Nevin Manimala

Expert Rev Med Devices. 2022 Aug 30. doi: 10.1080/17434440.2022.2118046. Online ahead of print.

ABSTRACT

INTRODUCTION: Favouring innovation by making timely medical technology available to people and by securing patients’ safety is a challenge.

AREAS COVERED: The new European medical device regulation (MDR) will have a central implication in the development of new devices and could affect their innovation and availability, as well as discourage investment in research within Europe.

EXPERT OPINION: Start-ups and small companies might not be able to cope with the increasing complexity and the required changes of perspective. Healthcare institutions are facing an increasing availability of complex technologies, while data on their clinical efficacy and cost-effectiveness are rarely provided.

A partnership/collaboration between healthcare institutions, academia and private industries will enhance their own specific interests with the common goal of improving overall health and quality of life. The complexity of the subject combined with the variety of specialists and stakeholders involved requires the implementation, in hospital centres of clinical excellence, of units dedicated to the whole path of the medical device innovation. Stakeholders should quickly provide adequate measures to facilitate the complex medical device innovation path under the more stringent MDR aimed to increase safety and quality of care.

PMID:36039712 | DOI:10.1080/17434440.2022.2118046

Pediatrics. 2022 Aug 30:e2021051252. doi: 10.1542/peds.2021-051252. Online ahead of print.

ABSTRACT

BACKGROUND: American Academy of Pediatrics guidelines recommend 400 IU of vitamin D supplementation daily for certain infants <1 year of age. We aimed to increase the proportion of reported appropriate vitamin D supplementation for infants born at our institution and those who followed up in our resident clinic through 6 months from 49% to 80% over 24 months.

METHODS: Our interdisciplinary quality improvement effort included vitamin D medication delivery before nursery discharge and family and staff education. The process measure was the percentage of families discharged from birth hospitalization with vitamin D and teaching. The outcome measure was the percentage of families reporting appropriate vitamin D supplementation at 2-, 4-, and 6-month well child visits. The balancing measure was the percentage of infants discharged from the nursery by 2 pm. Data were displayed on Statistical Process Control p charts and established rules for detecting special causes were applied.

RESULTS: Baseline and improvement data were collected for 587 hospital discharges and 220 outpatient encounters. The percentage of families discharged with vitamin D increased from 24.8% to 98% from 2016 to 2018. Percent of families reporting appropriate vitamin D supplementation at well child visits increased from 49% to 89% from 2016 to 2018. Overall, the percentage of discharges by 2 pm remained stable at 60%.

CONCLUSION: Bedside medication delivery and education in the newborn nursery improved reported vitamin D supplementation rates in the first 6 months of life. The intervention did not delay newborn hospital discharge.

PMID:36039691 | DOI:10.1542/peds.2021-051252

Pediatr Transplant. 2022 Aug 30:e14379. doi: 10.1111/petr.14379. Online ahead of print.

ABSTRACT

BACKGROUND: This study aims to establish multiple ML models and compare their performance in predicting tacrolimus concentration for infant patients who received LDLT within 3 months after transplantation.

METHODS: Retrospectively collected basic information and relevant biochemical indicators of included infant patients. CMIA was used to determine tacrolimus C₀ . PCR was used to determine the donors’ and recipients’ CYP3A5 genotypes. Multivariate stepwise regression analysis and stepwise elimination covariates were used for covariates selection. Thirteen machine learning algorithms were applied for the development of prediction models. APE, the ratio of the APE ≤3 ng ml^-1 and ideal rate (the proportion of the predicted value with a relative error of 30% or less) were used to evaluate the predictive performance of the model.

RESULTS: A total of 163 infant patients were included in this study. In the case of the optimal combination of covariates, the Ridge model had the lowest APE, 2.01 (0.85, 3.35 ng ml^-1 ). The highest ratio of the APE ≤3 ng ml^-1 was the LAR model (71.77%). And the Ridge model showed the highest ideal rate (55.05%). For the Ridge model, GRWR was the most important predictor.

CONCLUSIONS: Compared with other ML models, the Ridge model had good predictive performance and potential clinical application.

PMID:36039686 | DOI:10.1111/petr.14379

J Integr Bioinform. 2022 Aug 30. doi: 10.1515/jib-2022-0004. Online ahead of print.

ABSTRACT

Tinnitus is an annoying ringing in the ears, in varying shades and intensities. Tinnitus can affect a person’s overall health and social well-being (e.g., sleep problems, trouble concentrating, anxiety, depression and inability to work). The diagnostic procedure of tinnitus usually consists of three steps: an audiological examination, psychoacoustic measurement, and a disability evaluation. All steps are performed by physicians, who use specialised hardware/software and administer questionnaires. This paper presents a system, to be used by patients, for the diagnosis and self-management of tinnitus. The system is made up of an app and a device. The app is responsible for executing – through the device – a part of the required audiological and psychoacoustic examinations, as well as administering questionnaires that evaluate disability. The paper reviews the quality of the automated audiometric reporting and the user experience provided by the app. Descriptive and inferential statistics were used to support the findings. The results show that automated reporting is comparable with that of physicians and that user experience was improved by re-designing and re-developing the acufenometry of the app. As for the user experience, two experts in Human-Computer Interaction evaluated the first version of the app: their agreement was good (Cohen’s K = 0.639) and the average rating of the app was 1.43/2. Also patients evaluated the app in its initial version: the satisfactory tasks (audiometry and questionnaires) were rated as 4.31/5 and 4.65/5. The unsatisfactory task (acufenometry) was improved and the average rating increased from 2.86/5 to 3.96/5 (p = 0.0005). Finally, the general usability of the app was increased from the initial value of 73.6/100 to 85.4/100 (p = 0.0003). The strengths of the project are twofold. Firstly, the automated reporting feature, which – to the best of our knowledge – is the first attempt in this area. Secondly, the overall app usability, which was evaluated and improved during its development. In summary, the conclusion drawn from the conducted project is that the system works as expected, and despite some weaknesses, also the replication of the device would not be expensive, and it can be used in different scenarios.

PMID:36039680 | DOI:10.1515/jib-2022-0004

Aesthet Surg J. 2022 Aug 30:sjac233. doi: 10.1093/asj/sjac233. Online ahead of print.

ABSTRACT

BACKGROUND: Recently we have seen an expanding practice of targeting the deeper, subplatysmal structures in the neck. In particular, interventions targeting the “bulky” anterior digastric (AD) muscle have been described with excellent results. However, much remains to be understood about the deep anatomy of the neck and the age-associated changes of the AD.

OBJECTIVES: To examine the relationship between AD volume and age.

METHODS: This retrospective study calculated the AD volume utilizing MRI segmentation in subjects between the ages of 20-92 with prior MRIs. Those with compromised imaging due to pathology or artifact were excluded. Subjects were divided into four age-defined cohorts for clinical applicability.

RESULTS: This study included 129 patients (male n=64) with a mean age of 52.3. The AD volume of the reference group was 3.2 cm3. A linear decrease in muscle volume was observed with age compared to the reference group: age 45-54 cohort, 2.95 cm3 (p=.3), 55-64 cohort, 2.7 cm3 (p=.05) and >65 cohort, 2.45 cm3 (p<0.001). Male sex (p=.0001) and laterality (p=.003) were associated with significantly larger volumes. Overweight and obese BMI classification was not associated with a significantly different volume than normal or underweight subjects (p=.067).

CONCLUSIONS: Our findings suggest an age-associated reduction in AD volume. Gender and laterality significantly affected volume, while BMI did not. While our results do not support the theory of muscular hypertrophy with aging, they reveal that the perceived bulkiness may be due to changes in the surrounding anatomy affecting the morphology of the AD and subsequent blunting of the cervicomental angle.

PMID:36039633 | DOI:10.1093/asj/sjac233

Stat Med. 2022 Sep 10;41(20):4079. doi: 10.1002/sim.9518.

NO ABSTRACT

PMID:36039613 | DOI:10.1002/sim.9518

Dermatol Ther. 2022 Aug 30:e15796. doi: 10.1111/dth.15796. Online ahead of print.

ABSTRACT

BACKGROUND: Psoriasis is a papulosquamous disorder that causes significant social and psychological trauma to the patient. It is characterized by the presence of erythematous, indurated plaques covered with silvery-white scales. Despite the availability of several systemic agents that have been approved for the treatment of psoriasis, usually there are some residual lesions and there is a need to treat them for cosmetic reasons or symptomatic control.

AIMS: 1. Treatment of resistant localized psoriatic plaques or residuals after systemic treatment. 2. Recently, some intralesional agents have been used successfully for the treatment of psoriatic plaques as 5-FU, methotrexate, and botulinum toxin type-A, and nearly for 4 decades, no study focused on the effect of intralesional corticosteroids in the treatment of these psoriatic plaques. We decided to highlight their role and compare intralesional Triamcinolone to intralesional 5-FU regarding efficacy and safety in the treatment of plaque psoriasis.

METHODS: This study included 24 patients with localized plaque psoriasis. Each patient was treated by split-body therapy where one psoriatic plaque was treated with intralesional 5FU and another plaque with intralesional TAC. A total of three injections were given at two- week intervals and follow up was regularly every 2 weeks up to 12 weeks.

RESULTS: There was a statistically significant difference between both groups (p = 0.008) as the response rate on 5-FU side was 12.5% with no response, 29.2% with a moderate response, 41.7% with an excellent response, and 16.7% with a complete clearance, while on the TAC side it was16.7% with a moderate response, 20.8% with an excellent response and 62.5% with a complete clearance. Hyperpigmentation was the most irritating side effect of 5-FU that occurred. Pain, during and after injection, was greater in 5-FU group. Hypopigmentation and atrophy only occurred in TAC group in some patients but it seems to be reversible and not disfiguring.

CONCLUSION: 1-Intralesional TAC injection may have more efficacy and less side effects than 5-FU injection in the treatment of localized plaque psoriasis. Hyperpigmentation and pain were the most irritating side effects of 5-FU 2-Intralesional TAC can be effective in the treatment of localized psoriatic plaques with minimal side effects, especially in patients not suitable for systemic agents.

PMID:36039604 | DOI:10.1111/dth.15796

Clin Exp Emerg Med. 2022 Aug 31. doi: 10.15441/ceem.21.164. Online ahead of print.

ABSTRACT

OBJECTIVE: Since onsite education is difficult due to the COVID-19 pandemic, official development assistance (ODA) projects have implemented online training of trainers (ToT) for emergency medical experts and staff. This study aims to share and discuss the ToT experience and its results in Uzbekistan.

METHODS: We trained emergency medical advanced course instructors through online ToT among emergency medical service experts in Uzbekistan as a part of an ODA project. After the ToT, instructors were selected based on written tests, video monitoring of practice, and simulation performance. They operated the emergency medical course including lectures, practices, and simulations for 5 days. We tested the trainees through written tests before and after the course. They were surveyed regarding the course contents, its relevance, and their satisfaction with the course.

RESULTS: Six instructors were selected after the online ToT program. They educated 68 emergency medical workers through the three training courses. The total score of the pretest was 129.2±34.8, and the posttest score was 170.8±31.2, which was significantly higher (P<0.05). The satisfaction calculated by adding the values of survey items for this curriculum was 28.0 (interquartile range, 26.0-30.0), and there was no statistical difference regarding trainee satisfaction between the three courses (P=0.148).

CONCLUSION: Instructors trained by online ToT programs could provide an in-person emergency medical advanced course.

PMID:36039600 | DOI:10.15441/ceem.21.164

Clin Chem Lab Med. 2022 Aug 31. doi: 10.1515/cclm-2022-0447. Online ahead of print.

ABSTRACT

OBJECTIVES: Cellular analysis of body fluids (BF) has clinical relevance in several medical conditions. The objective of this study is twofold: (1) evaluate the analytical performance of the BF mode of Mindray BC-6800 Plus compared to manual counts under microscopy and (2) analyse if the high-fluorescent cell counts provided by the analyser (HF-BF) are useful to detect malignancy.

METHODS: A total of 285 BF was analysed: 250 corresponding to patients without neoplasia and 35 to patients with malignant diseases. Manual differential counts were performed in BF with ≥250 cells/μL. Percentages and absolute counts were obtained on the BC-6800Plus for total nucleated cells (TC-BF), mononuclear, polymorphonuclear and HF-BF. Statistical analysis was performed using Mann-Whitney U-test, Spearman’s correlation, Passing-Bablok regression, Bland-Altman graph and ROC curve.

RESULTS: To compare manual and automatic total cell counts, samples were divided in three groups: <250, 250-1,000 and >1,000 cells/μL. Correlation was good in all cases (r=0.72, 0.73 and 0.92, respectively) without significant differences between both methods (p=0.65, 0.39 and 0.30, respectively). The concordance between methods showed values of 90%. Considering malignant samples, median HF-BF values showed significant higher values (102 cells/μL) with respect to non-malignant (4 cells/μL) (p<0.001). The cut-off value of 8.5 HF-BF/μL was able to discriminate samples containing malignant cells showing sensitivity and specificity values of 89 and 71%, respectively. Considering both, HF-BF and TC-BF values, sensitivity and specificity values were 100 and 53%, respectively.

CONCLUSIONS: This study reveals that the Mindray BC-6800Plus offers an accurate and acceptable performance, showing results consistent with the manual method. It is recommended to consider both HF-BF and TC-BF values for the screening of the microscopic evaluation to ensure the detection of all malignant samples.

PMID:36039597 | DOI:10.1515/cclm-2022-0447

Zhong Nan Da Xue Xue Bao Yi Xue Ban. 2022 Jul 28;47(7):910-919. doi: 10.11817/j.issn.1672-7347.2022.220135.

ABSTRACT

OBJECTIVES: Many neuropsychiatric diseases are related to the abnormal development of brain tissue in infants. This study aims to analyze the changes in the parameters of magnetic resonance spectroscopy (MRS) and diffusion tensor imaging (DTI) in brain development of infants aged from 2 months to 2 years old, and to explore the value of MRS combined with DTI in evaluating brain development of infants aged from 2 months to 2 years old.

METHODS: A total of 116 normal infants, who received whole brain MRS and DTI examinations after delivery in Children Hospital of Shanxi Province from September 2020 to May 2021, were selected and were divided into a group A (n=7, at the age of 2-6 months), a group B (n=28, at the age of 7-12 months), a group C (n=41, at the age of 13-18 months), and a group D (n=40, at the age of 19-24 months). After collecting the MRS and DTI data, statistical analysis was performed to compare DTI parameters and MRS metabolic products ratio.

RESULTS: There were significant differences in the DTI parameters of frontal lobe, temporal lobe, occipital lobe, hind limb of internal capsule, fore limb of internal capsule, knee of corpus callosum, splenium of corpus callosum, and optic radiation among the 4 groups (P<0.05 or P<0.01). The values of fractional anisotropy (FA) showed an upward trend from the group A to the group D, while the values of apparent diffusion coefficient (ADC), axial diffusivity (AD), and radial diffusivity (RD) showed a downward trend, and the changes of parameters tended to slow down with age. In the left or right lentiform nucleus, the ratio of choline (Cho)/creatine (Cr) was decreased from the group A to the group D, and the group D was significantly lower than the group A and B (all P<0.01). The ratio of Cho/N-acetyl aspartate (NAA) was decreased from the group A to the group D, and the group D was significantly lower than the group A, B, and C (left lentiform nucleus, P<0.05 or P<0.01) or the group A, B (right lentiform nucleus, both P<0.01). The ratio of glutamine/glutamate (Glx)/Cr was decreased from the group A to the group D, and the group D was significantly lower than the group A, B and C (P<0.05 or P<0.01). The ratio of myo-inositol (mI)/Cr was increased from the group A to the group D, and the group D was significantly higher than the group A, B, and C (P<0.05 or P<0.01). The ratio of NAA/Cr was increased from the group A to the group D, and the group B, C, and D were significantly higher than the group A (P<0.05 or P<0.01). The ratios of mI/Cr and NAA/Cr in different brain regions from the group A to the group D showed an upward trend, and the ratios of Cho/Cr, Cho/NAA, and Glx/Cr showed a downward trend. The variation of each parameter tends to decrease with age.

CONCLUSIONS: MRS and DTI can detect the brain development of infants aged from 2 months to 2 years old, and provide a basis for predicting brain diseases.

PMID:36039588 | DOI:10.11817/j.issn.1672-7347.2022.220135