Avoiding Pitfalls While Implementing New Guidelines on Student Documentation

Making Colonoscopy Smarter With Standardized Computer-Aided Diagnosis

Reconciling the Discrepancies in Medicine's Relationship to Medical Marijuana

Unequal Pay for Equal Work: Where Are We Now?

Intensive Models of Hepatitis C Care for People Who Inject Drugs Receiving Opioid Agonist Therapy: A Randomized Controlled Trial: Annals of Internal Medicine: Vol 170, No 9

Background: Many people who inject drugs (PWID) are denied treatment for hepatitis C virus (HCV) infection, even if they are receiving opioid agonist therapy (OAT). Research suggests that HCV in PWID may be treated effectively, but optimal models of care for promoting adherence and sustained virologic response (SVR) have not been evaluated in the direct-acting antiviral (DAA) era. Objective: To determine whether directly observed therapy (DOT) and group treatment (GT) are more effective than self-administered individual treatment (SIT) in promoting adherence and achieving SVR among PWID receiving OAT. Design: Three-group, randomized controlled trial conducted from October 2013 to April 2017. (ClinicalTrials.gov: NCT01857245) Setting: Three OAT programs in Bronx, New York. Participants: Persons aged 18 years and older with genotype 1 HCV infection who were willing to receive HCV therapy on site in the OAT program. Of 190 persons screened, 158 were randomly assigned to a study group and 150 initiated treatment: DOT (n = 51), GT (n = 48), and SIT (n = 51). Intervention: 2 intensive interventions (DOT and GT) and 1 control condition (SIT). Measurements: Primary: adherence, measured by using electronic blister packs. Secondary: HCV treatment completion and SVR 12 weeks after treatment completion. Results: Mean age was 51 years; 65% of participants had positive results on urine drug testing during the 6 months before treatment, and 75% reported ever injecting drugs. Overall adherence, estimated from mixed-effects models using the daily timeframe, was 78% (95% CI, 75% to 81%) and was greater among participants randomly assigned to DOT (86% [CI, 80% to 92%]) than those assigned to SIT (75% [CI, 70% to 81%]; difference, 11% [CI, 5% to 18%]; Bonferroni-corrected P = 0.001). No significant difference in adherence was observed between participants randomly assigned to GT (80% [CI, 74% to 86%]) and those assigned to SIT (difference, 4.7% [CI, −2% to 11%]; Bonferroni-corrected P = 0.29). The HCV treatment completion rate was 97%, with no differences among groups (P = 0.53). Overall SVR was 94% (CI, 89% to 97%); the SVR rate was 98% in the DOT group, 94% in the GT group, and 90% in the SIT group (P = 0.152). Limitation: These findings may not be generalizable to PWID not enrolled in OAT programs. Conclusion: All models of onsite HCV care delivered to PWID in OAT programs resulted in high SVR, despite ongoing drug use. Directly observed therapy was associated with greater adherence than SIT. Primary Funding Source: National Institute on Drug Abuse and Gilead Sciences.

Data Sharing Statements for Clinical Trials: One Step Down the Road

Self-reported Physical Health of Women Who Did and Did Not Terminate Pregnancy After Seeking Abortion Services: A Cohort Study: Annals of Internal Medicine: Vol 171, No 4

Background: Research demonstrates worse short-term morbidity and mortality associated with childbirth than with abortion, but little research has examined long-term physical health in women with unwanted pregnancies after abortion versus childbirth. Objective: To examine the physical health of women who seek and receive or are denied abortion. Design: Prospective cohort study. Setting: 30 U.S. abortion facilities from 2008 to 2010. Participants: Of 1132 women seeking abortion who consented to participate, 874 were included in this analysis (328 who had first-trimester abortion, 383 who had second-trimester abortion, and 163 who gave birth). Measurements: Self-reported overall health; chronic abdominal, pelvic, back, and joint pain; chronic headaches or migraines; obesity; asthma; gestational and nongestational hypertension and diabetes; and hyperlipidemia were assessed semiannually for 5 years. Mortality was assessed by using verbal autopsy and public records. Results: No significant differences were observed in self-rated health or chronic pain after first-trimester versus second-trimester abortion. At 5 years, 27% (95% CI, 21% to 34%) of women who gave birth reported fair or poor health compared with 20% (CI, 16% to 24%) of women who had first-trimester abortion and 21% (CI, 18% to 25%) who had second-trimester abortion. Women who gave birth also reported more chronic headaches or migraines and joint pain, but experienced similar levels of other types of chronic pain and obesity. Gestational hypertension was reported by 9.4% of participants who gave birth. Eight of 1132 participants died during follow-up, 2 in the postpartum period. Maternal mortality did not differ statistically by group. Limitation: Self-reported outcome measures, uncertain generalizability, and 41% loss to follow-up at 5 years. Conclusion: Although some argue that abortion is detrimental to women's health, these study data indicate that physical health is no worse in women who sought and underwent abortion than in women who were denied abortion. Indeed, differences emerged suggesting worse health among those who gave birth. Primary Funding Source: An anonymous foundation.

The Next Stage of Buprenorphine Care for Opioid Use Disorder

Buprenorphine has been used internationally for the treatment of opioid use disorder (OUD) since the 1990s and has been available in the United States for more than a decade. Initial practice recommendations were intentionally conservative, were based on expert opinion, and were influenced by methadone regulations. Since 2003, the American crisis of OUD has dramatically worsened, and much related empirical research has been undertaken. The findings in several important areas conflict with initial clinical practice that is still prevalent. This article reviews research findings in the following 7 areas: location of buprenorphine induction, combining buprenorphine with a benzodiazepine, relapse during buprenorphine treatment, requirements for counseling, uses of drug testing, use of other substances during buprenorphine treatment, and duration of buprenorphine treatment. For each area, evidence for needed updates and modifications in practice is provided. These modifications will facilitate more successful, evidence-based treatment and care for patients with OUD.

Association Between Publication Characteristics and Treatment Effect Estimates: A Meta-epidemiologic Study: Annals of Internal Medicine: Vol 169, No 6

Background: Evidence about the effect on meta-analysis results of including unpublished trials or those published in languages other than English is unclear or discordant. Purpose: To compare treatment effects between published and unpublished randomized controlled trials (RCTs) and between trials published in English and other languages using a meta-epidemiologic approach. Data Sources: Cochrane reviews published between March 2011 and January 2017 and trial references cited in the reviews. Study Selection: RCTs included in meta-analyses of 3 or more trials with a binary efficacy outcome. Data Extraction: Trial characteristics were extracted by original review authors. A single reviewer assessed publication status and language, with quality assurance by another investigator. Data Synthesis: Among 5659 RCTs included in 698 meta-analyses, 5303 (93.7%) were published in journal articles and 356 (6.3%) were unpublished. Of journal articles, 92.6% (4910 of 5303) were published in English and 7.4% (393 of 5303) in another language. Treatment effects were larger in published than unpublished trials (combined ratio of odds ratios [ROR] for 174 meta-analyses, 0.90 [95% CI, 0.82 to 0.98]; I 2 = 19.3%; τ2 = 0.0492). Treatment effects were also larger for trials published in a language other than English than in English (combined ROR for 147 meta-analyses, 0.86 [CI, 0.78 to 0.95]; I 2 = 0%; τ2 = 0.0000). Limitation: Reliance on the primary reference cited by review authors as the record of interest. Conclusion: In meta-analyses, treatment effects were larger in published than unpublished trials and, for published trials, in those published in a language other than English than in English. Primary Funding Source: Cochrane France.

Brief Commentary: Confusing Treatment Guidelines for Patients With Type 2 Diabetes