Indwelling pleural catheter is useful for palliative management of recurrent malignant pleural effusion in that it benefits Quality of Life in outpatients with advanced malignancies. In lung cancer patients, scores indicated that indwelling pleural catheter also provides significant relief of dyspnea.
Three different assays for fïbrin/fibrinogen degradation products (FDP) were evaluated in patients with suspected pulmonary embolism (PE) as rapid screening tests with the aim of evaluating whether they could be used either as a substitute of ventilation/perfusion lung scanning or to supplement scintigraphy in patients in whom the scan was inconclusive (low or intermediate probability). D-Dimer by enzyme-linked immunosorbent assay (ELISA) and latex and total FDP by ELISA were measured prospectively in 85 consecutive patients with suspected PE. With a cutoff of 500 ng/ml, D-dimer by ELISA presented a 96% sensitivity and a 42% specificity, with positive and negative predictive values of 49 and 96%, respectively. D-Dimer by latex, also with a cutoff of 500 ng/ml showed a 93% sensitivity and 29% specificity, with positive and negative predictive values of 43 and 89%. For total FDP, with a cutoff of 900 ng/ml, the sensitivity and specificity were 96 and 26% respectively, with positive and negative predictive values of 42 and 93%. A normal assay may have reduced the necessity of a ventilation/perfusion only in 28% patients with D-dimer ELISA, 21% with D-dimer latex and 17% with total FDP ELISA and with a possible error of 4, 11 and 7%, respectively. Conclusions: (1) a D-dimer by ELISA < 500 ng/ml or total FDP by ELISA < 900 ng/ml excludes the diagnosis of PE, and no more studies are needed; (2) a D-dimer by ELISA > 500 ng/ml or total FDP by ELISA > 900 ng/ml does not exclude other diagnostic procedures, and (3) more extensive studies are needed to clarify the utility of D-dimer by latex.
Objectives
Our aim was to assess the value of nintedanib for non-idiopathic progressive fibrosing interstitial lung disease (non-IPF PF-ILD) and systemic sclerosis-associated ILD (SSc-ILD) in the Spanish context, using a multi-criteria decision analysis (MCDA).
Methods
Following an adaptation of the Evidence and Value: Impact on DEcision Making (EVIDEM) MCDA methodology, the estimated value of nintedanib was obtained by means of an additive linear model that combined individual weights (100-points distribution) of criteria with the individual scoring of nintedanib in each criterion for every indication, assigned by a multidisciplinary committee of twelve clinicians, patients, pharmacists, and decision-makers. To assess the reproducibility, an alternative weighting method was applied, as well as a re-test of weights and scores at a different moment of time.
Results
The experts committee recognized nintedanib as an intervention with a positive value contribution in comparison to placebo for the treatment of non-IPF PF-ILD (0.50 ± 0.16, on a scale from −1 to 1) and SSc-ILD (0.40 ± 0.12), diseases which were considered as very severe and with high unmet needs. The drug was perceived as a treatment that provides an added therapeutic benefit for patients (0.06–0.07), given its proven clinical efficacy (0.05–0.06), slight improvements in patient-reported outcomes (0.01–0.02), and similar safety profile than placebo (−0.04–0.00), which will likely be positioned as a recommended therapy in the next clinical practice guidelines updates.
Conclusions
Under this increasingly used methodology, nintedanib has shown to provide a positive value estimate for non-IPF PF-ILD and SSc-ILD when compared to placebo in Spain.
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