scholarly journals Safety and Outcomes of Linezolid Use for Nocardiosis

2020 ◽  
Vol 7 (4) ◽  
Author(s):  
Natalie Davidson ◽  
Matthew J Grigg ◽  
Sarah L Mcguinness ◽  
Robert J Baird ◽  
Nicholas M Anstey
Keyword(s):  
Adverse Events ◽  
Hospital Setting ◽  
Drug Susceptibility ◽  
Therapeutic Drug ◽  
Primary Analysis ◽  
Safety And Efficacy ◽  
Treatment Regimens ◽  
Linezolid Therapy ◽  
Tropical Australia ◽  
Clinically Significant

Abstract Background Tropical Australia has a high incidence of nocardiosis, with high rates of intrinsic antimicrobial resistance. Linezolid, the only antimicrobial to which all local Nocardia species are susceptible, has been recommended in empirical combination treatment regimens for moderate–severe Nocardia infections at Royal Darwin Hospital (RDH) since 2014. We report the safety and efficacy of linezolid use for nocardiosis in this setting. Methods We identified cases through a retrospective review of all RDH Nocardia isolates from December 2014 to August 2018 and included 5 linezolid-treated cases from a previous cohort. Laboratory, demographic, and clinical data were included in the primary analysis of safety and treatment outcomes. Results Between 2014 and 2018, Nocardia was isolated from 35 individuals; 28 (80%) had clinically significant infection and 23 (82%) received treatment. All isolates were linezolid-susceptible. Safety and efficacy were assessed for 20 patients receiving linezolid-containing regimens and 8 receiving nonlinezolid regimens. Median linezolid induction therapy duration was 28 days. Common adverse effects in those receiving linezolid were thrombocytopenia (45%) and anemia (40%). Adverse events prompted discontinuation of trimethoprim-sulfamethoxazole more often than linezolid (40% vs 20%). Linezolid therapeutic drug monitoring was used in 1 patient, with successful dose reduction and outcome. There was no difference in 30-day survival between those treated with linezolid (90%) vs no linezolid (87%). One Nocardia-attributed death occurred during linezolid therapy. Conclusions Linezolid is safe and efficacious in empirical treatment for moderate to severe nocardiosis in a monitored hospital setting, with 100% drug susceptibility and no difference in adverse events or outcomes compared with nonlinezolid regimens.

scholarly journals Safety and efficacy of restarting immune checkpoint inhibitors after clinically significant immune-related adverse events in metastatic renal cell carcinoma

2020 ◽  
Vol 8 (1) ◽  
pp. e000144 ◽  
Author(s):  
Sarah Abou Alaiwi ◽  
Wanling Xie ◽  
Amin H Nassar ◽  
Shaan Dudani ◽  
Dylan Martini ◽  
...  
Keyword(s):  
Renal Cell Carcinoma ◽  
Adverse Events ◽  
Cell Carcinoma ◽  
Median Time ◽  
Immune Checkpoint ◽  
Renal Cell ◽  
Immune Checkpoint Inhibitors ◽  
Checkpoint Inhibitors ◽  
Safety And Efficacy ◽  
Clinically Significant

BackgroundImmune checkpoint inhibitors (ICI) induce a range of immune-related adverse events (irAEs) with various degrees of severity. While clinical experience with ICI retreatment following clinically significant irAEs is growing, the safety and efficacy are not yet well characterized.MethodsThis multicenter retrospective study identified patients with metastatic renal cell carcinoma treated with ICI who had >1 week therapy interruption for irAEs. Patients were classified into retreatment and discontinuation cohorts based on whether or not they resumed an ICI. Toxicity and clinical outcomes were assessed descriptively.ResultsOf 499 patients treated with ICIs, 80 developed irAEs warranting treatment interruption; 36 (45%) of whom were restarted on an ICI and 44 (55%) who permanently discontinued. Median time to initial irAE was similar between the retreatment and discontinuation cohorts (2.8 vs 2.7 months, p=0.59). The type and grade of irAEs were balanced across the cohorts; however, fewer retreatment patients required corticosteroids (55.6% vs 84.1%, p=0.007) and hospitalizations (33.3% vs 65.9%, p=0.007) for irAE management compared with discontinuation patients. Median treatment holiday before reinitiation was 0.9 months (0.2–31.6). After retreatment, 50% (n=18/36) experienced subsequent irAEs (12 new, 6 recurrent) with 7 (19%) grade 3 events and 13 drug interruptions. Median time to irAE recurrence after retreatment was 2.8 months (range: 0.3–13.8). Retreatment resulted in 6 (23.1%) additional responses in 26 patients whose disease had not previously responded. From first ICI initiation, median time to next therapy was 14.2 months (95% CI 8.2 to 18.9) and 9.0 months (5.3 to 25.8), and 2-year overall survival was 76% (95%CI 55% to 88%) and 66% (48% to 79%) in the retreatment and discontinuation groups, respectively.ConclusionsDespite a considerable rate of irAE recurrence with retreatment after a prior clinically significant irAE, most irAEs were low grade and controllable. Prospective studies are warranted to confirm that retreatment enhances survival outcomes that justify the safety risks.

Safety and efficacy of chidamide in combination with decitabine plus anti-PD-1 camrelizumab after relapse or progression on decitabine-plus-camrelizumab in classical Hodgkin lymphoma.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e19515-e19515
Author(s):  
Chunmeng Wang ◽  
Jing Nie ◽  
Yang Liu ◽  
Qingming Yang ◽  
Weidong Han
Keyword(s):  
Adverse Events ◽  
Hodgkin Lymphoma ◽  
Objective Response Rate ◽  
Response Rate ◽  
Objective Response ◽  
Complete Response ◽  
Classical Hodgkin Lymphoma ◽  
Primary Resistance ◽  
Safety And Efficacy ◽  
Treatment Regimens

e19515 Background: The anti-PD-1 combination therapy significantly improves clinical outcomes in patients with relapsed/refractory classical Hodgkin lymphoma (cHL), and up to 71% of patients who receive decitabine-plus-anti-PD-1 camrelizumab could achieve a complete response. However, a subset of patients is recalcitrant to decitabine-plus-camrelizumab and half of patients might experience disease progression within three years. Effective treatment regimens for those with relapsed or progressive cHL who failed decitabine-plus-camrelizumab are needed. This Phase II study was designed to assess the safety and efficacy of the combination of decitabine-plus-camrelizumab and chidamide, a histone deacetylase inhibitor, in decitabine-plus-camrelizumab resistant cHL patients. Methods: Patients with relapsed/refractory cHL who had primary resistance or progressed/relapsed on decitabine-plus-camrelizumab were enrolled and administrated with chidamide at 10 mg (days 1 to 4) and 20 mg (days 8, 11,15 and 18); plus decitabine at 10 mg (days 1 to 5); and camrelizumab at 200 mg (day 6), every 3 weeks. Safety was assessed by CTCAEv5.0, and antitumor response by PET-CT according to the revised Lugano classification. The primary endpoint was objective response rate. Recruitment is ongoing. This trial is registered with ClinicalTrial.gov number, NCT04233294. Results: Between January 19, 2020, and January 31, 2021, nineteen patients with relapsed/refractory cHL after relapse or progression on decitabine-plus-camrelizumab were enrolled. A median of 20 cycles of prior decitabine-plus-camrelizumab was given (range, 4-28). Fourteen patients completed response evaluation with a median follow-up of 5.7 months. All eligible patients received this triplet-agent regimen with a median of 8 cycles (range, 3 to 12). Thirteen of the fourteen evaluated patients (93%) had an objective response, including six acquiring a complete remission (43%) and seven reaching a partial response (50%). The most common adverse events were leukocytopenia (58%; grade 3: 16%), nausea (53%) and hypertriglyceridemia (26%). No immune-related adverse events were observed. Conclusions: The preliminary result shows a high objective response rate with the combination of chidamide, decitabine and camrelizumab in patients with resistance to decitabine-plus-camrelizumab therapy. The addition of chidamide to decitabine-plus-camrelizumab has an acceptable safety profile, and does not trigger immune-related adverse events. Clinical trial information: NCT04233294.

scholarly journals Safety and Efficacy of Switching Injected Peptide Long-Acting Somatostatin Receptor Ligands to Once Daily Oral Paltusotine: ACROBAT Edge Phase 2 Study

2021 ◽  
Vol 5 (Supplement_1) ◽  
pp. A526-A527
Author(s):  
Monica R Gadelha ◽  
Murray B Gordon ◽  
Mirjana Doknic ◽  
Emese Mezősi ◽  
Miklós Tóth ◽  
...  
Keyword(s):  
Adverse Events ◽  
Treatment Period ◽  
Somatostatin Receptor ◽  
Study Drug ◽  
Receptor Ligands ◽  
Primary Analysis ◽  
Once Daily ◽  
Safety And Efficacy ◽  
Somatostatin Receptor Ligands ◽  
Long Acting

Abstract Patients with acromegaly not cured by surgery are often initially treated with injected peptide long-acting somatostatin receptor ligands (SRLs). Non-peptide small molecules can also activate the somatostatin receptor and do so with a high degree of precision for the target therapeutic receptor subtype. Paltusotine (formerly CRN00808) is a small molecule somatostatin type 2 (SST2) receptor agonist with high oral bioavailability (70%) and pharmacokinetic profile suitable for once daily dosing. In healthy volunteers, paltusotine has been shown to lower growth hormone (GH) and insulin-like growth factor-1 (IGF-1) levels. We hypothesized that patients with acromegaly could switch from injected SRLs to once daily oral paltusotine while maintaining baseline IGF-1 levels. ACROBAT Edge (NCT03789656) was a single-arm study designed to evaluate the safety and efficacy of switching from injected SRLs to paltusotine in patients with acromegaly. The primary analysis population consisted of those who had not achieved normal IGF-1 levels despite stable therapy with long-acting octreotide or lanreotide. Eligible patients received their last injection of SRL 4 weeks prior to switching to once daily oral paltusotine monotherapy for a 13-week treatment period. The starting dose of 10 mg per day was uptitrated in 10 mg increments at specified study visits to a maximal dose of 40 mg per day based on protocol specified study drug toleration and IGF-1 criteria. The primary endpoint was change in IGF-1 from baseline to the completion of the 13-week treatment period. Statistical testing was based on non-parametric Wilcoxon Sign Rank test of whether the median change is different from zero. In addition, the rise in IGF-1 during a 4-week washout period was used to provide supportive evidence of efficacy. Twenty-five patients were enrolled in the primary analysis group, three patients discontinued from the study for non-study drug related reasons, two during the treatment period and one during the washout period after completing treatment. The primary endpoint was achieved as paltusotine treatment resulted in no significant change in IGF-1 levels at week 13 compared to baseline [change in IGF-1 =-0.034 (-0.107, 0.107), median (IQR), p>0.6]. Of the 23 patients who completed the dosing period, 20 (87%) achieved IGF-1 levels at the end of treatment that were within 20% of baseline or lower. Median IGF-1 values rose significantly after paltusotine washout (p<0.0001). The most common treatment-emergent adverse events (>10%) included: headache, arthralgia, fatigue, peripheral swelling, paresthesia and hyperhidrosis. There were no discontinuations due to adverse events and no treatment related serious adverse events. These results suggest that patients with acromegaly treated with injected SRLs can switch to oral paltusotine while maintaining IGF-1 and that paltusotine appeared to be well tolerated.

Treatment of Toenail Onychomycosis with Oral Terbinafine Plus Aggressive Debridement

2006 ◽  
Vol 96 (6) ◽  
pp. 465-473 ◽  
Author(s):  
Maureen B. Jennings ◽  
Richard Pollak ◽  
Lawrence B. Harkless ◽  
Farid Kianifard ◽  
Amir Tavakkol
Keyword(s):  
Adverse Events ◽  
Marked Improvement ◽  
Clinical Cure ◽  
Liver Transaminase ◽  
Safety And Efficacy ◽  
Time Points ◽  
Clinically Significant ◽  
Aggressive Debridement ◽  
Cure Rates ◽  
Oral Terbinafine

This study was conducted to investigate the efficacy of oral terbinafine with and without aggressive debridement for the treatment of toenail onychomycosis. Onychomycosis patients aged 18 to 75 years received 12 weeks of terbinafine, 250 mg/day, alone (n = 255) or with aggressive debridement (n = 249). Both groups showed marked improvement from baseline at all time points. At week 48, complete, mycologic, and clinical cure rates were higher in the terbinafine plus debridement group compared with the terbinafine alone group, although significance was reached only for clinical cure (59.8% versus 51.4%; P = .023). Although approximately 39% of the patients received at least one antidiabetic, antihypertensive, or cholesterol-lowering agent concomitantly, including statins, the incidence of treatment-emergent adverse events was low and the adverse events were generally mild to moderate in severity. No clinically significant changes in liver transaminase levels were observed 6 weeks after treatment or after 12 weeks in those tested. These results support the well-established safety and efficacy of terbinafine for treatment of onychomycosis. (J Am Podiatr Med Assoc 96(6): 465–473, 2006)

scholarly journals Prospective exploratory study to assess the safety and efficacy of aflibercept in cystoid macular oedema associated with retinitis pigmentosa

2020 ◽  
pp. bjophthalmol-2019-315152
Author(s):  
Stacey A Strong ◽  
Tunde Peto ◽  
Catey Bunce ◽  
Wen Xing ◽  
Michalis Georgiou ◽  
...  
Keyword(s):  
Adverse Events ◽  
Retinitis Pigmentosa ◽  
Macular Oedema ◽  
Exploratory Study ◽  
Cystoid Macular Oedema ◽  
Open Label ◽  
Safety And Efficacy ◽  
Intravitreal Aflibercept ◽  
Clinically Significant

AimsTo report the safety and efficacy of intravitreal aflibercept (Eylea) (ivA) for retinitis pigmentosa-associated cystoid macular oedema (RP-CMO) at 12 months via mean central macular thickness (CMT) and reported adverse events.MethodsA prospective, exploratory, phase II, non-randomised, single-centre, open-label, 1-arm clinical trial involving 30 eyes of 30 patients. Serial ivA was given via loading dose (three injections) followed by treat and extend protocol over 12 months.ResultsTwenty-nine out of 30 (96.7%) patients completed 12 months of follow-up. A total of four to 11 injections per patient were given over the 12 month study. No statistically significant reduction of CMT or visual acuity (VA) improvement was demonstrated in the group overall. Eleven out of 29 (37.9%) participants were considered as ‘responders’, demonstrating at least an 11% reduction of CMT at 12 months on spectral domain optical coherence tomography compared with baseline. A reduction of CMT by mean (SD) 28.1% (12.9 %) was observed in responders at 12 months, however, no statistically significant corresponding improvement in best corrected VA was seen. Baseline characteristics were similar between responder and non-responder groups. No clinically significant adverse events were deemed secondary to ivA.ConclusionThis first prospective exploratory study demonstrates both the safety and acceptability of serial ivA in patients with RP-CMO, effective at reducing CMT in 37.9% of patients. All patients demonstrating anatomical response did so after their first injection. Longer duration of CMO did not negatively affect response to anti-VEGF. Further study in a larger cohort of patients with shorter CMO duration would be valuable to better establish the utility of VEGF blockade in RP-CMO.Trial registration numbersEudraCT (2015-003723-65); ClinicalTrials.gov (NCT02661711).

scholarly journals Exploring patient safety outcomes for people with learning disabilities in acute hospital settings: a scoping review

BMJ Open ◽  
2021 ◽  
Vol 11 (5) ◽  
pp. e047102
Author(s):  
Gemma Louch ◽  
Abigail Albutt ◽  
Joanna Harlow-Trigg ◽  
Sally Moore ◽  
Kate Smyth ◽  
...  
Keyword(s):  
Learning Disabilities ◽  
Patient Safety ◽  
Adverse Events ◽  
Grey Literature ◽  
Good Practice ◽  
Hospital Setting ◽  
Eligibility Criteria ◽  
Infant Outcomes ◽  
Safety Outcomes

ObjectivesTo produce a narrative synthesis of published academic and grey literature focusing on patient safety outcomes for people with learning disabilities in an acute hospital setting.DesignScoping review with narrative synthesis.MethodsThe review followed the six stages of the Arksey and O’Malley framework. We searched four research databases from January 2000 to March 2021, in addition to handsearching and backwards searching using terms relating to our eligibility criteria—patient safety and adverse events, learning disability and hospital setting. Following stakeholder input, we searched grey literature databases and specific websites of known organisations until March 2020. Potentially relevant articles and grey literature materials were screened against the eligibility criteria. Findings were extracted and collated in data charting forms.Results45 academic articles and 33 grey literature materials were included, and we organised the findings around six concepts: (1) adverse events, patient safety and quality of care; (2) maternal and infant outcomes; (3) postoperative outcomes; (4) role of family and carers; (5) understanding needs in hospital and (6) supporting initiatives, recommendations and good practice examples. The findings suggest inequalities and inequities for a range of specific patient safety outcomes including adverse events, quality of care, maternal and infant outcomes and postoperative outcomes, in addition to potential protective factors, such as the roles of family and carers and the extent to which health professionals are able to understand the needs of people with learning disabilities.ConclusionPeople with learning disabilities appear to experience poorer patient safety outcomes in hospital. The involvement of family and carers, and understanding and effectively meeting the needs of people with learning disabilities may play a protective role. Promising interventions and examples of good practice exist, however many of these have not been implemented consistently and warrant further robust evaluation.

scholarly journals Cardiovascular safety and efficacy of metformin-SGLT2i versus metformin-sulfonylureas in type 2 diabetes: systematic review and meta-analysis of randomized controlled trials

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Desye Gebrie ◽  
Desalegn Getnet ◽  
Tsegahun Manyazewal
Keyword(s):  
Blood Pressure ◽  
Type 2 Diabetes ◽  
Combination Therapy ◽  
Adverse Events ◽  
Meta Analysis ◽  
Controlled Trials ◽  
Safety And Efficacy ◽  
Randomized Controlled ◽  
Sodium Glucose Cotransporter

AbstractDiabetes is a serious threat to global health and among the top 10 causes of death, with nearly half a billion people living with it worldwide. Treating patients with diabetes tend to become more challenging due to the progressive nature of the disease. The role and benefits of combination therapies for the management of type 2 diabetes are well-documented, while the comparative safety and efficacy among the different combination options have not been elucidated. We aimed to systematically synthesize the evidence on the comparative cardiovascular safety and efficacy of combination therapy with metformin-sodium-glucose cotransporter-2 inhibitors versus metformin-sulfonylureas in patients with type 2 diabetes. We searched MEDLINE-PubMed, Embase, Cochrane Library, and ClinicalTrials.gov up to 15 August 2019 without restriction in the year of publication. We included randomized controlled trials of patients with type 2 diabetes who were on metformin-sodium-glucose cotransporter-2 inhibitors or metformin-sulphonylureas combination therapy at least for a year. The primary endpoints were all-cause mortality and serious adverse events, and the secondary endpoints were cardiovascular mortality, non-fatal myocardial infarction, non-fatal stroke, hypoglycemia, and changes in glycated hemoglobin A1c (HbA1c), body weight, fasting plasma glucose, blood pressure, high-density lipoprotein cholesterol, and low-density lipoprotein cholesterol. We used a random-effects meta-analysis model to estimate mean differences for continuous outcomes and risk ratio for dichotomous outcomes. We followed PICOS description model for defining eligibility and the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA-P) 2015 guidelines for reporting results. Of 3,190 citations, we included nine trials involving 10,974 participants. The pooled analysis showed no significant difference in all-cause mortality (risk ration [RR] = 0.93, 95% CI [0.52, 1.67]), serious adverse events (RR = 0.96, 95% CI [0.79, 1.17]) and adverse events (RR = 1.00, 95% CI [0.99, 1.02]) between the two, but in hypoglycemia (RR = 0.13, 95% CI [0.10, 0.17], P < 0.001). Participants taking metformin-sodium glucose cotransporter-2 inhibitors showed a significantly greater reduction in HbA1c (mean difference [MD] = − 0.10%, 95% CI [− 0.17, − 0.03], body weight (MD = − 4.57 kg, 95% CI [− 4.74, − 4.39], systolic blood pressure (MD = − 4.77 mmHg, 95% CI [− 5.39, − 4.16]), diastolic blood pressure (MD = − 2.07 mmHg, 95% CI [− 2.74, − 1.40], and fasting plasma glucose (MD = − 0.55 mmol/L, 95% CI [− 0.69, − 0.41]), p < 0.001. Combination therapy of metformin and sodium-glucose cotransporter-2 inhibitors is a safe and efficacious alternative to combination therapy of metformin and sulphonylureas for patients with type 2 diabetes who are at risk of cardiovascular comorbidity. However, there remains a need for additional long-term randomized controlled trials as available studies are very limited and heterogeneous.

scholarly journals Safety and efficacy of directly acting antivirals (sofosbuvir and daclatasvir) in treatment of chronic HCV in HIV-HCV co-infected Egyptian patients

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Inas E L-Khedr Mohamed ◽  
Kadry Mohamed EL-Saeed ◽  
Mahmoud Hassan Al-Sadik ◽  
Christina Alphonse Anwar
Keyword(s):  
Complete Blood Count ◽  
Virologic Response ◽  
Safety And Efficacy ◽  
Treatment Regimens ◽  
End Of Treatment ◽  
Increased Risk ◽  
Significant Difference ◽  
Egyptian Patients ◽  
Infected Adult ◽  
Chronic Hcv

Abstract Background Cure of chronic hepatitis C (HCV) in HIV/HCV co-infected patients is a priority due to their increased risk of complications. Daclatasvir and sofosbuvir treatment regimens with or without ribavirin are considered an important chance for better HCV treatment in patients with HIV/HCV co-infection. This study aimed at the assessment of safety and efficacy of sofosbuvir-daclatasvir treatment regimens in HIV/HCV co-infected Egyptian patients. Results Thirty HIV/HCV co-infected adult patients were included. All patients completed the study duration without major problems or drug interactions, HCV PCR was negative for all patients at the end of treatment, yet 12 weeks after ending treatment, only one patient (3.33%) had HCV relapse. Liver enzymes showed a significant decrease by the end of treatment and 12 weeks after end of treatment in comparison with their values before treatment (P-value = 0.0001). CD4 counts as well showed significant increase. There was non-significant change in serum albumin, total bilirubin, alfa fetoprotein, complete blood count (CBC), coagulation profile, random blood sugar, or serum creatinine. Ultrasonographic findings did not show significant difference. Conclusion Combination of daclatasvir and sofosbuvir have showed 96.67% sustained virologic response at 12 weeks after treatment (SVR 12) among HIV/HCV co-infected patients, with a good safety profile. Moreover, the treated patients showed a significant increase in CD4 lymphocytic count.

scholarly journals Low-dose amikacin in the treatment of Multidrug-resistant Tuberculosis (MDR-TB)

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Natasha F. Sabur ◽  
Mantaj S. Brar ◽  
Lisa Wu ◽  
Sarah K. Brode
Keyword(s):  
Hearing Loss ◽  
Adverse Events ◽  
Low Dose ◽  
Multidrug Resistant ◽  
Significant Rise ◽  
World Health ◽  
Therapeutic Drug ◽  
Successful Treatment Outcome ◽  
Mdr Tb ◽  
Health Organization

Abstract Background The World Health Organization recommends intravenous amikacin for the treatment of MDR-TB at a dose of 15 mg/kg. However, higher doses are associated with significant toxicity. Methods Patients with MDR-TB treated at our institution receive amikacin at 8–10 mg/kg, with dose adjustment based on therapeutic drug monitoring. We conducted a retrospective cohort study of patients with MDR-TB who received amikacin between 2010 and 2016. Results Forty-nine patients were included in the study. The median starting dose of amikacin was 8.9 mg/kg (IQR 8, 10), and target therapeutic drug levels were achieved at a median of 12 days (IQR 5, 26). The median duration of amikacin treatment was 7.2 months (IQR 5.7, 8), and median time to sputum culture conversion was 1 month (IQR 1,2). Six patients (12.2%) experienced hearing loss based on formal audiometry testing (95% CI 4.6–24.8%); 22.2% had subjective hearing loss (95% CI 11.2–37.1%) and 31.9% subjective tinnitus (95% CI 19.1–47.1%). Ten patients (23%) had a significant rise in serum creatinine (95% CI 11.8–38.6%), but only 5 patients had a GFR < 60 at treatment completion. 84% of patients had a successful treatment outcome (95% CI 84–99%). Conclusions Low dose amikacin is associated with relatively low rates of aminoglycoside-related adverse events. We hypothesize that low-dose amikacin can be used as a safe and effective treatment for MDR-TB in situations where an adequate regimen cannot be constructed with Group A and B drugs, and where careful monitoring for adverse events is feasible.

scholarly journals Scale of adverse events associated to nursing practices: a psychometric study in Portuguese hospital context

2018 ◽  
Vol 26 ◽  
Author(s):  
Teresa Neves ◽  
Vitor Rodrigues ◽  
João Graveto ◽  
Pedro Parreira
Keyword(s):  
Adverse Events ◽  
Public Hospital ◽  
Hospital Setting ◽  
Cross Sectional Study ◽  
Cross Sectional ◽  
Stable Factor ◽  
Hospital Units ◽  
Northern Regions ◽  
Structural Invariance ◽  
The Stability

Objective to contribute to the validation study of the Scale of Adverse Events associated with Nursing Practices in the hospital context. Method cross-sectional study, in public hospital units, in the central and northern regions of Portugal. The exploratory factor analysis of the Scale of Adverse Events associated to Nursing Practices was conducted with a sample of 165 nurses and the confirmatory factorial analysis was made with a sample of 685 nurses. Reliability, internal consistency and construct validity were estimated. The invariance of the model was evaluated in two subsamples to confirm the stability of the factorial solution. Results the global sample consisted of 850 nurses aged between 22 and 59, mostly licensed professionals. The model had a good overall fit in the subscales (Nursing Practices: χ2/df = 2.88, CFI = 0.90, GFI = 0.86, RMSEA = 0.05, MECVI = 3.30; Adverse Events: χ2/df = 4.62, CFI = 0.93, GFI = 0.95, RMSEA = 0.07, MECVI = 0.39). There was a stable factor structure, indicating strong invariance in the subscale Nursing Practices and structural invariance in the subscale Adverse Events. Conclusion the refined model of the Scale of Adverse Events associated with Nursing Practices revealed good fit and stability of the factorial solution. The instrument was adjusted to evaluate the perception of nurses about adverse events associated with health care, precisely nursing care, in the hospital setting.

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