Effectiveness of paliperidone palmitate vs haloperidol decanoate for maintenance treatment of schizophrenia: a randomized clinical trial.

Importance: Long-acting injectable antipsychotics are used to reduce medication nonadherence and relapse in schizophrenia-spectrum disorders. The relative effectiveness of long-acting injectable versions of second-generation and older antipsychotics has not been assessed.

Objective: To compare the effectiveness of the second-generation long-acting injectable antipsychotic paliperidone palmitate with the older long-acting injectable antipsychotic haloperidol decanoate.

Effect of an educational script on postpartum contraceptive use: a randomized controlled trial.

Objectives: Short interpregnancy intervals are associated with adverse perinatal outcomes. Increased postpartum use of long-acting reversible contraception (LARC) could reduce short interpregnancy intervals. Therefore, the primary objective of our study was to evaluate if a postpartum educational script about LARC (LARC script) could increase postpartum LARC utilization at the 6-week postpartum visit.

A pilot study of eptifibatide for treatment of acute pain episodes in sickle cell disease.

Introduction: The contribution of platelet activation to the pathogenesis of sickle cell disease (SCD) remains uncertain. We evaluated the safety and efficacy of eptifibatide, a synthetic peptide inhibitor of the αIIbβ3 receptor, in SCD patients during acute painful episodes.

Materials And Methods: In this single site, double-blind, placebo-controlled trial, eligible patients with SCD admitted for acute painful episodes were randomized to receive eptifibatide or placebo at a ratio of 2:1.

Characteristics associated with interest in long-acting reversible contraception in a postpartum population.

Background: Short interpregnancy intervals lead to adverse perinatal outcomes and could be prevented with increased use of long-acting reversible contraception (LARC) in the postpartum period. The primary objective of this study was to assess which baseline characteristics are associated with the intent to use LARC among postpartum women.

Study Design: This study was a substudy of baseline data from a randomized controlled trial.

Effect of hawthorn standardized extract on flow mediated dilation in prehypertensive and mildly hypertensive adults: a randomized, controlled cross-over trial.

Background: Hawthorn extract has been used for cardiovascular diseases for centuries. Recent trials have demonstrated its efficacy for the treatment of heart failure, and the results of several small trials suggest it may lower blood pressure. However, there is little published evidence to guide its dosing.

Predicting partner HIV testing and counseling following a partner notification intervention.

Provider-assisted methods of partner notification increase testing and counseling among sexual partners of patients diagnosed with HIV, however they are resource-intensive. The sexual partners of individuals enrolled in a clinical trial comparing different methods of HIV partner notification were analyzed to identify who was unlikely to seek testing on their own. Unconditional logistic regression was used to identify partnership characteristics, which were assigned a score based on their coefficient in the final model, and a risk score was calculated for each participant.

HIV partner notification is effective and feasible in sub-Saharan Africa: opportunities for HIV treatment and prevention.

Background: Sexual partners of persons with newly diagnosed HIV infection require HIV counseling, testing and, if necessary, evaluation for therapy. However, many African countries do not have a standardized protocol for partner notification, and the effectiveness of partner notification has not been evaluated in developing countries .

Methods: Individuals with newly diagnosed HIV infection presenting to sexually transmitted infection clinics in Lilongwe, Malawi, were randomized to 1 of 3 methods of partner notification: passive referral, contract referral, or provider referral.

Variable reliability of endoscopic findings with white-light and narrow-band imaging for patients with suspected eosinophilic esophagitis.

Background & Aims: Endoscopic findings have been used to support a diagnosis of eosinophilic esophagitis (EoE) and to assess response to therapy, but their reliability is unknown. The aim of the study was to assess inter- and intraobserver reliability of endoscopic findings with white-light endoscopy and to assess changes in interobserver reliability when narrow band imaging (NBI) was added to white light.

Methods: We collected data from 35 academic and 42 community adult gastroenterologists using 2 self-administered, online assessments of endoscopic images in patients with suspected EoE.

Changes in childhood diarrhea incidence in nicaragua following 3 years of universal infant rotavirus immunization.

Background: Although the pentavalent rotavirus vaccine was highly efficacious against rotavirus diarrhea in clinical trials, the effectiveness of vaccine under field conditions in the developing world is unclear. In October 2006, Nicaragua became the first developing nation to implement universal infant immunization with the pentavalent rotavirus vaccine. To assess the effect of the immunization program, we examined the incidence of diarrhea episodes between 2003 and 2009 among children in the state of León, Nicaragua.

Reproducibility of masked hypertension in adults with untreated borderline office blood pressure: comparison of ambulatory and home monitoring.

Background: We examined short-term reproducibility of masked hypertension (MH) among adults with recent "borderline" office blood pressure (BP) and compared agreement of ambulatory BP monitoring (ABPM) and home BP monitoring (HBPM) in detecting MH.

Methods: Fifty participants underwent repeated office BP measurements, 24-h ABPM, and HBPM sessions 1-week apart. Participants with office average <140/90 mm Hg were considered to have MH if daytime ABPM average was ≥135/85 mm Hg; they were considered to have MH by HBPM if the average was ≥135/85 mm Hg.

Development of instruments to measure the quality of breast cancer treatment decisions.

Background: Women with early-stage breast cancer face a multitude of decisions. The quality of a decision can be measured by the extent to which the treatment reflects what is most important to an informed patient. Reliable and valid measures of patients' knowledge and their goals and concerns related to breast cancer treatments are needed to assess the decision quality.

Prescription refill records as a screening tool to identify antidepressant non-adherence.

Purpose: Non-adherence is a significant problem with antidepressants. Identifying patients at highest risk for discontinuing antidepressant treatment can be used to target clinical management. Accordingly, our purpose was to determine the shortest gap in medication supply that is predictive of discontinuation, while minimizing false positive results.

Practical depression screening in residential care/assisted living: five methods compared with gold standard diagnoses.

Objective: To test the accuracy of five practical depression screening strategies in older adults residing in residential care/assisted living (RC/AL).

Design: Cross-sectional screening study.

Setting: Four RC/AL communities in North Carolina.

SAVVY (C31G) gel for prevention of HIV infection in women: a Phase 3, double-blind, randomized, placebo-controlled trial in Ghana.

Objective: The objective of this trial was to determine the effectiveness of 1.0% C31G (SAVVY) in preventing male-to-female vaginal transmission of HIV infection among women at high risk.

Methodology/principal Findings: This was a Phase 3, double-blind, randomized, placebo-controlled trial.

Pregnancy risk among oral contraceptive pill, injectable contraceptive, and condom users in Uganda, zimbabwe, and Thailand.

Objective: To estimate the probability of pregnancy for oral contraceptive pill (OCP), injectable contraceptive, and condom users in Uganda, Thailand, and Zimbabwe.

Methods: This study is a secondary analysis of 5,224 women who participated in a prospective study evaluating the association between hormonal contraception and human immunodeficiency virus (HIV) acquisition.

Results: The overall 12-month cumulative probability of pregnancy of injectable contraceptive users was 0.

Day-specific pregnancy probability estimation in barrier contraceptive effectiveness trials.

We apply an extension of a statistical model developed in the fertility research setting to the barrier contraceptive trial setting to obtain estimates of the probability of pregnancy per cycle day in the presence or absence of barrier use among participants of a randomised trial of female barrier contraceptives. The per cycle day pregnancy curve for the barrier trial participants was similar to previously published results from a fertility study that included a precise indicator of ovulation day. In addition, our analysis showed strong contraceptive effects for the diaphragm.

Will microbicide trials yield unbiased estimates of microbicide efficacy?

Objective: To evaluate the effect of adherence and condom use on apparent efficacy of microbicides.

Design: Hypothetical trial designs and scenarios.

Methods: Mathematical calculations of effectiveness.

Immunogenicity and protective efficacy of recombinant vaccine based on the receptor-binding domain of the Plasmodium vivax Duffy binding protein in Aotus monkeys.

Invasion of human erythrocytes by Plasmodium vivax requires interaction between Duffy binding protein (PvDBP) and the Duffy blood group antigen. The receptor-binding domain of PvDBP lies in a conserved N-terminal, cysteine-rich region, region II (PvRII). PvRII is a valuable malaria subunit vaccine candidate for asexual blood stages.

Monitoring a three-armed clinical trial with survival endpoints: Fisher's least significant difference approach.

Researchers have long recognized the importance of monitoring trials to determine whether to terminate a trial early or change a trial because of a substantial treatment effect. Fisher's least significant difference (LSD) procedure has been suggested by Proschan et al. [Proschan, M.

Understanding risk: a randomized controlled trial of communicating contraceptive effectiveness.

Objective: To determine which of three different approaches increased women's understanding of risk of pregnancy associated with different contraceptive methods.

Methods: We randomly assigned 461 reproductive-age women to one of three tables presenting pregnancy risk (Food and Drug Administration table with numbers, World Health Organization table with numbers and categories, or table with categories). We evaluated participant knowledge before and after being shown the assigned table.

Estimating and comparing correct-use failure probabilities in clinical studies of condom functionality.

In a clinical study comparing the failure probabilities of two condom types, the sample of all reported acts of intercourse in which a study condom was used by a randomized participant is typically defined to be the primary analysis sample. However, it may also be desirable to make comparisons among only those acts in which the participants correctly followed all condom use instructions before, during, and after the act of intercourse (i.e.

Estimating cycle pregnancy probability with incomplete data in contraceptive studies.

In studies on the effectiveness of barrier method contraceptives, researchers need to estimate the risk of pregnancy during consistent use of these methods. However, participants may not use assigned methods consistently, and only consistent-use cycles are included in the estimates. Inconsistent-use cycles are considered missing intervals, and a subject's early discontinuation from the study or pregnancy during inconsistent use is censored from the analysis.

Contraceptive effectiveness of a polyurethane condom and a latex condom: a randomized controlled trial.

Objective: To compare the contraceptive effectivenesses of a polyurethane condom and a standard latex condom. Secondary outcomes of interest were safety, functionality, discontinuation, and acceptability.

Methods: We randomized 901 couples to use either the polyurethane condom or a standard latex condom as their only form of contraception.

Termination of a randomized controlled trial of two vasectomy techniques.

Family Health International (FHI) and EngenderHealth conducted a multicenter, randomized controlled trial to evaluate a fascial interposition (FI) component of a vas occlusion procedure for male sterilization. A data monitoring committee (DMC) was established to provide independent review of the interim report. The DMC met to review the interim report after enrollment of 552 men.