Terms Of Outcome Parameters Research Articles

The effect of biofeedback on smoking cessation-asystematic short review.

PurposeThe aim of this systematic review was to focus on the effect of biofeedback on smoking cessation.Material and methodsThis review was conducted following the PRISMA guidelines. Peer-reviewed original articles including biofeedback and/or neurofeedback training as an intervention for smoking cessation were included. The PubMed, MEDLINE, Web of Science, Scopus, and Cochrane Library databases were screened for trials published up to July 2021. The effects on smoking rates and smoking behavior, and biofeedback/neurofeedback training measures are summarized here.ResultsIn total, three articles fulfilled the inclusion criteria. The total Downs and Black checklist scores ranged from 11 to 23 points, showing that the articles were of poor to good methodological quality. The included studies were heterogeneous, both in terms of treatment protocols and in terms of outcome parameters. Pooling of data for a meta-analysis was not possible. Therefore, we were limited to describing the included studies. The included biofeedback study demonstrated that skin temperature training might improve the patients’ ability to raise their skin temperature aiming at stress alleviation. All three studies reported positive effects of biofeedback/neurofeedback in supporting smokers to quit. Furthermore, individualized electroencephalography neurofeedback training showed promising results in one study in modulating craving-related responses.ConclusionThe results of the present review suggest that biofeedback/neurofeedback training might facilitate smoking cessation by changing behavioral outcomes. Although the investigated studies contained heterogeneous methodologies, they showed interesting approaches that could be further investigated and elaborated. To improve the scientific evidence, prospective randomized controlled trials are needed to investigate biofeedback/neurofeedback in clinical settings for smoking cessation.

Systematic Literature Review and Meta-Analysis of Sacral Neuromodulation (SNM) in Patients with Neurogenic Lower Urinary Tract Dysfunction (nLUTD): Over 20Years' Experience and Future Directions.

IntroductionSacral neuromodulation (SNM) has been used in carefully selected patients with neurogenic lower urinary tract dysfunctions (nLUTD) for over two decades.MethodsThe aim of the current work was to perform a systematic literature review and meta-analysis of studies reporting the safety and effectiveness of SNM in patients with nLUTD (neurogenic detrusor overactivity, non-obstructive urinary retention, or a combination of both). For this purpose a systematic literature research was conducted using Embase (OvidSP), MEDLINE (OvidSP), MEDLINE In-Process Citations & Daily Update (OvidSP), MEDLINE (OvidSP) e-Pub ahead of print, Cochrane Central Register of Controlled Trials (CENTRAL), NIH Clinicaltrials.gov, and WHO International Clinical Trials Registry Platform (ICTRP) between 1998 and March 2020, supplemented by a hand search.ResultsForty-seven studies were included in the systematic literature review. Twenty-one studies comprising a total of 887 patients were included in the meta-analysis of test SNM. The pooled success rate of SNM test stimulation was 66.2% (95% CI 56.9–74.4). Depending on neurogenic conditions test success rates varied greatly. Twenty-four studies with a total of 428 patients were included in the meta-analysis of permanent SNM. The success rate of pooled permanent SNM was 84.2% (95% CI 77.8–89.0). Among the identified studies, the most common adverse events (AEs) were loss of effectiveness, infection, pain at implant site, and lead migration with AE rates of 4.7%, 3.6%, 3.2%, and 3.2%, respectively. Limitations entail lower level of evidence (Oxford classification 3–4) of included studies, significant risk of bias, small sample sizes in some studies, the inclusion of retrospective case series, substantial between-study heterogeneity, heterogeneous patient populations, insufficient disease classification, and variations in terms of outcome parameters as well as techniques. Furthermore, long-term data are limited.ConclusionThis meta-analysis supports not only the benefits of permanent SNM for various nLUTDs but also high overall success rates, similar to idiopathic patients. Current data of the analyzed studies showed that SNM is safe for these patients. However, more vigorous studies and/or registries are needed before definitive conclusions can be drawn.Supplementary InformationThe online version contains supplementary material available at 10.1007/s12325-021-01650-9.

Large Animal Models of Meniscus Repair and Regeneration: A Systematic Review of the State of the Field.

Injury to the meniscus is common, but few viable strategies exist for its repair or regeneration. To address this, animal models have been developed to translate new treatment strategies toward the clinic. However, there is not yet a regulatory document guiding such studies. The purpose of this study was to carry out a systematic review of the literature on meniscus treatment methods and outcomes to define the state of the field. Public databases were queried by using search terms related to animal models and meniscus injury and/or repair over the years 1980-2015. Identified peer-reviewed manuscripts were screened by using Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. One of nine reviewers read each manuscript and scored them based on whether the publication described a series of predefined study descriptors and outcome measures. Additional data were extracted to identify common assays used. A total of 128 full-length peer-reviewed manuscripts were identified. The number of publications increased over the time frame analyzed, with 48% focused on augmented repair. Rabbit was, by far, the most prevalent species utilized (46%), with dog (21%) and sheep (20%) being the next most common. Analysis of study descriptors revealed that most studies appropriately documented details of the animal used, the surgical approach, and defect and implant characteristics (e.g., 63% of studies identified clearly the defect size). In terms of outcome parameters, most studies carried out macroscopic (85%), histologic (90%), and healing/integration (83%) analyses of the meniscus. However, many studies did not provide further analysis beyond these fundamental measures, and less than 40% reported on the adjacent cartilage and synovium, as well as joint function. There is intense interest in the field of meniscus repair. However, given the current lack of guidance documentation in this area, preclinical animal models are not performed in a standardized fashion. The development of a "Best Practices" document would increase reproducibility and external validity of experiments, while accelerating advancements in translational research. Advancement is of paramount importance given the high prevalence of meniscal injuries and the paucity of effective repair or regenerative strategies.

Pseudomonas aeruginosa Bacteremia After Burn Injury

To evaluate the clinical impact of multiple-drug resistance in burn patients with Pseudomonas aeruginosa (Pa) bacteremia. A retrospective cohort study in a 10-bed burn intensive care unit (BICU) was performed. Univariate and multivariate analyses were used to analyze the influence of multiple-drug resistance on mortality and length of BICU stay in Pa bacteremic patients. During a 21-year study period (1989-2009), 87 patients with Pa bacteremia were identified; 45 patients had multiple-drug resistant (MDR) strains and 42 susceptible strains. On comparison of the two populations, one with multiple-drug resistant strains and the other with the susceptible strains, the following parameters were found to be significantly different in the univariate analysis: age (32.7 vs 43.6 years; P = .013), sex (males: 91.1 vs 66.7%; P = .005), intubation status on admission (75.6 vs. 54.8%; P = .041), escharotomy (57.8 vs 33.3%; P = .022), burn size (51.0 vs 35.3% of TBSA; P = .002) and Abbreviated Burn Severity Index score (9.2 vs 8.1; P = .048). In terms of outcome parameters, multiple-drug resistance was not significantly related to mortality (adjusted odds ratio 1.076; 95% confidence interval [CI] 0.356-3.254; P = .897) and length of BICU stay after Pa bacteremia (Kaplan-Meier analysis log-rank test P = .945; Cox's proportional hazards regression hazards ratio, 0.994; 95% CI 0.513-1.925; P = .985) in the univariate and multivariate analyses. The data from this study suggest that multiple-drug resistance is not associated with significant increases in mortality and length of BICU stay among burn patients with Pa bacteremia.

Surgical synovectomy combined with yttrium 90 in patients with recurrent joint synovitis

Radiation synovectomy (RS) is one of many therapeutic options used for recurrent joint synovitis. Our aim was to analyze the effect of the surgical synovectomy combined with yttrium 90 ((90)Y) in the treatment for recurrent joint synovitis. A surgical combined RS procedure was used on 32 knees of 30 patients. They were divided into two groups. Group 1 consisted of 7 knees of 7 patients (5 women and 2 men) with a mean age of 40.7 years in whom RS was combined with the open synovectomy. Group 2 consisted of 25 knees of 23 patients (21 men and 2 women) with a mean age of 45.5 years in whom RS was combined with the arthroscopic synovectomy. Arthroscopic synovectomy or open surgery biopsy was carried out for all cases who diagnosed of having synovitis. A scintigraphic examination was conducted within 24 h after the RS procedure to investigate the systemic leakage of (90)Y in all patients. The outcome of treatment was assessed based on self-reporting using the visual analogue scale (VAS) of night pain, rest pain, activity pain, effusion, and satisfactory scores. The average follow-up period was 4.15 years. There was a significant difference between before and after treatment in terms of outcome parameters' VAS scores in both groups (p < 0.05). But there was no statistically significant difference between open and arthroscopic synovectomy groups in terms of outcome parameters (p > 0.05). Satisfactory outcome was excellent in 3 patients (42.8 %) in group 1 and 8 patients (32 %) in group 2. Surgical synovectomy with combined (90)Y could treat recurrent joint synovitis successfully. There was no statistically significant difference between open and arthroscopic synovectomy techniques combined with RS procedure.

Activity and safety of CPBev regimen (cisplatinum, pemetrexed, and bevacizumab) as first-line therapy for locally advanced or metastatic adenocarcinoma of the lung: Final results of a phase II study.

e18026 Background: During the past five years the paradigms of advanced lung cancer therapy dramatically changed; Bevacizumab and Pemetrexed, when administered separately in association with platinum salts, demonstrated to improve survival in patients with non-squamous histologies. In the aim to investigate activity and safety of a three-drugs-regimen containing both these agents and cis-platinum, we conducted a multi-institutional phase II study started on november 2007. Methods: chemonaive patients with non-squamous non-small cell lung cancer were considered eligible We adopt the two-stage of Simon model as statistical design of the study; activity of the regime, expressed as overall response rate and safety were the main end-points. Administered doses were 75 and 500 mg/p.s.m for cis-platinum and pemetrexed respectively and 7.5 mg./kg for Bevacizumab, for 3 - 6 cycles. G-CSF were administered only after the first cycle of therapy, whereas vitamin supplementation started from day 1 of the first cycle. No maintenance therapy was allowed. Results: We registered 9 partial responses among the first 15 patients treated so, accordingly with the design of the study, we completed the enrollment up to 32 patients. Patients characteristics are: male/female: 20/12, median age (years): 59 (r. 36 - 77), ECOG-WHO/PS 0/1: 21/11. One hundred eighty-three cycles of CPBev were administered: we registered only 13 cases of grade 3 adverse events. No grade 4 toxicities were observed. One case of allergic reaction to cis-platinum were observed. In terms of response rate, we registered 20/32 (62.5%) partial responses, 8/32 (25%) stable diseases and 4/32 (12.5%) progressive diseases, with a clinical benefit rate of 28/32 (87.5%). Results in terms of outcome parameters expressed by progression-free and overall survival will be presented at the meeting. Conclusions: On the basis of our data, CPBev have a good toxicity profile and seems to be extremely active in advanced non-squamous lung carcinomas.