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Nevin Manimala Statistics

Risk factors that predict major amputations and amputation time intervals for hospitalised diabetic patients with foot complications

Int Wound J. 2021 Dec 8. doi: 10.1111/iwj.13727. Online ahead of print.

ABSTRACT

Diabetes-related lower extremity amputations are an enormous burden on global health care and social resources because of the rapid worldwide growth of the diabetic population. This research aimed to determine risk factors that predict major amputation and analyse the time interval from first hospitalisation to amputation by using standard management protocols and Kaplan-Meier survival curves. Data from 246 patients with diabetes mellitus and diabetic foot ulcers from the Division of Plastic and Reconstructive Surgery of the Department of Surgery at XXX Hospital between January 2016 and May 2020 were analysed. Univariate and multivariate analyses of 44 potential risk factors, including invasive ulcer depth and C-reactive protein levels, showed statistically significant differences for those at increased risk for major amputation. The median time from hospitalisation to lower extremity amputation was approximately 35 days. Most patients with abnormal C-reactive protein levels and approximately 70% of patients with ulcers invading the bone were at risk for lower extremity amputations within 35 days. Therefore, invasive ulcer depth and C-reactive protein levels are significant risk factors. Other potential risk factors for major amputation and the time intervals from first hospitalisation to amputation should be analysed to establish further prediction strategies.

PMID:34879446 | DOI:10.1111/iwj.13727

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Nevin Manimala Statistics

A systematic review and meta-analysis of the relationship between erectile dysfunction and the neutrophil-to-lymphocyte and platelet-to-lymphocyte ratios

Andrologia. 2021 Dec 8:e14337. doi: 10.1111/and.14337. Online ahead of print.

ABSTRACT

Several studies were conducted to explore the association between haematological parameters and erectile dysfunction (ED), but the conclusions were contradictory with small sample size. The extensively search was conducted in PubMed, Cochrane Library and Web of science from inception to August 2021. Studies comparing the haematological parameter (at least NLR, PLR) between ED patients and healthy controls were eligible for the present meta-analysis. The differences in NLR and PLR between ED patients and healthy controls were assessed by calculating the standardised mean difference (SMD) and 95% confidence interval (95% CI). Eventually, 7 studies were remained for our meta-analysis, with a total of 929 ED patients and 737 healthy controls. For the methodological quality based on NOS, 5 studies were of high quality, scored 7, and 8. 2 studies were of moderate quality, scored 6. There were statistically significant differences in NLR values between ED patients and healthy controls, based on the pooled results (SMD: 0.53, 95% CI: 0.24-0.82). Pooled results from the 6 studies revealed that ED patients had higher PLR values than healthy controls (SMD: 0.70, 95%CI: 0.12-1.28). Our meta-analysis solidly confirmed the association between NLR, PLR and ED. Increased NLR and PLR should be independent risk factors for ED.

PMID:34879439 | DOI:10.1111/and.14337

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Nevin Manimala Statistics

Conservative In-Patient Treatment of Specific Back Pain Before and During the Coronavirus Disease Pandemic

Z Orthop Unfall. 2021 Dec 8. doi: 10.1055/a-1658-1101. Online ahead of print.

ABSTRACT

BACKGROUND: The measures taken in the coronavirus disease pandemic have had major structural and financial effects on orthopaedics and trauma surgery as many surgeries in this field. Experience Appropriate reports from non-surgical orthopaedics are not yet available.

AIMS OF THE STUDY: The study aimed to provide information on the changes that occurred in a group of patients with spinal diseases undergoing conservative in-patient treatment during the coronavirus disease pandemic, with regard to the number of cases, patient structure and course of treatment.

MATERIALS AND METHODS: Data from a total of 954 patients from an acute department for conservative treatment of back pain from the years 2019 and 2020 were retrospectively compared, thus allowing conclusions to be drawn about the course of in-patient conservative spinal treatment. In addition to sociodemographic data, numerical pain rating scales, scales for impairment by pain and physical function at the beginning and at the end of treatment were analysed using descriptive statistics and differentiation tests.

RESULTS: The study showed a 21% reduction in the number of cases in 2020 compared with those in 2019. The patient structure has changed in terms of diagnosis groups and physical function. The values of the assessments on discharge and their pre-post differences show an almost identical pattern of treatment outcomes before and after the start of the pandemic.

CONCLUSIONS: The relatively small decline in the number of in-patient admissions for the non-surgical treatment of specific spinal disorders indicates that this treatment option was also necessary in the pandemic-related crisis. With minor changes in the patient structure, comparable treatment results could be achieved.

PMID:34879418 | DOI:10.1055/a-1658-1101

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Nevin Manimala Statistics

Implant Stability Changes for a Single Implant Mandibular Overdenture

Eur J Dent. 2021 Dec 8. doi: 10.1055/s-0041-1736416. Online ahead of print.

ABSTRACT

OBJECTIVES: To compare the changes in implant stability for the nonsubmerged and submerged protocols for a single-implant retained mandibular overdenture using Cendres and Metaux Locator attachment throughout a 24-month follow-up.

MATERIALS AND METHODS: Eighty edentulous patients who were seeking to install a single implant in the midline of the completely edentulous mandible. At the day of implant installation, patients were randomized into two groups using sealed envelopes: the nonsubmerged and submerged groups. After 3 months of healing period, randomization using sealed envelopes was performed and patients were randomized to receive the Cendres and Metaux Locator attachment. The periotest readings were recorded using the Periotest M device, every 3 months for the first year and annually in the second year. The scope of this clinical trial focused only on results of the Cendres and Metaux attachment.

STATISTICAL ANALYSIS: The Mann-Whitney U-test was used for comparison between study groups for independent samples. Two-sided p-values less than 0.05 were considered statistically significant.

RESULTS: There was no statistically significant difference between the mean periotest readings of both groups throughout the 24-month follow-up. Both groups showed an improvement in mean periotest readings with the submerged group tending to show greater stability at 6, 12, and 24-month follow-ups.

CONCLUSIONS: The nonsubmerged and the submerged healing protocols resulted in reliable periotest readings with the submerged group showing greater improvement than the nonsubmerged, although this improvement is nonsignificant when using the Cendres and Metaux attachment for a single mandibular overdenture.

PMID:34879396 | DOI:10.1055/s-0041-1736416

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Nevin Manimala Statistics

Reduced cardiovascular morbidity in patients with hemophilia: results of a 5-year multinational prospective study

Blood Adv. 2021 Dec 8:bloodadvances.2021005260. doi: 10.1182/bloodadvances.2021005260. Online ahead of print.

ABSTRACT

Hemophilia is a congenital bleeding disorder caused by low clotting factor VIII or IX levels. Life expectancy of people with hemophilia (PWH) has increased with the availability of clotting factor concentrates. At the same time, the incidence of cardiovascular disease (CVD) has increased. In retrospective studies there are conflicting data if, despite this increase, the incidence is still lower than in the general population. We prospectively compared the incidence of CVD in PWH with the predicted incidence. This prospective, multicenter, observational study included adult PWH (>30y) from the Netherlands and United Kingdom (UK). They were followed for a 5-year period and CVD incidence was compared with a predicted event rate based on the QRISK2-2011 CVD risk model. The primary endpoint was the observed fatal and nonfatal CVD incidence after 5 years compared to the estimated events and in relation to severity of hemophilia. The study included 709 patients, of whom 687 (96.9%) completed 5 years follow up or reached an endpoint. For 108 patients the QRISK score could not be calculated at inclusion. For the remaining 579 fewer CVD events were observed than predicted: 9 versus 24 (RR 0.38; 95% CI: 0.18 – 0.80 p=0.01), corresponding with an absolute risk reduction of 2.4%. Severe hemophilia treated on demand had the highest risk reduction. There was no statistical significant relation between severity of hemophilia and incidence of CVD. In hemophilia a lower than predicted CVD incidence was found, supporting the theory that hemophilia protects against CVD. The study is registered at www.clinicaltrials.gov (identification number NCT01303900).

PMID:34879394 | DOI:10.1182/bloodadvances.2021005260

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Nevin Manimala Statistics

Bronchopulmonary Dysplasia and Risk of Developmental Delay: An EPIPAGE-2 Cohort Study

Neonatology. 2021 Dec 8:1-5. doi: 10.1159/000520451. Online ahead of print.

ABSTRACT

BACKGROUND: Overall and respiratory management of preterm children are constantly evolving, which might have changed both the pathophysiology and neurodevelopmental consequences of bronchopulmonary dysplasia (BPD).

OBJECTIVES: The objective of this study is to determine whether the previously shown association between BPD and risk of developmental delay persists.

METHODS: The study population was children born before 32 weeks’ gestation from the French prospective cohort EPIPAGE-2. The exposure was BPD assessed at 36 weeks’ postmenstrual age. The main outcome was risk of developmental delay defined by an Age & Stages Questionnaires (ASQ) score below threshold at 24 months’ corrected age.

RESULTS: The analyzed population included 2,706 children. Among those with available ASQ score, 196/1,587 had BPD and 671/1,587 had an ASQ score below threshold. BPD was associated with an ASQ score below threshold (odds ratio 1.52, 95% confidence interval 1.11-2.08; p = 0.008).

CONCLUSIONS: BPD was strongly associated with risk of developmental delay.

PMID:34879383 | DOI:10.1159/000520451

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Nevin Manimala Statistics

Synthesis of pseudo-CT images from pelvic MRI images based on MD-CycleGAN model for radiotherapy

Phys Med Biol. 2021 Dec 8. doi: 10.1088/1361-6560/ac4123. Online ahead of print.

ABSTRACT

OBJECTIVE: A multi-discriminator-based cycle generative adversarial network (MD-CycleGAN) model was proposed to synthesize higher-quality pseudo-CT from MRI.

APPROACH: The MRI and CT images obtained at the simulation stage with cervical cancer were selected to train the model. The generator adopted the DenseNet as the main architecture. The local and global discriminators based on convolutional neural network jointly discriminated the authenticity of the input image data. In the testing phase, the model was verified by four-fold cross-validation method. In the prediction stage, the data were selected to evaluate the accuracy of the pseudo-CT in anatomy and dosimetry, and they were compared with the pseudo-CT synthesized by GAN with generator based on the architectures of ResNet, sU-Net, and FCN.

MAIN RESULTS: There are significant differences(P<0.05) in the four-fold-cross validation results on peak signal-to-noise ratio and structural similarity index metrics between the pseudo-CT obtained based on MD-CycleGAN and the ground truth CT (CTgt). The pseudo-CT synthesized by MD-CycleGAN had closer anatomical information to the CTgt with root mean square error of 47.83±2.92 HU and normalized mutual information value of 0.9014±0.0212 and mean absolute error value of 46.79±2.76 HU. The differences in dose distribution between the pseudo-CT obtained by MD-CycleGAN and the CTgt were minimal. The mean absolute dose errors of Dosemax, Dosemin and Dosemean based on the planning target volume were used to evaluate the dose uncertainty of the four pseudo-CT. The u-values of the Wilcoxon test were 55.407, 41.82 and 56.208, and the differences were statistically significant. The 2%/2 mm-based gamma pass rate (%) of the proposed method was 95.45±1.91, and the comparison methods (ResNet_GAN, sUnet_GAN and FCN_GAN) were 93.33±1.20, 89.64±1.63 and 87.31±1.94, respectively.

SIGNIFICANCE: The pseudo-CT obtained based on MD-CycleGAN have higher imaging quality and are closer to the CTgt in terms of anatomy and dosimetry than other GAN models.

PMID:34879356 | DOI:10.1088/1361-6560/ac4123

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Nevin Manimala Statistics

%TTD and %TUDD: New SAS macro programs to calculate the survival data of the time to deterioration for patient-reported outcomes data in oncology

Comput Methods Programs Biomed. 2021 Nov 21;214:106537. doi: 10.1016/j.cmpb.2021.106537. Online ahead of print.

ABSTRACT

BACKGROUND AND OBJECTIVE: Longitudinal analysis of patient-reported outcome (PRO) data remains challenging, as no standardization of statistical methods has been proposed, making comparison of PRO results between clinical trials difficult. In this context, the time to deterioration approach has recently been proposed and is regularly used as a modality of longitudinal PRO analysis in oncology.

METHODS: Two new SAS macro programs were developed, %TTD and %TUDD, which implement longitudinal analysis of PRO data according to the time to deterioration approach. These programs implement the recommended deterioration definitions. We described the programs with their different functionalities.

RESULTS: The %TTD macro calculates the time to first or transient deterioration, and the %TUDD macro calculates the time until definitive deterioration. These macros allow to obtain the survival variables from the time to deterioration approach. We illustrate our programs by presenting different applications on the randomized phase II AFUGEM GERCOR clinical trial.

CONCLUSION: The implementation of the deterioration definitions in SAS software allows the dissemination of this approach, in order to move toward the goal of standardization of longitudinal PRO analysis in oncology clinical trials.

PMID:34879326 | DOI:10.1016/j.cmpb.2021.106537

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Nevin Manimala Statistics

Gender differences in specific trends of COPD mortality in Croatia

Public Health. 2021 Dec 5;202:26-31. doi: 10.1016/j.puhe.2021.10.016. Online ahead of print.

ABSTRACT

OBJECTIVES: Chronic obstructive pulmonary disease (COPD) is one of the most common lower respiratory chronic diseases. The aim of this study was to analyze the COPD mortality trends in Croatia for the period 2010-2019 and to identify possible changes and differences by age group and gender.

STUDY DESIGN AND METHODS: In data analysis were included COPD death cases for the period 2010-2019 defined as ICD-10 code J44.0 – J44.9. Mortality data were obtained from the Croatian Institute of Public Health based on death certificates. To model temporal changes in mortality rates joinpoint regression analysis was carried out.

RESULTS: The number of COPD deaths increased in men from 878 in 2010 to 1083 in 2019 and in women from 520 in 2010 to 737 in 2019. Over the 10-year period, there was a stable age-standardized COPD mortality rate among men and statistically significant increasing age-standardized COPD mortality rate among women at the national level.

CONCLUSIONS: The findings show a narrowing of the gender gap of COPD mortality. Observed higher COPD mortality rates with age in both men and women confirm previous data and imply that the number of COPD deaths will continue to increase in the future. The healthcare system should focus on the improvement of the quality of care and investment in health promotion and prevention programs aimed at reducing risk factors for COPD, especially tobacco smoking, as well as raising awareness and knowledge about COPD as a chronic disease.

PMID:34879319 | DOI:10.1016/j.puhe.2021.10.016

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Nevin Manimala Statistics

Brain Abnormalities in Pontine Infarction: A Longitudinal Diffusion Tensor Imaging and Functional Magnetic Resonance Imaging study

J Stroke Cerebrovasc Dis. 2021 Dec 5;31(2):106205. doi: 10.1016/j.jstrokecerebrovasdis.2021.106205. Online ahead of print.

ABSTRACT

OBJECTIVES: The aim of this study was to make a reasonable and accurate assessment of the prognosis of patients with pontine infarction. We assessed the changes in structure and function in the whole brain after pontine infarction from the acute to chronic phase using diffustion tensor imaging and functional magnetic resonance imaging.

MATERIALS AND METHODS: Sixteen individuals with a recent pontine infarction and sixteen healthy controls were recruited and underwent 3.0T DTI, resting-state fMRI and upper extremity Fugl-Myer (UE-FM) functional evaluation at five time points: within one week (T1), half a month (T2), one month (T3), three months (T4), and six months (T5) after onset. Tract-based spatial statistics was used to conduct a voxelwise analysis.

RESULTS: The fractional anisotropy (FA) values were significantly lower in the pontine infarction group than in the control group. Then, specific ROIs were analyzed. The FA values of 10 regions of interest were significantly increased at T2 compared with those at T1. The FA value of the corticospinal tract was significantly increased at T3 compared with that at T2. Regional brain activity results showed that the amplitude of low frequency fluctuations value of the frontal lobe decreased at T1, then increased. Finally, The UE-FM scores showed the same increased trend.

CONCLUSION: These findings show that the microstructure changes most significantly within half a month after pontine infarction and stabilizes after one month. The recovery of motor function in the later period is mainly caused by changes in the cortex. This facilitates more treatment options.

PMID:34879300 | DOI:10.1016/j.jstrokecerebrovasdis.2021.106205