Category: Nevin Manimala

Pediatr Transplant. 2023 Jul 13:e14525. doi: 10.1111/petr.14525. Online ahead of print.

ABSTRACT

BACKGROUND: Pediatric heart transplant candidates on the waitlist have the highest mortality rate among all solid organ transplants. A risk score incorporating a candidate’s individual risk factors may better predict mortality on the waitlist and optimize organ allocation to the sickest of those awaiting transplant.

METHODS: Using the United Network for Organ Sharing (UNOS) database, we evaluated a total of 5542 patients aged 0-18 years old on the waitlist for a single, first time, heart transplant from January 2010 to June 2019. We performed a univariate analysis on two-thirds (N = 3705) of these patients to derive the factors most associated with waitlist mortality or delisting secondary to deterioration within 1 year. Those with a p <0.2 underwent a multivariate analysis and the resulting factors were used to build a prediction model using the Fine-Grey model analysis. This predictive scoring model was then validated on the remaining one-third of the patients (N = 1852).

RESULTS: The Pediatric Risk to OHT (PRO) scoring model utilizes the following unique patient variables: blood type, diagnosis of congenital heart disease, weight, presence of ventilator support, presence of inotropic support, extracorporeal membrane oxygenation (ecmo) status, creatinine level, and region. A higher score indicates an increased risk of mortality. The PRO score had a predictive strength of 0.762 as measured by area under the ROC curve at 1 year.

CONCLUSION: The PRO score is an improved predictive model with the potential to better assess mortality for patients awaiting heart transplant.

PMID:37439081 | DOI:10.1111/petr.14525

BJS Open. 2023 Oct 3;7(4):zrad064. doi: 10.1093/bjsopen/zrad064.

ABSTRACT

BACKGROUND: Evidence is lacking regarding the earliest timing of initiating adjuvant chemotherapy to maximize its efficacy safely. A trial was designed and conducted to evaluate the safety and oncological efficacy of early adjuvant chemotherapy compared with conventional adjuvant chemotherapy. The short-term outcomes are reported here.

METHODS: A multicentre, randomized (1 : 1), open-label, phase III trial was conducted comparing early adjuvant chemotherapy with conventional adjuvant chemotherapy in patients with stage III colon cancer. Patients who underwent radical surgery who had stage III colon cancer confirmed by histopathological assessment were screened and randomized into the early adjuvant chemotherapy arm or the conventional adjuvant chemotherapy arm. The primary endpoint was 3-year disease-free survival. The adjuvant chemotherapy with FOLFOX was delivered between postoperative day 10 and 14 in the early adjuvant chemotherapy arm, and between postoperative day 24 and 28 in the conventional adjuvant chemotherapy arm. Toxicity and quality of life were evaluated.

RESULTS: Between 9 September 2011 and 6 March 2020, 443 patients consented to randomization at eight sites. The intention-to-treat population included 423 patients (209 in the early adjuvant chemotherapy arm and 214 in the conventional adjuvant chemotherapy arm), and the safety population included 380 patients (192 in the early adjuvant chemotherapy arm and 188 in the conventional adjuvant chemotherapy arm). There was no statistically significant difference in overall toxicity (28.1 per cent in the early adjuvant chemotherapy arm and 28.2 per cent in the conventional adjuvant chemotherapy arm, P = 0.244), surgical complications, and quality of life between the two arms.

CONCLUSION: Adjuvant chemotherapy can be safely initiated 2 weeks after surgery with toxicity and quality of life comparable to conventional adjuvant chemotherapy for stage III colon cancer.

PMID:37439066 | DOI:10.1093/bjsopen/zrad064

Tob Control. 2023 Jul 12:tc-2023-057932. doi: 10.1136/tc-2023-057932. Online ahead of print.

ABSTRACT

INTRODUCTION: Electronic nicotine delivery systems (ENDS) are known to contain heavy metals such as lead (Pb), nickel (Ni) and chromium (Cr). The presence of heavy metals in ENDS may be due to contamination of e-liquids or leaching from elements of the ENDS device. This study investigates differences in ENDS metal concentrations between product type, year of purchase, country of purchase and e-liquid flavour.

METHODS: Various open-system (refill e-liquids; n=116) and closed-system (prefilled with e-liquid; n=120) products were purchased in 2017 and 2018 from the USA, England, Canada and Australia. Electrothermal atomic absorption spectroscopy was used to analyse each product for Pb, Ni and Cr. Multiple linear regression and Kruskal-Wallis non-parametric statistical tests were conducted using GraphPad.

RESULTS: Linear regression showed system type, year of purchase (not supported by Kruskal-Wallis), country of purchase and flavour type each had significant impacts on heavy metal concentrations. Open-system e-liquid samples showed no quantifiable levels of heavy metals. Closed-system samples contained concerningly high concentrations of Pb, Ni and Cr. Closed-system samples from the USA commonly displayed higher average heavy metal concentrations than those from England. Some fruit and mint-flavoured closed-system products showed higher heavy metal concentrations than tobacco-flavoured products.

CONCLUSION: The presence of heavy metals only in closed-system products suggests that metals may be leaching from ENDS device parts. Highly variable heavy metal concentrations between ENDS products demonstrate that various product characteristics may affect the degree of leaching and that there is a need for further regulation of these products.

PMID:37438094 | DOI:10.1136/tc-2023-057932

Zhonghua Yi Xue Za Zhi. 2023 Jul 11;103(26):1986-1992. doi: 10.3760/cma.j.cn112137-20230330-00516.

ABSTRACT

Objective: To explore risk factors associated with in-hospital mortality in patients requiring extracorporeal membrane oxygenation (ECMO) in the perioperative period of heart transplantation. Methods: The data of ECMO cases in the perioperative period of heart transplantation from the Chinese Society of Extracorporeal Life Support (CSECLS) between January 2017 and December 2021 were retrospectively analyzed. These patients were divided into the survival group and non-survival group according to their outcomes at discharge. The demographics, indications and complications of ECMO between the two groups were compared, and the related risk factors of poor prognosis were analyzed. Results: A total of 77 patients were included in the study, including 67 males and 10 females, with a median age [M(Q₁, Q₃)] of 48 (36, 59) years. Sixty-three patients (81.8%) were successfully withdrawn from the ECMO and 46 patients (59.7%) survived to discharge. The median ECMO time was 139 (92, 253) hours. Compared with the survival group, the non-survival group (n=31) had more patients with chronic kidney disease before surgery [22.6% (7/31) vs 4.3% (2/46), P=0.034], and a higher proportion of continuous renal replacement therapy (CRRT) during ECMO [74.2% (23/31) vs 50.0% (23/46), P=0.034]. Moreover, the non-survival group had longer duration of extracorporeal circulation [262 (195, 312) vs 201 (155, 261) min, P=0.056] and higher lactate value in the first 24 hours of ECMO support [2.7 (2.1, 4.7) vs 2.3 (1.4, 3.8) mmol/L, P=0.060], but the differences were not statistically significant. Multivariate logistic regression analysis showed that perioperative application of CRRT was an independent risk factor for poor prognosis in ECMO patients during heart transplantation (OR=19.345, 95%CI: 1.209-309.440, P=0.036). Conclusion: CRRT treatment during ECMO is a risk factor for in-hospital mortality in patients undergoing heart transplantation.

PMID:37438080 | DOI:10.3760/cma.j.cn112137-20230330-00516

BMJ Open. 2023 Jul 12;13(7):e070656. doi: 10.1136/bmjopen-2022-070656.

ABSTRACT

OBJECTIVE: To determine the magnitude of hypertension, its association with obesity and the associated factors among employees of Wallaga University, Ethiopia.

DESIGN, SETTING AND PARTICIPANTS: This institution-based cross-sectional study was employed among 588 employees of the university. Respondents were selected by stratified random sampling technique and interviewed with the aid of a structured questionnaire.

THE MAIN OUTCOME MEASURED: Hypertension and obesity were measured using WHO Stepwise approach and recommendations. We used a stratified random sampling technique to select 588 employees of the university from 3 August 2021 to 15 October 2021. A structured questionnaire and anthropometric measurements were used for data collection. Multivariable logistic regression analysis was used to determine factors independently associated with hypertension. A p value less than or equal to 0.05 and its 95% confidence level was used to declare the statistical significance.

RESULTS: A total of 578 participants consented and completed the study, giving a response rate of 98.3%. The mean age of the respondents was 31.78 years with SD of 5.4. The overall prevalence of hypertension, general obesity and central obesity was 14.4% (95% CI 11.6% to 17.5%), 31.3% (95% CI 27.6% to 35.3%) and 37% (95% CI 33.1% to 41.1%), respectively. Obesity was significantly associated with hypertension (adjusted OR (AOR): 6.3; 95% CI 2.60 to 8.19). Age range from 35 to 46 (AOR 7.01; 95% CI 1.56 to 31.74), age ≥46 years (AOR 8.45; 95% CI 1.14 to 62.04), being non-academic staff (AOR 2.74; 95% CI 1.56 to 4.81), having additional income (AOR 2.48; 95% CI 1.08 to 5.70), physical inactivity (AOR 2.36; 95% CI 1.44 to 3.88) and poor practice of dietary salt consumption (AOR 1.65; 95% CI 1.01 to 2.87) were factors associated with hypertension.

CONCLUSION: One in seven, more than two in seven and nearly two in six of the employees of Wallaga University were hypertensive, centrally obese and generally obese, respectively. There was a positive association between obesity and hypertension. Comprehensive awareness creation and devising workplace intervention strategies are highly recommended to reduce the hypertension burden and associated obesity.

PMID:37438078 | DOI:10.1136/bmjopen-2022-070656

BMJ Open. 2023 Jul 12;13(7):e067545. doi: 10.1136/bmjopen-2022-067545.

ABSTRACT

OBJECTIVE: Despite the prevalence of osteoarthritis (OA) in England, few studies have examined the health economic impact of chronic pain associated with OA. The aim of this study was to compare outcomes in patients with moderate-to-severe chronic pain associated with OA and matched controls without known OA.

DESIGN: Retrospective, longitudinal, observational cohort study.

SETTING: Electronic records extracted from the Clinical Practice Research Datalink GOLD primary care database linked to Hospital Episode Statistics (HES) data set.

PARTICIPANTS: Patients (cases; n=5931) ≥18 years and with existing diagnosis of OA and moderate-to-severe pain associated with their OA, and controls matched on age, sex, comorbidity burden, general practitioner (GP) practice and availability of HES data.

INTERVENTIONS: None.

PRIMARY AND SECONDARY OUTCOME MEASURES: Total healthcare resource use (HCRU) and direct healthcare costs during 0-6, 0-12, 0-24 and 0-36 months of follow-up. Secondary outcomes measures included pharmacological management and time to total joint replacement.

RESULTS: Patients with moderate-to-severe chronic pain associated with OA used significantly more healthcare services versus matched controls, reflected by higher HCRU and significantly higher direct costs. During the first 12 months’ follow-up, cases had significantly more GP consultations, outpatient attendances, emergency department visits and inpatient stays than matched controls (all p<0.0001). Total mean costs incurred by cases during 0-12 months’ follow-up were five times higher in cases versus controls (mean (SD): £4199 (£3966) vs £781 (£2073), respectively). Extensive cycling through pharmacological therapies was observed; among cases, 2040 (34.4%), 1340 (22.6%), 841 (14.2%), 459 (7.7%) and 706 (11.9%) received 1-5, 6-10, 11-15, 16-20 and >20 lines of therapy, respectively.

CONCLUSIONS: This wide-ranging, longitudinal, observational study of real-world primary and secondary care data demonstrates the impact of moderate-to-severe chronic pain associated with OA in patients compared with matched controls. Further studies are required to fully quantify the health economic burden of moderate-to-severe pain associated with OA.

PMID:37438077 | DOI:10.1136/bmjopen-2022-067545

BMJ Open. 2023 Jul 12;13(7):e070927. doi: 10.1136/bmjopen-2022-070927.

ABSTRACT

OBJECTIVES: The use of electronic patient-reported outcome (ePRO) systems to support the management of patients with chronic kidney disease is increasing. This mixed-methods study aimed to comprehensively identify existing and developing ePRO systems, used in nephrology settings globally, ascertaining key characteristics and factors for successful implementation.

STUDY DESIGN: ePRO systems and developers were identified through a scoping review of the literature and contact with field experts. Developers were invited to participate in a structured survey, to summarise key system characteristics including: (1) system objectives, (2) population, (3) PRO measures used, (4) level of automation, (5) reporting, (6) integration into workflow and (7) links to electronic health records/national registries. Subsequent semistructured interviews were conducted to explore responses.

SETTING AND PARTICIPANTS: Eligible systems included those being developed or used in nephrology settings to assess ePROs and summarise results to care providers. System developers included those with a key responsibility for aspects of the design, development or implementation of an eligible system.

ANALYTICAL APPROACH: Structured survey data were summarised using descriptive statistics. Interview transcripts were analysed using Codebook Thematic Analysis using domains from the Consolidated Framework for Implementation Research.

RESULTS: Fifteen unique ePRO systems were identified across seven countries; 10 system developers completed the structured survey and 7 participated in semistructured interviews. Despite system heterogeneity, reported features required for effective implementation included early and sustained patient involvement, clinician champions and expanding existing electronic platforms to integrate ePROs. Systems demonstrated several common features, with the majority being implemented within research settings, thereby affecting system implementation readiness for real-world application.

CONCLUSIONS: There has been considerable research investment in ePRO systems. The findings of this study outline key system features and factors to support the successful implementation of ePROs in routine kidney care.Cite Now.

PMID:37438075 | DOI:10.1136/bmjopen-2022-070927

BMJ Open. 2023 Jul 12;13(7):e072582. doi: 10.1136/bmjopen-2023-072582.

ABSTRACT

OBJECTIVES: Studies on health effects of tobacco often rely on self-reported exposure data, which is subjective and can lead to misclassification. The aim of this study was to describe the prevalence of cigarette smoking, snus and e-cigarette use, as well as to validate self-reported tobacco use among young adults in Sweden.

METHOD: Participants of a population-based Swedish cohort (n=3052), aged 22-25 years, assessed their tobacco use in a web questionnaire. Urinary cotinine was analysed in a subsample of the study population (n=998). The agreement between self-reported tobacco use and urinary cotinine was assessed using Cohen’s Kappa coefficient (κ) at a cut-off level of 50 ng/mL.

RESULTS: Patterns of tobacco use differed between men and women. Among men, 20.0% reported daily snus use, 5.8% daily cigarette smoking and 5.6% any e-cigarette use. In contrast, 3.2% of the women reported daily snus use, 9.0% daily cigarette smoking and 2.4% any e-cigarette use. Among the tobacco use categories, daily snus users had the highest levels of cotinine. Of reported non-tobacco users, 3.5% had cotinine levels above the cut-off, compared with 68.0% among both occasional cigarette smokers and snus users, 67.5% among all e-cigarette users and 94.7% and 97.8% among daily cigarette smokers and snus users, respectively. Agreement between self-reported tobacco use and urinary cotinine was classified as strong for daily use of cigarettes (κ=0.824) and snus (κ=0.861), while moderate to weak for occasional smoking (κ=0.618), occasional snus use (κ=0.573) and any e-cigarette use (κ=0.576).

CONCLUSIONS: We found high validity of self-reported tobacco use in our study population, particularly for daily tobacco use. Further, we found that daily snus users were exposed to high levels of cotinine. Together with previous findings, our results indicate good validity of self-reported tobacco use among young adults.

PMID:37438074 | DOI:10.1136/bmjopen-2023-072582

BMJ Open. 2023 Jul 12;13(7):e070931. doi: 10.1136/bmjopen-2022-070931.

ABSTRACT

INTRODUCTION: Readiness to be freed from ventilatory support can be evaluated by spontaneous breathing trial (SBT) assessing the patient’s ability to sustain respiratory effort after extubation. Current SBT practices are heterogenous and there are few physiological studies on the topic. The objective of this study is to assess which SBT best reproduces inspiratory effort to breathe after extubation depending on the patient’s illness.

METHODS AND ANALYSIS: This will be a multicentre randomised cross-over physiological study, in a large population, in the era of modern intensive care units using last generation modern ventilators. Each included patient will perform three 15-minute SBTs in a random order: pressure support ventilation (PSV) level of 7 cmH₂O with positive end expiratory pressure (PEEP) level of 0 cmH₂O, PSV 0 cmH₂O with PEEP 0 cmH₂O and T-piece trial. A rest period of baseline state ventilation will be observed between the SBTs (10 min) and before extubation (30 min). Primary outcome will be the inspiratory muscle effort, reflected by pressure time product per minute (PTPmin). This will be calculated from oesophageal pressure measurements at baseline state, before and after each SBT and 20 min after extubation. Secondary outcomes will be PTPmin at 24 hours and 48 hours after extubation, changes in physiological variables and respiratory parameters at each step, postextubation respiratory management and the rate of successful extubation. One hundred patients with at least 24 hours of invasive mechanical ventilation will be analysed, divided into five categories of critical illness: abdominal surgery, brain injury, chest trauma, chronic obstructive pulmonary disease and miscellaneous (pneumonia, sepsis, heart disease).

ETHICS AND DISSEMINATION: The study project was approved by the appropriate ethics committee (2019-A01063-54, Comité de Protection des Personnes TOURS – Région Centre – Ouest 1, France). Informed consent is required, for all patients or surrogate in case of inability to give consent.

TRIAL REGISTRATION NUMBER: NCT04222569.

PMID:37438068 | DOI:10.1136/bmjopen-2022-070931

BMJ Open. 2023 Jul 12;13(7):e070896. doi: 10.1136/bmjopen-2022-070896.

ABSTRACT

INTRODUCTION: Men in sub-Saharan Africa are less likely than women to initiate antiretroviral therapy (ART) and more likely to have longer cycles of disengagement from ART programmes. Treatment interventions that meet the unique needs of men are needed, but they must be scalable. We will test the impact of various interventions on 6-month retention in ART programmes among men living with HIV who are not currently engaged in care (never initiated ART and ART clients with treatment interruption).

METHODS AND ANALYSIS: We will conduct a programmatic, individually randomised, non-blinded, controlled trial. ‘Non-engaged’ men will be randomised 1:1:1 to either a low-intensity, high-intensity or stepped arm. The low-intensity intervention includes one-time male-specific counseling+facility navigation only. The high-intensity intervention offers immediate outside-facility ART initiation+male-specific counselling+facility navigation for follow-up ART visits. In the stepped arm, intervention activities build in intensity over time for those who do not re-engage in care with the following steps: (1) one-time male-specific counselling+facility navigation→(2) ongoing male mentorship+facility navigation→(3) outside-facility ART initiation+male-specific counselling+facility navigation for follow-up ART visits. Our primary outcome is 6-month retention in care. Secondary outcomes include cost-effectiveness and rates of adverse events. The primary analysis will be intention to treat with all eligible men in the denominator and all men retained in care at 6 months in the numerator. The proportions achieving the primary outcome will be compared with a risk ratio, corresponding 95% CI and p value computed using binomial regression accounting for clustering at facility level.

ETHICS AND DISSEMINATION: The Institutional Review Board of the University of California, Los Angeles and the National Health Sciences Research Council in Malawi have approved the trial protocol. Findings will be disseminated rapidly in national and international forums and in peer-reviewed journals and are expected to provide urgently needed information to other countries and donors.

TRIAL REGISTRATION NUMBER: NCT05137210.

DATE AND VERSION: 5 May 2023; version 3.

PMID:37438067 | DOI:10.1136/bmjopen-2022-070896