Categories
Nevin Manimala Statistics

Attention-Deficit/Hyperactivity Disorder, Autism Spectrum Disorder, and Other Neurodevelopmental Outcomes Associated With Antipsychotic Drug Exposure During Pregnancy

J Clin Psychiatry. 2022 May 30;83(3):22f14529. doi: 10.4088/JCP.22f14529.

ABSTRACT

Between 0.3%-4.6% of women use antipsychotic (AP) drugs during pregnancy. Two large, retrospective, population-based cohort studies, conducted in Nordic countries and in the US, examined the risk of neurodevelopmental disorders (NDDs) following gestational exposure to APs. The Nordic study found that, in unadjusted analyses, exposure to APs during pregnancy was associated with increased risk of attention-deficit/hyperactivity disorder (ADHD) and autism spectrum disorder (ASD) in offspring; that the risk all but disappeared after adjusting for covariates; and that the risk appeared to be related to maternal major mental illness rather than to gestational exposure to APs. The US study also found that, in unadjusted analyses, gestational exposure to APs was associated with an increased risk of almost all of the study-specified NDDs in offspring; however, after adjusting for covariates, the risks were no longer meaningfully increased and, importantly, were no longer statistically significant for ADHD and ASD. Thus, these 2 studies suggest that gestational exposure to APs is a marker of NDD risk in offspring rather than a potential cause. Whereas a small but significantly increased risk was identified for aripiprazole in the US study, the signal was inconsistent across analyses, and confounding due to maternal mental illness was not ruled out. Previous studies have suggested that the use of APs during pregnancy is not associated with an increased risk of major congenital malformations and other adverse gestational outcomes. Considering the potential harm and suffering associated with major mental illness and the very low risks associated with AP use during pregnancy, initiation or continuation of APs appears to carry a favorable risk-benefit ratio in pregnant women who need these drugs; however, decision-making should be shared between patients, their caregivers, and the treating team.

PMID:35649168 | DOI:10.4088/JCP.22f14529

Categories
Nevin Manimala Statistics

A prediction model for dosimetric-based lung adaptive radiotherapy

Med Phys. 2022 Jun 1. doi: 10.1002/mp.15714. Online ahead of print.

ABSTRACT

PURPOSE: Anatomical changes occurred during the treatment course of radiation therapy for lung cancer patients may introduce clinically unacceptable dosimetric deviations from the planned dose. Adaptive radiotherapy (ART) can compensate these dosimetric deviations in subsequent treatments via plan adaption. Determining whether and when to trigger plan adaption during the treatment course is essential to the effectiveness and efficiency of ART. In this study, we aimed to develop a prediction model as an auxiliary decision-making tool for lung ART to identify the patients with intrathoracic anatomical changes that would potentially benefit from the plan adaptions during the treatment course.

METHODS: Seventy-one pairs of weekly cone-beam computer tomography (CBCT) and planning CT (pCT) from 17 advanced non-small cell lung cancer patients were enrolled in this study. To assess the dosimetric impacts brought by anatomical changes observed on each CBCT, dose distribution of the original treatment plan on the CBCT anatomy was calculated on a virtual CT generated by deforming the corresponding pCT to the CBCT, and compared to that of the original plan. A replan was deemed needed for the CBCT anatomy once the recalculated dose distribution violated our dosimetric-based trigger criteria. A three-dimensional region of significant anatomical changes (region of interest, ROI) between each CBCT and the corresponding pCT was identified and 16 morphological features of the ROI were extracted. Additionally, eight features from the overlapped volume histograms (OVHs) of patient anatomy were extracted for each patient to characterize the patient specific anatomy. Based on the 24 extracted features and the evaluated replanning needs of the pCT-CBCT pairs, a nonlinear supporting vector machine was used to build a prediction model to identify the anatomical changes on CBCTs that would trigger plan adaptions. The most relevant features were selected using the sequential backward selection (SBS) algorithm and a shuffling-and-splitting validation scheme was used for model evaluation.

RESULTS: Fifty-Five CBCT-pCT pairs were identified of having a ROI, among which 21 CBCT anatomies required plan adaptions. For these 21 positive cases, statistically significant improvements in the sparing of lung, esophagus and spinal cord were achieved by plan adaptions. A high model performance of 0.929 AUC and 0.851 accuracy was achieved with six selected features including five ROI shape features and one OVH feature. Without involving the OVH features in the feature selection process, the mean AUC and accuracy of the model significantly decreased to 0.826 and 0.779, respectively. Further investigation showed that poor prediction performance with AUC of 0.76 was achieved by the univariate model in solving this binary classification task.

CONCLUSION: We built a prediction model based on the features of patient anatomy and the anatomical changes captured by on-treatment CBCT imaging to trigger plan adaption for lung cancer patients. This model effectively associated the anatomical changes with the dosimetric impacts for lung ART. This model can be a promising tool to assist the clinicians in making decisions for plan adaptions during the treatment courses. This article is protected by copyright. All rights reserved.

PMID:35649103 | DOI:10.1002/mp.15714

Categories
Nevin Manimala Statistics

The impact of the rare disease and Orphan Drug Act in Taiwan

J Food Drug Anal. 2021 Dec 15;29(4):717-725. doi: 10.38212/2224-6614.3383.

ABSTRACT

The Rare Disease and Orphan Drug Act (the Act) was enacted in 2000 in Taiwan for the facilitation of the research, development, and accessibility of orphan drugs and special nutritional foods; for the prevention and early diagnosis of rare diseases; and for providing intensive care for patients with rare diseases. The aim was to investigate the impact of the Act on the availability and use of orphan drugs in Taiwan in the hope of identifying the remaining challenges and possible solutions to assist future policy making, which may be applicable in other countries as well. The information and statistics for rare diseases and orphan drugs retrieved from the official annual reports and documents were analyzed. There were 225 diseases recognized as rare diseases, and one-third (75/225) of them were congenital metabolic disorders. Among the 110 designated orphan drugs that could apply for listing in the National Health Insurance (NHI) Pharmaceutical Benefits and Reimbursement Scheme, approximately half (62/110) of them were granted marketing authorization. While the NHI program compulsory for all citizens increased patient accessibility to orphan drugs, the rapidly increasing economic burden became an urgent issue for the government. Emerging gene therapies may be the solution to unmet medical needs and also a financial obstacle to tackle. The Act increased the availability of orphan drugs while the NHI system facilitated patient access, which benefited many patients with rare diseases in Taiwan. However, the soaring economic burden was noticed and was anticipated to aggravate. More communication and cooperation between stakeholders is critical in finding solutions for the long-term sustainability of the NHI system.

PMID:35649145 | DOI:10.38212/2224-6614.3383

Categories
Nevin Manimala Statistics

Effect of an app on students’ knowledge about diabetes during the COVID-19 pandemic

Rev Lat Am Enfermagem. 2022;30:e3595. doi: 10.1590/1518-8345.5798.3595.

ABSTRACT

OBJECTIVE: to analyze the effect of an app on Nursing students’ knowledge about diabetes during the COVID-19 pandemic, as well as their self-assessment and satisfaction level.

METHOD: a quasi-experimental study carried out with 40 Nursing students from the Brazilian Northeast region. The E-MunDiabetes® app was used to assess the participants’ knowledge at the pre-test, immediate post-test and after 15 days, as well as their self-assessment and satisfaction level in relation to using the app. The analysis was performed by means of descriptive and inferential statistics (binomial test, Intraclass Correlation Coefficient and Wilcoxon’s test).

RESULTS: the comparison of the medians of correct answers in the three periods revealed a significant increase in the post-test. The self-assessment and satisfaction items presented an Agreement Index > 80%, with a total Agreement Index of 96.3% and an Intraclass Correlation Coefficient of 0.91.

CONCLUSION: the app was considered satisfactory and promoted a significant increase in the students’ knowledge, therefore being suitable for its intended use.

PMID:35649093 | DOI:10.1590/1518-8345.5798.3595

Categories
Nevin Manimala Statistics

The National Student Performance Examination and the quality of Brazilian higher education in health

Rev Lat Am Enfermagem. 2022;30:e3585. doi: 10.1590/1518-8345.5714.3585.

ABSTRACT

OBJECTIVE: to analyze higher education in the health area in Brazil according to the results of the students’ performance in the 2019 National Student Performance Examination.

METHOD: a cross-sectional and retrospective study with a quantitative approach and online data referring to 192,715 students from 3,712 health courses, collected in 2020. The students’ performance was expressed in concepts, ordered on a scale of one to five. Box-plots were prepared, prevalence values of the concepts were estimated, and the differences were evaluated through statistical tests (α=5%) according to the administrative and management characteristics, as well as those of the cities where the courses were offered.

RESULTS: there was a satisfactory level of higher education in health (70.0% with a score ≥3). The Medicine courses were the most satisfactorily evaluated while Speech Therapy and Nursing obtained the worst scores. Public, face-to-face and university education were associated with better teaching quality. Lower levels were found in the North region states, in small towns, outside metropolitan areas and in those under private management.

CONCLUSION: heterogeneity in the quality of higher education across the health courses was verified, indicating its association with the characteristics of the teaching institutions and with the infrastructure of the cities where the courses are offered, pointing out challenges to the quality of health education in Brazil.

PMID:35649091 | DOI:10.1590/1518-8345.5714.3585

Categories
Nevin Manimala Statistics

T2-weighted imaging hypointensity in an ovarian lesion: is it a benign finding?

Einstein (Sao Paulo). 2022 May 27;20:eAO6851. doi: 10.31744/einstein_journal/2022AO6851. eCollection 2022.

ABSTRACT

OBJECTIVE: To evaluate whether the presence of a hypointense signal at T2-weighted imaging in a solid ovarian lesion on magnetic resonance imaging is a predictor of stability and benignity.

METHODS: This is a single center study, prospectively read with retrospective acquired data. The database was searched for patients who underwent magnetic resonance imaging between January 2008 and October 2019 and whose reports mentioned solid ovarian lesions with low signal on T2-weighted imaging. A total of 47 nodules were included. A radiologist who was blinded to the clinical indication for magnetic resonance imaging and original reports evaluated the cases. Objective and subjective criteria of ovarian lesions in magnetic resonance imaging were evaluated.

RESULTS: Thirty-five nodules were considered benign/stable and 12 were considered non-stable. The analysis showed that the non-stable lesions showed statistically more hyperintensity at T1-weighted imaging compared to the stable lesions.

CONCLUSION: T2-weighted imaging hypointensity can be considered a predictor of stability in solid ovarian lesions when associated with iso/hypointensity in T1-weighted imaging.

PMID:35649059 | DOI:10.31744/einstein_journal/2022AO6851

Categories
Nevin Manimala Statistics

Comparison between somatostatin analog injections

Rev Assoc Med Bras (1992). 2022 Apr;68(4):514-518. doi: 10.1590/1806-9282.20211224.

ABSTRACT

OBJECTIVE: Long-acting depot formulations of somatostatin analogs, i.e., octreotide and lanreotide, are the first-line medical therapies for patients with acromegaly to whom surgery/radiotherapy cannot be performed or who have inadequate response. In this study, we aimed to evaluate the short-term local and systemic adverse reactions developed after the somatostatin analogs injections in the patients with acromegaly, in order to compare the side effects of somatostatin analogs injections.

METHODS: Patients diagnosed with acromegaly who were referred to our endocrinology clinic for monthly somatostatin analogs injections were questionnaired. Wong-Baker Faces Pain Rating Scale was used to evaluate the injection-site pain at the time of injection. The existence of leg pain, nausea, diarrhea, and abdominal pain following the previous injection was also investigated during the next injection.

RESULTS: A total of 49 patients were included in the study. The statistical difference could not be shown between the injection-site pain, anorexia, and leg pain frequencies of the groups, while the frequency of gastrointestinal disturbances, i.e., diarrhea and abdominal pain, was significantly lower in the octreotide group (p<0.001 and p=0.015, respectively).

CONCLUSIONS: This is the first prospective study that compared the severity of the injection-site pain by using a scoring scale, following the long-acting somatostatin analogs injections. We have shown that there was no significant association of the injection-site pain severity with the somatostatin analogs regimen nor the dose differences within each somatostatin analogs treatment.

PMID:35649076 | DOI:10.1590/1806-9282.20211224

Categories
Nevin Manimala Statistics

Telemedicine diagnosis of acute respiratory tract infection patients is not inferior to face-to-face consultation: a randomized trial

Einstein (Sao Paulo). 2022 May 27;20:eAO6800. doi: 10.31744/einstein_journal/2022AO6800. eCollection 2022.

ABSTRACT

OBJECTIVE: To analyze telemedicine diagnostic accuracy in patients with respiratory infections during COVID-19 pandemic compared to face-to-face evaluation in the emergency department.

METHODS: Randomized, unicentric study between September 2020 and November 2020 in patients with any respiratory symptom (exclusion criteria: age >65 years, chronic heart or lung diseases, immunosuppressed). Patients were randomized 1:1 for brief telemedicine followed by face-to-face consultation or direct face-to-face evaluation. The primary endpoint was the International Classification of Diseases code. The secondary analysis comprised length of stay, diagnostic test ordering, medical prescription, and proposed destination.

RESULTS: Ninety-eight patients were enrolled. The mean age was 36.3±9.7 years old, 57.1% were women, and 81.6% had diagnostic test ordered. Mean grouped by International Classification of Diseases code for upper respiratory tract infection, pharyngotonsillitis, and sinusitis showed no difference between study groups or secondary endpoints. The Telemedicine Group was representative of the population usually evaluated in this center. In the Telemedicine Group (n=48), 18.7% patients would be referred for evaluation at the emergency department. The distribution of diagnoses by telemedicine was 67.4% for upper respiratory tract infection, 2.3% for pharyngotonsillitis, and 0% for sinusitis, being statistically similar to the subsequent face-to-face assessment, respectively: 72.1%, 11.6% and 7% (Kappa 0.386 [95%CI: 0.112-0.66]; p=0.536). Telemedicine ordered COVID-19 molecular (RT-PCR) tests in 76.5% versus 79.4% in face-to-face evaluation (Kappa 0.715 [95%CI: 0.413-1]; p>0.999).

CONCLUSION: Diagnostic telemedicine consultation of low-risk patients with acute respiratory symptoms is not inferior to face-to-face evaluation at emergency department. Telemedicine is to be reinforced in the health care system as a strategy for the initial assessment of acute patients. ClinicalTrials.gov Identifier: NCT04806477.

PMID:35649057 | DOI:10.31744/einstein_journal/2022AO6800

Categories
Nevin Manimala Statistics

Impact of blood levels of progesterone on the day of ovulation onset on clinical, laboratory and reproductive parameters of young patients undergoing assisted reproduction: a cross-sectional study

Einstein (Sao Paulo). 2022 May 30;20:eAO6896. doi: 10.31744/einstein_journal/2022AO6896. eCollection 2022.

ABSTRACT

OBJECTIVE: To assess whether there is an association between the level of progesterone on the day of administration of human chorionic gonadotropin and clinical and laboratory characteristics, in addition to the results of in vitro fertilization of patients with a good prognosis.

METHODS: A cross-sectional study comprising 103 women who underwent intracytoplasmic sperm injection treatment, between November 2009 and May 2015, aged ≤35 years, with no comorbidities, with fresh embryo transfer. Data were collected from patient medical records.

RESULTS: There was a weak positive correlation between the level of progesterone on the day of human chorionic gonadotropin and the number of follicles larger than 14mm (ß=0.02, p=0.001), retrieved oocytes (ß=0.01, p=0.01) and oocytes in metaphase II (MII) (ß=0.02, p=0.02); that is, the increase in progesterone level has a slight association with increased values of these variables. Body mass index was inversely correlated with progesterone level on the day of human chorionic gonadotropin (ß=-0.01, p=0.02). No association was found between the level of progesterone on the day of human chorionic gonadotropin and the protocols used for controlled ovarian stimulation, quality of transferred embryos and the pregnancy rate.

CONCLUSION: There is an association between the value of progesterone on the day of human chorionic gonadotropin administration with body mass index, number of follicles larger than 14mm, number of retrieved oocytes and oocytes in metaphase II. Unlike embryo quality and pregnancy rate, which do not have a statistically significant relation with this value in the population studied.

PMID:35649054 | DOI:10.31744/einstein_journal/2022AO6896

Categories
Nevin Manimala Statistics

National Health Survey reveals high percentage of signs and symptoms of leprosy in Brazil

Cien Saude Colet. 2022 Jun;27(6):2255-2258. doi: 10.1590/1413-81232022276.18322021. Epub 2021 Sep 18.

ABSTRACT

Leprosy is a debilitating, infectious, systemic or localized dermato-neurological disease caused by Mycobacterium lepra. In Brazil, the magnitude and high disabling power keep the disease as a public health problem. Skin spotting and numbness are pathognomonic signs and symptoms in leprosy. The Instituto Brasileiro de Geografia e Estatística (IBGE) 2019 National Health Survey (PNS-2019) considered the following question as a proxy to estimate its magnitude in the country. “Do you have a spot with numbness or part of the skin with numbness?”. In Brazil, 1,921,289 adults reported having a patch or part of the skin with numbness, with no regional differences. As for the age group, the older, the higher the prevalence, for example, between 18 to 29 years old (235,445) and 30 to 39 years old (236,485), 0.7% had the condition, between 40 to 59 years old (827,887), 1.5% and among the elderly, 1.8% (621,472). Being able to estimate, in population-based surveys, with statistical representativeness, a reported morbidity such as leprosy is essential to support the formulation of public policies, notably those related to primary health care actions. In this way, the IBGE fulfills its constitutional role of portraying the reality of the Brazilian population and today it is the main external evaluator of the Unified Health System (SUS) and of public policies developed by the federal level.

PMID:35649013 | DOI:10.1590/1413-81232022276.18322021