Modifying diet and exercise in multiple sclerosis (MoDEMS): A randomized controlled trial for behavioral weight loss in adults with multiple sclerosis and obesity.

BACKGROUND: Obesity is a risk factor for developing multiple sclerosis (MS) and MS-related disability. The efficacy of behavioral weight loss interventions among people with MS (pwMS) remains largely unknown. OBJECTIVE: Examine whether a group-based telehealth weight loss intervention produces clinically significant weight loss in pwMS and obesity. METHODS: Seventy-one pwMS were randomized to the weight loss intervention or treatment-as-usual (TAU). The 6-month program promoted established guidelines for calorie reduction and increased physical activity. Anthropometric measurements, mobility tasks, self-report questionnaires, and accelerometry were used to assess changes at follow-up. RESULTS: Mean percent weight loss in the treatment group was 8.6% compared to 0.7% in the TAU group (p < .001). Sixty-five percent of participants in the intervention achieved clinically meaningful weight loss (⩾ 5%). Participants in the treatment group engaged in 46.2 minutes/week more moderate-to-vigorous physical activity than TAU participants (p = .017) and showed improvements in quality of life (p = .012). Weight loss was associated with improved mobility (p = .003) and reduced fatiguability (p = .008). CONCLUSION: Findings demonstrate the efficacy of a behavioral intervention for pwMS and obesity, with clinically significant weight loss for two-thirds of participants in the treatment condition. Weight loss may also lead to improved mobility and quality of life.

COVID-19 Testing in African American Churches Using a Faith-Health- Academic Partnership.

Increasing access to COVID-19 testing in influential, accessible community settings is needed to address COVID-19 disparities among African Americans. We describe COVID-19 testing intervention approaches conducted in Kansas City, Missouri, African American churches via a faith-health-academic partnership. Trained faith leaders promoted COVID-19 testing with church and community members by implementing multilevel interventions using a tailored toolkit and standard education information. The local health department conducted more than 300 COVID-19 tests during or after Sunday church services and outreach ministry activities. (Am J Public Health. 2022;112(S9):S887-S891. https://doi.org/10.2105/AJPH.2022.306981).

Impact of Variability in Echocardiographic Interpretation on Assessment of Adequacy of Repair Following Congenital Heart Surgery: A Pilot Study.

Technical Performance Score (TPS) is based largely on the presence and magnitude of residual lesions on postoperative echocardiograms; this score correlates with outcomes following repair of congenital heart defects. We evaluated reader variability for echocardiographic components of TPS for complete repair of tetralogy of Fallot (TOF) and arterial switch operation (ASO) in two centers and measured its effect on TPS. Postoperative echocardiograms were evaluated in 67 children (39 TOF and 28 ASO). Two readers (one per center) interpreted each echocardiogram. Reader variability in image quality assessments and measurements was compared using weighted kappa (κ), percent agreement, and intra-class correlation. TPS class (1 optimal-no residua, 2 adequate-minor residua, 3 inadequate-major residua) was assigned for each echocardiographic review by an independent investigator. The effect of reader interpretation variability on TPS classification was measured. There was strong agreement for TPS between the two readers (κ = 0.88). The readers were concordant for TPS classes for 57 children (85%) and discordant for classes 2 (minor residua) versus 3 (major residua) in six (9%). Coronary arteries and branch pulmonary arteries were frequently suboptimally visualized. Although inter-reader agreement for TPS was strong, inter-reader variation in echocardiographic interpretations had a small, but important effect on TPS for TOF and ASO, particularly for the distinction between minor and major residua. Further studies of generalizability and reproducibility of TPS and refinement of scoring modules may be needed before it can be used as a tool to assess pediatric cardiac surgical performance and outcomes.

Evaluation of the Impact of Corticosteroid Dose on the Incidence of Hyperglycemia in Hospitalized Patients with an Acute Exacerbation of Chronic Obstructive Pulmonary Disease.

PURPOSE: Guidelines recommend systemic corticosteroids for acute exacerbation of chronic obstructive pulmonary disease (AECOPD) albeit in lower doses than studies that cemented corticosteroids' place in therapy. Corticosteroids potentiate hyperglycemia, however it is undetermined how corticosteroid dose impacts hyperglycemia incidence. OBJECTIVES: To establish whether a greater incidence of steroid-induced hyperglycemia (SIHGLY) exists for high- versus low-dose corticosteroids. METHODS: Patients with primary discharge diagnosis 491.21/491.22 in a community hospital were retrospectively reviewed and divided into tertiles based on corticosteroid dosage. Baseline characteristics and primary endpoint were statistically assessed between tertiles using logistic regression analysis. A Cox proportional hazards (CPH) model adjusted for potential covariates. Post hoc analysis for primary outcome and CPH model was run removing non-insulin dependent diabetics because of disproportionate event count. A secondary endpoint used a Kaplan-Meier curve to evaluate time to event between tertiles. RESULTS: Tertile divisions were 125 and 187.5 mg methylprednisolone equivalents. The primary outcome for incidence of SIHGLY was insignificant; post hoc analysis removing non-insulin-dependent diabetics narrowly missed significance between tertiles 1 and 3 (P = .056). CPH analysis found significant differences in SIHGLY between tertiles 1 and 2 (hazard ratio [HR], 1.68; 95% CI, 1.02-2.76) and tertile 1 and 3 (HR, 1.79; 95% CI, 1.13-2.84), further post hoc analysis resulted in a loss of significance for the CPH analysis. Of 21 non-insulin-dependent diabetics, 20 met event status. The Kaplan-Meier analysis results were insignificant. CONCLUSIONS: Study results suggest that a link between larger corticosteroid doses and hyperglycemia incidence may exist, but it requires further study. RESULTS in non-insulin-dependent diabetics provide evidence for increased glucose monitoring upon initiation of corticosteroid therapy.

Does active dissemination of evidence result in faster knowledge transfer than passive diffusion?: An analysis of trends of the management of pediatric asthma and croup in US emergency departments from 1995 to 2009.

OBJECTIVE: This study aimed to compare knowledge transfer (KT) in the emergency department (ED) management of pediatric asthma and croup by measuring trends in corticosteroid use for both conditions in EDs. METHODS: A retrospective, cross-sectional study of the National Hospital Ambulatory Medical Care Survey data between 1995 and 2009 of corticosteroid use at ED visits for asthma or croup was conducted. Odds ratios (OR) were calculated using logistic regression. Trends over time were compared using an interaction term between disease and year and were adjusted for all other covariates in the model. We included children aged 2 to 18 years with asthma who received albuterol and were triaged emergent/urgent. Children aged between 3 months to 6 years with croup were included. The main outcome measure was the administration of corticosteroids in the ED or as a prescription at the ED visit. RESULTS: The corticosteroid use in asthma visits increased from 44% to 67% and from 32% to 56% for croup. After adjusting for patient and hospital factors, this trend was significant both for asthma (OR, 1.07; 95% confidence interval [CI], 1.04-1.10) and croup (OR, 1.07; 95% CI, 1.03-1.12). There was no statistical difference between the 2 trends (P = 0.69). Hospital location in a metropolitan statistical area was associated with increased corticosteroid use in asthma (OR, 1.76; 95% CI, 1.10-2.82). Factors including sex, ethnicity, insurance, or region of the country were not significantly associated with corticosteroid use. CONCLUSIONS: During a 15-year period, knowledge transfer by passive diffusion or active guideline dissemination resulted in similar trends of corticosteroid use for the management of pediatric asthma and croup.

Impact of brain tissue filtering on neurostimulation fields: a modeling study.

Electrical neurostimulation techniques, such as deep brain stimulation (DBS) and transcranial magnetic stimulation (TMS), are increasingly used in the neurosciences, e.g., for studying brain function, and for neurotherapeutics, e.g., for treating depression, epilepsy, and Parkinson's disease. The characterization of electrical properties of brain tissue has guided our fundamental understanding and application of these methods, from electrophysiologic theory to clinical dosing-metrics. Nonetheless, prior computational models have primarily relied on ex-vivo impedance measurements. We recorded the in-vivo impedances of brain tissues during neurosurgical procedures and used these results to construct MRI guided computational models of TMS and DBS neurostimulatory fields and conductance-based models of neurons exposed to stimulation. We demonstrated that tissues carry neurostimulation currents through frequency dependent resistive and capacitive properties not typically accounted for by past neurostimulation modeling work. We show that these fundamental brain tissue properties can have significant effects on the neurostimulatory-fields (capacitive and resistive current composition and spatial/temporal dynamics) and neural responses (stimulation threshold, ionic currents, and membrane dynamics). These findings highlight the importance of tissue impedance properties on neurostimulation and impact our understanding of the biological mechanisms and technological potential of neurostimulatory methods.

Correlates of HIV-Related Stigmas Among African American Church-Affiliated Populations in Kansas City.

HIV-related stigmas contribute to disparities, and contact with HIV-positive individuals has been suggested to reduce stigma. Faith-based organizations have been recognized as important to stigma reduction efforts among African American populations; however, relatively few church-based studies have measured HIV-related stigma. This study uses baseline data (N = 1,448) from a study with 14 African American churches in Kansas City, Missouri and Kansas, to examine correlates of HIV-related stigmas among church members and community members accessing church social services using two previously validated scales that measure discomfort interacting with individuals with HIV and anticipated stigma or rejection. Knowing someone with HIV was associated with lower discomfort, even after adjusting for sociodemographic characteristics and sexual risk, HIV knowledge, previous communication about HIV at church, and mean drug and homosexuality stigmas. Knowing someone with HIV was not associated with anticipated stigma or rejection after adjustment. Contact-based interventions hold promise for reducing discomfort around people with HIV among church-affiliated populations.

A pilot study evaluating the prefeasibility of a behavioral weight loss program in people with multiple sclerosis.

Weight loss interventions seldom include individuals with neurologic disease. The aims of the present study were to: 1) develop and assess the prefeasibility of a 6-month telehealth behavioral weight loss program for people with multiple sclerosis (MS) and obesity and 2) examine changes in weight loss (primary outcome), physical activity, and fruit/vegetable consumption at follow-up. Participants with obesity and MS engaged in a 24-week weight loss program. Participants followed established diet, exercise, and self-monitoring guidelines and attended weekly online group meetings. Median percentage weight loss was 10.54 % (SD = 7.19). Participants who adhered more closely to the self-monitoring guidelines (r = 0.81, p =.02), and who averaged higher weekly active minutes (r = 0.91, p =.002) achieved greater percentage weight loss. Six of the eight pilot participants achieved clinically meaningful weight loss (>5%) after 6-months.

Renin-Angiotensin Blockade Reduces Readmission for Acute Chest Syndrome in Sickle Cell Disease.

Rationale Acute chest syndrome (ACS) is a life-threatening complication of sickle cell disease (SCD). Current treatment is supportive-supplemental oxygen, transfusions, and antibiotics. Prevention of ACS may reduce morbidity and mortality in patients with SCD. Acute chest syndrome appears similar to pulmonary fat embolism (PFE), a complication of severe skeletal trauma or orthopedic procedures from pulmonary micro-vessel blockage by bone marrow fat. Vascular obstruction and bone marrow necrosis occur in PFE and ACS.  Pulmonary fat embolism rat models have shown that angiotensin-converting enzyme inhibitors (ACEI) and angiotensin II receptor blockers (ARB) mitigate damage in PFE. These medications could work similarly in ACS. We hypothesize that time to readmission after one hospitalization for ACS will be reduced in patients taking ACEI or ARB compared to patients who are not. Methods This is a retrospective cohort study. Inclusion criteria are adults (18 to 100 years) with sickle cell anaemia (HbSS), hemoglobin SC (HbSC) disease, sickle cell thalassemia (HbSßThal), hospitalized with ACS over 16 years (January 1, 2000, to March 31, 2016); patients who take and don't take ACEI or ARB. Children (<18 years old), elderly adults (>100 years old), pregnant patients, and patients with sickle cell trait were excluded. Data was collected from the Health Facts database, which contains de-identified information from the electronic medical records of hospitals in which Cerner© has a data use agreement. Kaplan-Meier estimates explored a time-to-event model of ACS readmission. Multivariable analysis (age, gender, smoking history) was conducted using Cox proportional hazards regression. Results were reported around a 95% confidence interval. Results There were 6972 patients in total. Of which, 9.6% (n = 667) reported taking ACEI or ARB. Results for the covariates were: average age of 38 years old; 63% female (n = 4366/6969); 16% smokers (n = 1132). Readmission rates were higher for patients not taking ACEI/ARB than those who did: 0.44 (95% CI 0.43, 0.46) versus 0.28 (95% CI 0.24, 0.31) at one year, and 0.56 (95% CI 0.55, 0.58) versus 0.33 (95% CI 0.29, 0.37) at two years. Age had the strongest effect on readmission rates for patients taking ACEI/ARB (adjusted hazards ratio 0.78 [95% CI 0.68, 0.91]). Conclusion Patients with SCD who reported taking ACEI or ARB had lower readmission rates for ACS; age was the strongest covariate. Our results may have a significant impact on the prevention of ACS. Prospective studies comparing ACEI or ARB therapy versus placebo are needed to confirm this preventative effect.

Risk of Recall Among Medical Devices Undergoing US Food and Drug Administration 510(k) Clearance and Premarket Approval, 2008-2017.

Importance: The US Food and Drug Administration (FDA) uses 510(k) clearance and premarket approval (PMA) pathways to ensure device safety before marketing. Premarket approval evaluates high-risk medical devices and requires clinical trials, whereas 510(k) clearance evaluates moderate-risk devices and relies on benchtop (nonclinical and biomechanical) and descriptive data. Existing literature suggests that the clinical trials required by PMA are associated with reduced risk of recall compared with devices granted 510(k) clearance. Several investigators have found weaknesses in pivotal PMA trials, raising safety concerns. Furthermore, methodological factors may have led to a previous underestimation of recall risk for devices with PMA. Objectives: To compare risk of recall and high-risk recall between devices that received 510(k) clearance and those that received PMA and to compare the risk of recall between devices for medical specialties. Design, Setting, and Participants: This cohort study compared devices with 510(k) clearance vs those with PMA that reached the market between January 1, 2008, and December 31, 2017. Two- to 12-year follow-up was obtained from the FDA's 510(k) and PMA medical device database. Orthopedic surgery was chosen arbitrarily as the reference category for analysis between specialties because no baseline exists. Statistical analysis was performed from February 1 to November 1, 2020. Main Outcomes and Measures: The FDA issues recalls for safety concerns. These recalls are stratified into class I, II, and III, with class I representing high-risk issues for serious harm or death. The main outcome was the hazard ratio of any recall and class I recall between devices with PMA and those with 510(k) clearance. The secondary outcome was the recall hazard ratio between specialties with respect to the reference category. A single Cox proportional hazards regression model evaluating the association of medical specialty and FDA approval pathway with the risk of recall was performed. Results: During the study period, 28 246 devices received 510(k) clearance and 310 devices (10.7%) received PMA; 3012 devices (10.7%) with 510(k) clearance and 84 devices (27.1%) with PMA were recalled. A total of 216 devices (0.8%) with 510(k) clearance and 16 devices (5.2%) with PMA had class I recalls. Devices with PMA compared with those with 510(k) clearance had a hazard ratio for recall of 2.74 (95% CI, 2.19-3.44; P < .001) and a hazard ratio for high-risk recall of 7.30 (95% CI, 4.39-12.13; P < .001). Only radiologic devices were associated with an increased risk of recall (hazard ratio, 1.57; 95% CI, 1.32-1.87; P < .001), whereas 6 specialties were assocated with a decreased risk compared with the orthopedic reference category: general and plastic surgery, otolaryngology, obstetrics and gynecology, physical medicine, hematology, and general hospital. Conclusions and Relevance: This study suggests that high-risk medical devices approved via PMA are associated with a greater risk of recall than previously reported. Most recalls are for devices with 510(k) clearance, also raising safety concerns. Strengthening postmarketing surveillance strategies and pivotal trials may improve device safety.

The Use of Direct Oral Anticoagulants in the Management of Venous Thromboembolism in Patients With Obesity.

Introduction The use of direct oral anticoagulants (DOACs) has gained significant traction given the lack of therapeutic monitoring and the need for anticoagulant bridging. There is a paucity of data on their effectiveness in obese patients with venous thromboembolism (VTE). Preliminary subgroup and pharmacokinetic analyses suggest reduced efficacy in those with a bodyweight >120 kg or body mass index (BMI) ≥40 kg per m2 and it is currently not recommended that these agents be used as first-line agents. We aimed to assess the rate of VTE recurrence in obese patients diagnosed with VTE and treated with DOAC therapy. Methods We utilized the Health Facts Center National Data Warehouse (Cerner) to perform a retrospective analysis of patients with VTE (acute deep venous thrombosis (DVT) or pulmonary embolism) that presented to the hospital between 2010 and 2016 and were managed with DOACs. The cohort of patients diagnosed with DVT or PE were identified using International Classification of Disease (ICD-9-CM, ICD-10-CM). Patients were divided into two groups based on their weight: 1) weight <120 kg or 2) weight>120 kg. Six-month VTE recurrence rates were recorded. Summary and univariate statistics were performed. Results A total of 18,147 patients with a mean (±SD) age of 62 (17) years were included; 48% (n=8732) were male. A total of 2,419 (13%) patients weighed >120 kg while the rest (N=15,728, 87%) weighed <120 kg. There were significantly more female patients weighing<120 kg (54% vs 42%, p<0.0001); otherwise, there was no significant difference in age or tobacco use between both groups (p>0.05). There was no significant difference in six-month readmission rates for VTE recurrence in patients that weighed <120 kg (34%) in comparison with patients >120 kg (36%) (p=0.08). Conclusion Our study suggests that the use of DOACs in obese patients is equally efficacious with similar VTE recurrence rates in comparison with non-obese patients. This study paves the way for prospective multi-institutional randomized control trials to further reinforce the safe use of such agents in this patient population.

Noninvasive radial artery tonometry augmentation index and urinary albumin/creatinine levels in early adolescents with type 1 diabetes mellitus.

Patients with type 1 diabetes mellitus (DM1) are at an even greater risk compared to the general population for the development of cardiovascular disease. Studies have determined that the pathological changes seen in atherosclerosis develop at a very early age. There is a growing consensus within the medical community that early identification of chronic disease may help to reduce morbidity and mortality. The aim of this study was to assess the degree of arterial stiffness by measuring the augmentation index (AIx), using noninvasive radial artery tonometry, in adolescent children with DM1 compared with age-matched controls. In addition, urinary albumin/creatinine ratios were obtained to assess a possible relationship between renal and cardiac dysfunction in patients with DM1. Forty-five adolescents with DM1 and 42 controls between the ages of 12 and 14 years were recruited. Radial artery stiffness and urinary albumin/creatinine ratios of the adolescents with DM1 were not different from controls.

Interindividual variability in acetaminophen sulfation by human fetal liver: implications for pharmacogenetic investigations of drug-induced birth defects.

BACKGROUND: Acetaminophen (APAP) use in early pregnancy has been associated with the risk of gastroschisis, a rare but serious congenital defect of the abdominal wall. The purpose of this study was to characterize the variability of APAP sulfation in a panel of human fetal livers and to identify the sulfotransferases (SULT) isoform(s) responsible for catalyzing that activity. METHODS: APAP sulfation was determined in a panel of human fetal (n = 73) and postnatal (n = 18) liver cytosol preparations and correlated with the catalytic activity of various SULT isoforms as determined using prototypic substrates and specific antibodies. RESULTS: Of 10 heterologously expressed SULT isoforms examined, SULT1A1, SULT1A3/4, SULT1E1, and SULT2A1 all catalyzed the formation of APAP sulfate with K(m) values of 2.4, 1.5, 1.9, and 3.7 mM, respectively. Catalytic activities for these four isoforms were expressed at varying levels in human fetal liver, and APAP sulfation was positively correlated with each of the four prototypic activities. Several regression and clustering approaches revealed that SULT1A3/4 was the primary determinant of prenatal APAP sulfation but that SULT1A1 or SULT1E1 were also major contributors in subsets of samples. CONCLUSIONS: The results of this study lead to the hypothesis that genetic variation in SULT1A3/4 represents a risk factor for the development of gastroschisis in the offspring of mothers exposed to APAP early in pregnancy. Interpretation of genetic association studies conducted to test this hypothesis will be complicated by the variable contributions of other SULTs toward APAP-sulfate formation in individual subjects.

Variations in psychological profile among children with recurrent abdominal pain.

This study was designed to determine whether distinct subgroups of children with recurrent abdominal pain (RAP) could be identified based on patterns of psychological functioning. Two hundred and eighty-three children (ages 8-17 years), and a primary caretaker, completed the Behavior Assessment System for Children (BASC) during the initial evaluation of RAP at a pediatric gastroenterology clinic. Cluster analysis of BASC scores supported a 3-cluster solution, with fair agreement observed between parents and children on cluster assignment. Approximately half of the sample identified no significant psychological problems. A small percentage (13%) evidenced intense and broad-based psychological problems, while the remainder (35-45%) indicated relative elevations in anxiety only. Cluster membership did not vary systematically by age, gender, race, or functional gastrointestinal disorder diagnosis. Distinct psychological profiles appear to exist for children with RAP. Targeting treatments to these profiles may improve the effectiveness and efficiency with which health professionals address pediatric abdominal pain.

Resource utilization and expenditures for overweight and obese children.

OBJECTIVES: To compare health care utilization and expenditures for healthy-weight patients, overweight patients, and patients with diagnosed and undiagnosed obesity and to examine factors associated with a diagnosis of obesity. DESIGN: Retrospective study using claims data from a large pediatric integrated delivery system. SETTING: An urban academic children's hospital. PARTICIPANTS: Children aged 5 to 18 years who presented to a primary care clinic for well-child care visits during the calendar years 2002 and 2003 and who were followed up for 12 months. MAIN OUTCOME MEASURES: Diagnosis of obesity, primary care visits, emergency department visits, laboratory use, and health care charges. RESULTS: Of 8404 patients, 57.9% were 10 years or older, 61.2% were African American, and 72.9% were insured by Medicaid. According to the criteria of body mass index (calculated as weight in kilograms divided by the square of height in meters), 17.8% were overweight and 21.9% were obese. Of the obese children, 42.9% had a diagnosis of obesity. Increased laboratory use was found in both children with diagnosed obesity (odds ratio [OR], 5.49; 95% confidence interval [CI], 4.65-6.48) and children with undiagnosed obesity (OR, 2.32; 95% CI, 1.97-2.74), relative to the healthy-weight group. Health care expenditures were significantly higher for children with diagnosed obesity (adjusted mean difference, $172; 95% CI, $138-$206) vs the healthy-weight group. Factors associated with the diagnosis of obesity were age 10 years and older (OR, 2.7; 95% CI, 2.0-3.4), female sex (OR, 1.5; 95% CI, 1.2-1.8), and having Medicaid (OR, 1.6; 95% CI, 1.1-2.3). CONCLUSIONS: Increased health care utilization and charges reported in obese adults are also present in obese children. Most children with obesity had not been diagnosed as having obesity in this administrative data set.

The use of technology to address patterns of risk among teenage drivers.

INTRODUCTION: The crash risk of teens is high, with fatal crash rates of teen drivers higher than any other age group. New approaches to reduce teen traffic fatalities are clearly needed. METHOD: A possible approach to reduce the incidence of teen driver crashes and fatalities is through the use of vehicle-based intelligent driver support systems. To be most effective, the system should address the behaviors associated with an overwhelming number of teen fatal crashes: speed, low seatbelt use, and alcohol impairment. In-vehicle technology also offers an opportunity to address the issue of inexperience through enforcement of certain Graduated Driver's License provisions. RESULTS: To fully understand the capability of such technologies, there should be a concerted effort to further their development, and human factors testing should take place to understand their effects on the driver. IMPACT: If successfully implemented, a Teen Driver Support System (TDSS), such as the one described here, could significantly decrease the number of teens killed in traffic crashes.

The Methodology of Clinical Studies Used by the FDA for Approval of High-Risk Orthopaedic Devices.

BACKGROUND: The purpose of this investigation was to examine the methodology of clinical trials used by the U.S. Food and Drug Administration (FDA) to determine the safety and effectiveness of high-risk orthopaedic devices approved between 2001 and 2015. METHODS: Utilizing the FDA's online public database, this systematic review audited study design and methodological variables intended to minimize bias and confounding. An additional analysis of blinding as well as the Checklist to Evaluate a Report of a Nonpharmacological Trial (CLEAR NPT) was applied to the randomized controlled trials (RCTs). RESULTS: Of the 49 studies, 46 (94%) were prospective and 37 (76%) were randomized. Forty-seven (96%) of the studies were controlled in some form. Of 35 studies that reported it, blinding was utilized in 21 (60%), of which 8 (38%) were reported as single-blinded and 13 (62%) were reported as double-blinded. Of the 37 RCTs, outcome assessors were clearly blinded in 6 (16%), whereas 15 (41%) were deemed impossible to blind as implants could be readily discerned on imaging. When the CLEAR NPT was applied to the 37 RCTs, >70% of studies were deemed "unclear" in describing generation of allocation sequences, treatment allocation concealment, and adequate blinding of participants and outcome assessors. CONCLUSIONS: This study manifests the highly variable reporting and strength of clinical research methodology accepted by the FDA to approve high-risk orthopaedic devices.

A time to be promoted. The Prospective Study of Promotion in Academia (Prospective Study of Promotion in Academia).

OBJECTIVE: The study's objectives were to determine (1) the rate at which department of medicine faculty in the United States are promoted, (2) if clinician-educators (CEs) are promoted to Associate Professor at the same rate as clinician-investigators (CIs), and (3) the variables that predict promotion. METHODS: The Prospective Study of Promotion in Academia was a part-retrospective, part-prospective (from 2000 to 2003) cohort study. Six-hundred and four Internal Medicine junior faculty across the United States who had been registered as new appointees with the Association of American Medical Colleges in 1995 were invited to participate. Twenty-one percent of these had already left their institution when the study began. One hundred and eighty-three Internal Medicine faculty from 87 institutions in 35 states enrolled. The main outcome measure was the time from appointment as Assistant Professor to promotion to Associate Professor. RESULTS: Follow-up was complete for all 183 faculty. Among the faculty that achieved promotion, the estimated median time to promotion was 6.0 years (95% Conf. Int.=5.8 to 6.2). The unadjusted sixth-year promotion rate for CEs was 16%, while for CIs it was 26% (P=.002). Independent negative predictors of promotion included low amount of research time (Hazard Ratio [HR] =0.3, 95% Conf. Int.=0.2 to 0.5), having a manuscript review service (HR=0.4, 95% Conf. Int.=0.2 to 0.7), never meeting with Chairman/Chief about promotion (HR=0.4, 95% Conf. Int.=0.2 to 0.7), low job satisfaction (HR=0.5, 95% Conf. Int.=0.3 to 0.9), and working in the Northeast (HR=0.6, 95% Conf. Int.=0.4 to 1.1). Positive predictors included making between 130 dollars and 149,000 dollars per year (HR=1.9, 95% Conf. Int.=1.1 to 3.4), working more than 60 h/wk (HR=1.9, 95% Conf. Int.=1.1 to 3.0), having a career mentor available (HR=1.8, 95% Conf. Int.=1.1 to 2.9), and having access to a grant office (HR=1.6, 95% Conf. Int.=1.0 to 2.6). CONCLUSION: CEs and CIs appear to be promoted at different rates. The characteristics that are independently associated with earlier promotion may be helpful for institutions and individual faculty that are committed to achieving promotion efficiently.