2 Minute Medicine Rewind February 25, 2019

Induction of Labor at 41 Weeks Versus Expectant Management Until 42 Weeks (INDEX): Multicenter, Randomized Non-Inferiority Trial

It has been well established that pregnancy extending beyond 42 weeks is associated with higher rates of perinatal morbidity and mortality. However, there is variability in the current management of pregnancies extending beyond 41 weeks. In this randomized controlled non-inferiority trial, 1801 low-risk women with an uncomplicated singleton pregnancy were randomized to undergo either induction of labor at 41 weeks or expectant management until 42 weeks to compare outcomes in perinatal mortality and neonatal morbidity. A composite score of perinatal mortality and neonatal morbidity, as measured by the presence of any of several pathologies or admission to the Neonatal Intensive Care Unit, was used as the primary outcome. Researchers found that expectant management, with 3.1% of women having adverse perinatal outcomes, was inferior to induction of labor at 41 weeks, with 1.7% of women having adverse outcomes in that group (absolute risk difference -1.4%, 95% CI -2.9% to 0.0%, p=0.22 for non-inferiority). In addition, infants in the induction group were less likely to have an Apgar score less than 7 at 5 minutes when compared to the expectant management group (RR 0.48, 95% CI 0.23 to 0.98). The two treatment arms did not differ in terms of rates of caesarean section or adverse maternal outcomes. This study therefore shows that induction of labor at 41 weeks in low-risk women with an uncomplicated singleton pregnancy is associated with improved perinatal outcomes.

Clinical Outcomes of Escalation vs Early Intensive Disease-Modifying Therapies with Multiple Sclerosis

High-efficacy disease-modifying therapies (DMTs) are not typically used in the management of early multiple sclerosis (MS), unless patients present with very aggressive or resistant forms of the disease, and therefore with poor prognostic signs. The use of DMTs has been associated with little improvement in long-term disability outcomes. However, optimal treatment strategies are currently unknown and delays imposed by escalating therapies may represent a lost therapeutic opportunity. In this retrospective cohort study, 592 patients who had ever been prescribed a DMT for MS were followed up to assess long-term outcomes, according to whether they were treated initially with high-efficacy or moderate-efficacy DMT (with subsequent escalation if indicated). Researchers found that the 5-year change in Expanded Disability Status Scale score, a measure of disability, was significantly lower in the early intensive treatment arm, as compared to escalation therapy (0.3 vs. 1.2, p=0.002). The time to sustained accumulation of disability did not differ significantly between patients that received early intensive therapy versus escalation therapy (6 years vs. 3.14 years, p=0.05). There was also no difference in the risk of sustained accumulation of disability between the two groups. This study therefore shows that early intensive therapy is associated with significantly less progression of disability after 5 years, as compared to escalation therapy. Further studies are needed in assessing whether improved selection and escalation criteria can negate the long-term risk of disability accumulation observed in patients not receiving early intensive treatment with DMTs.

Automated Insulin Dosing Guidance to Optimize Insulin Management in Patients with Type 2 Diabetes: a Multicenter, Randomized Controlled Trial

Over one fourth of patients with type 2 diabetes use insulin as part of their therapeutic regimen. However, only a third of those being treated with insulin reach their goal glycated hemoglobin levels, a measure of therapeutic success. Therapy insulin would be more effective if clinicians were able to regularly titrate dosing based on blood glucose levels. This randomized controlled trial aimed to compare whether a new device that measures glucose, determines patterns, and automatically titrates the appropriate next insulin dose, when used with health-care support, is associated with improvements in glycated hemoglobin, as compared to health-care support alone. Patients with type 2 diabetes and glycated hemoglobin levels of 7.5% or higher (n=181) were enrolled and randomized to one of the two therapeutic regimens, and followed up over 6 months. Researchers found that the mean decrease in glycated hemoglobin at 6 months was significantly higher in the group who used the automated device, as compared to those that received healthcare support alone (1% vs. 0.3%, p<0.0001). The rate of hypoglycemic events was similar between the two groups (p=0.96). Investigators therefore concluded that automated insulin titration, when combined with healthcare support, led to improved glucose control and did not lead to an increase in hypoglycemic events.

Serious Adverse Events and Lifetime Risk of Reoperation After Elective Shoulder Replacement: Population Based Cohort Study Using Hospital Episode Statistics for England

The incidence of elective primary shoulder replacements in the management of end-stage glenohumeral arthropathies is rapidly increasing.  However, little data exists on long-term outcomes, including the risks of revision surgery. In this population-based cohort study, 58,054 elective shoulder placements performed in 51,895 patients age 50 years of older (1998-2017) were followed up to provide risk estimates of serious adverse events after elective shoulder replacement surgery for arthritis, including the lifetime risk of revision surgery. The lifetime risk of revision surgery was calculated using an actuarial life table approach and the cumulative probability method. Researchers found that the lifetime risk of revision surgery varied considerably with sex and age. The highest risk for revision surgery was found among men age 55 to 59 years and was 23.6% (95% CI 23.2% to 24.0%). The lowest risk, 2.7%, was in women age 85 years or older (95% CI 2.6% to 2.8%). The 30 and 90-day risks for any serious adverse event were 3.5% (95% CI 3.4% to 3.7%) and 4.6% (95% CI 4.4% to 4.8%), respectively. Rates of serious adverse events increased in males, with advancing age, and increasing comorbidities. The results of this study therefore show that relatively younger males have a higher likelihood of early failure of shoulder replacement and therefore a higher risk of requiring more complex revision replacement surgery. This represents an important contribution to effective counseling surrounding these risks, including the risk of adverse events, in these surgical candidates.

Efficacy and Posttreatment Effects of Therapist-Delivered Cognitive Behavioral Therapy vs Supportive Psychotherapy for Adults with Body Dysmorphic Disorder: A Randomized Clinical Trial

Body dysmorphic disorder (BDD) affects between 1.7% and 2.9% of the population, and is associated with substantial functional impairment, high rates of suicidality and hospitalization. Cognitive behavioral therapy (CBT) has been shown to be effective in treating this disorder, however, therapist-delivered supportive psychotherapy is the psychosocial treatment most commonly received by individuals wit BDD. In this randomized clinical trial, 120 patients with BDD with at least moderate severity symptoms were randomized to receive weekly CBT or supportive psychotherapy for 24 weeks to compare CBT with supportive psychotherapy in the treatment of BDD. Follow-up occurred at 3 and 6 months. Researchers found that at one of the two treatment sites in this study, severity of BDD symptoms, as measured by the Yale-Brown Obsessive-Compulsive Scale Modified for BDD, was not significantly different between CBT and supportive psychotherapy groups (p=0.48). However, at the other treatment site, CBT was associated with a greater reduction in BDD symptoms, as compared to supportive psychotherapy (p<0.001). At 6-month follow-up, there was no significant difference in post-treatment symptom changes. Investigators therefore concluded that both CBT and supportive psychotherapy are associated with symptomatic improvement in BDD, though symptomatic improvement associated with supportive psychotherapy varied more by treatment site.

Image: PD

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