Establishing an evaluation index system of nursing quality for clinical drug trials: A Delphi study.

AIMS: To construct a quality evaluation index system for clinical drug trials nursing management and obtain the weight of all indicators. DESIGN: A mixed-method research design with a quantitative component was used, primarily qualitative. METHODS: Through a literature review and semi-structured interview, an expert consultation questionnaire on the quality of nursing evaluation indicators for clinical drug trials was developed in April 2021. Eighteen experts in clinical drug trial nursing, medical, and pharmacy conducted 2 rounds of consultation according to the Delphi method to determine the indicators for evaluating the quality of clinical drug trial nursing. The weights of each indicator were determined using analytic hierarchical analysis. RESULTS: The established quality evaluation system of clinical drug trial nursing mainly includes 3 first-level indicators, 12 second-level indicators, and 59 third-level indicators. The positive coefficients of the two rounds of expert consultation were 90%-100%, and the authority coefficients were 0.831 and 0.885, respectively; the coordination coefficients were 0.189 and 0.214, respectively. The consulting results and weight settings are reliable. The evaluation index system we constructed is in line with the characteristics of the clinical drug trial nursing profession, with clear index levels and strong clinical operability, which can provide a reference for the assessment, monitoring and improvement of nursing quality in clinical drug trials. It will also clarify how nurses contribute to subjects' safety.

Genomic analysis of Lactococcus garvieae isolates.

Lactococcus garvieae is a well-known fish pathogen, and in recent years, a human pathogen of increasing clinical significance. However, not much is known about the variances in characteristics of strains isolated locally and overseas. This study aims at conducting comparative genomic analysis on local and overseas L. garvieae isolates, to further understand the phylogenetic and virulence variances between the two groups. The genomic DNA of 11 local L. garvieae isolates (fish 6, human 5) were sequenced, annotated and typed using multi-locus sequence typing (MLST). A total of six novel sequence types (STs) were found in the local isolates. Genotypic overlapping of the STs was observed between local fish and human isolates with overseas fish, food and human clinical isolates. Thereby, suggesting a possible transmission between fish or food and humans. Virulence genes (putative internalin and putative mucus adhesin) were found to be specific to genomic clusters (GC), GC2 and GC3. A higher incidence of resistance genes was also observed in local isolates (n=8, 72.72%) when compared to the overseas isolates (n=7, 41.18%). This study represents the first evidence of genetic variances amongst local and overseas isolates, and virulence characteristics specific to the phylogeny of L. garvieae.

The efficacy and safety of selective COX-2 inhibitors for postoperative pain management in patients after total knee/hip arthroplasty: a meta-analysis.

BACKGROUND: Many selective cyclooxygenase (COX-2) inhibitors are currently used in clinical practice. COX-2 inhibitors have good anti-inflammatory, analgesic, antipyretic effects, and gastrointestinal safety. However, the analgesic effects and adverse reactions of COX-2 after total knee/hip arthroplasty (TKA/THA) are not fully known. OBJECTIVE: To evaluate the efficacy and safety of selective COX-2 inhibitors in postoperative pain management in patients receiving TKA/THA. METHODS: Randomized controlled trials (RCTs) were retrieved from medical literature databases. Risk ratios (RR) Std mean difference (SMD) and 95% confidence intervals (CI) were calculated to analyze the primary and safety endpoints. RESULTS: In total, 18 articles (23 trial comparisons) were retrieved comprising 3104 patients. Among them, 1910 patients (61.5%) were randomized to the experimental group whereas 1194 patients (38.5%) were randomized to the control group. The primary endpoints were the patients' VAS score at rest or on ambulation (within 3 days). We found that VAS score in patients that received selective COX-2 inhibitor was significantly lower compared to those of the control group. CONCLUSION: This meta-analysis shows that selective COX-2 inhibitor therapy is effective, safe, and reliable in relieving postoperative pain of THA/TKA.

The efficacy of regular penis-root masturbation, versus Kegel exercise in the treatment of primary premature ejaculation: A quasi-randomised controlled trial.

To explore the efficacy of regular penis-root masturbation (PRM) versus Kegel exercise (KE) in the treatment of primary premature ejaculation (PPE). This study was a prospective quasi-randomised controlled trial. Thirty-seven heterosexual males with PPE were selected according to the time sequence of outpatient consultations and the preliminary results of a pre-experiment and were assigned to an PRM group and a KE group. Differences in intravaginal ejaculatory latency times (IELTs) and premature ejaculation diagnostic tool (PEDT) scores were compared between the two groups. The study was approved by the Ethics Committee of the First Affiliated Hospital of Guangxi Medical University. Among the 37 PPE patients, 18 performed PRM and 19 patients performed KE. The IELTs of patients who performed PRM and KE were significantly prolonged before treatment, and the difference after treatment was statistically significant (p < .05). Compared with the KE group, the IELT prolongation effect in the PRM group was more significant PRM (p < .05). The PEDT scores of patients after performing PRM and KE were significantly lower than those before performing these exercises (p < .05). Compared with the KE group, the PEDT scores of the PRM group exhibited a greater decrease (p < .05). Thus, both PRM and KE have therapeutic effects on PPE. Compared with KE, PRM is more effective in the treatment of PPE.

Rivaroxaban versus Aspirin in Prevention of Venous Thromboembolism: A Meta-Analysis of 9 Randomized Controlled Trials comprising 7,656 Patients.

AIM: This article evaluates the preventive effects of rivaroxaban versus aspirin on venous thromboembolism (VTE) through meta-analysis of recent randomized controlled trials (RCTs). METHODS: RCTs were retrieved from medical literature databases. Risk ratios (RRs) and 95% confidence intervals (CIs) were calculated to compare the primary and safety endpoints. RESULTS: In total, 9 trials (11 trial comparisons) were retrieved which contained 7,656 patients. Among these patients, 4,383 patients (57.2%) received rivaroxaban, whereas 3,273 patients (42.8%) received aspirin. Compared with aspirin, rivaroxaban significantly reduced VTE (1.3% vs. 3.5%) (RR: 0.36, 95% CI, 0.26-0.48, I 2 = 27.9%), but significantly increased nonmajor bleeding (11.5% vs. 7.5%) (RR: 1.28, 95% CI, 1.13-1.44, I 2 = 38.6%). There were no significant differences in the all-cause mortality (0.3% vs. 0.3%) (RR: 0.75, 95% CI, 0.35-1.61, I 2 = 32.0%) and major bleeding (0.3% vs. 0.4%) (RR: 0.81, 95% CI, 0.42-1.55, I 2 = 33.7%) between the two groups. CONCLUSION: This meta-analysis indicated that rivaroxaban can significantly reduce the incidence of VTE when compared with aspirin. The preventive effect of rivaroxaban on VTE was more potent than that of aspirin. However, rivaroxaban had some negative side effects to patients such as nonmajor bleeding compared to aspirin.

Effect of Alprostadil on the Prevention of Contrast-Induced Nephropathy: A Meta-Analysis of 36 Randomized Controlled Trials.

Contrast-induced nephropathy (CIN) is the third leading cause of acquired acute renal injury in hospitalized patients. Alprostadil plays a role in the maintenance and redistribution of intrarenal blood flow and the excretion of electrolytes and water. However, the effectiveness of alprostadil in preventing CIN remains controversial. Thirty-six articles with a total of 5495 patients were included in this study. Both groups (experimental group and control group) received standard hydration therapy. In the experimental group, patients received different doses of alprostadil. Serum creatinine (SCr), blood urea nitrogen (BUN), estimated glomerular filtration rate (eGFR), cystatin C, creatinine clearance rate (CCr), and ß2-microglobulin (ß2-MG) were measured at 24, 48, and 72 hours after contrast media injection. The incidence of CIN in the experimental group was significantly lower than that in the control group (6.56% vs 16.74%). The level of SCr, cystatin C, BUN, and ß2-MG in the experimental group was lower than those in the control group; CCr and eGFR in the experimental group were higher than those in the control group. This study demonstrated that alprostadil may reduce the incidence of CIN in patients undergoing coronary angiogram and/or percutaneous coronary intervention.