Categories
Nevin Manimala Statistics

Implementation of a multicomponent family support intervention in adult intensive care units: study protocol for an embedded mixed-methods multiple case study (FICUS implementation study)

BMJ Open. 2023 Aug 8;13(8):e074142. doi: 10.1136/bmjopen-2023-074142.

ABSTRACT

BACKGROUND: The implementation of complex interventions is considered challenging, particularly in multi-site clinical trials and dynamic clinical settings. This study protocol is part of the family intensive care units (FICUS) hybrid effectiveness-implementation study. It aims to understand the integration of a multicomponent family support intervention in the real-world context of adult intensive care units (ICUs). Specifically, the study will assess implementation processes and outcomes of the study intervention, including fidelity, and will enable explanation of the clinical effectiveness outcomes of the trial.

METHODS AND ANALYSIS: This mixed-methods multiple case study is guided by two implementation theories, the Normalisation Process Theory and the Consolidated Framework for Implementation Research. Participants are key clinical partners and healthcare professionals of eight ICUs allocated to the intervention group of the FICUS trial in the German-speaking part of Switzerland. Data will be collected at four timepoints over the 18-month active implementation and delivery phase using qualitative (small group interviews, observation, focus group interviews) and quantitative data collection methods (surveys, logs). Descriptive statistics and parametric and non-parametric tests will be used according to data distribution to analyse within and between cluster differences, similarities and factors associated with fidelity and the level of integration over time. Qualitative data will be analysed using a pragmatic rapid analysis approach and content analysis.

ETHICS AND DISSEMINATION: Ethics approval was obtained from the Cantonal Ethics Committee of Zurich BASEC ID 2021-02300 (8 February 2022). Study findings will provide insights into implementation and its contribution to intervention outcomes, enabling understanding of the usefulness of applied implementation strategies and highlighting main barriers that need to be addressed for scaling the intervention to other healthcare contexts. Findings will be disseminated in peer-reviewed journals and conferences.

PROTOCOL REGISTRATION NUMBER: Open science framework (OSF) https://osf.io/8t2ud Registered on 21 December 2022.

PMID:37553195 | DOI:10.1136/bmjopen-2023-074142

Categories
Nevin Manimala Statistics

Systematic review of the relationship between burn-out and spiritual health in doctors

BMJ Open. 2023 Aug 8;13(8):e068402. doi: 10.1136/bmjopen-2022-068402.

ABSTRACT

OBJECTIVE: To investigate the relationship between burn-out and spiritual health among medical doctors.

DESIGN: Systematic literature review and narrative synthesis of cross-sectional studies.

SETTING: Any setting, worldwide.

DATA SOURCES: Five databases were searched from inception to March 2022, including Medline, Embase, PsycINFO, Scopus and Web of Science.

ELIGIBILITY CRITERIA: Any study design that involved medical doctors (and other healthcare staff if assessed alongside medical doctors), that measured (in any way) both burn-out (or similar) and spiritual health (or similar) medical doctors.

DATA EXTRACTION AND SYNTHESIS: All records were double screened. Data extraction was performed by one reviewer and a proportion (10%) checked by a second reviewer. Quality was assessed using the Appraisal of Cross-sectional Studies tool. Due to the heterogeneity of the included studies, a narrative review was undertaken without a meta-analysis.

RESULTS: Searches yielded 1049 studies. 40 studies met eligibility criteria and were included in this review. Low reported levels of spirituality were associated with high burn-out scores and vice versa. Religion was not significantly associated with lower levels of burn-out. Few studies reported statistically significant findings, few used validated spiritual scores and most were vulnerable to sampling bias.

CONCLUSIONS: Published research suggests that burn-out is linked to spiritual health in medical doctors but not to religion. Robust research is needed to confirm these findings and develop effective interventions.

PROSPERO REGISTRATION NUMBER: CRD42020200145.

PMID:37553194 | DOI:10.1136/bmjopen-2022-068402

Categories
Nevin Manimala Statistics

Validity and Reliability Evidence of the Munro Scale for Perioperative Patients Part I: Correlation, Multiple Regression, and Reliability

J Nurs Meas. 2023 Aug 8:JNM-2022-0051.R1. doi: 10.1891/JNM-2022-0051. Online ahead of print.

ABSTRACT

Background and Purpose: Patients undergoing surgery are at risk of pressure injury development and should be assessed to ensure measures are taken for prevention. The study’s purpose was to examine the causal relationships and reliability of the Munro Pressure Injury Risk Assessment Scale for Perioperative Patients (Munro Scale). The Munro Scale is the first dynamic risk scale available for this patient population in the acute clinical setting. Methods: This study was a retrospective review to explore the relationships of the variables in the Munro Scale, identify the strongest predictors, and measure the reliability of previously collected data from two northeastern community hospitals. A total of 630 risk assessments were analyzed to obtain regression, correlation, and reliability evidence for the Munro Scale. Results: The correlation analysis among the 15 risk variables and combined comorbidities revealed commonalities among the variables and significant relationships to the final postoperative injury score. The model as a whole is significant to predict the final level of risk. Cronbach’s α revealed a lower than anticipated reliability when compared to the Chinese, Turkish, and Brazilian versions of the Munro Scale. Conclusions: There are significant relationships among the variables, and the scale is acceptable for use in the acute perioperative practice setting. This study has both clinical and statistical significance.

PMID:37553161 | DOI:10.1891/JNM-2022-0051

Categories
Nevin Manimala Statistics

Validation of the Brazilian Version of the Langer Mindfulness Scale

J Nurs Meas. 2023 Aug 8:JNM-2021-0096.R1. doi: 10.1891/JNM-2021-0096. Online ahead of print.

ABSTRACT

Background and Purpose: The Langer Mindfulness Scale (LMS) is distinguished from other mindfulness scales by its dimensions, which are closely related to the awareness and experience of novelty, and by being a scale derived from a cognitive perspective of information processing. There are no mindfulness instruments of this type available in Brazil. Therefore, this study aimed to carry out a translation and cultural adaptation of the LMS into Brazilian Portuguese and to validate and assess the internal consistency and convergent construct validity of the translated instrument. Methods: The study had two distinct stages: (a) translation and cultural adaptation of the LMS into Brazilian Portuguese and (b) validation of the adapted instrument using a sample of 543 participants. Results: The Brazilian version of the LMS demonstrated acceptable internal consistency, with confirmatory factor analysis supporting the original four-factor model. Correlations between LMS, and the Five Facets of Mindfulness Questionnaire and the Mindfulness Attention Awareness Scale were statistically significant and in the expected directions. Conclusions: Our findings suggest that the Brazilian version of LMS, with its four dimensions, presents acceptable psychometric properties and seems to be a reliable and valid instrument for assessing the state of mindfulness in a Brazilian cultural context.

PMID:37553159 | DOI:10.1891/JNM-2021-0096

Categories
Nevin Manimala Statistics

Comparison of Laparoscopic and Open Gastrectomy for Patients With Gastric Cancer Treated With Neoadjuvant Chemotherapy: A Multicenter Retrospective Study Based on the Korean Gastric Cancer Association Nationwide Survey

J Gastric Cancer. 2023 Jul;23(3):499-508. doi: 10.5230/jgc.2023.23.e28.

ABSTRACT

PURPOSE: Despite scientific evidence regarding laparoscopic gastrectomy (LG) for advanced gastric cancer treatment, its application in patients receiving neoadjuvant chemotherapy remains uncertain.

MATERIALS AND METHODS: We used the 2019 Korean Gastric Cancer Association nationwide survey database to extract data from 489 patients with primary gastric cancer who received neoadjuvant chemotherapy. After propensity score matching analysis, we compared the surgical outcomes of 97 patients who underwent LG and 97 patients who underwent open gastrectomy (OG). We investigated the risk factors for postoperative complications using multivariate analysis.

RESULTS: The operative time was significantly shorter in the OG group. Patients in the LG group had significantly less blood loss than those in the OG group. Hospital stay and overall postoperative complications were similar between the two groups. The incidence of Clavien-Dindo grade ≥3 complications in the LG group was comparable with that in the OG group (1.03% vs. 4.12%, P=0.215). No statistically significant difference was observed in the number of harvested lymph nodes between the two groups (38.60 vs. 35.79, P=0.182). Multivariate analysis identified body mass index (odds ratio [OR], 1.824; 95% confidence interval [CI], 1.029-3.234; P=0.040) and extent of resection (OR, 3.154; 95% CI, 1.084-9.174; P=0.035) as independent risk factors for overall postoperative complications.

CONCLUSIONS: Using a large nationwide multicenter survey database, we demonstrated that LG and OG had comparable short-term outcomes in patients with gastric cancer who received neoadjuvant chemotherapy.

PMID:37553135 | DOI:10.5230/jgc.2023.23.e28

Categories
Nevin Manimala Statistics

Complication After Gastrectomy for Gastric Cancer According to Hospital Volume: Based on Korean Gastric Cancer Association-Led Nationwide Survey Data

J Gastric Cancer. 2023 Jul;23(3):462-475. doi: 10.5230/jgc.2023.23.e24.

ABSTRACT

PURPOSE: This study aimed to analyze the incidence and risk factors of complications following gastric cancer surgery in Korea and to compare the correlation between hospital complications based on the annual number of gastrectomies performed.

MATERIALS AND METHODS: A retrospective analysis was conducted using data from 12,244 patients from 64 Korean institutions. Complications were classified using the Clavien-Dindo classification (CDC). Univariate and multivariate analyses were performed to identify the risk factors for severe complications.

RESULTS: Postoperative complications occurred in 14% of the patients, severe complications (CDC IIIa or higher) in 4.9%, and postoperative death in 0.2%. The study found that age, stage, American Society of Anesthesiologists (ASA) score, Eastern Cooperative Oncology Group (ECOG) score, hospital stay, approach methods, and extent of gastric resection showed statistically significant differences depending on hospital volumes (P<0.05). In the univariate analysis, patient age, comorbidity, ASA score, ECOG score, approach methods, extent of gastric resection, tumor-node-metastasis (TNM) stage, and hospital volume were significant risk factors for severe complications. However, only age, sex, ASA score, ECOG score, extent of gastric resection, and TNM stage were statistically significant in the multivariate analysis (P<0.05). Hospital volume was not a significant risk factor in the multivariate analysis (P=0.152).

CONCLUSIONS: Hospital volume was not a significant risk factor for complications after gastric cancer surgery. The differences in the frequencies of complications based on hospital volumes may be attributed to larger hospitals treating patients with younger age, lower ASA scores, better general conditions, and earlier TNM stages.

PMID:37553132 | DOI:10.5230/jgc.2023.23.e24

Categories
Nevin Manimala Statistics

Outcomes of Gastrectomy for Gastric Cancer in Patients Aged >80 Years: A Systematic Literature Review and Meta-Analysis

J Gastric Cancer. 2023 Jul;23(3):428-450. doi: 10.5230/jgc.2023.23.e23.

ABSTRACT

This meta-analysis examined the surgical management of older patients (>80 years) with gastric cancer, who were often excluded from randomized controlled trials. We analyzed 23 retrospective cohort studies involving 18,372 patients and found that older patients had a higher in-hospital mortality rate (relative risk [RR], 3.23; 95% confidence interval [CI], 1.46-7.17; P<0.01) and more post-operative complications (RR, 1.36; 95% CI, 1.19-1.56; P<0.01) than did younger patients. However, the surgical complications were similar between the two groups. Older patients were more likely to undergo less extensive lymph node dissection and longer hospital stays. Although older patients had statistically significant post-operative medical complications, they were not deprived of surgery for gastric cancer. The comorbidities and potential risks of post-operative complications should be carefully evaluated in older patients, highlighting the importance of careful patient selection. Overall, this meta-analysis provides recommendations for the surgical management of older patients with gastric cancer. Careful patient selection and evaluation of comorbidities should be performed to minimize the risk of post-operative complications in older patients, while recognizing that they should not be deprived of surgery for gastric cancer.

PMID:37553130 | DOI:10.5230/jgc.2023.23.e23

Categories
Nevin Manimala Statistics

Is an episiotomy always necessary during an operative vaginal delivery with vacuum? A longitudinal study

J Matern Fetal Neonatal Med. 2023 Dec;36(2):2244627. doi: 10.1080/14767058.2023.2244627.

ABSTRACT

Objective: The use of episiotomy during operative vaginal birth (OVB) is rather debated among operators and in literature. It is also important to evaluate the indications for which episiotomy is performed. In fact, the consequences of an episiotomy can be invalidating for patients with long-lasting results. The aim of this study is the evaluation of the role of episiotomy during OVB with the vacuum extractor and its correlation with Obstetric Anal Sphincter Injuries (OASIs).Methods: On of 9165 vaginal births, a total of 498 OVB (5.4%) were enrolled in a longitudinal prospective observational study. The incidence of OASIs was evaluated in our population after OVB performed with the vacuum extractor, during which the execution of episiotomy was performed indicated by clinician in charge.Results: OASIs occurred in 4% of the patients (n = 20). Episiotomy was performed in 39% of them (n = 181). OASIs incidence was 6% (n = 17) in the No Episiotomy and 1.8% (n = 3) in Episiotomy group (p<.001). Performance of episiotomy during OVB determined a protective effect against OASIs (p = 0.025 in full cohort and p = 0.013 in the primiparous group). An expulsive phase under one hour was an almost significant protective factor (p = 0.052).Conclusions: The use of episiotomy during OVB was associated with much lower OASIs rates in nulliparous women with a vacuum extraction; OR 0.23 (CI 95% 0.07-0.81) p = 0.037 in nulliparous women and the number necessary to treat was 18 among nulliparous women to prevent 1 OASIs. A further risk factor that emerged from the analysis is a prolonged expulsive period, whereas fundal pressure does not seem to have a statistically significant influence.

PMID:37553125 | DOI:10.1080/14767058.2023.2244627

Categories
Nevin Manimala Statistics

How to convince the vaccine-hesitant? An ease-of-access nudge, but not risk-related information increased Covid vaccination-related behaviors in the unvaccinated

Appl Psychol Health Well Being. 2023 Aug 8. doi: 10.1111/aphw.12479. Online ahead of print.

ABSTRACT

In this study, we contrast how different benefit and harm information formats and the presence or absence of an ease-of-access nudge may facilitate COVID vaccination uptake for a sample of 620 unvaccinated Dutch adults at a timepoint when the vaccine had been widely available for more than a month. Using a 2 × 2 between-subjects factorial design, we varied the information format on mRNA COVID vaccination statistics (generic text vs. facts box) and an affirmative nudge emphasizing the ease of making a vaccination appointment (absent vs. present). We assessed the acceptance of the vaccination information provided, perceptions on the vaccination, and whether participants directly visited a COVID vaccination appointment website. Whereas the facts box did not significantly affect participants’ information acceptance, vaccination attitudes, intentions, and link clicking, the affirmative nudge alongside an online link systematically increased the likelihood of clicking on the link to make a vaccination appointment. A verbal nudge emphasizing the ease of vaccine accessibility is more likely to increase vaccination uptake in an unvaccinated population than informational campaigns on vaccine effectiveness.

PMID:37553124 | DOI:10.1111/aphw.12479

Categories
Nevin Manimala Statistics

Maternal and neonatal outcomes in pregnant women with heart disease with single evaluation vs. semi-structured evaluation by a cardio-obstetric team

Arch Cardiol Mex. 2023;93(3):300-307. doi: 10.24875/ACM.22000057.

ABSTRACT

INTRODUCTION: Cardiovascular diseases in pregnant women are challenging, with high maternal and perinatal morbidity and mortality, so a cardio-obstetric team is recommended for their care. Even so, little data evaluates the impact of these teams. Therefore, the present study aims to compare the obstetric, maternal, and neonatal outcomes of semi-structured follow-up (SSF) in a Cardio-obstetric clinic concerning regular or unstructured follow-up (USF) in pregnant women with heart disease.

METHODS: A prospective registry of pregnant women with heart disease was carried out. Patients with SSF by a cardio-obstetric team were compared with those with single evaluation or USF. The risk of events was calculated according to the modified World Health Organization (mWHO) classification and the CARPREG-II scale, and cardiac, obstetric, and neonatal outcomes were evaluated.

RESULTS: One hundred sixty-eight patients were evaluated, 37 with SSF and 131 with single evaluation (USF). The primary diagnoses were congenital heart disease, arrhythmias, and valve disease. The average CARPREG-II in USF patients was 2.48 (SD 2.3); in SSF patients, it was 3.37 (SD 2.45; p = 0.041). The average of the mWHO in patients with USF was 2.1 (SD 1.6), and with SSF, it was 2.65 (SD 0.95; p = 0.0052). There were no significant differences in primary cardiac outcomes (13.8% in USF vs. 5.4% in SSF; p = 0.134), secondary cardiac (5.3% in USF vs. 2.7% in SSF; p = 0.410), obstetric (10% in USF vs. 16.2% in SSF; p = 0.253) and neonatal (35.9% in USF and 40.5% in SSF; p = 0.486) even though patients with SSF had a higher risk than patients with USF according to the mWHO and CARPREG-II scales.

CONCLUSIONS: In pregnant women with heart disease, an SSF compared with a USF by a cardio-obstetric team did not show statistically significant differences in cardiovascular, obstetric, and neonatal outcomes. However, patients with SSF had a significantly higher risk of adverse outcomes due to the mWHO and CARPREG-II scales. This result suggests that the SSF achieves at least equal outcomes despite the higher risk of adverse events that patients in this group had.

PMID:37553104 | DOI:10.24875/ACM.22000057