To improve reporting transparency and research integrity, some journals have begun publishing study protocols and statistical analysis plans alongside trial publications. To determine the overall availability and characteristics of protocols and statistical analysis plans this study reviewed all randomized clinical trials (RCT) published in 2016 in the following 5 general medicine journals: Annals of Internal Medicine, BMJ, JAMA, Lancet, and NEJM. Characteristics of RCTs were extracted from the publication and clinical trial registry. A detailed assessment of protocols and statistical analysis plans was conducted in a 20% random sample of trials. Dataset contains extraction sheets (as SAS data files), code to calculate the values in the tables in the manuscript, and a supplemental file with additional notes on methods used in the study.

For two decades the standard drug therapy for patients with Crohn’s disease (CD) and ulcerative colitis (UC) has been anti-tumor necrosis factor agents (anti-TNFs) such as adalimumab (Humira), certolizumab pegol (Cimzia), infliximab (Remicade) and several others. More recently, vedolizumab (Entyvio) has entered the market as the first gut-selective integrin blocker that offers an alternative treatment for inflammatory bowel disease (IBD). Using the FDA Adverse Event Reporting System (FAERS) database, this study compared adverse event reports (AE) for the two types of therapies. The search retrieved 499 reports for vedolizumab and 119,620 for anti-TNFs for the years 1998 through 2015. Using the proportional reporting ratio (PPR) and the empirical Bayesian geometric mean (EBGM) algorithms, AE data were reviewed for signals of disproportionate reporting for the two types of drugs. This dataset includes statistical summary tables of characteristics (demographic) and a variety of adverse event comparisons of vedolizumab, anti-TNFs, and all other medications. Cleaned FAERS data was provided with permission by DrugLogic, Inc. Interested researchers may contact DrugLogic Inc. (Reston, VA) by calling 800-393-1313 or emailing swordham@druglogic.com

Beta-lactams provide superior outcomes in comparison to vancomycin in treating methicillin-susceptible Staphylococcus aureus (MSSA) infections complicated by bacteremia. However, approximately 11% of inpatients report a penicillin (PCN) allergy when it is estimated that only 1% of the general population is truly allergic to the antibiotic. Consequently, many patients may be receiving suboptimal treatment for a serious infection with a high mortality rate. This study evaluated the cost-effectiveness of penicillin skin testing (PST) in adult inpatients self-reporting PCN allergy and undergoing treatment for MSSA bacteremia. A decision analytic model was developed comparing an acute care PST intervention to a scenario with no confirmatory allergy testing. This dataset includes a decision analytic model diagram, model inputs, and an Excel file with MSSA bacteremia model parameters and probabilistic simulation calculations.

Dataset comprises hospitalization rates for opioid injection-related skin and soft-tissue infections (O-SSTI) correlated with changes in the price and purity of heroin for the years 1993 through 2010, inclusive. Data is derived from the Healthcare Cost and Utilization Project (HCUP) Nationwide Inpatient Sample (NIS) and the Drug Enforcement Administration (DEA) System to Retrieve Information from Drug Evidence (STRIDE) databases for 27 Metropolitan Statistical Areas (MSAs).

Dataset is comprised of heroin overdose-related and prescription opioid overdose-related hospitalization rates for the years 2000 through 2014. Data is derived from the Healthcare Cost and Utilization Project (HCUP) Nationwide Inpatient Sample (NIS). Included are rates by census region and division with separate rates for age and race.

Officials from Medicaid programs in all 50 states and the District of Columbia were invited to participate in a telephone survey assessing psychotropic-monitoring programs targeting youth. 38 completed the survey which was administered between August 2011 and December 2012. This dataset includes information about program characteristics, implementation strategies, review agency, professional oversight, periodic review, psychotropic drug class, concomitant use, and prescriber credentials.

This dataset represents a comparison of polypharmacy among youth with serious emotional and behavioral disorders enrolled in coordinated care services (CCS) versus those receiving traditional mental health services. Data were extracted from Medicaid administrative claims (demographic, diagnosis by ICD-9 code, procedure codes, and psychotropic medication), child welfare administrative records, and juvenile justice records. The final analytic sample included a total of 814 CCS youths and 993 in the traditional care cohort.

Data from Medicaid fee-for-service and managed care claims from one Mid-Atlantic state were analyzed for this cross-sectional study. The dataset consists of a total of 16,969 youths under the age of 20 with a mental health diagnosis and a pharmacy claim for antipsychotic medication in 2003. Data for each individual includes demographic, Medicaid program category (ie, foster care, disabled), psychiatric diagnostic codes, and psychotropic medications by major therapeutic class.

Data were extracted from a review of computerized administrative claims for 15,507 Medicaid youth in an effort to assess differences in rates of mental health treatment for enrollees in one of 3 categories of aid. The study population consisted of individuals aged 0-19 years residing in a suburban county in a mid-Atlantic state during 1996 and enrolled in the fee-for-service Medicaid program. Mental health services were analyzed and compared for youth in foster care, receiving Supplemental Security Income (SSI), and all other forms of assistance such as Aid to Families with Dependent Children (AFDC). The dataset includes demographic information, type of mental health services provided, mental disorder diagnoses (in 15 subcategories), as well as psychotropic and certain nonpsychotropic medications prescribed.

Periodic limb movements in sleep (PLMS) are associated with sleep fragmentation and sympathetic nervous system activation, which in turn have been linked to cognitive and behavioral deficits in children and cardiovascular morbidity in both adults and children. Emerging evidence indicates that many children with sickle cell disease (SCD) have elevated PLMS. The specific aims of this prospective, repeated-measures, descriptive study were to assess the agreement between PLMS measurement by actigraphy and concurrent polysomnography (PSG), to test the feasibility of measuring PLMS by actigraphy at home, to evaluate PLMS variability over consecutive nights by actigraphy, and to provide preliminary data on objective and subjective correlates of PLMS. Twenty children with SCD and restless legs syndrome (RLS) symptoms or polysomnography-documented PLMS underwent concurrent attended polysomnography and ankle activity monitoring over one to two nights and home activity monitoring for three nights. Serum iron and ferritin were measured pre- and post-polysomnography. The datasets associated with this study include demographic data, SCD subtype, polysomnographic/activity monitor values, medical history, and clinical measures.