Nevin Manimala

J Tissue Viability. 2024 Jun 25:S0965-206X(24)00086-X. doi: 10.1016/j.jtv.2024.06.011. Online ahead of print.

ABSTRACT

AIM OF THE STUDY: This research is a descriptive and cross-sectional study aimed at examining the use of three different scales to assess the risk of pressure injury (PI) in surgical patients.

MATERIALS AND METHODS: This study was conducted between February 1 and July 1, 2022. The study included patients who had planned surgery in general surgery clinic. The sample size was 388 patients. Patients who agreed to participate in the study were asked to fill out the ” Introductory Information Form ” and perform a risk assessment using the Braden, Munro and 3S Scales. The statistics program IBM SPSS Statistics 25.0 packaged software was used in the analyses of data.

RESULTS: It is evident that the relationship between the scales and the diagnosis of PI, as well as the strength of this relationship, are statistically significant (p < 0.05). The Munro Scale exhibited the highest value of Phi value and validity coefficient c, indicating a stronger association with the diagnosis of PI, thus suggesting its greater effectiveness in discrimination. According to the validity coefficients found, it can be stated that the correct classification percentages for Munro, Braden, and 3S Scales were 91 %, 71 %, and 66 %, respectively.

CONCLUSION: The findings of this study indicate that both the Braden, Munro, and 3S Scales can be used for PI risk assessment in surgical patients, but the Munro Scale exhibits superior predictive validity compared to the Braden and 3S Scales in terms of overall sensitivity and specificity.

PMID:38942648 | DOI:10.1016/j.jtv.2024.06.011

RMD Open. 2024 Jun 28;10(2):e004278. doi: 10.1136/rmdopen-2024-004278.

ABSTRACT

OBJECTIVES: To investigate the efficacy, safety, pharmacokinetics and pharmacodynamics of nipocalimab in participants with moderate to severe active rheumatoid arthritis (RA) and inadequate response or intolerance to ≥1 antitumour necrosis factor agent.

METHODS: In this phase 2a study, participants with RA seropositive for anticitrullinated protein antibodies (ACPA) or rheumatoid factors were randomised 3:2 to nipocalimab (15 mg/kg intravenously every 2 weeks) or placebo from Weeks 0 to 10. Efficacy endpoints (primary endpoint: change from baseline in Disease Activity Score 28 using C reactive protein (DAS28-CRP) at Week 12) and patient-reported outcomes (PROs) were assessed through Week 12. Safety, pharmacokinetics and pharmacodynamics were assessed through Week 18.

RESULTS: 53 participants were enrolled (nipocalimab/placebo, n=33/20). Although the primary endpoint did not reach statistical significance for nipocalimab versus placebo, a numerically higher change from baseline in DAS28-CRP at Week 12 was observed (least squares mean (95% CI): -1.03 (-1.66 to -0.40) vs -0.58 (-1.24 to 0.07)), with numerically higher improvements in all secondary efficacy outcomes and PROs. Serious adverse events were reported in three participants (burn infection, infusion-related reaction and deep vein thrombosis). Nipocalimab significantly and reversibly reduced serum immunoglobulin G, ACPA and circulating immune complex levels but not serum inflammatory markers, including CRP. ACPA reduction was associated with DAS28-CRP remission and 50% response rate in American College of Rheumatology (ACR) criteria; participants with a higher baseline ACPA had greater clinical improvement.

CONCLUSIONS: Despite not achieving statistical significance in the primary endpoint, nipocalimab showed consistent, numerical efficacy benefits in participants with moderate to severe active RA, with greater benefit observed for participants with a higher baseline ACPA.

TRIAL REGISTRATION NUMBER: NCT04991753.

PMID:38942592 | DOI:10.1136/rmdopen-2024-004278

BMJ Paediatr Open. 2024 Jun 28;8(1):e002685. doi: 10.1136/bmjpo-2024-002685.

ABSTRACT

BACKGROUND: Limited evidence exists regarding children receiving home healthcare devices (HHDs). This study aimed to describe the range and type of HHD use by children with chronic medical conditions in Japan and explore factors leading to increased use of these devices.

METHODS: This retrospective cohort study was conducted using data from the National Database of Health Insurance Claims and Specific Health Checkups of Japan. Children receiving HHD aged ≤18 years between April 2011 and March 2019 were included. Children newly administered HHD between 2011 and 2013 were followed up for 5 years, and logistic regression analysis was performed to assess the relationship between increased HHD use and each selected risk factor (comorbidity or types of HHD). The models were adjusted for age category at home device introduction, sex and region.

RESULTS: Overall, 52 375 children receiving HHD were identified. The number (proportion) of children receiving HHD increased during the study period (11 556 [0.05%] in 2010 and 25 593 [0.13%] in 2018). The most commonly administered HHD was oxygen (51.0% in 2018). Among the 12 205 children receiving HHD followed up for 5 years, 70.4% and 68.3% who used oxygen or continuous positive airway pressure, respectively, were released from the devices, while only 25.8% who used mechanical ventilation were released from the device. The following diagnosis/comorbidities were associated with increased HHD use: other neurological diseases (OR): 2.85, 95% CI): 2.54-3.19), cerebral palsy (OR: 2.16, 95% CI: 1.87 to 2.49), congenital malformations of the nervous system (OR: 1.70, 95% CI: 1.34 to 2.13) and low birth weight (OR: 1.68, 95% CI: 1.41 to 2.00).

CONCLUSIONS: This study provides nationwide population-based empirical data to clarify the detailed information regarding children receiving HHD in Japan. This information could assist healthcare professionals in improving the quality of life of these children and their families and help health policymakers consider measures.

PMID:38942589 | DOI:10.1136/bmjpo-2024-002685

BMJ Paediatr Open. 2024 Jun 28;8(1):e002421. doi: 10.1136/bmjpo-2023-002421.

ABSTRACT

INTRODUCTION: To determine the prevalence and associated factors of scabies among the children living in the Madrasahs (Islamic religious educational institution) of Bangladesh was the objective of the study.

METHODS: This cross-sectional study was conducted in eight selected Madrasahs from May to October 2023 among male and female children aged between 3 and 18 years. Children were screened for scabies according to criteria developed by the International Alliance for the Control of Scabies.

RESULTS: It was found that overall prevalence of scabies among the children living in Madrasahs was almost 34% (mild 73.5%, moderate 24.9% and severe 1.6%). Prevalence of scabies among male was higher than female (39.4% vs 28.4%). Male gender (aOR 2.09, 95% CI 1.27 to 3.47, p=0.004) and age (aOR 0.95, 95% CI 0.91 to 0.99, p=0.017) were two significant predictors of scabies among children. Besides, living in Madrasahs having more boarders (aOR 1.37, 95% CI 1.06 to 1.69, p=0.025), shared bedding, clothes or toilet stuffs with other children (aOR 1.46, 95% CI 1.03 to 2.09, p=0.036) and history of pruritus in the close entourage (aOR 4.19, 95% CI 3.07 to 5.73, p<0.001) were associated with a higher chance of being infected by scabies.

CONCLUSION: Almost one-third of the children living in the Islamic boarding schools in Bangladesh are suffering from scabies, more prevalence in male and younger children. Accommodation of higher number of boarders, sharing personal staffs and pruritus in close contacts increase the risk of scabies in these children.

PMID:38942588 | DOI:10.1136/bmjpo-2023-002421

Lancet Public Health. 2024 Jul;9(7):e432-e442. doi: 10.1016/S2468-2667(24)00100-2.

ABSTRACT

BACKGROUND: The COVID-19 pandemic disrupted health-care delivery, including difficulty accessing in-person care, which could have increased the need for strong pharmacological pain relief. Due to the risks associated with overprescribing of opioids, especially to vulnerable populations, we aimed to quantify changes to measures during the COVID-19 pandemic, overall, and by key subgroups.

METHODS: For this interrupted time-series analysis study conducted in England, with National Health Service England approval, we used routine clinical data from more than 20 million general practice adult patients in OpenSAFELY-TPP, which is a a secure software platform for analysis of electronic health records. We included all adults registered with a primary care practice using TPP-SystmOne software. Using interrupted time-series analysis, we quantified prevalent and new opioid prescribing before the COVID-19 pandemic (January, 2018-February, 2020), during the lockdown (March, 2020-March, 2021), and recovery periods (April, 2021-June, 2022), overall and stratified by demographics (age, sex, deprivation, ethnicity, and geographical region) and in people in care homes identified via an address-matching algorithm.

FINDINGS: There was little change in prevalent prescribing during the pandemic, except for a temporary increase in March, 2020. We observed a 9·8% (95% CI -14·5 to -6·5) reduction in new opioid prescribing from March, 2020, with a levelling of the downward trend, and rebounding slightly after April, 2021 (4·1%, 95% CI -0·9 to 9·4). Opioid prescribing rates varied by demographics, but we found a reduction in new prescribing for all subgroups except people aged 80 years or older. Among care home residents, in April, 2020, parenteral opioid prescribing increased by 186·3% (153·1 to 223·9).

INTERPRETATION: Opioid prescribing increased temporarily among older people and care home residents, likely reflecting use to treat end-of-life COVID-19 symptoms. Despite vulnerable populations being more affected by health-care disruptions, disparities in opioid prescribing by most demographic subgroups did not widen during the pandemic. Further research is needed to understand what is driving the changes in new opioid prescribing and its relation to changes to health-care provision during the pandemic.

FUNDING: The Wellcome Trust, Medical Research Council, The National Institute for Health and Care Research, UK Research and Innovation, and Health Data Research UK.

PMID:38942555 | DOI:10.1016/S2468-2667(24)00100-2

Lancet Public Health. 2024 Jul;9(7):e421-e431. doi: 10.1016/S2468-2667(24)00098-7.

ABSTRACT

BACKGROUND: Overdose is the leading cause of death for people released from prison, and opioid agonist treatment is associated with reductions in mortality after imprisonment. However, few studies have explored the interplay of the potential modifiable risk factors and protective factors for mortality after release from prison. We aimed to describe all-cause mortality and overdose mortality among individuals released from Norwegian prisons during 2000-22 and to identify pre-existing risk factors associated with both types of mortality among these individuals for 6 months.

METHODS: For this prospective analysis, we used data from the Norwegian Prison Release Study (nPRIS), which includes all people in prison in Norway between Jan 1, 2000, and Dec 31, 2022; the Norwegian Cause of Death Registry; the Norwegian Prison Registry; the Norwegian Patient Registry; and Statistics Norway. All prisons in Norway that were open during this period were included. People who did not have a Norwegian personal identification number or were serving their sentence outside of prison units were excluded from this analysis. To identify pre-existing risk factors associated with all-cause and overdose mortality among people released from prison, we left-censored the observation period on Jan 1, 2010, creating a subsample of individuals. We calculated crude mortality rates (CMRs) and corresponding 95% CIs as the number of deaths per 100 000 person-years for several time periods after release. The primary outcomes were all-cause mortality and overdose mortality according to the ICD-10, assessed in all participants and analysed via two separate Cox proportional-hazards models.

FINDINGS: The total nPRIS cohort included 112 877 individuals released from prison in Norway between 2000 and 2022, 11 995 (10·6%) of whom were female and 100 865 (89·4%) of whom were male. We identified 13 004 instances of all-cause mortality and 3085 instances of overdose mortality during the 1 463 035 person-years. The estimated CMR for all-cause mortality was 889 (95% CI 874-904) per 100 000 person-years and for overdose mortality was 211 (203-218) per 100 000 person-years. Among people diagnosed with opioid use disorder before entering prison during 2010-22 (n=6830), provision of opioid agonist treatment was estimated to be associated with reductions in both all-cause mortality (hazard ratio 0·58, 95% CI 0·39-0·85) and overdose mortality (0·51, 0·31-0·82) in the 6 months after leaving prison after adjustment for sociodemographic, prison-related, and clinical characteristics.

INTERPRETATION: In people diagnosed with opioid use disorder released from Norwegian prisons, opioid agonist treatment provided while in prison was a protective factor for both all-cause and overdose mortality at 6 months. Provision of opioid agonist treatment while in prison is crucial in reducing mortality for 6 months after release and should be available to all people in prison who have treatment needs.

FUNDING: South-Eastern Norway Regional Health Authority and the Research Council of Norway.

PMID:38942554 | DOI:10.1016/S2468-2667(24)00098-7

Lancet Public Health. 2024 Jul;9(7):e412-e413. doi: 10.1016/S2468-2667(24)00105-1.

NO ABSTRACT

PMID:38942547 | DOI:10.1016/S2468-2667(24)00105-1

PDA J Pharm Sci Technol. 2024 Jun 28:pdajpst.2023.012867. doi: 10.5731/pdajpst.2023.012867. Online ahead of print.

ABSTRACT

Vial and syringe filling by peristaltic pump has been widely implemented by contract manufacturing organizations and biopharmaceutical companies. Fill volume is commonly considered as critical quality attribute related in aseptic filling process and the variation needs to be well controlled to guarantee the safety, efficacy and consistency of drug products. However, the criteria for justifying the filling variation and underlying mechanisms that affect the variability are not fully revealed quantitatively in the literatures. This study selected filling accuracy, filling process capability and filling precision as three criteria for evaluating the filling process performance with four statistical indexes: Relative Error Mean, Critical Control Limit (Cpk ≥ 1.33), Relative Standard Deviation and Relative Moving Range Mean. The impact of liquid properties, pump tubing sizes and pump settings on above indexes were investigated using a bench-top system with a peristatic pump and a high-precision balance. The results showed that the viscosity, target fill volume, pump tubing size, pump speed, acceleration/deceleration rate and suck-back had statistical significance on the fill volume variability. Definitive Screening Design was further applied to clarify and visualize the priorities and interaction impact of above factors on fill volume variability. Stepwise approach for fill volume variability optimization and control based on predictive models was established and verified for drug product solution with viscosity between 1-23 cp and target fill volume between 0.2-2.0 mL.

PMID:38942483 | DOI:10.5731/pdajpst.2023.012867

Korean J Radiol. 2024 Jul;25(7):656-661. doi: 10.3348/kjr.2024.0049.

ABSTRACT

Evaluating the performance of a binary diagnostic test, including artificial intelligence classification algorithms, involves measuring sensitivity, specificity, positive predictive value, and negative predictive value. Particularly when comparing the performance of two diagnostic tests applied on the same set of patients, these metrics are crucial for identifying the more accurate test. However, comparing predictive values presents statistical challenges because their denominators depend on the test outcomes, unlike the comparison of sensitivities and specificities. This paper reviews existing methods for comparing predictive values and proposes using the permutation test. The permutation test is an intuitive, non-parametric method suitable for datasets with small sample sizes. We demonstrate each method using a dataset from MRI and combined modality of mammography and ultrasound in diagnosing breast cancer.

PMID:38942459 | DOI:10.3348/kjr.2024.0049

Korean J Radiol. 2024 Jul;25(7):634-643. doi: 10.3348/kjr.2023.1207.

ABSTRACT

OBJECTIVE: This study aimed to evaluate the diagnostic efficacy and safety of low-contrast-dose, dual-source dual-energy CT before transcatheter aortic valve replacement (TAVR) in patients with compromised renal function.

MATERIALS AND METHODS: A total of 54 consecutive patients (female:male, 26:38; 81.9 ± 7.3 years) with reduced renal function underwent pre-TAVR dual-energy CT with a 30-mL contrast agent between June 2022 and March 2023. Monochromatic (40- and 50-keV) and conventional (120-kVp) images were reconstructed and analyzed. The subjective quality score, vascular attenuation, contrast-to-noise ratio (CNR), and signal-to-noise ratio (SNR) were compared among the imaging techniques using the Friedman test and post-hoc analysis. Interobserver reliability for aortic annular measurement was assessed using the intraclass correlation coefficient (ICC) and Bland-Altman analysis. The procedural outcomes and incidence of post-contrast acute kidney injury (AKI) were assessed.

RESULTS: Monochromatic images achieved diagnostic quality in all patients. The 50-keV images achieved superior vascular attenuation and CNR (P < 0.001 in all) while maintaining a similar SNR compared to conventional CT. For aortic annular measurement, the 50-keV images showed higher interobserver reliability compared to conventional CT: ICC, 0.98 vs. 0.90 for area and 0.97 vs. 0.95 for perimeter; 95% limits of agreement width, 0.63 cm² vs. 0.92 cm² for area and 5.78 mm vs. 8.50 mm for perimeter. The size of the implanted device matched CT-measured values in all patients, achieving a procedural success rate of 92.6%. No patient experienced a serum creatinine increase of ≥ 1.5 times baseline in the 48-72 hours following CT. However, one patient had a procedural delay due to gradual renal function deterioration.

CONCLUSION: Low-contrast-dose imaging with 50-keV reconstruction enables precise pre-TAVR evaluation with improved image quality and minimal risk of post-contrast AKI. This approach may be an effective and safe option for pre-TAVR evaluation in patients with compromised renal function.

PMID:38942457 | DOI:10.3348/kjr.2023.1207