Category: Nevin Manimala

Expert Rev Pharmacoecon Outcomes Res. 2024 Jan 8. doi: 10.1080/14737167.2024.2302431. Online ahead of print.

ABSTRACT

INTRODUCTION: An avalanche of early stage cancer clinical trials is coming. The majority of these solely use surrogate outcomes that have not been validated against a target outcome of interest (e.g. overall survival). Current HTA guidance on surrogate outcome validation are not methodologically or practically conducive to this scenario.

AREAS COVERED: We provide a high-level overview of methods, approaches and conceptual thinking for making better use of limited evidence within early stage cancer HTA submissions. We outline regulatory and HTA issues and emphasize how evidence transitions from one to another, what major gaps currently exist, and how these may be bridged. We summarize current methodologies and practices, their pros and cons. We outline how complementary measurements strengthen evaluations and address fallacies and biases of conventional statistical methods for surrogate outcomes validation. The value of real-world data to support some of the necessary validity components is discussed. Lastly, we address the importance of the patient voice for better understanding which surrogate outcomes may appropriately inform HTA.

EXPERT OPINION: Conventional surrogate outcome validation represents a fraught and sub-optimal framework for HTA purposes, particularly for early stage cancer. Tools for optimizing use of limited evidence exist. Education of stakeholders is highly needed.

PMID:38189086 | DOI:10.1080/14737167.2024.2302431

Eur J Midwifery. 2024 Jan 5;8. doi: 10.18332/ejm/174478. eCollection 2024.

ABSTRACT

INTRODUCTION: Family planning is a right and a tool that offers the possibility of choosing how many children to have. Its importance lies in the possibility of avoiding an unwanted pregnancy and its consequences. Our objective was to determine the factors associated with discontinuing hormonal contraceptives in women of childbearing age who attended the La Libertad Health Center in January 2023.

METHODS: The study was observational, analytical, and cross-sectional. A total of 100 women of childbearing age who were users of hormonal contraceptives were included. Descriptive statistics were performed, frequency measurements and measures of central tendency were calculated, bivariate statistics were performed and the prevalence ratio (PR) was calculated, and a robust Poisson regression model was performed to assess the associated independent factors. All calculations were made with a confidence level of 95%.

RESULTS: The educational level (PR=1.74; 95% CI: 1.22-2.48, p=0.006), the distance to the health center (PR=7.32; 95% CI: 1.1-48.5, p=0.001), having presented adverse events (PR=26.38; 95% CI: 3.8-183, p=0.001), and that the health staff had not identified the need for contraception (PR=3.12; 95% CI: 0.87-11.10, p=0.01) were associated with stopping a hormonal contraceptive. After introducing the variables to the regression model, the only independently associated factor was having presented an adverse event with the use of hormonal contraceptives (adjusted prevalence ratio, APR=3.33; 95% CI: 2.1-5.2, p<0.001).

CONCLUSIONS: In this population, the factors associated with the discontinuation of hormonal contraceptives were education level, distance to the health center, having presented some adverse event with its use, and that health staff had not identified the need for contraception. The only independently associated factor was having presented an adverse event.

PMID:38189079 | PMC:PMC10767759 | DOI:10.18332/ejm/174478

J Cutan Aesthet Surg. 2023 Jul-Sep;16(3):214-220. doi: 10.4103/JCAS.JCAS_116_21.

ABSTRACT

BACKGROUND: Nevus of Ota is a facial dermal melanocytic hamartoma occurring more commonly in Asians. The mainstay of treatment is 1064-nm Q-Switched neodymium-doped yttrium aluminum garnet (Nd:YAG) laser, which has shown variable results in pigmented skin.

OBJECTIVE: The aim of this study was to determine whether Q-Switched Nd:YAG laser treatment combined with fractional CO₂ laser is more efficacious than Q-Switched Nd:YAG laser alone.

MATERIALS AND METHODS: This was a prospective study with 81 patients. The patients were randomly divided into two groups. Group 1 received 1064-nm Q-Switched Nd:YAG laser alone and group 2 in addition received a fractional CO₂ laser as well. Both groups received six sittings at monthly intervals. The treatment response was documented with physician global assessment (PGA) and patient’s treatment satisfaction on Wong-Baker Facial Pain Scale (WBFPS). Dermoscopic evaluation was done to see subsurface pigment clearance.

RESULTS: In the combination group, 25% of patients had more than 50% improvement as compared with 5.71% in group 1. To achieve a mean PGA score of 1.4, it took six sessions for group 1 versus only four for group 2. Dermoscopic evaluation showed faster pigment clearance in the combination group.

CONCLUSION: Combining two lasers shows statistically significant faster and greater degree of improvement as compared with Q-Switched Nd:YAG laser monotherapy in nevus of Ota.

PMID:38189068 | PMC:PMC10768965 | DOI:10.4103/JCAS.JCAS_116_21

J Cutan Aesthet Surg. 2023 Jul-Sep;16(3):221-226. doi: 10.4103/JCAS.JCAS_40_22.

ABSTRACT

BACKGROUND: The aesthetic aspect of Type I incomplete split ear lobe is underestimated. Most of the hole-retaining techniques described for large and split ear lobes are difficult to perform in Type I deformity.

AIM: (1) To conduct a pilot study based on the postoperative review of the cases of Type I ear lobe deformities surgically managed with hole-retaining lobeplasty in a tertiary care centre in South India.(2) To assess the postoperative outcome of the hole retaining lobeplasty based on the Global aesthetic improvement scale and Patient satisfaction in Likert scale.

MATERIALS AND METHODS: A pilot study of hole-retaining lobeplasty technique was done based on the postoperative review of 6 patients with bilateral type1 incomplete split ear lobes who were operated in our institution with the same. The results were validated based on descriptive statistics and postoperative outcomes using GAIS score and Patient Satisfaction Score measured in a Likert scale.

RESULTS: None of the patients had any postoperative complications. At six months follow up, all patients had centrally placed, circular ear holes, well settled support flap and rounded lobe contour with an average GAIS score of 4.83 ± 0.38. All the patients were satisfied with their newly created ear hole and lobe contour, with an average Patient Satisfaction Score of 4.8 ± 0.4.

CONCLUSION: Hole- retaining lobeplasty is a simple, cost effective, single staged, day-case procedure for repair of Type I large ear holes, that can be easily duplicated by young plastic surgeons with is aesthetically better, circular and centrally placed ear hole with a more rounded ear lobe with support to prevent recurrence.

PMID:38189062 | PMC:PMC10768956 | DOI:10.4103/JCAS.JCAS_40_22

ScientificWorldJournal. 2023 Dec 31;2023:1863346. doi: 10.1155/2023/1863346. eCollection 2023.

ABSTRACT

Rainfall is one of the climatic factors that influence various human activities and affect decision making in daily life activities. High intensity of rainfall can turn into a threat and cause serious problems such as causing various natural disasters. Therefore, it is essential to conduct rainfall forecasting to anticipate and enable preventive actions and can be used as a decision consideration in increasing the productivity and mobility of human activities. The aim of this study is to compare rainfall accuracy between the Gregorian and the lunar calendars using the bidirectional long short-term memory (Bi-LSTM) machine learning model through the grid search approach. This method was used because it can capture patterns arising from the simultaneous effects of two asynchronous calendars, Gregorian and lunar, which were used in this study by finding the right parameters. Monthly rainfall data from Bogor City, Indonesia, were used from the period of 2001 to 2022. The results show that the MAPE of the lunar calendar is relatively smaller at 14.82% which indicates the better forecasting ability than the Gregorian calendar which is 35.12%.

PMID:38189057 | PMC:PMC10771920 | DOI:10.1155/2023/1863346

Scientifica (Cairo). 2023 Dec 29;2023:6652112. doi: 10.1155/2023/6652112. eCollection 2023.

ABSTRACT

Diabetes mellitus is a chronic metabolic disorder which has greatly led to an increase in morbidity and mortality globally. Although Xerophyta spekei is widely used for the management of diabetes among the Embu and Mbeere communities in Kenya, it has never been empirically evaluated for its hypoglycemic activity. This study was carried out to verify the hypoglycemic activity of dichloromethane (DCM) extract of Xerophyta spekei as well as its antioxidant activity using various in vitro techniques. Phytochemicals associated with its antioxidant activity were identified through GC-MS. Data were subjected to descriptive statistics and expressed as mean ± standard error of the mean (X̄ ± SEM). Comparison between various variables was performed by using unpaired Student’s t-test and one-way analysis of variance (ANOVA), followed by Tukey’s post-hoc test. The confidence interval was set at 95%. The obtained results were presented in tables and graphs. Results showed that there was no difference in α-amylase inhibition activity between the plant extract and the standard (IC₅₀ 525.9 ± 12.34 and 475.1 ± 9.115, respectively; p > 0.05). Besides, the glucose adsorption activity of the extract increased with an increase in glucose concentration (from 5.89 to 32.64 mg/dl at 5 mmol and 30 mmol of glucose, respectively; p < 0.05). The extract also limited the diffusion of glucose more than the negative control (7.49 and 17.63 mg/dl, respectively; p < 0.05). It also enhanced glucose uptake by yeast cells. In addition, the studied plant extract showed notable antioxidant activities. The therapeutic effects exhibited by this plant in managing diabetes mellitus and other ailments could be due to its antioxidant as well as its hypoglycemic activity. The study recommends the evaluation of X. spekei for in vivo hypoglycemic and antioxidant activities. Besides, the isolation of bioactive phytochemicals from the plant may lead to the development of new hypoglycaemic agents.

PMID:38188987 | PMC:PMC10769734 | DOI:10.1155/2023/6652112

J Drug Deliv Sci Technol. 2024 Jan;91:105110. doi: 10.1016/j.jddst.2023.105110. Epub 2023 Nov 15.

ABSTRACT

Obesity is a severe public health problem. Healthy lifestyle interventions are commonly recommended for fighting obesity. But they are hard to follow and have low efficacy. Pharmacotherapy and surgery are of high efficacy but are beset with side effects. Browning subcutaneous white adipose tissue (WAT) is a practical and efficient approach for combating obesity. Metformin, a commonly used FDA-approved antidiabetic drug, is potent to induce browning of WAT through phosphorylation and activation of AMP-activated protein kinase. However, oral administration of metformin has low oral bioavailability, fast renal clearance, and low target specificity that limit metformin’s application in browning WAT. Local and transdermal delivery of metformin directly to subcutaneous WAT using injection or microneedle (MN) in combination with iontophoresis (INT) may solve these problems. In this paper, we administered metformin to C57BL/6J obese mice using the following three routes: transdermal delivery (MN and INT), local injection into inguinal WAT (IgWAT, a type of subcutaneous WAT in mice), and oral gavage. The anti-obesity and metabolic effects of metformin via these delivery routes were determined and compared. As compared to local IgWAT injection and oral gavage delivery, transdermal delivery of metformin using MN and INT resulted in 9% lower body weight and 7% decrease in body fat% accompanied by improved energy metabolism and decreased inflammation through browning IgWAT in obese C57BL/6J mice. Transdermal delivery of metformin using MN and INT is an effective approach in browning subcutaneous WAT for combating obesity and improving metabolic health.

PMID:38188941 | PMC:PMC10768944 | DOI:10.1016/j.jddst.2023.105110

Res Synth Methods. 2024 Jan 7. doi: 10.1002/jrsm.1690. Online ahead of print.

ABSTRACT

Literature screening is the process of identifying all relevant records from a pool of candidate paper records in systematic review, meta-analysis, and other research synthesis tasks. This process is time consuming, expensive, and prone to human error. Screening prioritization methods attempt to help reviewers identify most relevant records while only screening a proportion of candidate records with high priority. In previous studies, screening prioritization is often referred to as automatic literature screening or automatic literature identification. Numerous screening prioritization methods have been proposed in recent years. However, there is a lack of screening prioritization methods with reliable performance. Our objective is to develop a screening prioritization algorithm with reliable performance for practical use, for example, an algorithm that guarantees an 80% chance of identifying at least $80\%$ of the relevant records. Based on a target-based method proposed in Cormack and Grossman, we propose a screening prioritization algorithm using sampling with replacement. The algorithm is a wrapper algorithm that can work with any current screening prioritization algorithm to guarantee the performance. We prove, with mathematics and probability theory, that the algorithm guarantees the performance. We also run numeric experiments to test the performance of our algorithm when applied in practice. The numeric experiment results show this algorithm achieve reliable performance under different circumstances. The proposed screening prioritization algorithm can be reliably used in real world research synthesis tasks.

PMID:38185812 | DOI:10.1002/jrsm.1690

Sports Med Open. 2024 Jan 7;10(1):4. doi: 10.1186/s40798-023-00669-2.

ABSTRACT

BACKGROUND: Better methods to support talent identification and development processes may contribute to more effective and efficient athlete development programs in racket sports. Both researchers and practitioners recommend multidimensional and longitudinal approaches to better understand the nature of talent (development). However, the added value of these ‘innovative’ approaches has not yet been clarified for racket sports. This systematic review intends to gain further insight into the outcomes of multidimensional and longitudinal approaches for talent identification and development in racket sports and to provide directions for future talent research.

METHODS: Electronic searches were conducted in PubMed, Scopus, SPORTDiscus, and Web of Science (January 2000-August 2022). Search terms covered the areas of racket sports and talent in sports. Studies using multidimensional and/or longitudinal talent approaches were included and analyzed regarding the methodology, included performance characteristics (i.e., anthropometrical, physiological, technical, tactical, psychological), and study findings.

RESULTS: A total of thirty-two studies were included using multidimensional (n = 15), unidimensional longitudinal (n = 3) or multidimensional longitudinal designs (n = 14). Most research covered physiological characteristics (n = 28), while fewer articles investigated anthropometrics (n = 21) and technical characteristics (n = 16). Only limited research investigated psychological (n = 4) and tactical characteristics (n = 1). Almost all studies measured physiological characteristics in combination with other characteristics. There was moderate to strong evidence that physiological and technical characteristics have value for athlete development programs in racket sports. Positive but limited evidence was found for psychological and tactical characteristics. Anthropometrical assessments were generally used as controlling variables for maturation. Study designs varied, and many studies used unidimensional statistical models and analyses within multidimensional study designs and datasets.

CONCLUSIONS: This review provides an overview of talent research using multidimensional and/or longitudinal approaches within racket sports and gives guidance on what characteristics to include in decision-making and monitoring processes. However, it remains difficult to draw conclusions about the added values of these approaches due to their variety in methodology. Future talent research should include more consistent study designs and conduct multidimensional and longitudinal studies using multivariate statistical approaches that benefit from the data’s multidimensionality.

PMID:38185790 | DOI:10.1186/s40798-023-00669-2

BMC Oral Health. 2024 Jan 7;24(1):38. doi: 10.1186/s12903-023-03829-8.

ABSTRACT

BACKGROUND: Various methods can be used for creating zirconia dental restorations, including 3-dimensional (3D) printing and computer-aided design/ computer-aided manufacturing (CAD/CAM) milling. The fused deposition modeling (FDM) printing method for zirconia presents numerous advantages, albeit research on the mechanical properties of these materials and resultant restorations remains scarce. Such developments are undeniably intriguing and warrant further investigation. The objective of the present study was to evaluate the impact of the sintering firing cycle (Conventional vs. Speed sintering) on the flexural strength, flexural modulus, and Vickers Microhardness of milled vs. FDM printed zirconia.

METHODS: A total of 60 bars (2 × 5 × 27 mm) were fabricated for flexural strength testing, along with 40 discs (12 × 1.5 mm) for Vickers microhardness testing. Half of the specimens underwent conventional sintering, while the other half underwent a speed sintering cycle. The flexural strength and modulus were determined by a three-point bending test in a universal testing machine. The microhardness of the specimens was evaluated using a Vickers microhardness tester. Statistical analysis was performed using a two-way ANOVA test with a post-hoc Tukey test (p < 0.05).

RESULTS: CAD/CAM milled zirconia had significantly higher flexural strength and modulus than FDM-printed zirconia. The sintering process did not significantly affect the flexural strength or modulus of milled or FDM-printed zirconia. The milled speed sintering group had significantly higher values in the Vickers microhardness test compared to the other groups.

CONCLUSIONS: The mechanical properties of FDM-printed zirconia specimens were not found to be comparable to those of milled zirconia. Speed sintering cycle may produce milled zirconia restorations with similar flexural strength and modulus to conventional sintering, and even higher Vickers Microhardness values.

PMID:38185744 | DOI:10.1186/s12903-023-03829-8