Evaluation of trace calls by Xpert MTB/RIF ultra for clinical management in low TB burden settings

Background Clinical interpretation of trace results by Xpert MTB/RIF Ultra assay (Ultra) used as an initial diagnostic test for tuberculosis (TB) may be challenging. The aim of the study was to evaluate the frequency and epidemiology of trace readouts in routine clinical practice in a low TB prevalence setting and to propose guidance on how to manage patients with trace calls considering the data available (clinical, radiological, bacteriological etc.). Materials and methods A retrospective, observational, monocentric study was conducted at IRCCS Azienda Ospedaliero-Universitaria of Bologna, Italy between November 2017—December 2020. Presumptive TB patients with at least one Ultra trace result during diagnostic workup before treatment were included in the study. Patients with ongoing anti-TB treatment at the time of the trace call result or with no clinical data available were excluded from the study. Results Fifty-nine presumptive TB patients with Ultra trace readouts were included in the study (mean age 37.0 years, 61% males). Four patients had a history of TB in the last 2 years. Twenty-five (42.4%) of the 59 samples with trace results were respiratory material. 57/59 (96.6%) patients started anti-TB treatment soon after obtaining trace results, based on clinical, radiological or other information available, while for two patients with a recent history of TB the trace result did not lead to anti-TB treatment. Culture was positive for M. tuberculosis for 31/59 (52.5%) samples with trace calls: 13/25 (52.0%) were respiratory samples and 18/33 (54.5%) non-respiratory samples. The clinical and/or radiological findings of 47/57 (82.4%) patients given anti-TB therapy improved during treatment. Conclusion In low TB incidence settings, Ultra trace calls in presumptive TB patients should be considered as true-positive and treatment should be started promptly, except in cases of recent history of TB, where careful evaluation of other diagnostic criteria is necessary before starting anti-TB treatment. A decisional algorithm for clinical management is proposed

Acupuncture for Fibromyalgia: An Open-Label Pragmatic Study on Effects on Disease Severity, Neuropathic Pain Features, and Pain Catastrophizing

The treatment of fibromyalgia syndrome (FMS) is still far from being optimally coded, and pharmacological strategies are often unsatisfactory. Acupuncture plays a role among nonpharmacological intervention approaches; however, there is still no clarity as to when to integrate it into therapy. The objective of this study is to explore the role of acupuncture, in terms of efficacy on main disease severity measures and pain features, in patients with nonresponsive disease, defining nonresponsive FMS characterized by a revised Fibromyalgia Impact Questionnaire (FIQ-R) ≥39 and a Patient Health Questionnaire 15-item (PHQ15) ≥5 despite optimal drug therapy. Patients were treated with weekly sessions, for a total of eight acupuncture sessions. At the baseline and at the end of the treatment cycle, a comprehensive clinical evaluation was carried out to evaluate improvements in terms of disease severity and impact on neuropathic pain features (measured with the painDETECT questionnaire (PDQ)) and pain catastrophizing (measured with the Pain Catastrophizing Scale (PCS)). At the end of the eight-week treatment, patients experienced a significant improvement in all evaluated parameters (for FIQ-R, PDQ, and PHQ15 p<0.0001, for PCS p=0.001). Of particular note is the effectiveness on manifestations that are difficult to treat such as neuropathic pain features and on negative psychological perceptions such as pain catastrophizing. It can be stated that acupuncture can be proposed also in phases of high severity of disease. Intervention with multimodal strategies, including acupuncture, could be of great benefit to patients

Suspected acute exacerbation of idiopathic pulmonary fibrosis as an outcome measure in clinical trials

Background: Acute exacerbation of idiopathic pulmonary fibrosis has become an important outcome measure in clinical trials. This study aimed to explore the concept of suspected acute exacerbation as an outcome measure.Methods: Three investigators retrospectively reviewed subjects enrolled in the Sildenafil Trial of Exercise Performance in IPF who experienced a respiratory serious adverse event during the course of the study. Events were classified as definite acute exacerbation, suspected acute exacerbation, or other, according to established criteria.Results: Thirty-five events were identified. Four were classified as definite acute exacerbation, fourteen as suspected acute exacerbation, and seventeen as other. Definite and suspected acute exacerbations were clinically indistinguishable. Both were most common in the winter and spring months and were associated with a high risk of disease progression and short-term mortality.Conclusions: In this study one half of respiratory serious adverse events were attributed to definite or suspected acute exacerbations. Suspected acute exacerbations are clinically indistinguishable from definite acute exacerbations and represent clinically meaningful events. Clinical trialists should consider capturing both definite and suspected acute exacerbations as outcome measures. © 2013 Collard et al.; licensee BioMed Central Ltd

Suspected acute exacerbation of idiopathic pulmonary fibrosis as an outcome measure in clinical trials

Background: Acute exacerbation of idiopathic pulmonary fibrosis has become an important outcome measure in clinical trials. This study aimed to explore the concept of suspected acute exacerbation as an outcome measure.Methods: Three investigators retrospectively reviewed subjects enrolled in the Sildenafil Trial of Exercise Performance in IPF who experienced a respiratory serious adverse event during the course of the study. Events were classified as definite acute exacerbation, suspected acute exacerbation, or other, according to established criteria.Results: Thirty-five events were identified. Four were classified as definite acute exacerbation, fourteen as suspected acute exacerbation, and seventeen as other. Definite and suspected acute exacerbations were clinically indistinguishable. Both were most common in the winter and spring months and were associated with a high risk of disease progression and short-term mortality.Conclusions: In this study one half of respiratory serious adverse events were attributed to definite or suspected acute exacerbations. Suspected acute exacerbations are clinically indistinguishable from definite acute exacerbations and represent clinically meaningful events. Clinical trialists should consider capturing both definite and suspected acute exacerbations as outcome measures. © 2013 Collard et al.; licensee BioMed Central Ltd