External Validity of a Randomized Controlled Trial on Duration of Antibiotics for the Treatment of Gram-Negative Bacteremia.

INTRODUCTION: Reports regarding the external validity of randomized controlled trials (RCTs) are scarce. We aimed to assess the population external validity of an investigator-initiated RCT on the duration of antibiotics for the treatment of Gram-negative bacteremia by comparing patients included in the RCT to patients that were not included in the trial. METHODS: Hospitalized patients with Gram-negative bacteremia were recruited into an RCT and randomized to receive 7 or 14 days of covering antibiotic therapy in Israel and Italy from 2013 to 2017. In a concomitant observational study, RCT participants were compared with patients who fulfilled the inclusion criteria but were not included in the trial due to participation in other trials, discharge before approached by researchers, refusal to participate, or unwillingness of the treating physician to allow participants' recruitment. RESULTS: Six hundred and four RCT patients were compared with 613 nonincluded patients. Almost 50% of nonincluded patients (288/613) were dependent on others for activities of daily living at baseline compared to 37.7% of RCT participants (228/604). Dementia was nearly 2-fold more frequent in nonincluded patients than those included (5.9% [36/613] versus 3.6% [22/604], p = 0.07). Patients who were not included in the RCT were more likely to acquire their infection in the hospital (53.3% [327/613] versus 29.1% [176/604], p < 0.001). The primary composite outcome of mortality, clinical failure, readmissions, or extended hospitalization at 90 days occurred in 353 of 613 nonincluded patients (57.6%) compared to 299 of 604 RCT participants (49.6%), p = 0.005. However, on multivariate analysis noninclusion in the RCT was not an independent risk factor for clinical failure and mortality. CONCLUSIONS: RCTs, even with broad eligibility criteria, do not represent the whole spectrum of patients and leave out a population with more severe illness for whom the evidence is lacking.

Adapting the vertical position of implants with a conical connection in relation to soft tissue thickness prevents early implant surface exposure: A 2-year prospective intra-subject comparison.

AIM: To evaluate the effect of soft tissue thickness on bone remodelling and to investigate whether implant surface exposure can be avoided by adapting the vertical implant position in relation to the soft tissue thickness. MATERIALS AND METHODS: Twenty-five patients received two non-splinted implants supporting an overdenture in the mandible. Soft tissue thickness was measured using bone sounding and ultrasonically. One implant was installed equicrestally (control), and the vertical position of the second implant was adapted to the site-specific soft tissue thickness (test). Crestal bone levels were determined on digital peri-apical radiographs and compared with baseline (implant placement). RESULTS: Twenty-five patients were consecutively treated. No implants failed during the follow-up. A significant correlation was observed between soft tissue thickness and bone level alterations after 6 months (ultrasound ICC = 0.610; bone sounding ICC = 0.641) with inferior bone levels for equicrestal implants when thin tissues are present. Subcrestal implants showed significantly better bone levels after 6-month (n = 24, 0.04 mm versus 0.72 mm; p < .001), 1-year (n = 24, 0.03 mm versus 0.77 mm; p < .001) and 2-year follow-up (n = 24, 0.04 mm versus 0.73 mm; p < .001). CONCLUSION: Initial bone remodelling was affected by soft tissue thickness. Anticipating biologic width re-establishment by adapting the vertical position of the implant seemed highly successful to avoid implant surface exposure.

Tardive Syndrome Is a Mysterious Phenomenon with Different Clinical Manifestations-Review.

Tardive syndrome (TS) refers to persistent hyperkinetic, hypokinetic, and sensory complaints appearing after chronic neuroleptics and other dopamine receptor-blocking agents (DRBAs). It is defined as involuntary movements, often rhythmic, choreiform, or athetoid, involving the tongue, face, extremities, and sensory urges such as akathisia and lasts for a few weeks. TS develops in association with neuroleptic medication usage for a few months at least. There is usually a delay between the initiation of the causative drug and the onset of abnormal movements. However, it was soon noted that TS can also develop early, even days or weeks after DRBAs begin. However, the longer the exposure, the greater the risk of developing TS. Tardive dyskinesia, dystonia, akathisia, tremor, and parkinsonism are frequent phenomenologies of this syndrome.