Scientific Misconduct in Academia: A Survey and Analysis of Applicable Law

During the 1980s, public trust in science as a discipline and the integrity of scientists has been challenged by multiple reports of data falsification, plagiarism, and misrepresentation of research results. This Comment defines scientific misconduct, analyzes its origins, and surveys applicable federal agency regulations and federal laws that structure the response of the academic community to this complex problem. The author argues that misconduct in science has its origins in the culture of medical education, academic promotion policies, editorial peer review deficiencies, and lack of institutional action. The Article concludes that additional institutional self-regulation and a more vigorous application of existing laws may be required to prevent and detect scientific misconduct

Randomized clinical trial of the effects of screening and brief intervention for illicit drug use: the Life Shift/Shift Gears study.

BackgroundAlthough screening, brief intervention, and referral to treatment (SBIRT) has shown promise for alcohol use, relatively little is known about its effectiveness for adult illicit drug use. This randomized controlled trial assessed the effectiveness of the SBIRT approach for outcomes related to drug use among patients visiting trauma and emergency departments (EDs) at two large, urban hospitals.MethodsA total of 700 ED patients who admitted using illegal drugs in the past 30 days were recruited, consented, provided baseline measures of substance use and related problems measured with the Addiction Severity Index-Lite (ASI-Lite), and then randomized to the Life Shift SBIRT intervention or to an attention-placebo control group focusing on driving and traffic safety (Shift Gears). Both groups received a level of motivational intervention matched to their condition and risk level by trained paraprofessional health educators. Separate measurement technicians conducted face-to-face follow-ups at 6 months post-intervention and collected hair samples to confirm reports of abstinence from drug use. The primary outcome measure of the study was past 30-day drug abstinence at 6 months post-intervention, as self-reported on the ASI-Lite.ResultsOf 700 participants, 292 (42%) completed follow-up. There were no significant differences in self-reported abstinence (12.5% vs. 12.0% , p = 0.88) for Life Shift and Shift Gears groups, respectively. When results of hair analyses were applied, the abstinence rate was 7 percent for Life Shift and 2 percent for Shift Gears (p = .074). In an analysis in which results were imputed (n = 694), there was no significant difference in the ASI-Lite drug use composite scores (Life Shift +0.005 vs. Shift Gears +0.017, p = 0.12).ConclusionsIn this randomized controlled trial, there was no evidence of effectiveness of SBIRT on the primary drug use outcome.Trial registrationClinicalTrials.gov NCT01683227

Characteristics of Cannabis-Only and Other Drug Users Who Visit the Emergency Department

Emergency department (ED) settings have gained interest as venues for illegal drug misuse prevention and intervention, with researchers and practitioners attempting to capitalize on the intersection of need and opportunity within these settings. This study of 686 adult patients visiting two EDs for various reasons who admitted drug use compared daily cannabis-only users, nondaily cannabis-only users, and other drug users on sociodemographic and drug-related severity outcomes. The three drug use groups did not differ on most sociodemographic factors or medical problem severity scores. Forty-five percent of the sample was identified as having a drug use problem. ED patients who used drugs other than cannabis were at particular risk for high drug use severity indicators and concomitant problems such as psychiatric problems and alcohol use severity. However, 19-29% of cannabis-only users were identified as having problematic drug use. Furthermore, daily cannabis-only users fared less well than nondaily cannabis users with regard to drug use severity indicators and self-efficacy for avoiding drug use. Results may assist emergency medicine providers and medical social workers in matching patients to appropriate intervention. For example, users of drugs other than cannabis (and perhaps heavy, daily cannabis-only users) may need referral to specialty services for further assessment. Enhancement of motivation and self-efficacy beliefs could be an important target of prevention and treatment for cannabis-only users screened in the ED

Randomized clinical trial of the effects of screening and brief intervention for illicit drug use: the Life Shift/Shift Gears study.

BackgroundAlthough screening, brief intervention, and referral to treatment (SBIRT) has shown promise for alcohol use, relatively little is known about its effectiveness for adult illicit drug use. This randomized controlled trial assessed the effectiveness of the SBIRT approach for outcomes related to drug use among patients visiting trauma and emergency departments (EDs) at two large, urban hospitals.MethodsA total of 700 ED patients who admitted using illegal drugs in the past 30 days were recruited, consented, provided baseline measures of substance use and related problems measured with the Addiction Severity Index-Lite (ASI-Lite), and then randomized to the Life Shift SBIRT intervention or to an attention-placebo control group focusing on driving and traffic safety (Shift Gears). Both groups received a level of motivational intervention matched to their condition and risk level by trained paraprofessional health educators. Separate measurement technicians conducted face-to-face follow-ups at 6 months post-intervention and collected hair samples to confirm reports of abstinence from drug use. The primary outcome measure of the study was past 30-day drug abstinence at 6 months post-intervention, as self-reported on the ASI-Lite.ResultsOf 700 participants, 292 (42%) completed follow-up. There were no significant differences in self-reported abstinence (12.5% vs. 12.0% , p = 0.88) for Life Shift and Shift Gears groups, respectively. When results of hair analyses were applied, the abstinence rate was 7 percent for Life Shift and 2 percent for Shift Gears (p = .074). In an analysis in which results were imputed (n = 694), there was no significant difference in the ASI-Lite drug use composite scores (Life Shift +0.005 vs. Shift Gears +0.017, p = 0.12).ConclusionsIn this randomized controlled trial, there was no evidence of effectiveness of SBIRT on the primary drug use outcome.Trial registrationClinicalTrials.gov NCT01683227

Efficacy and Safety of Direct Acting Antivirals in Kidney Transplant Recipients with Chronic Hepatitis C Virus Infection

The prevalence of Hepatitis C Virus (HCV) infection is significantly higher in patients with end-stage renal disease compared to the general population and poses important clinical challenges in patients who undergo kidney transplantation. Historically, interferon-based treatment options have been limited by low rates of efficacy and significant side effects, including risk of precipitating rejection. Limited data exist on the use of all-oral, interferon-free direct-acting antiviral (DAA) therapies in kidney transplant recipients. In this study, we performed a retrospective chart review with prospective clinical follow-up of post-kidney transplant patients treated with DAA therapies at three major hospitals in Boston, MA. A total of 24 kidney recipients with HCV infection received all-oral DAA therapy post-transplant. Patients were predominantly male (79%) with a median age of 60 years (range 34–70 years), median creatinine of 1.2 mg/dL (0.66–1.76), and 42% had advanced fibrosis or cirrhosis. The majority had HCV genotype 1a infection (58%). All patients received full-dose sofosbuvir; it was paired with simeprevir (9 patients without and 3 patients with ribavirin), ledipasvir (7 patients without and 1 patient with ribavirin) or ribavirin alone (4 patients). The overall sustained virologic response (SVR12) was 91% (21 out of 23 patients). One patient achieved SVR4 but demised prior to SVR12 check point due to treatment unrelated cause. Two treatment failures were successfully retreated with alternative DAA regimens and achieved SVR. Both initials failures occurred in patients with advanced fibrosis or cirrhosis, with genotype 1a infection, and prior HCV treatment failure. Adverse events were reported in 11 patients (46%) and were managed clinically without discontinuation of therapy. Calcineurin inhibitor trough levels did not significantly change during therapy. In this multi-center series of patients, all-oral DAA therapy appears to be safe and effective in post-kidney transplant patients with chronic HCV infection

Study Population.

<p>HCV DAA regimen stratification of the study population. A flow chart of the study population, stratifying by the type/combination of DAA regimens patients received. Abbreviations SOF: sofosbuvir; SMV: simeprevir; LDV: ledipasvir; RBV: ribavirin</p

Hepatitis C Direct-Acting Antiviral.

<p>FDA approved direct-acting antiviral treatment for hepatitis C. HCV RNA is translated into a long polyprotein which consists of three structural proteins and seven non-structural (NS) proteins. The NS3/4A protease cleaves the downstream NS proteins into individual subunits. The major DAA classes consist of NS3/4A protease inhibitors, NS5A replication complex inhibitors and NS5B polymerase inhibitors.</p

Tacrolimus Trough Levels.

<p>Tacrolimus trough levels while on antiviral treatment. The chart demonstrates the trough level of tacrolimus on the sixteen patients receiving this agent, individually, at different treatment time points.</p

Sustained Virologic Response.

<p>Overall sustained virologic response, stratified by stage of fibrosis. The graph indicates the number of patient who achieved undetectable HCV viral load at 12 weeks post-treatment. Of note, one patient had a negative HCV viral load measured at week 4 post-treatment and was counted towards achieving SVR.</p