Tag: nevin manimala

PLoS One. 2024 Aug 19;19(8):e0309154. doi: 10.1371/journal.pone.0309154. eCollection 2024.

ABSTRACT

INTRODUCTION: The incidence of varicella in Canada has decreased by almost 99% since vaccination was introduced. However, variation in the timing and eligibility of vaccination programs across the country has resulted in some cohorts being under-vaccinated and therefore potentially susceptible to infection.

METHODS: We used nationally representative specimens from the Biobank of Statistics Canada’s Canadian Health Measures Survey (CHMS) as well as residual specimens from Ontario collected between 2009-2014 to estimate population immunity across age-groups and geography, and identify any groups at increased risk of varicella infection.

RESULTS: The weighted proportion of specimens with antibody levels above the threshold of protection was 93.6% (95% CI: 92.4, 95.0). Protection was lowest among those aged 3-5 years (54.3%; 95% CI: 47.3, 61.4), but increased with age. Individuals born outside Canada had more than twice the odds of varicella susceptibility than those born in Canada (aOR: 2.7; 95% CI: 1.4, 5.0; p = 0.004). There were no differences by sex or geography within Canada, and there were no statistically significant differences when Ontario CHMS sera were compared to Ontario residual sera, apart from in participants aged 12-19 year age-group, for whom the CHMS estimate (91.2%; 95% CI: 86.7, 95.7) was significantly higher (p = 0.03) than that from residual specimens (85.9%, 95% CI: 81.1, 90.8).

DISCUSSION: Varicella immunity in Canada is changing. Children appear to have low population immunity, placing them at greater risk of infection and at increased risk of severe disease as they age. Our results underscore the importance of performing periodic serosurveys to monitor further population immunity changes as the proportion of vaccine-eligible birth-cohorts increases, and to continually assess the risk of outbreaks.

PMID:39159217 | DOI:10.1371/journal.pone.0309154

J Gerontol A Biol Sci Med Sci. 2024 Aug 19:glae202. doi: 10.1093/gerona/glae202. Online ahead of print.

ABSTRACT

PURPOSE: This observational study aimed to investigate associations between dietary live microbe intake and mortality, as well as biological aging.

METHODS: Adults from the 1999-2018 National Health and Nutrition Examination Survey were categorized into low, medium, and high dietary live microbe groups. Foods with medium and high live microbe content were aggregated into a medium-high consumption category. The outcomes included all-cause, cardiovascular, and cancer mortality, along with biological age (BA) acceleration assessed by the Klemera-Doubal method (KDM) and PhenoAge. Multiple regression analyses and mediation analyses were conducted to assess associations, adjusting for potential confounders.

RESULTS: A total of 34,133 adults were included in our analyses. Over an average follow-up period of 9.92 years, 5,462 deaths occurred. In multivariate adjusted models, every 100 grams of medium-high group foods consumed was associated with reduced all-cause mortality (hazard ratio [HR] 0.94, 95% confidence interval [CI] 0.91 to 0.97, P < 0.001) and cardiovascular mortality (HR 0.91, 95% CI 0.86 to 0.96, P < 0.001), but not with cancer mortality (HR 1.01, 95% CI 0.95 to 1.07, P = 0.768). Every 100 grams medium-high group foods consumption was associated with decreased KDM BA acceleration (fully adjusted regression coefficient -0.09, 95% CI -0.15 to -0.04, P = 0.001) and PhenoAge acceleration (fully adjusted regression coefficient -0.07, 95% CI -0.11 to -0.03, P < 0.001). Mediation analysis showed that BA acceleration partially mediated live microbes-mortality associations.

CONCLUSION: Our results suggest that higher dietary live microbe intake is associated with lower mortality risk and slower biological aging. However, further research is needed to verify these findings.

PMID:39158955 | DOI:10.1093/gerona/glae202

JMIR Med Inform. 2024 Aug 19;12:e57153. doi: 10.2196/57153.

ABSTRACT

BACKGROUND: Leveraging electronic health record (EHR) data for clinical or research purposes heavily depends on data fitness. However, there is a lack of standardized frameworks to evaluate EHR data suitability, leading to inconsistent quality in data use projects (DUPs). This research focuses on the Medical Informatics for Research and Care in University Medicine (MIRACUM) Data Integration Centers (DICs) and examines empirical practices on assessing and automating the fitness-for-purpose of clinical data in German DIC settings.

OBJECTIVE: The study aims (1) to capture and discuss how MIRACUM DICs evaluate and enhance the fitness-for-purpose of observational health care data and examine the alignment with existing recommendations and (2) to identify the requirements for designing and implementing a computer-assisted solution to evaluate EHR data fitness within MIRACUM DICs.

METHODS: A qualitative approach was followed using an open-ended survey across DICs of 10 German university hospitals affiliated with MIRACUM. Data were analyzed using thematic analysis following an inductive qualitative method.

RESULTS: All 10 MIRACUM DICs participated, with 17 participants revealing various approaches to assessing data fitness, including the 4-eyes principle and data consistency checks such as cross-system data value comparison. Common practices included a DUP-related feedback loop on data fitness and using self-designed dashboards for monitoring. Most experts had a computer science background and a master’s degree, suggesting strong technological proficiency but potentially lacking clinical or statistical expertise. Nine key requirements for a computer-assisted solution were identified, including flexibility, understandability, extendibility, and practicability. Participants used heterogeneous data repositories for evaluating data quality criteria and practical strategies to communicate with research and clinical teams.

CONCLUSIONS: The study identifies gaps between current practices in MIRACUM DICs and existing recommendations, offering insights into the complexities of assessing and reporting clinical data fitness. Additionally, a tripartite modular framework for fitness-for-purpose assessment was introduced to streamline the forthcoming implementation. It provides valuable input for developing and integrating an automated solution across multiple locations. This may include statistical comparisons to advanced machine learning algorithms for operationalizing frameworks such as the 3×3 data quality assessment framework. These findings provide foundational evidence for future design and implementation studies to enhance data quality assessments for specific DUPs in observational health care settings.

PMID:39158950 | DOI:10.2196/57153

Clin Transplant. 2024 Aug;38(8):e15435. doi: 10.1111/ctr.15435.

ABSTRACT

BACKGROUND: Delayed graft function (DGF) after kidney transplantation is associated with adverse patients and allograft outcomes. A longer duration of DGF is predictive of worse graft outcomes compared to a shorter duration. Posttransplant serum β2-microglobulin (B2M) is associated with long-term graft outcomes, but its relationship with DGF recovery is unknown.

METHODS: We included all kidney-only transplant recipients with DGF enrolled in the E-DGF trial. Duration of DGF was defined as the interval between the transplant and the last dialysis session. We analyzed the association of standardized serum creatinine (Scr) and B2M on postoperative Days (POD) 1-7 during the subsequent days of DGF with the recovery of DGF.

RESULTS: A total of 97 recipients with DGF were included. The mean duration of DGF was 11.0 ± 11.2 days. Higher Scr was not associated with the duration of DGF in unadjusted or adjusted models. Higher standardized B2M, in contrast, was associated with a prolonged duration of DGF. This association remained in models adjusting for baseline characteristics from POD 2 (3.19 days longer, 95% CI: 0.46-5.93; p = 0.02) through Day 6 of DGF (4.97 days longer, 95% CI: 0.75-9.20; p = 0.02). There was minimal change in mean Scr (0.01 ± 0. 10 mg/dL per day; p = 0.32), while B2M significantly decreased as the time to recovery approached (-0.14 ± 0.05 mg/L per day; p = 0.006), among recipients with DGF.

CONCLUSION: B2M is more strongly associated with DGF recovery than Scr. Posttransplant B2M may be an important biomarker to monitor during DGF.

TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT03864926.

PMID:39158946 | DOI:10.1111/ctr.15435

JMIR Res Protoc. 2024 Aug 19;13:e56727. doi: 10.2196/56727.

ABSTRACT

BACKGROUND: Feedback is an essential tool for learning and improving performance in any sphere of education, including training of resident physicians. The learner’s perception of the feedback they receive is extremely relevant to their learning progress, which must aim at providing qualified care for patients. Studies pertinent to the matter differ substantially with respect to methodology, population, context, and objective, which makes it even more difficult to achieve a clear understanding of the topic. A scoping review on this theme will unequivocally enhance and organize what is already known.

OBJECTIVE: The aim of this study is to identify and map out data from studies that report surgical residents’ perception of the feedback received during their education.

METHODS: The review will consider studies on the feedback perception of resident physicians of any surgical specialty and age group, attending any year of residency, regardless of the type of feedback given and the way the perceptions were measured. Primary studies published in English, Spanish, and Portuguese since 2017 will be considered. The search will be carried out in 6 databases and reference lists will also be searched for additional studies. Duplicates will be removed, and 2 independent reviewers will screen the selected studies’ titles, abstracts, and full texts. Data extraction will be performed through a tool developed by the researchers. Descriptive statistics and qualitative analysis (content analysis) will be used to analyze the data. A summary of the results will be presented in the form of diagrams, narratives, and tables.

RESULTS: The findings of this scoping review were submitted to an indexed journal in July 2024, currently awaiting reviewer approval. The search was executed on March 15, 2024, and resulted in 588 articles. After the exclusion of the duplicate articles and those that did not meet the eligibility criteria as well as the inclusion of articles through a manual search, 13 articles were included in the review.

CONCLUSIONS: Conducting a scoping review is the best way to map what is known about a subject. By focusing on the feedback perception more than the feedback itself, the results of this study will surely contribute to gaining a deeper understanding of how to proceed to enhance internal feedback and surgical residents’ learning progress.

TRIAL REGISTRATION: Open Science Framework yexb; https://osf.io/yexkb.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/56727.

PMID:39158942 | DOI:10.2196/56727

Holist Nurs Pract. 2024 Aug 15. doi: 10.1097/HNP.0000000000000685. Online ahead of print.

ABSTRACT

The aim of this study was to assess the effects of online mindfulness-based breathing therapy combined with music on the levels of perceived strain, caregiver burden and burnout in caregivers of palliative care patients. This was a prospective, single-blind, randomized-controlled study. A total of 100 caregivers were randomly assigned to the intervention group (n = 50) and the control group (n = 50). Participants in the intervention group agreed to 3 sessions of mindfulness-based breathing therapy per week. Participants in the control group agreed to sit in a comfortable position in a quiet environment for 30 minutes for 3 consecutive days. We found statistical differences in groups in strain (P < .001), burden (P = .015) and burnout (P = .039) when comparing intervention and control groups. Mindfulness-based breathing therapy combined with music is a non-pharmacological approach that may reduce perceived strain, caregiver burden and burnout in caregivers.

PMID:39158927 | DOI:10.1097/HNP.0000000000000685

JAMA Netw Open. 2024 Aug 1;7(8):e2425614. doi: 10.1001/jamanetworkopen.2024.25614.

ABSTRACT

IMPORTANCE: Many patients with diabetic peripheral neuropathic pain (DPNP) experience inadequate relief, despite best available medical treatments. There are no approved and effective therapies for patients with DPNP in China.

OBJECTIVE: To evaluate the efficacy and safety of capsules containing γ-aminobutyric acid (GABA) analogue HSK16149 in the treatment of Chinese patients with DPNP.

DESIGN, SETTING, AND PARTICIPANTS: This phase 2 to 3 adaptive randomized clinical trial was multicenter, double blind, and placebo and pregabalin controlled. The trial started on December 10, 2020, and concluded on July 8, 2022. In stage 1, various doses of HSK16149 were evaluated to determine safety and efficacy for stage 2. The second stage then validated the efficacy and safety of the recommended dose.

INTERVENTION: In stage 1, enrolled patients (n = 363) were randomized 1:1:1:1:1:1 to 4 HSK16149 doses (40, 80, 120, or 160 mg/d), pregabalin (300 mg/d), or placebo. In stage 2, patients (n = 362) were randomized 1:1:1 to receive HSK16149, 40 or 80 mg/d, or placebo. The final efficacy and safety analysis pooled data from patients receiving the same treatment.

MAIN OUTCOMES AND MEASURES: The primary efficacy end point in stage 1 was the change from baseline in average daily pain score (ADPS) at week 5. The primary efficacy end point in stage 2 was the change from baseline in ADPS at week 13. When the final statistical analysis was performed, the P values calculated from the independent data of each phase were combined using the weighted inverse normal method to make statistical inferences.

RESULTS: Of 725 randomized patients in the full-analysis set (393 men [54.2%]; mean [SD] age, 58.80 [9.53] years; 700 [96.6%] of Han Chinese ethnicity), 177 received placebo; 178, HSK16149, 40 mg/d; 179, HSK16149, 80 mg/d; 66, HSK16149, 120 mg/d; 63, HSK16149, 160 mg/d; and 62, pregabalin, 300 mg/d. A total of 644 patients (88.8%) completed the study. The 40- and 80-mg/d doses of HSK16149 were recommended in stage 2. At week 13, the ADPS mean (SD) change from baseline was -2.24 (1.55) for the 40-mg/d and -2.16 (1.79) for 80-mg/d groups and -1.23 (1.68) for the placebo group, showing statistical significance for both HSK16149 doses vs placebo (both P < .001). In a safety set (n = 726), 545 patients (75.1%) had adverse events, which were generally mild to moderate, with dizziness and somnolence being the most common.

CONCLUSIONS AND RELEVANCE: Forty- and eighty-mg/d doses of HSK16149 were recommended for treating patients with DPNP in China. The efficacy of HSK16149 capsules was superior to placebo in all groups for relieving DPNP and appeared well tolerated.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04647773.

PMID:39158916 | DOI:10.1001/jamanetworkopen.2024.25614

JAMA Netw Open. 2024 Aug 1;7(8):e2427576. doi: 10.1001/jamanetworkopen.2024.27576.

ABSTRACT

IMPORTANCE: Return to work after breast cancer (BC) treatment depends on several factors, including treatment-related adverse effects. While cancer-related cognitive impairment is frequently reported by patients with BC, to date, no longitudinal studies have assessed its association with return to work.

OBJECTIVE: To examine whether cognition, assessed using objective and subjective scores, was associated with return to work 2 years after BC diagnosis.

DESIGN, SETTING, AND PARTICIPANTS: In a case series of the French Cancer Toxicities (CANTO) cohort, a study of patients with stage I to III BC investigated cognition from April 2014 to December 2018 (2 years’ follow-up). Participants included women aged 58 years or younger at BC diagnosis who were employed or looking for a job.

MAIN OUTCOMES AND MEASURES: The outcome was return to work assessed 2 years after BC diagnosis. Objective cognitive functioning (tests), cognitive symptoms, anxiety, depression, and fatigue were prospectively assessed at diagnosis (baseline), 1 year after treatment completion, and 2 years after diagnosis. Multivariable logistic regression models were used to explain return to work status at year 2 according to each cognitive measure separately, adjusted for age, occupational class, stage at diagnosis, and chemotherapy.

RESULTS: The final sample included 178 women with BC (median age: 48.7 [range, 28-58] years), including 37 (20.8%) who did not return to work at year 2. Patients who returned to work had a higher (ie, professional) occupational class and were less likely to have had a mastectomy (24.1% vs 54.1%; P < .001). Return to work at year 2 was associated with lower overall cognitive impairment (1-point unit of increased odds ratio [1-pt OR], 0.32; 95% CI, 0.13-0.79; P = .01), higher working memory (1-pt OR, 2.06; 95% CI, 1.23-3.59; P = .008), higher processing speed (1-pt OR, 1.97; 95% CI, 1.20-3.36; P = .01) and higher attention performance (1-pt OR, 1.63; 95% CI, 1.04-2.64; P = .04), higher perceived cognitive abilities (1-pt OR, 1.12; 95% CI, 1.03-1.21; P = .007), and lower depression (1-pt OR, 0.83; 95% CI, 0.74-0.93; P = .001) at year 2 assessment. Return to work at year 2 was associated with several measures assessed at baseline and year 1: higher processing speed (1-pt OR, 2.38; 95% CI, 1.37-4.31; P = .003 and 1.95; 95% CI, 1.14-3.50; P = .02), higher executive performance (1-pt OR, 2.61; 95% CI, 1.28-5.75; P = .01, and 2.88; 95% CI, 1.36-6.28; P = .006), and lower physical fatigue (10-pt OR, 0.81; 95% CI, 0.69-0.95; P = .009 and 0.84; 95% CI, 0.71-0.98; P = .02).

CONCLUSIONS AND RELEVANCE: In this case series study of patients with BC, return to work 2 years after diagnosis was associated with higher cognitive speed performance before and after BC treatment. Cognitive difficulties should be assessed before return to work to propose suitable management.

PMID:39158915 | DOI:10.1001/jamanetworkopen.2024.27576

JAMA Netw Open. 2024 Aug 1;7(8):e2428287. doi: 10.1001/jamanetworkopen.2024.28287.

ABSTRACT

IMPORTANCE: Type 1 diabetes (T1D) requires demanding self-management health behaviors, and adolescents with T1D are at risk for poor psychosocial and medical outcomes. Developing resilience skills may help adolescents with T1D and elevated distress navigate common stressors and achieve positive outcomes.

OBJECTIVE: To test the efficacy of the Promoting Resilience in Stress Management (PRISM) intervention on levels of hemoglobin A1c (HbA1c), diabetes distress, self-management behaviors, resilience, and quality of life among adolescents.

DESIGN, SETTING, AND PARTICIPANTS: This phase 3, parallel, 1:1 randomized clinical trial that followed up 172 participants for 12 months was conducted from January 1, 2020, to November 30, 2022, at each of 2 children’s hospitals, in Seattle, Washington, and Houston, Texas. Participants were ages 13 to 18 years with T1D for at least 12 months and elevated diabetes distress.

INTERVENTION: PRISM, a manualized, skills-based, individual intervention program that teaches stress management, goal setting, reframing, and meaning-making, facilitated by a coach and accompanied by a digital app, was delivered in three 30- to 60-minute sessions approximately 2 weeks apart.

MAIN OUTCOMES AND MEASURES: The 2 primary outcomes, diabetes distress and HbA1c levels, and 3 secondary outcomes, resilience, quality of life, and engagement in self-management behaviors, were assessed at baseline and 6 and 12 months after baseline. Linear mixed-effects regression models were used to evaluate associations between PRISM or usual care (UC) and these outcomes at both time points for the intention-to-treat population.

RESULTS: Among 172 adolescents (mean [SD] age, 15.7 [1.6] years), 96 were female (56%), and their baseline mean (SD) HbA1c level was 8.7% (2.0%). No differences were evident between PRISM and UC recipients in HbA1c levels (β, -0.21 [95% CI, -0.65 to 0.22]; P = .33) or diabetes distress (β, -2.71 [95% CI, -6.31 to 0.90]; P = .14) or any participant-reported outcome (eg, β, 2.25 [95% CI, -0.30 to 4.80]; P = .08 for self-management behaviors) at 6 months. At 12 months, there was no statistically significant difference between arms in HbA1c levels (β, -0.26 [95% CI, -0.72 to 0.19]; P = .25); however, PRISM recipients reported significantly greater amelioration of diabetes distress (β, -4.59 [95% CI, -8.25 to -0.94]; P = .01) and improvement in self-management behaviors (β, 3.4 [95% CI, 0.9 to 5.9]; P = .01) compared with UC recipients.

CONCLUSIONS AND RELEVANCE: The findings in this randomized clinical trial of psychosocial and behavioral improvements associated with PRISM at 12 months illustrate the value of a strengths-based intervention. Integrating resilience skills-building with traditional diabetes care may be a promising approach for improving outcomes among adolescents with T1D and elevated diabetes distress.

TRIAL REGISTRATION: ClinicalTrials.gov number: NCT03847194.

PMID:39158914 | DOI:10.1001/jamanetworkopen.2024.28287

JAMA Netw Open. 2024 Aug 1;7(8):e2428769. doi: 10.1001/jamanetworkopen.2024.28769.

ABSTRACT

IMPORTANCE: Many studies show the adverse consequences of insufficient nurse staffing in hospitals, but safe and effective staffing is unlikely to be just about staff numbers. There are considerable areas of uncertainty, including whether temporary staff can safely make up shortfalls in permanent staff and whether using experienced staff can mitigate the effect of staff shortages.

OBJECTIVE: To explore the association of the composition of the nursing team with the risk of patient deaths.

DESIGN, SETTING, AND PARTICIPANTS: This patient-level longitudinal observational study was conducted in 185 wards in 4 acute hospital trusts in England between April 2015 and March 2020. Eligible participants were patients with an overnight stay and nursing staff on adult inpatient wards. Data analysis was conducted from month April 2022 to June 2023.

EXPOSURE: Naturally occurring variation during the first 5 days of hospital admission in exposure to days of low staffing from registered nurses (RNs) and nursing support (NS) staff, the proportion of RNs, proportion of senior staff, and proportion of hospital-employed (bank) and agency temporary staff.

MAIN OUTCOMES AND MEASURES: The primary outcome was death within 30 days of admission. Mixed-effect Cox proportional hazards survival models were used.

RESULTS: Data from 626 313 admissions (319 518 aged ≥65 years [51.0%]; 348 464 female [55.6%]) were included. Risk of death was increased when patients were exposed to low staffing from RNs (adjusted hazard ratio [aHR], 1.08; 95% CI 1.07-1.09) and NS staff (aHR, 1.07; 95% CI, 1.06-1.08). A 10% increase in the proportion of temporary RNs was associated with a 2.3% increase in the risk of death, with no difference between agency (aHR, 1.023; 95% CI, 1.01-1.04) and bank staff (aHR, 1.02; 95% CI, 1.01-1.04). A 10% increase in the proportion of agency NS was associated with a 4% increase in risk of death (aHR, 1.04; 95% CI, 1.02-1.06). Evidence on the seniority of staff was mixed. Model coefficients were used to estimate the association of using temporary staff to avoid low staffing and found that risk was reduced but remained elevated compared with baseline.

CONCLUSIONS AND RELEVANCE: This cohort study found that having senior nurses in the nursing team did not mitigate the adverse outcomes associated with low nurse staffing. These findings indicate that while the benefits of avoiding low staffing may be greater than the harms associated with using temporary staff, particularly for RNs, risk remains elevated if temporary staff are used to fill staffing shortages, which challenges the assumption that temporary staff are a cost-effective long-term solution to maintaining patient safety.

PMID:39158911 | DOI:10.1001/jamanetworkopen.2024.28769