the risk of bias and affecting the integrity of the trial. We describe the development of a sampling strategy tool and its use in the PREPARE trial to circumvent the challenge of unmanageable work flow.MethodsGiven the broad eligibility criteria and high fracture volume at participating clinical sites in the PREPARE trial, a pragmatic sampling strategy was needed. Using data from PREPARE, descriptive statistics were used to describe the use of the sampling strategy across clinical sites. A Chi-square test was performed to explore whether use of the sampling strategy was associated with a reduction in the number of missed eligible patients.Results7 of 20 clinical sites (35%) elected to adopt a sampling strategy. There were 1539 patients excluded due to the use of the sampling strategy, which represents 30% of all excluded patients and 20% of all patients screened for participation. Use of the sampling strategy was associated with lower odds of missed eligible patients (297/4545 (6.5%) versus 341/3200 (10.7%) p l 0.001).ConclusionsImplementing a sampling strategy in the PREPARE trial has helped to limit the number of missed eligible patients. This sampling strategy represents a simple, easy to use tool for managing work flow at clinical sites and maintaining the integrity of a large trial.

Copyright © 2018 by the American Society of Plastic Surgeons. Background: Soft-tissue complications often dictate the success of limb salvage and the overall outcome of open fractures. Based on prior work at the R Adams Cowley Shock Trauma Center, the authors hypothesize that wounds larger than 200 cm2 are associated with a greater likelihood of both flap-related reoperation and wound complications among patients requiring soft-tissue reconstruction with a rotational flap or free tissue transfer. Methods: This study was a secondary analysis of Fluid Lavage in Open Wounds trial data that included all patients who received a rotational or free tissue flap transfer for an open fracture. The primary outcome was flap-related reoperation within 12 months of injury. The secondary outcome was wound complication, which included events treated operatively or nonoperatively. Multivariable logistic regression was used to assess the association between wound size and outcomes, adjusting for confounders. Results: Seventeen percent of the 112 patients required a flap-related reoperation. A wound size greater than 200 cm2 was not associated with reoperation in an unadjusted model (p = 0.64) or adjusting for Gustilo type (p = 0.70). The sample had an overall wound complication rate of 47.3 percent. Patients with a wound size of greater than 200 cm2 were three times more likely to experience wound complications (OR, 3.05; 95 percent CI, 1.08 to 8.62; p = 0.04) when adjusting for moderate to severe wound contamination and wound closure in the operating room. Conclusion: The findings of this study demonstrate that wound surface area is an integral determinant for wound complication following soft-tissue flap treatment, but found no association between wound surface area and flap-related reoperation rates.

Disaster shelter assessments are environmental health assessments conducted during disaster situations to evaluate the living environment of shelters for hygiene, sanitation, and safety conditions. We conducted a secondary data analysis of shelter assessment records available (n = 108) on ice storms, floods, and tornado events from 1 state jurisdiction. Descriptive statistics were used to analyze results of environmental health deficiencies found in the facilities. The greater numbers of environmental health deficiencies were associated with sanitation (26%), facility physical issues (19%), and food areas (17%). Most deficiencies were reported following ice storms, tornadoes, and flood events. This report describes the first analysis of environmental health deficiencies found in disaster shelters across a spectrum of disaster events. Although the number of records analyzed for this project was small and results may not be generalizable, this new insight into the living environment in shelter facilities offers the first analysis of deficiencies of the shelter operation and living environment that have great potential to affect the safety and health of shelter occupants.

The increasing use of hip arthroscopy has led to further development in our understanding of hip anatomy and potential post-operative complications. Iatrogenic gross hip instability following hip arthroscopy is a concerning complication described in recent orthopaedic literature. Post-arthroscopy hip instability is thought to be multifactorial, related to a variety of patient, surgical and post-operative factors. Given its infrequency, there is scarcity of literature describing appropriate surgical management and operative technique for addressing this instability. This study reports a case of gross hip instability following hip arthroscopy, describing a novel technique of management through anterior hip capsuloligamentous reconstruction with Achilles tendon allograft. Level of evidence V, Case Study.

Background. Non-communicable diseases (NCDs)—a term which includes diabetes, cardiovascular disease, cancers, chronic respiratory diseases, and mental illness—are now the major cause of death in India and pose healthcare and economic challenges. There is an urgent need for enhanced clinical research training and capacity building for NCD prevention and control in India. Methods. We describe a multi-pronged approach funded in part by the US National Institutes of Health Fogarty International Center, which was initiated in 2001, to train Indian present and future scientists/doctors in NCD prevention and control. The approaches used were annual national seminars, intensive training courses, in-house workshops, short-term training sessions in the USA and monthly video conferences. Results. During 2001–2016, a total of 3650 undergraduate, postgraduate and faculty from medical colleges and institutes from almost all states in India and several neighbouring countries participated in seminars and other capacity-building workshops held at the Madras Diabetes Research Foundation, Chennai and at six other medical colleges; 883 delegates participated in the in-house workshops, 463 in the intensive interactive sessions; 244 in workshops on advanced techniques in genomics; and 37 in short-term training sessions held in the USA. Conclusion. Through this unique capacity-building programme, more than 5000 individuals representing faculty and students from various medical colleges and research institutes across, and beyond, India, underwent training in the prevention and control of NCDs.

Objective— To study the independent associations of polycystic ovary syndrome (PCOS), and its 2 components, hyperandrogenism and anovulation, with coronary artery calcification (CAC) and carotid artery intima-media thickness (IMT). Approach and Results— At the year 20 of the Coronary Artery Risk Development in Young Adults (CARDIA) study, a population-based multicenter cohort of young adults, women (mean age, 45 years) with information on menses and hirsutism in their twenties were assessed for CAC (n=982) and IMT (n=988). We defined PCOS as women who had both irregular menses and hyperandrogenism (n=55); isolated oligomenorrhea (n=103) as women who only had irregular menses; and isolated hyperandrogenism (n=156) as women who had either hirsutism or increased testosterone levels. Logistic regressions and general linear models were used to estimate the associations between components of PCOS and subclinical CVD. The prevalence of CAC was 10.3% overall. Women with PCOS had a multivariable adjusted odds ratio of 2.70 (95% confidence interval, 1.31–5.60) for CAC. Women with either isolated oligomenorrhea or isolated hyperandrogenism had no increased risk of CAC when compared with unexposed women. Women with PCOS had significantly increased bulb and internal carotid-IMT measurements; however, no significant differences were noted in bulb or internal carotid artery IMT among women with either isolated oligomenorrhea or isolated hyperandrogenism when compared with unexposed women. There were no differences in common carotid-IMT among the 4 study groups. Conclusions— In this study, women with PCOS, manifested as both anovulation and hyperandrogenism, but not women with one of these manifestations alone, were at increased risk for the development of subclinical CVD.

Alpha and beta angles are commonly used radiographic measures to assess the sphericity of the proximal femur and distance between the pathologic head–neck junction and the acetabular rim, respectively. The aim of this study was to explore the relationship between these two measurements on frog-leg lateral hip radiographs. Fifty frog-leg lateral hip radiographs were evaluated by two orthopaedic surgeons and two radiologists. Each reviewer measured the alpha and beta angles on two separate occasions to determine the relationship between positive alpha and beta angles and the inter- and intra-observer reliability of these measurements. There was no significant association between positive alpha and beta angles, [kappa range −0.043 (95 % CI −0.17 to 0.086) to 0.54 (95 % CI 0.33–0.75)]. Intra-observer reliability was high [alpha angle intra-class correlation coefficient (ICC) range 0.74 (95 % CI 0.58–0.84) to 0.99 (95 % CI 0.98–0.99) and beta angle ICC range 0.86 (95 % CI 0.76–0.92) to 0.97 (95 % CI 0.95–0.98)]. There is no statistical or functional relationship between readings of positive alpha and beta angles. The radiographic measurements resulted in high intra-observer and fair-to-moderate inter-observer reliability. Results of this study suggest that the presence of a CAM lesion on lateral radiographs as suggested by a positive alpha angle does not necessitate a decrease in clearance between the femoral head and acetabular rim as measured by the beta angle and thus may not be the best measure of functional impingement. Understanding the relationship between these two aspects of femoroacetabular impingement improves a surgeon’s ability to anticipate potential operative management. III.

Forced vital capacity (FVC), a spirometric measure of pulmonary function, reflects lung volume and is used to diagnose and monitor lung diseases. We performed genome-wide association study meta-analysis of FVC in 52,253 individuals from 26 studies and followed up the top associations in 32,917 additional individuals of European ancestry. We found six new regions associated at genome-wide significance (P

Lead exposure is known to cause apoptotic neurodegeneration and neurobehavioral abnormalities in developing and adult brain by impairing cognition and memory. Coriandrum sativum is an herb belonging to Umbelliferae and is reported to have a protective effect against lead toxicity. In the present investigation, an attempt has been made to evaluate the protective activity of the hydroalcoholic extract of C. sativum seed against lead-induced oxidative stress. Male Wistar strain rats (100–120 g) were divided into four groups: control group: 1,000 mg/L of sodium acetate; exposed group: 1,000 mg/L lead acetate for 4 weeks; C. sativum treated 1 (CST1) group: 250 mg/kg body weight/day for seven consecutive days after 4 weeks of lead exposure; C. sativum treated 2 (CST2) group: 500 mg/kg body weight/day for seven consecutive days after 4 weeks of lead exposure. After the exposure and treatment periods, rats were sacrificed by cervical dislocation, and the whole brain was immediately isolated and separated into four regions: cerebellum, hippocampus, frontal cortex, and brain stem along with the control group. After sacrifice, blood was immediately collected into heparinized vials and stored at 4 °C. In all the tissues, reactive oxygen species (ROS), lipid peroxidation products (LPP), and total protein carbonyl content (TPCC) were estimated following standard protocols. An indicator enzyme for lead toxicity namely delta-amino levulinic acid dehydratase (δ-ALAD) activity was determined in the blood. A significant (p

Objective Following a successful 2005–2012 phase with three regional practice-based research networks (PBRNs), a single, unified national network called “The National Dental PBRN” was created in 2012 in the United States to improve oral health by conducting practice-based research and serving dental professionals through education and collegiality. Methods Central administration is based in Alabama. Regional centres are based in Alabama, Florida, Minnesota, Oregon, New York and Texas, with a Coordinating Centre in Maryland. Ideas for studies are prioritized by the Executive Committee, comprised mostly of full-time clinicians. Results To date, 2763 persons have enrolled, from all six network regions; enrollment continues to expand. They represent a broad range of practitioners, practice types, and patient populations. Practitioners are actively improving every step of the research process, from idea generation, to study development, field testing, data collection, and presentation and publication. Conclusions Practitioners from diverse settings are partnering with fellow practitioners and academics to improve clinical practice and meet the needs of clinicians and their patients. Clinical significance This “nation's network” aims to serve as a precious national resource to improve the scientific basis for clinical decision-making and foster movement of the latest evidence into routine practice.

The National Institute of Dental and Craniofacial Research funded three practice-based research networks (PBRNs), NW-PRECEDENT, PEARL and DPBRN to conduct studies relevant to practicing general dentists. These PBRNs collaborated to develop a questionnaire to assess the impact of network participation on changes in practice patterns. This report presents results from the initial administration of the questionnaire.Questionnaires were administered to network dentists and a non-network reference group. Practice patterns including caries diagnosis and treatment, pulp cap materials, third molar extraction, dentine hypersensitivity treatments and endodontic treatment and restoration were assessed by network, years in practice, and level of network participation. Test-retest reliability of the questionnaire was evaluated.950 practitioners completed the questionnaire. Test-retest reliability was good-excellent (kappa0.4) for most questions. Significant differences in responses by network were not observed. The use of caries risk assessment forms differed by both network participation (p0.001) and years since dental degree (p=0.026). Recent dental graduates are more likely to recommend third molar removal for preventive reasons (p=0.003).Practitioners in the CONDOR research networks are similar to their US colleagues. As a group, however, these practitioners show a more evidence-based approach to their practice. Dental PBRNs have the potential to improve the translation of evidence into daily practice. Designing methods to assess practice change and the associated factors is essential to addressing this important issue.

An RCT pilot-study was conducted to assess efficacy of a 48-h continuous local infiltration of intra-articular bupivacaine (0.5% at 2 cc/h) versus placebo (0.5% saline at 2 cc/h) in decreasing PCA morphine consumption following TKA. Secondary outcomes included 48-h VAS pain, opioid side effects, length of stay, and knee function scores up to 1-year postoperatively. Of 67 randomized patients, 49 completed the trial including 24 bupivacaine, and 25 placebo patients. Mean 48-h PCA morphine consumption did not differ significantly between treatment (39 mg ± 27.1) and placebo groups (53 mg ± 30.4) (P = .137). The intervention did not improve pain scores, or any other outcome studied. Given study results we would conclude that analgesia outcomes with a multimodal analgesia regimen are not significantly improved by adding 48 h of 0.5% bupivacaine infiltration at 2 cc/h.

Background The Dental Practice-Based Research Network (DPBRN) provided a means to investigate whether certain procedures were performed routinely. The authors conducted a study to quantify rubber dam use during root canal treatment (RCT) among general dentists and to test the hypothesis that certain dentist or practice characteristics were associated with rubber dam use. Methods DPBRN practitioner-investigators (P-Is) answered a questionnaire that included items about rubber dam use and other forms of isolation during RCT. DPBRN enrollment questionnaire data provided information regarding practitioner and practice characteristics. Results A total of 729 (74 percent) of 991 P-Is responded; 524 were general dentists who reported providing at least some RCTs and reported the percentage of RCTs for which they used a rubber dam. Of these 524 P-Is, 44 percent used a rubber dam for all RCTs, 24 percent used it for 51 to 99 percent of RCTs, 17 percent used it for 1 to 50 percent of RCTs, and 15 percent never used it during RCT. Usage varied significantly by geographic region and practice type. The use of cotton rolls and other forms of isolation also was reported. Conclusions Similar to other reports in the literature, not all DPBRN general dentists used a rubber dam during RCT. Clinical Implications Because the clinical reference standard is to use a rubber dam during RCT, increasing its use may be important.

We recently reported an association between the bother and severity of lower urinary tract symptoms secondary to benign prostatic hyperplasia and the severity of sleep disturbance. However, few studies have examined whether alterations in the severity of urinary symptoms influence the degree of sleep problems over time.The severity of lower urinary tract symptoms in men enrolled in CAMUS (Complementary and Alternative Medicine for Urological Symptoms), a clinical trial of saw palmetto (Serenoa repens), was evaluated using AUASI (American Urological Association symptom index) and quality of life scores. Sleep disturbance was evaluated by the Jenkins sleep scale at 0, 24, 48 and 72 weeks. Statistical analyses were used to assess the relationship(s) between changes in lower urinary tract symptoms and sleep disturbance.The baseline characteristics of the 339 men (172 placebo arm and 167 saw palmetto arm) enrolled in the CAMUS trial with assessment of sleep disturbance and urinary symptoms were similar. There were no differences between improvements in the severity of sleep disturbance or urinary symptoms between the 2 experimental arms. Combined analyses of the entire cohort revealed significant associations (p0.001) between the AUASI score and sleep disturbance severity with time. Multivariate analyses demonstrated that improvements in lower urinary tract symptoms other than nocturia were the most significant predictors of improvements in sleep disturbance. Specific analyses adjusting for other baseline characteristics demonstrated that a 3-point improvement in AUASI score was associated with a 0.73-point improvement in the Jenkins sleep scale with time.Improvements in lower urinary tract symptoms correlate with changes in sleeping abilities with time in men with benign prostatic hyperplasia. While nocturia is significantly associated with sleep disturbance, other changes in overall lower urinary tract symptoms are better predictors of changes in sleep dysfunction.

Single-well chemical tracer tests (SWCTT) have proven to be a valuable technique for evaluating Enhanced Oil Recovery (EOR) responses in clastic reservoirs. Development of carbonate waterflood EOR technologies are relatively immature in comparison, but the use of SWCTT for providing evidential basis in the field promises to be quick and relatively inexpensive compared with inter-well trials.SWCTTs measure the remaining oil saturation (Sor) to waterflood at a 15-20 feet distance from the wellbore. The technique indirectly measures the Sor by analysing back-produced fluids for partitioning tracers in a well which is producing at 100% water cut. Completing the test pre- and post-EOR treatment quantifies the EOR benefit, at least in that near-well region.Laboratory studies suggest that the use of ionically designed waters for EOR in carbonate reservoirs is temperature sensitive. This makes the design of a single-well test complex as it is essential to understand the thermal behavior of the well and the near-wellbore reservoir during any sequence of SWCTTs. Commercial simulators were used to investigate the thermal characteristics of the well and the near-wellbore reservoir respectively. These simulation results were also benchmarked against a water injection trial in another analogous well. The results showed that to ensure the temperature in the near-well region is kept sufficiently high to trigger an EOR response, it is necessary to pre-heat the injection water to >100°C. This is a complex operation especially offshore where the technical and HSE considerations need to be integrated into a sufficiently-sized heating system where space may be limited. Artificial lifting of produced fluids from a well which is producing at 100% water is also problematic offshore. Benefits and drawbacks of various lift options will be reviewed. The effect that delays during the production phase can have on the quality of data from the SWCTT will be shown as well as the options considered to reduce the likelihood of such problems occurring.The need to test this EOR technique in a controlled manner places stringent requirements on the surface facilities to deliver a test within the design specification. The need for low salinity water injection led to the selection of an integrated water treatment system able to produce desalinated water on-demand.This paper is the first of a series of papers aimed at describing the development of an ionically designed waterflood EOR technology for a giant carbonate oil field.

Purpose We assessed whether longitudinal changes in body mass index (BMI) are positively associated with changes in 10-year American College of Cardiology/American Heart Association atherosclerotic cardiovascular disease (ASCVD) risk scores in middle-aged blacks compared to whites. Methods Data were from 1691 participants enrolled in the Coronary Artery Risk Development in Young Adults Study aged 40 years or more in 2000–2001, who had follow-up examinations 5 and 10 years later. Results The prevalence of obesity increased from 32.3% in 2000–2001 (mean age: 42.8 years) to 41.7% in 2010–2011, higher in blacks than whites. The corresponding change in 10-year ASCVD risk was significantly higher for blacks (men: 4.5%–9.6%, women: 1.7%–5.0%) than whites (men: 2.4%–5.2%, women: 0.7%–1.6%). In 2010–2011, 57.5% of black men had ASCVD risk scores of 7.5% or more compared to white men (14.7%), black women (17.4%), and white women (1.6%). Although BMI trends were positively associated with 10-year change in ASCVD risk scores (0.07% per 1 kg/m 2 increase), it explained very little variance in risk score trends in all race–sex groups. Conclusions In middle-aged adults, longitudinal changes in BMI had little independent influence on changes in 10-year ASCVD risk scores as its effect may be largely mediated through ASCVD risk factors already accounted for in the risk score.

Background The authors conducted a study to identify components of patient satisfaction with restorative dental care and to test the hypothesis that certain dentist, patient and procedure factors are associated with patient satisfaction. Methods Practitioner-investigators (P-Is) from 197 practices in The Dental Practice-Based Research Network (DPBRN) recruited consecutively seen patients who had defective permanent-tooth restorations that were replaced or repaired. At the end of the treatment visit, P-Is asked each participant to complete a satisfaction survey and mail it directly to a DPBRN regional coordinator. Results Analysis of the results of 5,879 satisfaction surveys revealed three satisfaction components: interpersonal relationship-comfort factors, material choice-value factors and sensory-evaluative factors. Satisfaction was highest among patients who received care in a private practice model, whose restorations were repaired rather than replaced and whose restored teeth were not molars. Conclusion These data suggest that a patient's judgments of a dentist's skills and quality of care are based on personal interactions with the dentist, the level of comfort the patient perceives while receiving care and any experience of posttreatment sensitivity in the treated tooth. These conclusions have direct implications for management of patient care before, during and after the procedure. Practice Implications By taking a patient-centered approach, dentists should seek to understand how patients evaluate and rate the service provided, thereby enabling themselves to focus on what each patient values most.

OBJECTIVE Although hyperinsulinemia, a surrogate of insulin resistance, may play a role in the pathogenesis of hypertension (HTN), the longitudinal association between fasting insulin level and HTN development is still controversial. We examined the relation between fasting insulin and incidence of HTN in a large prospective cohort. RESEARCH DESIGN AND METHODS A prospective cohort of 3,413 Americans, aged 18–30 years, without HTN in 1985 (baseline) were enrolled. Six follow-ups were conducted in 1987, 1990, 1992, 1995, 2000, and 2005. Fasting insulin and glucose levels were assessed by a radioimmunoassay and hexokinase method, respectively. Cox proportional hazards models were used to calculate hazard ratios (HRs) and 95% CIs of incident HTN (defined as the initiation of antihypertensive medication, systolic blood pressure ≥140 mmHg, or diastolic blood pressure ≥90 mmHg). RESULTS During the 20-year follow-up, 796 incident cases were identified. After adjustment for potential confounders, participants in the highest quartile of insulin levels had a significantly higher incidence of HTN (HR 1.85 [95% CI 1.42–2.40]; Ptrend < 0.001) compared with those in the lowest quartile. The positive association persisted in each sex/ethnicity/weight status subgroup. A similar dose-response relation was observed when insulin-to-glucose ratio or homeostatic model assessment of insulin resistance was used as exposure. CONCLUSIONS Fasting serum insulin levels or hyperinsulinemia in young adulthood was positively associated with incidence of HTN later in life for both men and women, African Americans and Caucasians, and those with normal weight and overweight. Our findings suggested that fasting insulin ascertainment may help clinicians identify those at high risk of HTN.

Introduction: Slow HR recovery (HRR) from a graded exercise treadmill test (GXT) is a marker of impaired parasympathetic reactivation that is associated with elevated mortality. Our objective was to test whether demographic, behavioral, or CHD risk factors during young adulthood were associated with the development of slow HRR. Methods: Participants from the Coronary Artery Risk Development in Young Adults study underwent symptom-limited maximal GXT using a modified Balke protocol at baseline (1985�1986) and 20-yr follow-up (2005�2006) examinations. HRR was calculated as the difference between peak HR and HR 2 min after cessation of the GXT. Slow HRR was defined as 2-min HRR

The authors conducted a study to quantify the reasons for restoring noncarious tooth defects (NCTDs) by dentists in The Dental Practice-Based Research Network (DPBRN) and to assess the tooth, patient and dentist characteristics associated with those reasons.Data were collected by 178 DPBRN dentists regarding the placement of 1,301 consecutive restorations owing to NCTDs. Information gathered included the main clinical reason, other than dental caries, for restoration of previously unrestored permanent tooth surfaces; characteristics of patients who received treatment; dentists' and dental practices' characteristics; teeth and surfaces restored; and restorative materials used.Dentists most often placed restorations to treat lesions caused by abrasion, abfraction or erosion (AAE) (46 percent) and tooth fracture (31 percent). Patients 41 years or older received restorations mainly because of AAE (P.001). Premolars and anterior teeth were restored mostly owing to AAE; molars were restored mostly owing to tooth fracture (P.001). Dentists used directly placed resin-based composite (RBC) largely to restore AAE lesions and fractured teeth (P.001).Among DPBRN practices, AAE and tooth fracture were the main reasons for restoring noncarious tooth surfaces. Pre-molars and anterior teeth of patients 41 years and older are most likely to receive restorations owing to AAE; molars are most likely to receive restorations owing to tooth fracture. Dentists restored both types of NCTDs most often with RBC.

Pulmonary function measures reflect respiratory health and are used in the diagnosis of chronic obstructive pulmonary disease. We tested genome-wide association with forced expiratory volume in 1 second and the ratio of forced expiratory volume in 1 second to forced vital capacity in 48,201 individuals of European ancestry with follow up of the top associations in up to an additional 46,411 individuals. We identified new regions showing association (combined P < 5 x 10(-8)) with pulmonary function in or near MFAP2, TGFB2, HDAC4, RARB, MECOM (also known as EVI1), SPATA9, ARMC2, NCR3, ZKSCAN3, CDC123, C10orf11, LRP1, CCDC38, MMP15, CFDP1 and KCNE2. Identification of these 16 new loci may provide insight into the molecular mechanisms regulating pulmonary function and into molecular targets for future therapy to alleviate reduced lung function.

Background: A higher dietary intake of carotenoid-rich foods and higher circulating concentrations of carotenoids have been associated with better lung function in cross-sectional studies; however, the longitudinal association between carotenoids and lung function has shown conflicting results. Objective: We examined the longitudinal association between serum carotenoids (β-cryptoxanthin, α-carotene, β-carotene, lutein/zeaxanthin, and lycopene) and the evolution of lung function. Design: We evaluated our hypothesis in the Coronary Artery Risk Development in Young Adults (CARDIA) prospective cohort study. Spirometry testing was conducted at year 0 (1985–1986) and at follow-up in years 2, 5, 10, and 20; serum carotenoids were assayed at years 0 and 15, and diet was assessed at years 0 and 20. Results: Year 0 sum of provitamin A carotenoids and β-cryptoxanthin concentrations were associated with maximum forced vital capacity (FVC) (P ≤ 0.01) and forced expiratory volume in 1 s (FEV1) (P ≤ 0.05) (maximum across years 0–10) in linear regression models adjusted for age, race, height, study center, amount of physical activity, smoking status, and BMI. Year 0 lutein/zeaxanthin and lycopene were not associated with maximum lung function. Baseline concentrations of lutein/zeaxanthin, lycopene, sum of the 3 provitamin A carotenoids, β-carotene, and β-cryptoxanthin were each inversely associated with a decline from maximum FVC and FEV1 (P ≤ 0.04). The sum of provitamin A carotenoids and lycopene remained significant after adjustment for dietary intake related to serum carotenoids (P ≤ 0.03). The 15-y change in provitamin A carotenoid and lutein/zeaxanthin concentrations was associated with a slower decline from maximum FVC and FEV1 (P ≤ 0.04). Conclusion: These findings support an association between serum carotenoid concentrations and a decline in lung function.

Purpose. Examine the effectiveness of a community-based, multimedia intervention on medication adherence among hypertensive adults. Design. Randomized controlled trial. Setting. Rural south Alabama. Subjects. Low-income adults (N = 434) receiving medication at no charge from a public health department or a Federally Qualified Health Center. Intervention. Both interventions were home-based and delivered via computer by a community health advisor. The adherence promotion (AP) intervention focused on theoretical variables related to adherence (e.g., barriers, decisional balance, and role models). The cancer control condition received general cancer information. Measures. Adherence was assessed by pill count. Other adherence-related variables, including barriers, self-efficacy, depression, and sociodemographic variables, were collected via a telephone survey. Analysis. Chi-square analysis tested the hypothesis that a greater proportion of participants in the AP intervention are ≥80% adherent compared to the control group. General linear modeling examined adherence as a continuous variable. Results. Participants receiving the intervention did not differ from individuals in the control group (51% vs. 49% adherent, respectively; p = .67). Clinic type predicted adherence (p < .0001), as did forgetting to take medications (p = .01) and difficulty getting to the clinic to obtain medications (p < .001). Conclusions. Multilevel interventions that focus on individual behavior and community-level targets (e.g., how health care is accessed and delivered) may be needed to improve medication adherence among low-income rural residents.

Purpose: Recent reports suggest that nephrolithiasis and atherosclerosis share a number of risk factors. To our knowledge there has been no previous examination of the relationship between kidney stones and subclinical atherosclerotic disease. We studied the relationship between nephrolithiasis, and carotid wall thickness and carotid stenosis assessed by B-mode ultrasound in the general community using data from the CARDIA study.Materials and Methods: The CARDIA study is a United States, population based, observational study of 5,115 white and African-American men and women between the ages of 18 and 30 years at recruitment in 1985 to 1986.Results: By the year 20 examination 200 (3.9%) CARDIA participants had reported ever having kidney stones. Symptomatic kidney stones were associated with greater carotid wall thickness measured at the year 20 examination, particularly of the internal carotid/bulb region. Using a composite dichotomous end point of carotid stenosis and/or the upper quartile of internal ca...

Background The statistical power of cluster randomized trials depends on two sample size components, the number of clusters per group and the numbers of individuals within clusters (cluster size). Variable cluster sizes are common and this variation alone may have significant impact on study power. Previous approaches have taken this into account by either adjusting total sample size using a designated design effect or adjusting the number of clusters according to an assessment of the relative efficiency of unequal versus equal cluster sizes. Purpose This article defines a relative efficiency of unequal versus equal cluster sizes using noncentrality parameters, investigates properties of this measure, and proposes an approach for adjusting the required sample size accordingly. Methods We focus on comparing two groups with normally distributed outcomes using t-test, and use the noncentrality parameter to define the relative efficiency of unequal versus equal cluster sizes and show that statistical power depends only on this parameter for a given number of clusters. We calculate the sample size required for an unequal cluster sizes trial to have the same power as one with equal cluster sizes. Results Relative efficiency based on the noncentrality parameter is straightforward to calculate and easy to interpret. It connects the required mean cluster size directly to the required sample size with equal cluster sizes. Consequently, our approach first determines the sample size requirements with equal cluster sizes for a pre-specified study power and then calculates the required mean cluster size while keeping the number of clusters unchanged. Our approach allows adjustment in mean cluster size alone or simultaneous adjustment in mean cluster size and number of clusters, and is a flexible alternative to and a useful complement to existing methods. Comparison indicated that we have defined a relative efficiency that is greater than the relative efficiency in the literature under some conditions. Limitations Our measure of relative efficiency might be less than the measure in the literature under some conditions, underestimating the relative efficiency. Conclusions The relative efficiency of unequal versus equal cluster sizes defined using the noncentrality parameter suggests a sample size approach that is a flexible alternative and a useful complement to existing methods.

Summary Appetite regulatory neural network and adipocyte homeostasis molecular pathways are critical to long-term weight maintenance. Associations between obesity-related phenotypes and four genes in these pathways – leptin (LEP), leptin receptor (LEPR), neuropeptide Y2 receptor (NPY2R) and peptide YY (PYY) were examined in CARDIA Study participants (aged 18–30 at recruitment in 1985–6). Weight, BMI and waist circumference were measured at baseline and at years 2, 5, 7, 10, 15, and 20. Genotyping was conducted using tag SNPs characterising common genetic variations in these genes. Generalized estimating equation (GEE) models estimated associations between SNPs and repeated anthropometric measurements, controlling for sex and age. False discovery rate was used to adjust for multiple testing. In African-Americans, SNPs across the LEP gene demonstrated significant overall associations with all obesity-related phenotypes. The associations between LEP rs17151919 with weight tended to strengthen with time – the difference in weight associated with each additional minor allele increased from 2.6 kg at baseline to 4.8 kg at year 20 (SNP*time interaction p = 0.0193). NPY2R gene SNPs were associated with waist circumference among African-American men (p = 0.0462). In Caucasians, LEP SNPs also tended to be associated with weight (p = 0.0471), and PYY rs11684664 was associated with obesity-related phenotypes in women only (p = 0.010–0.026). Several LEP, and NPY2R and PYY SNPs were associated with obesity-related phenotypes in young adults, particularly among African-Americans.

Background In this study, the authors tested the frequency of dentists' recommendations for and use of caries-preventive agents for children as compared with adults. Methods The authors surveyed 467 general dentists in the Dental Practice-Based Research Network who practice within the United States and treat both pediatric and adult patients. They asked dentists to identify the percentage of their patients for whom they had administered or recommended dental sealants, in-office and at-home fluoride, chlorhexidine rinse and xylitol gum. Results Dentists were less likely to provide adult patients than pediatric patients with in-office caries-preventive agents. However, the rate at which they recommended at-home preventive regimens for the two groups of patients was similar. Dentists with a conservative approach to caries treatment were the most likely to use and recommend the use of caries-preventive agents at similar rates in adults as in children. In addition, dentists in practices with a greater number of patients who had dental insurance were significantly more likely to provide in-office fluoride or sealants to adult patients than to pediatric patients. Conclusion General dentists use in-office caries-preventive agents more commonly with their pediatric patients than with their adult patients. Practice Implications General dentists should consider providing additional in-office caries-preventive agents for their adult patients who are at increased risk of experiencing dental caries.

Summary Rationale End of test criteria can influence spirometry results. Epidemiology studies initiated before adoption of the 1987 American Thoracic Society (ATS) guidelines typically used a 1 or 2 s plateau on the volume-time curve, not a minimum test duration of 6 s, to terminate a test. Objectives To determine the effect of changing guidelines on FEV 1 , FVC and FEV 1 /FVC during a longitudinal study of young adults. Methods Spirometry was performed on participants in the Coronary Artery Risk Development in Young Adults (CARDIA) study. Values obtained at entry and 2, 5 and 10 years later using accepted procedures were re-evaluated using the 2005 ATS–ERS guidelines, which were in effect for the year 20 exam. Generalized estimating equations were used to adjust tests with short exhalations that were acceptable by then current end of test criteria. Results The percentage of participants at years 0, 2, 5, and 10 with exhalations less than 6 s but with an acceptable plateau was 33%, 29%, 9%, and 2%, respectively. Exhalations less than 6 s occurred more frequently in younger and female participants, and were associated with lower FVC and higher FEV 1 /FVC. For short exhalations the adjusted FVC was 47 ml and 110 ml higher than the measured FVC when 6 and 8 s exhalation times were used. Conclusions In longitudinal studies of young adults, changing end of test criteria may affect lung function, especially among younger and female participants. Determining adjusted values for tests with short exhalations may better represent the lung health of participants.