Category: Statistics

Arch Gynecol Obstet. 2023 Aug 23. doi: 10.1007/s00404-023-07190-7. Online ahead of print.

ABSTRACT

PURPOSE: To determine whether the use of pre-implantation genetic testing (PGT) under a specific sex selection policy is associated with alterations in offspring sex ratio.

METHODS: This was a single-center retrospective cohort study of singleton live births from January 2018-December 2020 achieved via single blastocyst non-PGT or PGT frozen embryo transfer (FET). Per institutional policy, sex may be disclosed following PGT. If both sexes are available and morphologic grade is similar, patients may select the sex of the embryo to be transferred. Demographics and cycle characteristics were compared between non-PGT vs. PGT cycles with Mann-Whitney U or χ². Poisson regression with robust variance estimates was used to model the probability of female vs. male offspring among non-PGT vs. PGT cycles, reported as risk ratio (RR) and 95% confidence interval (CI).

RESULTS(S): Among 541 live births, 350 (64.7%) were achieved with PGT and 191 (35.3%) without PGT. In both groups, female sex was more common, representing 59.4% of PGT-offspring and 55.0% of non-PGT offspring. After adjusting for potential confounders, the use of PGT was not significantly associated with an increased likelihood of female offspring (RR 1.04, 95% CI 0.98-1.11, p = 0.22).

CONCLUSION(S): Singletons born following FET had a higher rate of female sex than male. Allowing sex selection per institutional policy did not increase this ratio. These results contrast with those of prior publications and should motivate individual centers to monitor their own sex ratios. As utilization of PGT increases, local, regional, and national monitoring will become increasingly important.

PMID:37610634 | DOI:10.1007/s00404-023-07190-7

Psychiatr Q. 2023 Aug 23. doi: 10.1007/s11126-023-10046-7. Online ahead of print.

ABSTRACT

Internet addiction (IA), one of the behavioral addictions, is also related to impulsivity. Although studies on its etiology and risks continue, the number of studies is limited. In this study, we aimed to assess the roles of behavioral systems, emotional regulation (ER), and impulsivity in the development of IA in adolescents and also to assess the relationship between all these clinical parameters and brain-derived neurotrophic factor (BDNF) and neuropeptide Y (NPY). Forty-two adolescents with IA and 30 healthy controls (ages 12 -17) were included in the study. Self-reported measures included the Internet Addiction Scale. (IAS), Behavioral Activation and Behavioral Inhibition Scale (BAS/BIS), Barratt. Impulsiveness Scale-11 (BIS-11), and Difficulties in Emotion Regulation Scale-16 (DERS-16) were used for the assessment of the participants. The levels of plasma brain BDNF and NPY were evaluated with the ELISA method. BAS/BIS subscale scores, BIS-11, and DERS-16 scale total scores were found to be statistically significantly higher, while BDNF and NPY levels were found to be lower in adolescents with IA compared to the healthy controls. IA severity was not found to correlate with both BDNF and NPY. IA was found to be more related to BIS than to BAS. There is a need for further studies evaluating developmental features and possible diagnostic biomarkers that may be associated with IA in adolescents.

PMID:37610629 | DOI:10.1007/s11126-023-10046-7

J Endocrinol Invest. 2023 Aug 23. doi: 10.1007/s40618-023-02177-2. Online ahead of print.

ABSTRACT

PURPOSE: Patients with hypoparathyroidism (hypoPT) have low bone turnover and high bone mineral density (BMD). However, data on fracture risk are conflicting. The objectives of this study were: 1. To describe clinical/biochemical characteristics of hypoPT patients followed at a single medical center. 2. To identify postsurgical hypoPT patients and investigate their fracture rate compared with gender/age-matched post-surgical normocalcemic patients.

METHODS: Retrospective analysis of patient’s medical records treated at the tertiary medical center in 2010-2021 identified by computerized medical database search.

RESULTS: The cohort included 133 patients (91% women, mean age 64 ± 13 years) of whom 105 (79%) had post-thyroidectomy hypoparathyroidism and the remainder had an autoimmune/idiopathic/other etiology. Mean follow-up time was 21 ± 12 and 27 ± 12 years, respectively. The control group included 142 post-thyroidectomy patients without hypoparathyroidism. Patients in the postsurgical hypoparathyroidism group were older and had higher calcium and PTH levels at diagnosis than the non-surgical hypoPT patients. Comparing the postsurgical hypoPT and postsurgical normocalcemic control patients revealed a significantly higher BMD in the hypoPT group. Yet, fracture rates were 31% in the postsurgical hypoparathyroidism group and 21% in the control group (P = 0.1) over a similar median follow-up period (17 and 18.4 years, respectively). In both groups the most common fracture site was the spine (50% and 70%, respectively; p = 0.33), mainly nonclinical morphometric fractures. Higher phosphorus blood level was associated with increased fracture risk.

CONCLUSIONS: The relatively high BMD in patients with postsurgical hypoparathyroidism is not associated with lower fracture risk. Silent morphometric fractures are quite common in this group of patients.

PMID:37610611 | DOI:10.1007/s40618-023-02177-2

Indian J Gastroenterol. 2023 Aug 23. doi: 10.1007/s12664-023-01400-5. Online ahead of print.

ABSTRACT

BACKGROUND: Both Budd-Chiari syndrome (BCS) and portal vein thrombosis (PVT) have been linked to various prothrombotic (PT) conditions. The PT profile in Asians is different from the west and there are no nationwide epidemiological surveys from India. Hence, the present meta-analysis was aimed at analyzing the prevalence of acquired and hereditary thrombophilia among Indian patients with non-cirrhotic PVT and BCS.

METHODS: A comprehensive literature search of Embase, Medline and Scopus was conducted from January 2000 to February 2022 for studies evaluating the prevalence of various PT conditions in Indian patients with PVT and BCS. Pooled prevalence rates across studies were expressed with summative statistics.

RESULTS: Thirty-five studies with 1005 PVT patients and 1391 BCS patients were included in the meta-analysis. At least one PT condition was seen in 46.2% (28.7-63.7) of the PVT patients and 44.9% (37.3-60.7) of the BCS patients. Multiple PT conditions were seen in 13.0% (4.2-21.8) of the PVT patients and 7.9% (3.5-12.4) of the BCS patients. Among PVT patients, hyperhomocysteinemia was the commonest prothrombotic condition (21.6%) followed by protein C (PC) deficiency (10.7%), Janus kinase 2 (JAK-2) mutation (8.5%) and antiphospholipid antibodies (APLA) (7.5%). Among patients with BCS, PC deficiency was the commonest prothrombotic condition (10.6%) followed by methylenetetrahydrofolate reductase (MTHFR) mutation (9.8%), APLA (9.7%) and JAK-2 mutation (9.1%).

CONCLUSION: The PT profile in Indian patients with abdominal vein thrombosis is different from that of the western data with a lower prevalence of PT conditions in patients with BCS.

PMID:37610562 | DOI:10.1007/s12664-023-01400-5

Can J Anaesth. 2023 Aug 23. doi: 10.1007/s12630-023-02547-7. Online ahead of print.

ABSTRACT

PURPOSE: Limiting family presence runs counter to the family-centred values of Canadian pediatric intensive care units (PICUs). This study explores how implementing and enforcing COVID-19-related restricted family presence (RFP) policies impacted PICU clinicians nationally.

METHODS: We conducted a cross-sectional, online, self-administered survey of Canadian PICU clinicians to assess experience and opinions of restrictions, moral distress (Moral Distress Thermometer, range 0-10), and mental health impacts (Impact of Event Scale [IES], range 0-75 and attributable stress [five-point Likert scale]). For analysis, we used descriptive statistics, multivariate regression modelling, and a general inductive approach for free text.

RESULTS: Representing 17/19 Canadian PICUs, 368 of 388 respondents (94%) experienced RFP policies and were predominantly female (333/368, 91%), English speaking (338/368, 92%), and nurses (240/368, 65%). The mean (standard deviation [SD]) reported moral distress score was 4.5 (2.4) and was associated with perceived differential impact on families. The mean (SD) total IES score was 29.7 (10.5), suggesting moderate traumatic stress with 56% (176/317) reporting increased/significantly increased stress from restrictions related to separating families, denying access, and concern for family impacts. Incongruence between RFP policies/practices and PICU values was perceived by 66% of respondents (217/330). Most respondents (235/330, 71%) felt their opinions were not valued when implementing policies. Though respondents perceived that restrictions were implemented for the benefit of clinicians (252/332, 76%) and to protect families (236/315, 75%), 57% (188/332) disagreed that their RFP experience was mainly positive.

CONCLUSION: Pediatric intensive care unit-based RFP rules, largely designed and implemented without bedside clinician input, caused increased psychological burden for clinicians, characterized as moderate moral distress and trauma triggered by perceived impacts on families.

PMID:37610552 | DOI:10.1007/s12630-023-02547-7

Clin Pharmacokinet. 2023 Aug 23. doi: 10.1007/s40262-023-01281-z. Online ahead of print.

ABSTRACT

BACKGROUND AND OBJECTIVE: Mirikizumab is a humanized anti-interleukin-23-p19 monoclonal antibody being developed for ulcerative colitis and Crohn’s disease. This analysis characterized mirikizumab pharmacokinetics using phase II and III trial data from patients with moderately to severely active ulcerative colitis.

METHODS: Serum pharmacokinetic data in patients receiving mirikizumab 50-1000 mg intravenously every 4 weeks as induction treatment and mirikizumab 200 mg subcutaneously every 4 or 12 weeks as maintenance treatment across three trials (N = 1362) were analyzed using non-linear mixed-effects modeling. Covariate effects on mirikizumab exposure were evaluated using simulation-based estimations.

RESULTS: Mirikizumab pharmacokinetics was best described by a linear two-compartment model with first-order absorption. Clearance, volume of distribution for central and peripheral compartments, and half-life were estimated at approximately 0.022 L/h (linear), 3.11 L and 1.69 L, and 9.5 days, respectively. Statistically significant effects of body weight and serum albumin levels on clearance, body weight on central and peripheral volumes of distribution, and body mass index on bioavailability were observed but effects were small relative to random inter-individual variability (% coefficient of variation: 18-64%). The subcutaneous bioavailability of mirikizumab was 48%.

CONCLUSIONS: Mirikizumab displayed pharmacokinetic characteristics typical of a monoclonal antibody where clearance increased with body weight and decreased with the albumin level, and bioavailability decreased with body mass index. These effects were small relative to random variability, indicating that a dose adjustment for patient factors is not required.

CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov: NCT02589665 (28 October, 2015), NCT03518086 (8 May, 2018), NCT03524092 (14 May, 2018).

PMID:37610533 | DOI:10.1007/s40262-023-01281-z

Ann Surg Oncol. 2023 Aug 23. doi: 10.1245/s10434-023-14139-2. Online ahead of print.

ABSTRACT

BACKGROUND: This study aimed to systematically evaluate the effect of early oral feeding (EOF) versus late oral feeding (LOF) on postoperative complications and rehabilitation outcomes for patients with esophageal cancer.

METHODS: This study searched relevant literature published up to March 2023 by computer retrieval of PubMed, Embase, The Cochrane Library, and Web of Science. A meta-analysis was performed using Review Manager 5.4 software to compare the effects of EOF and LOF on postoperative complications and recovery outcomes of patients with esophageal cancer.

RESULTS: The study included 14 articles, including 9 retrospective studies, 4 randomized controlled trials (RCTs), and 1 prospective study. The 2555 patients included in the study comprised 1321 patients who received EOF and 1234 patients who received LOF. The results of the meta-analysis showed that compared with the LOF group, the EOF group has a shorter time to the first flatus postoperatively (mean difference [MD], – 1.12; 95% confidence interval [CI], (- 1.25 to – 1.00; P < 0.00001), a shorter time to the first defecation postoperatively (MD, – 1.31; 95% CI, – 1.67 to – 0.95;, P < 0.00001], and a shorter hospital stay postoperatively (MD, – 2.87; 95% CI, – 3.84 to – 1.90; P < 0.00001). The two groups did not differ significantly statistically in terms of postoperative anastomotic leakage rate (P = 0.10), postoperative chyle leakage rate (P = 0.10), or postoperative pneumonia rate (P = 0.15).

CONCLUSION: Early oral feeding after esophageal cancer surgery can shorten the time to the first flatus and the first defecation postoperatively, shorten the hospital stay, and promote the recovery of patients. Moreover, it has no significant effect on the incidence of postoperative complications.

PMID:37610489 | DOI:10.1245/s10434-023-14139-2

J Cancer Surviv. 2023 Aug 23. doi: 10.1007/s11764-023-01446-6. Online ahead of print.

ABSTRACT

PURPOSE: The objective of this study is to evaluate whether the presence of a cancer history constitutes a risk for encountering unfavourable health outcomes and functional limitations. Moreover, the study also aims to identify specific attributes of cancer survivors that are associated with an increased risk of experiencing poor health and disability.

METHODS: This study has utilized data from Longitudinal Ageing Study in India (LASI) conducted in 2017-18. The analytical sample size for this study was 65,562 older individuals of age 45 years and above. We have focused on individuals diagnosed with cancer, i.e., cancer survivors, and compared their health outcomes to those of a similar group (without a cancer history) with similar socioeconomic and demographic features. Descriptive statistics and logistic regression models were used to assess the adjusted effect of explanatory variables on cancer survivors.

RESULTS: The result shows that the overall number of cancer survivors is 673 per 100.000 older adults and is higher in Urban areas (874 per 100.000) than in rural areas (535 per 100.000). 43.7% of the survivors reported poor self-rated health, and around 34.0% of cancer survivors reported depression, while this prevalence was much lower among older adults without a cancer history. Individuals who were diagnosed with cancer a long time ago have a significantly lower likelihood of experiencing poor SRH, depression, and diminished life satisfaction in comparison to those diagnosed more recently.

CONCLUSION: The study highlights the importance of factors such as time since diagnosis and the number of cancer sites in influencing health outcomes among survivors. Additionally, socioeconomic factors, such as wealth and access to health insurance, appear to play a role in the health status of cancer survivors.

IMPLICATIONS FOR CANCER SURVIVORS: Healthcare policies should recognize the long-term impact of cancer and prioritize the provision of long-term survivorship care. This may involve establishing survivorship clinics or dedicated healthcare centres that provide specialized care for cancer survivors, addressing their unique needs throughout the survivorship continuum.

PMID:37610478 | DOI:10.1007/s11764-023-01446-6

Biom J. 2023 Aug 23:e2200370. doi: 10.1002/bimj.202200370. Online ahead of print.

ABSTRACT

Decentralized clinical trials (DCTs), that is, studies integrating elements of telemedicine and mobile/local healthcare providers allowing for home-based assessments, are an important concept to make studies more resilient and more patient-centric by taking into consideration participant’s views and shifting trial activities to better meet the needs of trial participants. There are however, not only advantages but also challenges associated with DCTs. An area to be addressed by appropriate statistical methodology is the integration of data resulting from a possible mix of home and clinic assessments at different visits for the same variable, especially in adjusting for sources of possible systematic differences. One source of systematic bias may be how a participant perceives their disease and treatment in their home versus in a clinical setting. In this paper, we will discuss these issues with a focus on Neuroscience when participants have the choice between home and clinic assessments to illustrate how to identify systematic biases and describe appropriate approaches to maintain clinical trial scientific rigor. We will describe the benefits and challenges of DCTs in Neuroscience and then describe the relevance of home versus clinic assessments using the estimand framework. We outline several options to enable home assessments in a study. Results of simulations will be presented to help deciding between design and analysis options in a simple scenario where there might be differences in response between clinic and home assessments.

PMID:37609878 | DOI:10.1002/bimj.202200370

Disaster Med Public Health Prep. 2023 Aug 23;17:e459. doi: 10.1017/dmp.2023.110.

ABSTRACT

OBJECTIVE: The aim of this study was to investigate the occurrence of the disease and research risk factors through sociodemographic data of children aged 0 to 15 years, with symptoms suggestive of COVID-19 in 3 Brazilian municipalities in an international border region.

METHODS: Epidemiological and RT-PCR test results were collected from the COVID-19 notification records in suspected children and adolescents from March 1 to August 31, 2020, in municipalities (Assis Chateaubriand, Tupãssi, and Formosa do Oeste) located in an international border region. The results obtained and the variables associated were subjected to statistical analysis using the Chi-Square Test (x²) or Fisher’s Exact Test, using the statistical program SPSS v. 21.0 (IBM Corp., Armonk, New York, USA) at the 5% significance level.

RESULTS: Among the 147 children from the 3 municipalities, 20 (13.60%) were diagnosed as positive. The predominance of cases was in male children (60.00%) and in children living in urban areas (80%). The most frequent symptoms observed in children were fever (65.00% of the cases), followed by headache (60.00%), cough (55.00%), and nasal congestion, as well as sore throat, both found in 35.00% of the cases.

CONCLUSION: All these data highlight the importance and the need for more epidemiological studies, especially in children and adolescents, as COVID-19 becomes part of the child health panorama worldwide, with serious direct and indirect impacts for humans, animals, and the environment.

PMID:37609851 | DOI:10.1017/dmp.2023.110