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Nevin Manimala Statistics

A Randomized, Double Blinded, Split-Face Study of the Efficacy of Using a Broad Spectrum Sunscreen with Anti-Inflammatory Agent to Reduce Post Inflammatory Hyperpigmentation After Picosecond Laser

Clin Cosmet Investig Dermatol. 2022 Feb 27;15:331-337. doi: 10.2147/CCID.S355329. eCollection 2022.

ABSTRACT

BACKGROUND: Post inflammatory hyperpigmentation (PIH) is a sequela of laser procedures observed commonly in darker-skin individuals. In general, regular UV filters are beneficial in preventing PIH, but the comparison with sunscreen containing anti-inflammatory ingredients remains unexplored.

OBJECTIVE: To compare the efficacy of a sunscreen with anti-inflammatory agent (sunscreen A) in the reduction of PIH after a picosecond laser with that of regular sunscreen (sunscreen B).

METHODS: Fifty-nine acne vulgaris and acne scar patients with skin phototypes III and IV were treated with 1 session of picosecond laser with the microlens array to the whole face. Sunscreens A and B were randomized to be applied on either side of the face. Hyperpigmentation assessed by brown score mode on Visia®, acne quantity, porphyrins and patient satisfaction were evaluated at baseline, weeks 1, 2, 4 and 6.

RESULTS: Sunscreen A caused a higher reduction of the brown score compared to the other side but there was no statistically significant difference. Interestingly, a significant decrease of inflammatory acne lesions compared with baseline was observed as early as week 2 on the sunscreen A side (weeks 2, 4 and 6; P = 0.017, P = <0.001, and P = <0.001, respectively). Compared with sunscreen B, levels of porphyrins on sunscreen A side were significantly less at weeks 1 and 6 (weeks 1 and 6; P = 0.022 and P = 0.029, respectively).

CONCLUSION: This study demonstrated a tendency towards lower post-laser pigmentation when the sunscreen with anti-inflammatory agents was applied. This product also had an effective outcome as an adjunctive treatment option of acne vulgaris.

THAI CLINICAL TRIALS REGISTRY ID: TCTR20210305004 (URL: http://www.thaiclinicaltrials.org/show/TCTR20210305004).

PMID:35250287 | PMC:PMC8894080 | DOI:10.2147/CCID.S355329

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Nevin Manimala Statistics

Prevalence of Vitamin D Deficiency Between Type 2 Diabetes Mellitus Patients and Non-Diabetics in the Arab Gulf

Diabetes Metab Syndr Obes. 2022 Feb 28;15:647-657. doi: 10.2147/DMSO.S350626. eCollection 2022.

ABSTRACT

BACKGROUND: The link between the risk of type 2 diabetes mellitus (T2DM) and vitamin D deficiency has perplexed the medical society due to the controversy in the data available. Saudi Arabia (SA) is a sunny region; however, ample amount of data reported the increased prevalence of vitamin D deficiency along with T2DM. Thus, this study aimed to compare vitamin D deficiency between healthy and T2DM patients in SA, alongside with the risk factors associated with that.

METHODS: A cross-sectional study was conducted in the Medical Unit, Taibah University in Al-Madinah Al-Munawarah, SA, from November 2017 to May 2018. The involved participants were non-diabetics and T2DM men. Measuring vitamin D for T2DM and non-diabetics group was done by trained technicians. Data analysis was done via SPSS.

RESULTS: Sixty-four participants (T2DM group = 32; non-diabetics group = 32) were recruited, and the mean age of T2DM patients was 48.6 ± 10.4, while that of the non-diabetics was 42.4 ± 6.5. The mean of vitamin D level was found higher in the non-diabetic participants than in diabetic patients. There was statistically significant association between vitamin D deficiency and T2DM (P = 0.001). Besides, duration of diabetes was the only factor, found to be positively correlated with vitamin D deficiency in T2DM patients.

CONCLUSION: Early screening for vitamin D serum-level is recommended for T2DM patients in Saudi Arabia. Therefore, early correction of vitamin D levels should be considered, and medical and scientific societies, along with other sectors such as the media, should highlight and increase the awareness of the importance of vitamin D and the seriousness of its deficiency.

PMID:35250286 | PMC:PMC8896538 | DOI:10.2147/DMSO.S350626

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Nevin Manimala Statistics

Statin Prescription Patterns and Associated Factors Among Patients with Type 2 Diabetes Mellitus Attending Diabetic Clinic at Muhimbili National Hospital, Dar es Salaam, Tanzania

Diabetes Metab Syndr Obes. 2022 Feb 27;15:633-646. doi: 10.2147/DMSO.S347765. eCollection 2022.

ABSTRACT

PURPOSE: To determine statin prescription patterns and associated factors among type 2 diabetes patients attending the diabetic clinic at Muhimbili National Hospital (MNH) in Dar es Salaam, Tanzania.

PATIENTS AND METHODS: A hospital-based cross-sectional study involving outpatients was conducted from September 2020 to November 2020. Statin prescription history (both type and dosage) was obtained from patients as well as from the electronic medical records for determination of patterns. Participants were categorized as moderate or high risk for cardiovascular disease whereas prescription patterns were categorized as moderate and high intensity statins. Logistic regression was used to examine association, control confounders and effect modifier whereby p <0.05 was considered statistically significant.

RESULTS: Of 400 patients who were approached for the study, 395 (98.8%) were eligible for statin prescriptions. The mean (±SD) age of the study participants was 58.1±10.3 years, out of which 371 (93.9%) belonged to the age group ≥40 years. Two-thirds(241 61.0%) of the patients were female. About two-thirds(257; 69.4%) of patients had health insurance coverage. Statins were prescribed in 47.3% of the participants. Moderate intensity statin was the only pattern prescribed. In the adjusted model, insurance coverage (OR: 0.056; 95% CI: 0.03-0.12), and hypertension (OR: 0.259; 95% CI: 0.12-0.54) were associated with an increased likelihood of being prescribed a moderate intensity statin.

CONCLUSION: A significant number of patients at MNH diabetic clinic were not on statins despite qualifying for the prescription. The findings call for further studies on reasons for low statin prescription practices in this tertiary facility.

PMID:35250285 | PMC:PMC8894101 | DOI:10.2147/DMSO.S347765

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Nevin Manimala Statistics

Statistical shape model-based tibiofibular assessment of syndesmotic ankle lesions using weightbearing CT

J Orthop Res. 2022 Mar 6. doi: 10.1002/jor.25318. Online ahead of print.

ABSTRACT

Forced external rotation is hypothesized as the key mechanism of syndesmotic ankle injuries, inducing a three-dimensional deviation from the normal distal tibiofibular joint alignment. However, current diagnostic imaging modalities are impeded by a two-dimensional assessment, without considering ligamentous stabilizers. Therefore, our aim is three-fold: (1) to construct an articulated statistical shape model of the normal distal tibiofibular joint with inclusion of ligamentous morphometry, (2) to investigate the effect of weightbearing on the distal tibiofibular joint alignment and (3) to detect differences in predicted syndesmotic ligament length of patients with syndesmotic lesions with respect to normative data. Training data comprised non-weightbearing CT scans from asymptomatic controls (N= 76), weightbearing CT scans from patients with syndesmotic ankle injury (N = 13) and their weightbearing healthy contralateral side (N = 13). Path and length of the syndesmotic ligaments were predicted using a discrete element model, wrapped around bony contours. Statistical shape model evaluation was based on accuracy, generalization and compactness. The predicted ligament length in patients with syndesmotic lesions was compared to healthy controls. With respect to the first aim, our presented skeletal shape model described the training data with an accuracy of 0.23 +/- 0.028 mm. Mean prediction accuracy of ligament insertions was 0.53 +/- 0.12 mm. In accordance to the second aim, our results showed an increased tibiofibular diastasis in healthy ankles after weight-bearing. Corcerning our third aim, a statistically significant difference in anterior syndesmotic ligament length was found between ankles with syndesmotic lesions and healthy controls (p = 0.017). There was a significant correlation between presence of syndesmotic injury and the positional alignment beween the distal tibia and fibula (r = 0.873, p < 0,001). Clinical Significance: Statistical shape modelling combined with patient-specific ligament wrapping techniques can facilitate the diagnostic workup of syndesmosic ankle lesions under weightbearing conditions. In doing so, an increased anterior tibiofibular distance was detected, corresponding to an ‘anterior open-book injury’ of the ankle syndesmosis as a result of anterior inferior tibiofibular ligament elongation/rupture. This article is protected by copyright. All rights reserved.

PMID:35249244 | DOI:10.1002/jor.25318

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Nevin Manimala Statistics

Validation of questionnaires for restless legs syndrome in the general population: the Trøndelag Health Study (HUNT)

J Sleep Res. 2022 Mar 6:e13571. doi: 10.1111/jsr.13571. Online ahead of print.

ABSTRACT

Questionnaires for restless legs syndrome have rarely been validated against face-to-face interviews in the general population. We aimed to validate the modified Norwegian, seven-item Cambridge-Hopkins restless legs syndrome questionnaire and a single diagnostic question for restless legs syndrome. We also aimed to stratify validity at 65 years of age. Among a random sample of 1,201 participants from the fourth wave of the Trøndelag Health Study, 232 (19%) agreed to participate, out of whom 221 had complete data for analyses. Participants completed the questionnaires for restless legs syndrome immediately before attending a face-to-face interview using the latest diagnostic criteria. We calculated sensitivity, specificity, and Cohen’s kappa statistic (κ) of questionnaire- versus interview-based diagnoses. We found acceptable validity of the seven-item modified Cambridge-Hopkins diagnostic questionnaire for restless legs syndrome (κ = 0.37, 95% confidence interval [CI] 0.23-0.51) and good validity of the single diagnostic question (κ = 0.47, 95% CI 0.35-0.58). We also found good validity through the combination of modified Cambridge-Hopkins diagnostic questionnaire for restless legs syndrome items 2 and 5, while item 1 or 2 alone showed only acceptable validity. The single diagnostic question was significantly more valid among those aged <65 years (κ = 0.60 versus κ = 0.26). Both single- and two-item questionnaire-based diagnoses overestimated interview-based restless legs syndrome prevalence. The seven-item modified Cambridge-Hopkins diagnostic questionnaire for restless legs syndrome will be useful for epidemiological studies although low sensitivity may cause underestimation of true restless legs syndrome prevalence in the general population, especially among elderly. Brief questionnaire-based diagnoses of up to three items seem best utilised as an initial screen. Future studies should identify brief and even more valid questionnaire-based diagnoses for restless legs syndrome in order to estimate prevalence accurately in large epidemiological studies.

PMID:35249243 | DOI:10.1111/jsr.13571

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Nevin Manimala Statistics

Oral immunosuppressants improve pregnancy outcomes in women with idiopathic recurrent miscarriage: A meta-analysis

J Clin Pharm Ther. 2022 Mar 6. doi: 10.1111/jcpt.13629. Online ahead of print.

ABSTRACT

WHAT IS KNOWN AND OBJECTIVE: Reports said immunotherapy is effective for the treatment of idiopathic recurrent miscarriage (RM). Immunotherapy is invasive, and lymphocyte therapy carries some risk of infection. Oral immunosuppressants have the advantages of simple administration and convenience; however, there is no statistical analysis of whether they can improve pregnancy outcomes in patients with idiopathic RM.

METHODS: Six databases were searched for studies on oral immunosuppressants and RM; 374 articles were identified. There were two oral immunosuppressants, cyclosporine A and prednisone; two studies were on cyclosporine A and three studies were on prednisone for RM.

RESULTS AND DISCUSSION: In total, 554 RM patients were included in this analysis, including 357 patients who received oral immunosuppressive agents and 197 patients who received basic treatment, placebo, or no treatment. Oral administration of cyclosporine A or prednisolone increases live birth rate (OR = 3.6, 95% CI: 2.1-6.15, p < 0.00001) and ongoing pregnancy rate (OR = 8.82, 95% CI: 2.91-26.75, p = 0.0001) in patients with idiopathic RM. Drug use reduced miscarriage rate (OR = 0.21, 95% CI: 0.08-0.52, p = 0.0007); however, there was significant heterogeneity (I2 = 73%) and a moderate-to-severe risk of bias. There was no effect on premature birth rate (OR = 2.26, 95% CI: 0.96-5.31, p = 0.06). This meta-analysis cannot provide a reference for the duration of medication treatment because the selected studies had inconsistent durations.

WHAT IS NEW AND CONCLUSION: We did a statistical analysis and found that oral immunosuppressants (including cyclosporine A or prednisolone) can improve pregnancy outcomes in patients with idiopathic RM, increase live birth rate and ongoing pregnancy rate, and reduce miscarriage rate.

PMID:35249235 | DOI:10.1111/jcpt.13629

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Nevin Manimala Statistics

The prognostic value of left ventricular dimensions at the time of transcatheter aortic valve replacement: A propensity-matched analysis

J Card Surg. 2022 Mar 6. doi: 10.1111/jocs.16381. Online ahead of print.

ABSTRACT

AIMS: In the clinical practice a noteworthy proportion of severe symptomatic aortic stenosis patients presents with low-flow low-gradients features, these having reported a less favorable prognosis even when surgically or transcatheter treated.

METHODS AND RESULTS: We retrospectively analyzed the prospectively collected data on 1051 consecutive patients undergone balloon-expandable transcatheter aortic valve replacement at our Institution from January 2008 to January 2020. We divided the population according with a mean aortic gradient (MAG) < or ≥40 mmHg and we performed a propensity-matched analysis based on the Society of Thoracic Surgery Score and age, obtaining two homogeneous groups of 314 patients each (Groups A and B, respectively). We then analyzed the outcomes of the two groups by implementing adjusted Cox models adjusted for significant clinical differences between the two groups, such as sex, ejection fraction, comorbidities and other variables not included in the propensity-matched analysis. The only variable associated with both cardiovascular and all-cause events was an ejection fraction ≤35%. Finally, a sensitivity analysis found that an ejection fraction ≤35% was associated with an increase cardiovascular and all-cause mortality only in patients with an indexed end-diastolic volume >97 ml/m2 (p = .0438 and .3363, respectively).

CONCLUSIONS: In our series a MAG <40 mmHg was not found to be per se an independent risk factor for cardiac and all-cause mortality after transcatheter aortic valve replacement. The ejection fraction was found to be an independent risk factor only in the context of enlarged left ventricular dimensions.

PMID:35249231 | DOI:10.1111/jocs.16381

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Nevin Manimala Statistics

Signals of Muscle Relaxant Drug Interactions Associated with Unintentional Traumatic Injury: A Population-Based Screening Study

CNS Drugs. 2022 Mar 6. doi: 10.1007/s40263-022-00909-1. Online ahead of print.

ABSTRACT

BACKGROUND: Use of muscle relaxants is rapidly increasing in the USA. Little is understood about the role of drug interactions in the known association between muscle relaxants and unintentional traumatic injury, a clinically important endpoint causing substantial morbidity, disability, and death.

OBJECTIVE: We examined potential associations between concomitant drugs (i.e., precipitants) taken with muscle relaxants (affected drugs, i.e., objects) and hospital presentation for unintentional traumatic injury.

METHODS: In a series of self-controlled case series studies, we screened to identify drug interaction signals for muscle relaxant + precipitant pairs and unintentional traumatic injury. We used Optum’s de-identified Clinformatics® Data Mart Database, 2000-2019. We included new users of a muscle relaxant, aged 16-90 years, who were dispensed at least one precipitant drug and experienced an unintentional traumatic injury during the observation period. We classified each observation day as precipitant exposed or precipitant unexposed. The outcome was an emergency department or inpatient discharge diagnosis for unintentional traumatic injury. We used conditional Poisson regression to estimate rate ratios adjusting for time-varying confounders and then accounted for multiple estimation via semi-Bayes shrinkage.

RESULTS: We identified 74,657 people who initiated muscle relaxants and experienced an unintentional traumatic injury, in whom we studied concomitant use of 2543 muscle relaxant + precipitant pairs. After adjusting for time-varying confounders, 16 (0.6%) pairs were statistically significantly and positively associated with injury, and therefore deemed signals of a potential drug interaction. Among signals, semi-Bayes shrunk, confounder-adjusted rate ratios ranged from 1.29 (95% confidence interval 1.04-1.62) for baclofen + sertraline to 2.28 (95% confidence interval 1.14-4.55) for methocarbamol + lamotrigine.

CONCLUSIONS: Using real-world data, we identified several new signals of potential muscle relaxant drug interactions associated with unintentional traumatic injury. Only one among 16 signals is currently reported in a major drug interaction knowledge base. Future studies should seek to confirm or refute these signals.

PMID:35249204 | DOI:10.1007/s40263-022-00909-1

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Nevin Manimala Statistics

On the Frontline-A bibliometric Study on Sustainability, Development, Coronaviruses, and COVID-19

Environ Sci Pollut Res Int. 2022 Mar 6. doi: 10.1007/s11356-021-18396-0. Online ahead of print.

ABSTRACT

The COVID-19 pandemic has placed the world’s population in a state of unprecedented public health and global health vulnerability. Risks to public and global health have escalated due to COVID-19 contamination. This has raised the statistics of inequity and environmental concerns. A possible outlook entails reducing the pandemic consequences by prioritizing development, biodiversity, and adaptability, offering buffer solutions. It contains vital methods for studying, comprehending, and unraveling events-examining early responses to COVID-19, sustainability, and development, relating them with overall Coronaviruses reaction. This study maps out environmental, socioeconomic, and medical/technological issues using as statistical techniques multiple correspondence analysis and validated cluster analysis. The findings encourage rapid, long-term development policy involvement to address the pandemic. The resulting crises have highlighted the necessity for the revival of health justice policies anchored in distinctive public health ethical patterns in response to them. As a general rule, resilience and preparedness will be targeted at developing and vulnerable nations and are prone to include access to vaccines, public health care, and health investment. Our findings show the relevance of innovating on sustainable development routes and yardsticks. Sustainable global health requires crucial measures in prevention, preparation, and response. Long-term policy recommendations are needed to address pandemics and their interrelated crises and foster sustained growth and socioecological protection.

PMID:35249187 | DOI:10.1007/s11356-021-18396-0

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Nevin Manimala Statistics

Clinical Explainability Failure (CEF) & Explainability Failure Ratio (EFR) – Changing the Way We Validate Classification Algorithms

J Med Syst. 2022 Mar 5;46(4):20. doi: 10.1007/s10916-022-01806-2.

ABSTRACT

Adoption of Artificial Intelligence (AI) algorithms into the clinical realm will depend on their inherent trustworthiness, which is built not only by robust validation studies but is also deeply linked to the explainability and interpretability of the algorithms. Most validation studies for medical imaging AI report the performance of algorithms on study-level labels and lay little emphasis on measuring the accuracy of explanations generated by these algorithms in the form of heat maps or bounding boxes, especially in true positive cases. We propose a new metric – Explainability Failure Ratio (EFR) – derived from Clinical Explainability Failure (CEF) to address this gap in AI evaluation. We define an Explainability Failure as a case where the classification generated by an AI algorithm matches with study-level ground truth but the explanation output generated by the algorithm is inadequate to explain the algorithm’s output. We measured EFR for two algorithms that automatically detect consolidation on chest X-rays to determine the applicability of the metric and observed a lower EFR for the model that had lower sensitivity for identifying consolidation on chest X-rays, implying that the trustworthiness of a model should be determined not only by routine statistical metrics but also by novel ‘clinically-oriented’ models.

PMID:35249179 | DOI:10.1007/s10916-022-01806-2