Category: Nevin Manimala

J Pediatr Gastroenterol Nutr. 2023 Jan 31. doi: 10.1097/MPG.0000000000003718. Online ahead of print.

ABSTRACT

BACKGROUND AND AIMS: There is a subset of intestinal failure patients with associated chronic intestinal inflammation resembling inflammatory bowel disease. This study aimed to evaluate factors associated with chronic intestinal inflammation in pediatric intestinal failure.

METHODS: This was a single-center retrospective case-control study of children <18 years old with intestinal failure. Cases were defined by abnormal amounts of chronic intestinal inflammation on biopsies. Children with diversion colitis, eosinophilic colitis, or isolated anastomotic ulceration were excluded. Cases were matched 1:2 to intestinal failure controls based on sex, etiology of intestinal failure, and duration of intestinal failure. Multivariable conditional logistic regression was used to compare clinical factors between cases and controls, accounting for clustering within matched sets. A subgroup analysis was performed assessing factors associated with escalation of anti-inflammatory therapy.

RESULTS: Thirty cases were identified and matched to 60 controls. On univariate analysis, longer parenteral nutrition duration (1677 vs 834 days, p=0.03), current parenteral nutrition use (33.3% vs 20.0%, p=0.037) and culture-proven bacterial overgrowth (53.3% vs 31.7%, p=0.05) were associated with chronic intestinal inflammation. On multivariable analysis, no variable reached statistical significance. On subgroup analysis, duration of intestinal failure, location of inflammation, and worst degree of inflammation on histology were associated with escalation of therapy.

CONCLUSION: Parenteral nutrition dependence and intestinal dysbiosis are associated with chronic intestinal inflammation in children with intestinal failure. Severity of inflammation is associated with escalation of therapy. Further analysis is needed to assess these associations and the efficacy of treatments in this population.

PMID:36720109 | DOI:10.1097/MPG.0000000000003718

J Pediatr Gastroenterol Nutr. 2023 Jan 31. doi: 10.1097/MPG.0000000000003714. Online ahead of print.

ABSTRACT

OBJECTIVES: We sought to evaluate the safety and effectiveness of fecal microbiota transplantation (FMT) for recurrent Clostridioides difficile infection (CDI) in pediatric immunocompromised (IC) patients.

METHODS: This is a multi-center retrospective cohort study of pediatric participants who underwent FMT between March 2013 and April 2020 with 12-week follow-up. Pediatric patients were included if they met the definition of IC and were treated with FMT for an indication of recurrent CDI. We excluded patients over 18 years of age, those with incomplete records, insufficient follow up, or not meeting study definition of IC. We also excluded those treated for Clostridioides difficile recurrence without meeting the study definition and those with inflammatory bowel disease without another immunocompromising condition.

RESULTS: Of 59 pediatric patients identified at nine centers, there were 42 who met inclusion and no exclusion criteria. Included patients had a median age of 6.7 years. Etiology of IC included: solid organ transplantation (18, 43%), malignancy (12, 28%), primary immunodeficiency (10, 24%), or other chronic conditions (2, 5%). Success rate was 79% after first FMT and 86% after one or more FMT. There were no statistically significant differences in patient characteristics or procedural components when patients with a failed FMT were compared to those with a successful FMT. There were 15 total serious adverse events (SAEs) in 13 out of 42 (31%) patients that occurred during the follow-up period; four (9.5%) of which were likely treatment-related. There were no deaths or infections with multi-drug resistant organisms during follow-up and all patients with a serious adverse event fully recovered.

CONCLUSIONS: The success rate of FMT for recurrent CDI in this pediatric IC cohort is high and mirrors data for IC adults and immunocompetent children. FMT-related SAEs do occur (9.5%) and highlight the need for careful consideration of risk and benefit.

PMID:36720105 | DOI:10.1097/MPG.0000000000003714

Medwave. 2023 Jan 16;22(1):e2668. doi: 10.5867/medwave.2023.01.2668.

ABSTRACT

Introduction: Knee osteoarthritis affects the quality of life, with knee arthroplasty being a cost-effective treatment for the severe stage of this disease. Access to knee arthroplasty is a health indicator of the Organisation for Economic Co-operation and Development. The objectives of this study are to determine the incidence of knee arthroplasty between 2004 and 2021 in beneficiaries of the National Health Fund in Chile, the proportion of patients who underwent surgery in the private system, and to estimate the patient’s out-of-pocket expenditure for surgery. Methods: Cross-sectional study. We used the Department of Statistics and Health Information database. Patients discharged from a Chilean health center who underwent knee arthroplasty surgery between 2004 and 2021 were investigated. We analyzed the proportion of patients by their National Health Fund category and whether their surgery was performed in public or private network facilities. Results: Of the 31 526 knee arthroplasty procedures, 21 248 (67.38%) were performed on National Health Fund patients and 16 238 in public institutions (51.49%). Patients from the National Health Fund showed a systematic increase in knee arthroplasty volume until 2019 but decreased in 2020 and 2021 by 68% and 51%. Of the total number of patients in the public system operated on for knee arthroplasty, 856 (9%) belonged to group A1, 12 806 (60%) to group B, 2044 (10%) to group C, and 4421 (21%) to group D. The expenditure incurred by these patients was estimated to vary between 24.4% and 27.2%. The historical proportions of access to this surgery in private institutions are 7% in group A, 13% in group B, 24% in group C, and 52% in group D. Conclusion: Fifty percent of knee arthroplasty surgeries are performed in public institutions, and two-thirds are performed on patients of the National Health Fund. Forty-six percent of the C and D groups were operated in the private system. The pandemic has increased the access gap, leading to a substantial increase in the proportion of patients from the National Health Fund of the B, C, and D groups who have migrated to the private system to access this surgery.

PMID:36720104 | DOI:10.5867/medwave.2023.01.2668

J Contin Educ Nurs. 2023 Feb;54(2):89-96. doi: 10.3928/00220124-20230113-08. Epub 2023 Feb 1.

ABSTRACT

BACKGROUND: Spiritual care helps individuals encounter the transcendent meaning of their crises. However, nurses report various barriers to providing spiritual care in clinical settings. To facilitate spiritual care among nurses, a more comprehensive understanding of this field is needed. This study was conducted to establish a path model for multiple factors predicting spiritual care among nurses working in hospitals.

METHOD: A cross-sectional descriptive design was used. The participants were 370 nurses with more than 6 months of experience working in general hospitals in South Korea. The measures used in this study were nursing workplace spirituality, a spiritual well-being scale, the Maslach Burnout Inventory-Human Services Survey for Medical Personnel, a scale for compassionate care, a general self-efficacy scale, and spiritual care in practice. Path analysis was performed using IBM SPSS Statistics, version 24.0, and SPSS Amos, version 20.0.

RESULTS: Workplace spirituality and spiritual well-being predicted higher spiritual care in practice by sequentially mediating burnout and compassionate care.

CONCLUSION: This study suggests that nurses’ spiritual care can be increased via the development of specific strategies focused on enhancing the nursing work-place spirituality of hospital organizations, promoting individual spiritual well-being and compassionate behavior, and reducing burnout among nurses. [J Contin Educ Nurs. 2023;54(2):89-96.].

PMID:36720095 | DOI:10.3928/00220124-20230113-08

J Clin Oncol. 2023 Jan 31:JCO2202186. doi: 10.1200/JCO.22.02186. Online ahead of print.

ABSTRACT

PURPOSE: The phase III ADAURA (ClinicalTrials.gov identifier: NCT02511106) primary analysis demonstrated a clinically significant disease-free survival (DFS) benefit with adjuvant osimertinib versus placebo in EGFR-mutated stage IB-IIIA non-small-cell lung cancer (NSCLC) after complete tumor resection (DFS hazard ratio [HR], 0.20 [99.12% CI, 0.14 to 0.30]; P < .001). We report an updated exploratory analysis of final DFS data.

METHODS: Overall, 682 patients with stage IB-IIIA (American Joint Committee on Cancer/Union for International Cancer Control, seventh edition) EGFR-mutated (exon 19 deletion/L858R) NSCLC were randomly assigned 1:1 (stratified by stage, mutational status, and race) to receive osimertinib 80 mg once-daily or placebo for 3 years. The primary end point was DFS by investigator assessment in stage II-IIIA disease analyzed by stratified log-rank test; following early reporting of statistical significance in DFS, no further formal statistical testing was planned. Secondary end points included DFS in stage IB-IIIA, overall survival, and safety. Patterns of recurrence and CNS DFS were prespecified exploratory end points.

RESULTS: At data cutoff (April 11, 2022), in stage II-IIIA disease, median follow-up was 44.2 months (osimertinib) and 19.6 months (placebo); the DFS HR was 0.23 (95% CI, 0.18 to 0.30); 4-year DFS rate was 70% (osimertinib) and 29% (placebo). In the overall population, DFS HR was 0.27 (95% CI, 0.21 to 0.34); 4-year DFS rate was 73% (osimertinib) and 38% (placebo). Fewer patients treated with osimertinib had local/regional and distant recurrence versus placebo. CNS DFS HR in stage II-IIIA was 0.24 (95% CI, 0.14 to 0.42). The long-term safety profile of osimertinib was consistent with the primary analysis.

CONCLUSION: These updated data demonstrate prolonged DFS benefit over placebo, reduced risk of local and distant recurrence, improved CNS DFS, and a consistent safety profile, supporting the efficacy of adjuvant osimertinib in resected EGFR-mutated NSCLC.

PMID:36720083 | DOI:10.1200/JCO.22.02186

Menopause. 2023 Jan 31. doi: 10.1097/GME.0000000000002138. Online ahead of print.

ABSTRACT

OBJECTIVE: Neurokinin (NK)-3 and NK-1 receptors have been implicated in the etiology of vasomotor symptoms (VMS) and sleep disturbances associated with menopause. This phase 2b, adaptive, dose-range finding study aimed to assess the efficacy and safety of multiple doses of elinzanetant (NT-814), a selective NK-1,3 receptor antagonist, in women experiencing VMS associated with menopause, and investigate the impact of elinzanetant on sleep and quality of life.

METHODS: Postmenopausal women aged 40 to 65 years who experienced seven or more moderate-to-severe VMS per day were randomized to receive elinzanetant 40, 80, 120, or 160 mg or placebo once daily using an adaptive design algorithm. Coprimary endpoints were reduction in mean frequency and severity of moderate-to-severe VMS at weeks 4 and 12. Secondary endpoints included patient-reported assessments of sleep and quality of life.

RESULTS: Elinzanetant 120 mg and 160 mg achieved reductions in VMS frequency versus placebo from week 1 throughout 12 weeks of treatment. Least square mean reductions were statistically significant versus placebo at both primary endpoint time points for elinzanetant 120 mg (week 4: -3.93 [SE, 1.02], P < 0.001; week 12: -2.95 [1.15], P = 0.01) and at week 4 for elinzanetant 160 mg (-2.63 [1.03]; P = 0.01). Both doses also led to clinically meaningful improvements in measures of sleep and quality of life. All doses of elinzanetant were well tolerated.

CONCLUSIONS: Elinzanetant is an effective and well-tolerated nonhormone treatment option for postmenopausal women with VMS and associated sleep disturbance. Elinzanetant also improves quality of life in women with VMS.

PMID:36720081 | DOI:10.1097/GME.0000000000002138

Menopause. 2023 Jan 31. doi: 10.1097/GME.0000000000002155. Online ahead of print.

ABSTRACT

OBJECTIVE: This study aimed to describe the menopause experience of people with cystic fibrosis (CF).

METHODS: We conducted a computer-based cross-sectional survey of women with CF 25 years or older at 10 US CF centers exploring a range of sexual and reproductive health concerns, including menopause. We used descriptive statistics to analyze results.

RESULTS: Of 460 participants, 5 (3%) were perimenopausal and 34 (7%) were postmenopausal. Of participants perimenopausal or menopausal (n = 39), 97% reported the following menopausal symptoms occurring at least once a week: most commonly early wake-up (83%); stiffness/soreness in joints, neck, or shoulders (65%); and night sweats (65%). Among menopausal participants, the median self-reported age at menopause was 48.5 years (interquartile range, 5.5 y). Thirty percent experienced worsened CF symptoms during menopause, and 42% experienced worsening CF symptoms after menopause. Twenty-four percent of menopausal participants were on estrogen therapy and 15% on estrogen and progesterone therapy. Three-fourths of participants using hormone therapy reported no change in their CF symptoms. One percent of the 460 survey participants reported discussing menopause with their CF provider, despite 19% wanting to discuss this topic with their CF team.

CONCLUSIONS: This is the first study to describe menopause symptoms of people with CF. People with CF experience a variety of menopausal symptoms and often report a worsening of their CF symptoms after menopause, suggesting an interplay between female sex hormones and CF. Larger studies are needed comparing the sexual and reproductive health experiences and care needs of people with CF in the menopause transition to the general population.

PMID:36720079 | DOI:10.1097/GME.0000000000002155

Int J Pharm Compd. 2023 Jan-Feb;27(1):39-46.

ABSTRACT

Whether sterile compounds are prepared in a brand new state-of-the-art cleanroom suite or in an aging space, compounders rely heavily on their primary and secondary engineering controls when sterilizing or maintaining sterility of the final preparation. With the release of the latest revision to United States Pharmacopeia Chapter <797>, organizations that prepare sterile compounds must now sample and test each classified area for the presence of microbiological contaminants at a higher frequency. Facilities that are not purpose-built, as well as those that do not operate within a state of control, are predicted to repeatedly exceed action levels as set by the United States Pharmacopeia Convention, Inc. Before the United States Pharmacopeia revision becomes active and enforceable, it is advised that sterile compounding practice sites undergo an environmental-baseline study to gather statistically significant data to demonstrate how the cleanroom(s) perform and to assess whether or not dynamic operations increase the levels of bioburden.

PMID:36720062

Dimens Crit Care Nurs. 2023 Mar-Apr 01;42(2):104-114. doi: 10.1097/DCC.0000000000000572.

ABSTRACT

PURPOSE: The present research was conducted to reveal the impact of abdominal massage on enteral nutrition-induced ventilator-associated pneumonia and the gastrointestinal system in mechanically ventilated patients.

MATERIALS AND METHODS: The present research is a prospective, randomized, controlled clinical trial. This study was completed with 63 patients (31 in the experimental group and 32 in the control group). Data collection was performed using a patient information form, a patient follow-up form, and the Bristol Stool Scale. After patients were under mechanical ventilation for 48 hours, the data collection tools were filled out twice a day for 3 days by visiting the mechanical ventilation patients. The experimental group received 15 minutes of abdominal massage twice a day before nursing care was delivered in the morning and the evening.

RESULTS: According to the intergroup evaluations, the experimental group had lower gastric residual volume and abdominal distension, types of stool closer to normal, and higher defecation frequency. Differences between the groups were statistically significant (P < .05). In accordance with the intragroup evaluations, the experimental group had lower gastric residual volume, abdominal distension, and ventilator-associated pneumonia. The difference between the groups was revealed to be statistically significant (P < .05).

CONCLUSION: Abdominal massage reduces ventilator-associated pneumonia development to a statistically significant degree. Furthermore, it decreases gastric residual volume and abdominal distension, causes stools to be closer to the normal/ideal stool, increases defecation frequency, and regulates bowel movements and excretion (P < .05).

PMID:36720035 | DOI:10.1097/DCC.0000000000000572

Clin J Am Soc Nephrol. 2023 Jan 1;18(1):28-35. doi: 10.2215/CJN.0000000000000035.

ABSTRACT

BACKGROUND: Prediction tools that incorporate self-reported health information could increase CKD awareness, identify modifiable lifestyle risk factors, and prevent disease. We developed and validated a survey-based prediction equation to identify individuals at risk for incident CKD (eGFR <60 ml/min per 1.73 m2), with and without a baseline eGFR.

METHODS: A cohort of adults with an eGFR ≥70 ml/min per 1.73 m2 from Ontario, Canada, who completed a comprehensive general population health survey between 2000 and 2015 were included (n=22,200). Prediction equations included demographics (age, sex), comorbidities, lifestyle factors, diet, and mood. Models with and without baseline eGFR were derived and externally validated in the UK Biobank (n=15,522). New-onset CKD (eGFR <60 ml/min per 1.73 m2) with ≤8 years of follow-up was the primary outcome.

RESULTS: Among Ontario individuals (mean age, 55 years; 58% women; baseline eGFR, 95 (SD 15) ml/min per 1.73 m2), new-onset CKD occurred in 1981 (9%) during a median follow-up time of 4.2 years. The final models included lifestyle factors (smoking, alcohol, physical activity) and comorbid illnesses (diabetes, hypertension, cancer). The model was discriminating in individuals with and without a baseline eGFR measure (5-year c-statistic with baseline eGFR: 83.5, 95% confidence interval [CI], 82.2 to 84.9; without: 81.0, 95% CI, 79.8 to 82.4) and well calibrated. In external validation, the 5-year c-statistic was 78.1 (95% CI, 74.2 to 82.0) and 66.0 (95% CI, 61.6 to 70.4), with and without baseline eGFR, respectively, and maintained calibration.

CONCLUSIONS: Self-reported lifestyle and health behavior information from health surveys may aid in predicting incident CKD.

PODCAST: This article contains a podcast at https://dts.podtrac.com/redirect.mp3/www.asn-online.org/media/podcast.aspx?p=CJASN&e=2023_01_10_CJN05650522.mp3.

PMID:36720027 | DOI:10.2215/CJN.0000000000000035