Clinical and Resource Utilization Patterns in Patients with Refractory Neuropathic Pain Prescribed Pregabalin for the First Time in Routine Medical Practice in Primary Care Settings in Spain

Abstract Context and Objective. To describe clinical and resource utilization patterns in patients with refractory neuropathic pain (NeP) who were prescribed pregabalin for the first time in routine medical practice in primary care settings. Methods. Post-hoc analysis of a 12-week prospective observational study including pregabalin naïve adult patients with refractory chronic NeP of at least 6-months duration. Self-reported pain intensity, disability, sleep disturbances, symptoms of anxiety and depression, disability, health-related quality of life (HRQoL), health care resource utilization, and corresponding costs were assessed in this post-hoc analysis. Results. One thousand three hundred fifty-four patients were enrolled in the study, and three treatment groups were identified: 1) 598 patients replaced prior pain treatments with pregabalin as monotherapy; 2) 589 added pregabalin to their existing pain treatments; and 3) 167 other pain treatments were prescribed according with physician routine medical practice. Statistically significant differences were reported at baseline for intensity of pain, patient disability, severity of depressive symptoms, and HRQoL (P < 0.01 in all cases). No statistically significant differences were reported among the three treatment groups for anxiety bs_bs_banner Pain Medicine 2013; 14: 1954-1963 1954 severity or sleep disturbances. Subjects who received add-on pregabalin had greater use of direct and indirect resources vs the other groups, resulting in significantly higher quarterly overall costs per patient: €2,397 (2,308), €2,470 (1,857), and €3,110 (2,496), respectively (P < 0.001). Conclusion. These findings suggest that primary care physicians chose pregabalin as an option for treating refractory patients who tended to have much more severe NeP profiles, costing society more than when they chose other therapeutic strategies not including pregabalin

Analgesic efficacy of zoledronic acid and its effect on functional status of prostate cancer patients with metastasis

Objectives: A multi-centered observational study evaluated the efficacy of zoledronic acid for improving pain and mobility, and preventing skeletal-related events (SRE) (fracture, spinal compression, pain-relieving radiotherapy), in patients with prostate cancer and bone metastasis. Materials and Methods: Males (n = 218) with prostate cancer and bone metastasis undergoing oncologic therapy received zoledronic acid (4 mg iv/month) for 6 months. Parameters evaluated were: 1) pain and movement after 2 consecutive doses; 2) quality of life; 3) SRE incidence and time-to-appearance. Medication tolerance and treatment satisfaction were assessed using a questionnaire. Results: A total of 170 that matched all the inclusion criteria (78%) out of 218 were evaluable for efficacy. There was a measurable statistically significant reduction in pain at rest and on movement as well as an improvement in the quality of life compared with baseline. Best results were obtained with early treatment. Overall incidence of bone events was 11.2%. Of the 212 patients (97.2%) evaluable for safety, 16% suffered adverse events and 66% expressed satisfaction with the treatment Discussion: Zoledronic acid is effective for reducing pain, improving mobility, and increasing the quality of life in patients with prostate cancer with bone metastasis. Its easy administration and good tolerability make zoledronic acid one of the principal therapeutic tools in the management of patients with pain associated with bone metastasis from prostate cancer.Ye

First Metatarsophalangeal Arthrodesis Fixation with an Intramedullary System

Category: Midfoot/Forefoot Introduction/Purpose: Artrhrodesis is a commonly and successfully used procedure to deal with advanced hallux rigidus, severe hallux valgus, inflammatory and posttraumatic arthritis and as a salvage of previous failed surgeries. Many different techniques, in terms of joint preparation and fixation constructs, have been reported. The purpose of this study is to evaluate our short time results with an intramedullary device to perform the first metatarsophalangeal (MTP) arthrodesis. Methods: A descriptive observational study with prospective follow-up was developed. We included 21 arthrodesis using an Intramedullary Fusion Device, which consists in a 6.5 mm intramedullary metatarsal implant and a hooked 4.0 mm lag screw. The indications were hallux rigidus grade 4 in 10 cases, severe hallux valgus in 7, two patients with hallux varus and two cases of salvage surgery of a previous Keller Brandes. Clinical outcomes were assessed with American College of Foot and Ankle Surgeons (ACFAS) scoring scale preoperatively and at the time of the radiological fusion. The degree of satisfaction of patients was also evaluated using the Coughlin and Mann scale. Results: Fusion was achieved at five to twelve weeks in 19 patients. The grade of satisfaction was excellent and good in 18 patients. In two cases, implant breakage occurred. ACFAS score improved 40 points respect to preoperative status. No complications related to infection were reported. Conclusion: Dorsal plate fixation augmented with plantar lag screw fixation is nowadays the reference technique to perform first MTP arthrodesis, nevertheless titanium staples and crossed screws have also reported good results. In these constructs, sometimes is necessary a second surgery to remove some disturbing material. An intramedullary device would avoid the soft tissue irritation due to the underlying material and seems reliable to provide a strong fixation to achieve early MTP fusion with good short-term evolution

Association between convalescent plasma treatment and mortality in COVID-19: a collaborative systematic review and meta-analysis of randomized clinical trials

Abstract Background Convalescent plasma has been widely used to treat COVID-19 and is under investigation in numerous randomized clinical trials, but results are publicly available only for a small number of trials. The objective of this study was to assess the benefits of convalescent plasma treatment compared to placebo or no treatment and all-cause mortality in patients with COVID-19, using data from all available randomized clinical trials, including unpublished and ongoing trials (Open Science Framework, https://doi.org/10.17605/OSF.IO/GEHFX ). Methods In this collaborative systematic review and meta-analysis, clinical trial registries (ClinicalTrials.gov, WHO International Clinical Trials Registry Platform), the Cochrane COVID-19 register, the LOVE database, and PubMed were searched until April 8, 2021. Investigators of trials registered by March 1, 2021, without published results were contacted via email. Eligible were ongoing, discontinued and completed randomized clinical trials that compared convalescent plasma with placebo or no treatment in COVID-19 patients, regardless of setting or treatment schedule. Aggregated mortality data were extracted from publications or provided by investigators of unpublished trials and combined using the Hartung–Knapp–Sidik–Jonkman random effects model. We investigated the contribution of unpublished trials to the overall evidence. Results A total of 16,477 patients were included in 33 trials (20 unpublished with 3190 patients, 13 published with 13,287 patients). 32 trials enrolled only hospitalized patients (including 3 with only intensive care unit patients). Risk of bias was low for 29/33 trials. Of 8495 patients who received convalescent plasma, 1997 died (23%), and of 7982 control patients, 1952 died (24%). The combined risk ratio for all-cause mortality was 0.97 (95% confidence interval: 0.92; 1.02) with between-study heterogeneity not beyond chance (I2 = 0%). The RECOVERY trial had 69.8% and the unpublished evidence 25.3% of the weight in the meta-analysis. Conclusions Convalescent plasma treatment of patients with COVID-19 did not reduce all-cause mortality. These results provide strong evidence that convalescent plasma treatment for patients with COVID-19 should not be used outside of randomized trials. Evidence synthesis from collaborations among trial investigators can inform both evidence generation and evidence application in patient care

Association between convalescent plasma treatment and mortality in COVID-19: a collaborative systematic review and meta-analysis of randomized clinical trials

Abstract Background Convalescent plasma has been widely used to treat COVID-19 and is under investigation in numerous randomized clinical trials, but results are publicly available only for a small number of trials. The objective of this study was to assess the benefits of convalescent plasma treatment compared to placebo or no treatment and all-cause mortality in patients with COVID-19, using data from all available randomized clinical trials, including unpublished and ongoing trials (Open Science Framework, https://doi.org/10.17605/OSF.IO/GEHFX ). Methods In this collaborative systematic review and meta-analysis, clinical trial registries (ClinicalTrials.gov, WHO International Clinical Trials Registry Platform), the Cochrane COVID-19 register, the LOVE database, and PubMed were searched until April 8, 2021. Investigators of trials registered by March 1, 2021, without published results were contacted via email. Eligible were ongoing, discontinued and completed randomized clinical trials that compared convalescent plasma with placebo or no treatment in COVID-19 patients, regardless of setting or treatment schedule. Aggregated mortality data were extracted from publications or provided by investigators of unpublished trials and combined using the Hartung–Knapp–Sidik–Jonkman random effects model. We investigated the contribution of unpublished trials to the overall evidence. Results A total of 16,477 patients were included in 33 trials (20 unpublished with 3190 patients, 13 published with 13,287 patients). 32 trials enrolled only hospitalized patients (including 3 with only intensive care unit patients). Risk of bias was low for 29/33 trials. Of 8495 patients who received convalescent plasma, 1997 died (23%), and of 7982 control patients, 1952 died (24%). The combined risk ratio for all-cause mortality was 0.97 (95% confidence interval: 0.92; 1.02) with between-study heterogeneity not beyond chance (I2 = 0%). The RECOVERY trial had 69.8% and the unpublished evidence 25.3% of the weight in the meta-analysis. Conclusions Convalescent plasma treatment of patients with COVID-19 did not reduce all-cause mortality. These results provide strong evidence that convalescent plasma treatment for patients with COVID-19 should not be used outside of randomized trials. Evidence synthesis from collaborations among trial investigators can inform both evidence generation and evidence application in patient care