Nevin Manimala

Nurs Open. 2021 Jul 11. doi: 10.1002/nop2.985. Online ahead of print.

ABSTRACT

AIMS: To develop a competency scale for operating room nurses and test its reliability and validity.

BACKGROUND: The existing Chinese Registered Nurse Competency Scale and the core competency scale for operating room nurses developed abroad cannot fully meet the capacity needs of Chinese operating room nurses.

METHODS: The scale was developed based on the results of qualitative interview and the Delphi method. Ten experts were selected for expert consultation, and 300 operating room nurses were recruited by convenience sampling for a cross-sectional survey to test the reliability and validity of instrument.The reliability and validity of the scale was assessed based on internal consistency reliability, test-retest reliability and confirmatory factor analysis. Data collection was conducted between March to July, 2015.

RESULTS: An initial scale with 42 items was confirmed, and 36 items remained. The internal consistency Cronbach’s α was 0.97 for the overall scale and 0.88-0.94 for the subscales. The retest reliability ranged from 0.55-0.96. Five factors were extracted by exploratory factor analysis, and they explained 66% of the total variance. The fitting indices of the confirmatory factor analysis were as follows: χ2/df = 3.47, CFI = 0.83, TLI = 0.81, SRMR = 0.06 and RMSEA = 0.09.

CONCLUSIONS: The core competency scale for operating room nurses with 5 components and 36 items had acceptable reliability and validity. The scale could continue to be optimized in the future.

PMID:34247455 | DOI:10.1002/nop2.985

Health Expect. 2021 Jul 10. doi: 10.1111/hex.13306. Online ahead of print.

ABSTRACT

BACKGROUND: Patient participation is essential for achieving high-quality care and positive outcomes, especially among patients with multimorbidity, which is a major challenge for health care due to high prevalence, care complexity and impact on patients’ lives.

OBJECTIVE: To explore the patient participation related to their own care among patients with multimorbidity in primary health-care settings.

METHODS: A cross-sectional survey was conducted among adult multimorbid patients who visited primary health-care facilities. The key instrument used was the Participation in Rehabilitation Questionnaire. Data representing 125 patients were analysed using various statistical methods.

RESULTS: The respondents generally felt patient participation to be important, yet provided highly varying accounts regarding the extent to which it was realized by professionals. Information and knowledge and Respect and encouragement were considered the most important and best implemented subcategories of participation. Several patient-related factors had a statistically significant effect on patient perceptions of participation for all subcategories and as explanatory factors for perceptions of total participation in univariate models. Most patients reported active participation in health-care communication, positively associated with patient activation and adherence. Gender, perceived health, patient activation and active participation were explanatory factors for total importance of participation in multivariate models, while patient activation was retained for realization of participation.

CONCLUSIONS: Multimorbid patients require individualized care that promotes participation and active communication; this approach may further improve patient activation and adherence. Poor perceived health and functional ability seemed to be related to worse perceptions of participation.

PATIENT AND PUBLIC INVOLVEMENT: The study topic importance was based on the patients’ experiences in author’s previous research and the need to develop patient-centred care.

PMID:34247439 | DOI:10.1111/hex.13306

Helicobacter. 2021 Jul 10:e12830. doi: 10.1111/hel.12830. Online ahead of print.

ABSTRACT

BACKGROUND: Vonoprazan fumarate is a novel potassium-competitive acid blocker more effective in suppressing acid production than proton pump inhibitors (PPIs) and when combined with antibiotics has been used to eradicate Helicobacter pylori (H. pylori) infection. However, it has not yet been examined in an Australian setting. This study aimed to report on the efficacy and safety of vonoprazan-containing antibiotic combination therapies in the eradication of H. pylori.

METHODS: A single-center, exploratory, clinical review of patients 18 years or over, positive for H. pylori on Urea Breath Test (UBT), and/or histopathology who underwent a 10-day treatment of combination antibiotics plus vonoprazan between January 2017 and September 2019 was conducted. Eleven different combinations of antibiotics that included 2-5 different antibiotics predominantly amoxicillin, rifabutin, levofloxacin, furazolidone, nitazoxanide, and tetracycline were included. The eradication success was based on negative UBT results and/or histopathology results after the treatment. Descriptive statistics were summarized.

RESULTS: One hundred and fifty-three patients (Female n = 74, 48%) with a positive for H. pylori were treated with vonoprazan-containing antibiotic combination therapy during the study period. Of the 153 patients, 48 (31%) had previously failed a PPI-based H. pylori treatment. Follow-up was available for 66/153 (43%) patients. In those who completed follow-up, overall eradication was achieved in 97% (64/66) of patients. In the subgroup of patients treated for the first time, eradication was achieved in 100% (44/44). In those who had failed prior, non-vonoprazan-containing treatment, eradication was achieved in 91% (20/22) of patients.

CONCLUSIONS: Vonoprazan-containing antibiotic therapy is an effective H. pylori eradication treatment. It is capable of achieving 100% efficacy in patients treated for the first time and even 91% efficacy in patients with previous eradication failure. Subsequent studies utilizing a factorial design will be needed to optimize each regimen as most regimens contained more than two antibiotics.

PMID:34247436 | DOI:10.1111/hel.12830

Andrologia. 2021 Jul 11:e14180. doi: 10.1111/and.14180. Online ahead of print.

ABSTRACT

Our study objective was to assess the effect of various sperm DNA fragmentation levels on clinical intracytoplasmic sperm injection outcome. This retrospective study included 392 patients who underwent ICSI and performed sperm DNA fragmentation testing before the procedure. Based on sperm DNA fragmentation cut-off values, the patients were differentiated into 3 groups as <20%, 20%-30% and >30%. According to the female status, patients were differentiated into favourable group (n = 259) with female age <35 years and anti-Mullerian hormone level ≥7.1 pmol/L; and unfavourable group (n = 133) with female age ≥35 years and anti-Mullerian hormone level ≤7.1 pmol/L. The patient’s medical records were reviewed, and patient’s demographic, laboratory data including semen analysis, sperm DNA fragmentation determined by means of sperm chromatin dispersion, hormonal profile and data regarding intracytoplasmic sperm injection cycle were collected. This cohort reported that the clinical reproductive outcomes of intracytoplasmic sperm injection showed no statistical significance with increase sperm DNA fragmentation levels. In sperm DNA fragmentation above 30%, favourable females had significantly higher clinical pregnancy rate and live birth rate than unfavourable females, while fertilisation rate and miscarriage rate showed no significance between the subgroups. High sperm DNA fragmentation is linked to poor semen parameters.

PMID:34247427 | DOI:10.1111/and.14180

Andrologia. 2021 Jul 11:e14188. doi: 10.1111/and.14188. Online ahead of print.

ABSTRACT

In this study, we aimed to elucidate the relationship between AZF deletion type and clinical information of azoospermic patients with AZF microdeletion in the Turkish population. Azoospermic patients with normal karyotype and AZF microdeletion were analysed retrospectively by collecting clinical data including hormone profile, demographic characteristics and micro-TESE results. As a result of the AZF microdeletion tests of 42 cases with 46 XY karyotype, AZFa deletion was detected in 3 cases, AZFb deletion in 2 cases, AZFc deletion in 31 cases, AZFb + AZFc deletion in 4 cases and AZFa + AZFb + AZFc deletion in 2 cases respectively. Spermatozoon was obtained in 16 cases with AZFc microdeletion with micro-TESE. Pregnancy was achieved in 2 cases. There was no statistically significant difference between the type of deletion and age, height, weight, body mass index, hormone profile and testicular volume. When AZF is evaluated according to the type of microdeletion, it will be appropriate to plan the medical and surgical options more carefully in a multidisciplinary manner in cases with deletions including AZFa, AZFb or their combinations. Also, genotype-phenotype correlation was found to be consistent with the literature; particularly patients having AZFc deletions were found to have a chance for pregnancy.

PMID:34247421 | DOI:10.1111/and.14188

Biom J. 2021 Jul 11. doi: 10.1002/bimj.202000269. Online ahead of print.

ABSTRACT

Motivated by a clinical trial conducted by Janssen Pharmaceutica in which a flexible dosing regimen is compared to placebo, we evaluate how switchers in the treatment arm (i.e., patients who were switched to the higher dose) would have fared had they been kept on the low dose. This is done in order to understand whether flexible dosing is potentially beneficial for them. Simply comparing these patients’ responses with those of patients who stayed on the low dose does not likely entail a satisfactory evaluation because the latter patients are usually in a better health condition. Because the available information in the considered trial is too limited to enable a reliable adjustment, we will instead transport data from a fixed dosing trial that has been conducted concurrently on the same target, albeit not in an identical patient population. In particular, we propose an estimator that relies on an outcome model, a model for switching, and a propensity score model for the association between study and patient characteristics. The proposed estimator is asymptotically unbiased if either the outcome or the propensity score model is correctly specified, and efficient (under the semiparametric model where the randomization probabilities are known and independent of baseline covariates) when all models are correctly specified. The proposed method for transporting information from an external study is more broadly applicable in studies where a classical confounding adjustment is not possible due to near positivity violation (e.g., studies where switching takes place in a (near) deterministic manner). Monte Carlo simulations and application to the motivating study demonstrate adequate performance.

PMID:34247409 | DOI:10.1002/bimj.202000269

Biom J. 2021 Jul 11. doi: 10.1002/bimj.202100019. Online ahead of print.

ABSTRACT

Cluster randomized trials evaluate the effect of a treatment on persons nested within clusters, with clusters being randomly assigned to treatment. The optimal sample size at the cluster and person level depends on the study cost per cluster and per person, and the outcome variance at the cluster and the person level. The variances are unknown in the design stage and can differ between treatment arms. As a solution, this paper presents a Maximin design that maximizes the minimum relative efficiency (relative to the optimal design) over the variance parameter space, for trials with two treatment arms and a quantitative outcome. This maximin relative efficiency design (MMRED) is compared with a published Maximin design which maximizes the minimum efficiency (MMED). Both designs are also compared with the optimal designs for homogeneous costs and variances (balanced design) and heterogeneous costs and homogeneous variances (cost-conscious design), for a range of variances based upon three published trials. Whereas the MMED is balanced under high uncertainty about the treatment-to-control variance ratio, the MMRED then tends towards a balanced budget allocation between arms, leading to an unbalanced sample size allocation if costs are heterogeneous, similar to the cost-conscious design. Further, the MMRED corresponds to an optimal design for an intraclass correlation (ICC) in the lower half of the assumed ICC range (optimistic), whereas the MMED is the optimal design for the maximum ICC within the ICC range (pessimistic). Attention is given to the effect of the Welch-Satterthwaite degrees of freedom for treatment effect testing on the design efficiencies.

PMID:34247406 | DOI:10.1002/bimj.202100019

Zhonghua Yi Xue Yi Chuan Xue Za Zhi. 2021 Jul 10;38(7):681-685. doi: 10.3760/cma.j.cn511374-20200430-00318.

ABSTRACT

OBJECTIVE: To assess the association of polymorphisms of receptor of advanced glycation end products (RAGE) gene, monocyte to high-density lipoprotein cholesterol ratio (MHR) and variability of heart rate among patients with coronary heart disease (CHD).

METHODS: 120 patients with CHD and 120 healthy individuals were respectively selected as the observation group and the control group. Allelic and genotypic differences of -429T>C, 1704G>T, 82G>S, MHR ratio and heart rate variability between the two groups and patients with different severity were analyzed. The correlation between their genotypes and MHR ratio and heart rate variability was analyzed.

RESULTS: The 82G>S polymorphism of the RAGE gene and the allelic difference between the two groups and patients with different severity were statistically significant (P< 0.05). Compared with the control group and patients with mild to moderate phenotype, monocyte, total cholesterol, triglyceride, low density lipoprotein, MHR, low frequency in the observation group and patients with severe symptoms were significantly higher, while their high density lipoprotein, standard deviation of NN intervals (SDNN), standard deviation average of NN intervals (SDANN), root mean square successive differences, percentage of differences exceeding 50ms between adjacent normal number of intervals (PMN50), high frequency (HF) were significantly lower. The gene frequencies of G-Gly-T, T-Gly-T, G-Ser-T and G-Gly-C were correlated with SDNN, SDANN, rMSSD, PMN50, HF and MHR, but negatively correlated with low frequency.

CONCLUSION: Polymorphisms of the RAGE gene in patients with coronary heart disease are associated with the MHR ratio and heart rate variability, which can be used as markers for the diagnosis and efficacy evaluation.

PMID:34247378 | DOI:10.3760/cma.j.cn511374-20200430-00318

Ann Surg Oncol. 2021 Jul 10. doi: 10.1245/s10434-021-10441-z. Online ahead of print.

ABSTRACT

BACKGROUND: Management of axillary lymph nodes in breast cancer has undergone significant change over the past decade through landmark clinical trials. This study aimed to assess national practice patterns in axillary management in patients undergoing upfront mastectomy and examines what guides provider recommendations.

METHODS: A national case-based survey study was performed of surgeons and radiation oncologists from July to August 2020. Surgeons were identified through the American Society of Breast Surgeons (ASBrS) after review and approval by the ASBrS Research Committee, and radiation oncologists were identified through an institutional database. Both descriptive and comparative statistical analyses were performed.

RESULTS: Overall, 994 providers responded-680 surgeons and 314 radiation oncologists. Surgeons were older and in practice longer (p < 0.05) and treated a higher percentage of breast patients (81% vs. 40%, p < 0.001). Most surgeons were hospital-employed (43%), whereas most radiation oncologists were in private practice (40%; p < 0.001). Fifty-two percent of surgeons routinely send sentinel lymph nodes (SLNs) for frozen section (52%) during mastectomy, of which 78% proceed directly to axillary lymph node dissection (ALND) if positive. There was significant variability in treatment recommendations between the two groups among the hypothetical cases (p < 0.001). In the setting of low disease burden in the SLNs, > 30% of surgeons recommended ALND, while radiation oncologists recommend axillary radiotherapy over axillary clearance (p < 0.001).

CONCLUSION: There is significant heterogeneity in the management of the axilla in mastectomy patients with pathologically positive SLNs, both between and among surgeons and radiation oncologists. Efforts should be made to assist both groups in identifying de-escalation opportunities to ensure that mastectomy patients with positive SLNs are treated appropriately.

PMID:34247336 | DOI:10.1245/s10434-021-10441-z

Curr HIV/AIDS Rep. 2021 Jul 11. doi: 10.1007/s11904-021-00567-w. Online ahead of print.

ABSTRACT

PURPOSE OF REVIEW: To provide the current state of the development and application of cardiovascular disease (CVD) prediction tools in people living with HIV (PLWH).

RECENT FINDINGS: Several risk prediction models developed on the general population are available to predict CVD risk, the most notable being the US-based pooled cohort equations (PCE), the Framingham risk functions, and the Europe-based SCORE (Systematic COronary Risk Evaluation). In validation studies in cohorts of PLWH, these models generally underestimate CVD risk, especially in individuals who are younger, women, Black race, or predicted to be at low/intermediate risk. An HIV-specific CVD prediction model, the Data Collection on Adverse Events of Anti-HIV Drugs (D:A:D) model, is available, but its performance is modest, especially in US-based cohorts. Enhancing CVD prediction with novel biomarkers of inflammation or coronary artery calcification is of interest but has not yet been evaluated in PLWH. Finally, studies on CVD risk prediction are lacking in diverse PLWH globally. While available risk models for CVD prediction in PLWH remain suboptimal, clinicians should remain vigilant of higher CVD risk in this population and should use any of these risk scores for risk stratification to guide preventive interventions. Focus on established traditional risk factors such as smoking remains critical in PLWH. Risk prediction functions tailored to PLWH in diverse settings will enhance clinicians’ ability to deliver optimal preventive care.

PMID:34247329 | DOI:10.1007/s11904-021-00567-w