Tag: statistics

Skeletal Radiol. 2023 Aug 31. doi: 10.1007/s00256-023-04437-x. Online ahead of print.

ABSTRACT

OBJECTIVES: To assess how pars interarticularis fracture characteristics on T1-VIBE and STIR MRI relate to healing and identify anatomical parameters that may impact healing.

MATERIALS AND METHODS: A retrospective review of an MRI series of lumbar pars interarticularis injuries in elite athletes over a 3-year period. Fracture configurations, signal intensities and anatomical parameters were recorded by two radiologists. Statistical analysis employed multilevel mixed-effects linear regressions, adjusted for repeated measures and baseline covariates.

RESULTS: Forty-seven lumbar pars interarticularis injuries among 31 athletes were assessed. On final scans for each athlete, 15% (7/47) injuries had worsened, 23% (11/47) remained stable, 43% (20/47) partially healed and 19% (9/47) healed completely. Healing times varied, quickest was 49 days for a chronic fracture in a footballer. Bone marrow oedema signal was highest in worsened fractures, followed by improved, and lowest in stable fractures. As healing progressed, T1-VIBE signal at the fracture line decreased. Bone marrow oedema and fracture line signal peaked at 90-120 days before decreasing until 210-240 days. Fractures with smaller dimensions, more vertical orientation and a longer superior articular facet beneath were significantly associated with better healing (p < 0.05).

CONCLUSION: Most diagnosed athletic pars interarticularis injuries improve. Normalising T1-VIBE signal at the fracture line is a novel measurable indicator of bony healing. Contrastingly, bone marrow oedema signal is higher in active fractures irrespective of healing or deterioration. Injuries initially perceived as worsening may be exhibiting the normal osteoclastic phase of healing. Better outcomes favour smaller, vertical fractures with a longer superior articular facet beneath.

PMID:37650925 | DOI:10.1007/s00256-023-04437-x

Int Urogynecol J. 2023 Aug 31. doi: 10.1007/s00192-023-05635-w. Online ahead of print.

ABSTRACT

OBJECTIVE: The aim of this review is to synthesize existing evidence on the combined effects of the vaginal microenvironment on pelvic dysfunctional diseases.

METHODS: This systematic review was conducted in accordance with the PRISMA guidelines. The PubMed, Embase, Cochrane Library, Web of Science, Wanfang, and China Knowledge Network (CNKI) databases were systematically searched up to January 2023 using the following MeSH terms: “pelvic organ prolapse”, “stress urinary incontinence” and “vaginal microenvironment”, “microenvironment”, “vaginal cleanliness”, “vaginitis”, “lactobacillus” and other related keywords. Study methods were limited to case-control studies or cross-sectional studies. Quality assessment was performed using the Newcastle-Ottawa scale, and meta-analysis of the included literature was performed using Review Manager 5.3.

RESULTS: A total of eight articles were included in this systematic review (SR) and meta-analysis (MA), which involved a total of 7298 study participants. The pooled results of this meta-analysis showed that the vaginal microenvironment (number of vaginal lactobacilli, leukorrhea cleanliness, and presence of vaginitis) were all statistically significantly associated with pelvic dysfunctional diseases in Chinese women.

CONCLUSION: This review indicates that the vaginal microenvironment has an impact on the development of PFD in Chinese women.

TRIAL REGISTRATION: The protocol of this systematic review (SR) and meta-analysis (MA) has been registered in PROSPERO databases with the Registration number of CRD42023407251.

PMID:37650904 | DOI:10.1007/s00192-023-05635-w

Acta Anaesthesiol Scand. 2023 Aug 31. doi: 10.1111/aas.14324. Online ahead of print.

ABSTRACT

BACKGROUND: Health-related quality of life (HRQoL) is a patient-centred outcome increasingly used as a secondary outcome in critical care research. It may cover several important dimensions of clinical status in intensive care unit (ICU) patients that arguably elude other more easily quantified outcomes such as mortality. Poor associations with harder outcomes, conflicting data on HRQoL in critically ill compared to the background population, and paradoxical effects on HRQoL and mortality complicate the current operationalisation in critical care trials. This protocol outlines a simulation study that will gauge if the areas under the HRQoL trajectories could be a viable alternative.

METHODS: We will gauge the behaviour of the proposed HRQoL operationalisation through Monte Carlo simulations, under clinical scenarios that reflect a broad critical care population eligible for inclusion in a large pragmatic trial. We will simulate 15,360 clinical scenarios based on a full factorial design with the following seven simulation parameters: number of patients per arm, relative mortality reduction in the interventional arm, acceleration of HRQoL improvement in the interventional arm, the relative improvement in final HRQoL in the interventional arm, dampening effect of mortality on HRQoL values at discharge from the ICU, proportion of so-called mortality benefiters in the interventional arm and mortality trajectory shape. For each clinical scenario, we will simulate 100,000 two-arm trials with 1:1 randomisation. HRQoL will be sampled fortnightly after ICU discharge. Outcomes will include HRQoL in survivors and all patients at the end of follow-up; mean areas under the HRQoL trajectories in both arms; and mean difference between areas under the HRQoL trajectories and single-sampled HRQoLs at the end of follow-up.

DISCUSSION: In the outlined simulation study, we aim to assess whether the area under the HRQoL trajectory curve could be a candidate for reconciling the seemingly paradoxical effects on improved mortality and reduced HRQoL while remaining sensitive to early or accelerated improvement in patient outcomes. The resultant insights will inform subsequent methodological work on prudent collection and statistical analysis of such data from real critically ill patients.

PMID:37650374 | DOI:10.1111/aas.14324

Womens Health (Lond). 2023 Jan-Dec;19:17455057231189544. doi: 10.1177/17455057231189544.

ABSTRACT

BACKGROUND: Violence during childbirth indirectly contributes to maternal and neonatal morbidity and mortality. It also causes intrapartum health consequences such as prolonged labor, postpartum hemorrhage, and postpartum psychological problems, including postpartum depression, post-traumatic stress disorder, and other negative feelings that lead to a decreased desire for facility delivery and increase the events of home deliveries which reduce the quality of life. In Tanzania, several efforts have been made to promote respectful maternity care. However, violence during childbirth continues to create a critical barrier for facility-based delivery and is in need of considerable attention throughout the health system.

OBJECTIVES: This study aimed to assess types of intrapartum violence and its determinants among postnatal women in the Dodoma Region, Tanzania.

DESIGN: A cross-sectional study using a questionnaire to interview postnatal women at the exit point after being discharged from the health facility to assess intrapartum violence and its determinants.

METHODS: This study was conducted in Dodoma Region involving 307 postnatal women from April to June 2022. A simple random method was used to select respondents. The Chi-square and Fisher’s exact tests were used to assess the association between the categorical variables. The predictors of intrapartum violence were determined using binary logistic regression analysis. Statistical analysis was performed using Statistical Package for Social Science version 25.0. P < 0.05 was considered to be significant.

RESULTS: Overall, 307 postnatal women participated in the study. Among them, 158 (51.5%) postnatal women experienced at least one form of intrapartum violence. The most common forms of intrapartum violence included breach of confidentiality 205 (66.8%), undignified care/verbal abuse 178 (58%), physical abuse 139 (45.3%), and denial or neglected care by midwives 113 (36.8%). Husband employment, urban residence, and being referred from primary hospitals were significant determinants associated with intrapartum violence (adjusted odds ratio = 0.233, 95% confidence interval = 0.057-0.952, p = 0.043, adjusted odds ratio = 2.67, 95% confidence interval = 1.13-10.93, p = 0.026 and adjusted odds ratio = 3.673, 95% confidence interval = 1.131-11.934, p = 0.030, respectively).

CONCLUSION: Violence during childbirth was highly prevalent in this study. Understanding the prevalence and types of intrapartum violence is important in order to promote changes in all levels of the health system. This study reveals the need for key interventions to effect change at many levels; including an interventional study to educate women and birth partners on client rights, and strengthening the health system to meet the needs of women during labor and childbirth. Policies and systems that support respectful maternity care are urgently needed in this setting, including universal training of health professionals in respectful maternity care.

PMID:37650373 | DOI:10.1177/17455057231189544

Womens Health (Lond). 2023 Jan-Dec;19:17455057231190952. doi: 10.1177/17455057231190952.

ABSTRACT

BACKGROUND: Sleep disturbances are associated with adverse perinatal outcomes. Thus, it is necessary to understand the continuous patterns of sleep during pregnancy and how moderators such as maternal age and pre-pregnancy body mass index impact sleep.

OBJECTIVE: This study aimed to examine the continuous changes in sleep parameters objectively (i.e. sleep stages, total sleep time, and awake time) in pregnant women and to describe the impact of maternal age and/or pre-pregnancy body mass index as moderators of these objective sleep parameters.

DESIGN: This was a longitudinal observational design.

METHODS: Seventeen women with a singleton pregnancy participated in this study. Mixed model repeated measures were used to describe weekly patterns, while aggregated changes describe these three pregnancy periods (10-19, 20-29, and 30-39 gestational weeks).

RESULTS: For the weekly patterns, we found significantly decreased deep (1.26 ± 0.18 min/week, p < 0.001), light (0.72 ± 0.37 min/week, p = 0.05), and total sleep time (1.56 ± 0.47 min/week, p < 0.001) as well as increased awake time (1.32 ± 0.34 min/week, p < 0.001). For the aggregated changes, we found similar patterns to weekly changes. Women (⩾30 years) had an even greater decrease in deep sleep (1.50 ± 0.22 min/week, p < 0.001) than those younger (0.84 ± 0.29 min/week, p = 0.04). Women who were both overweight/obese and ⩾30 years experienced an increase in rapid eye movement sleep (0.84 ± 0.31 min/week, p = 0.008), but those of normal weight (<30 years) did not.

CONCLUSION: This study appears to be the first to describe continuous changes in sleep parameters during pregnancy at home. Our study provides preliminary evidence that sleep parameters could be potential non-invasive physiological markers predicting perinatal outcomes.

PMID:37650368 | DOI:10.1177/17455057231190952

Psychol Med. 2023 Aug;53(11):5001-5011. doi: 10.1017/S0033291722001982. Epub 2022 Jul 15.

ABSTRACT

BACKGROUND: Only a limited number of patients with major depressive disorder (MDD) respond to a first course of antidepressant medication (ADM). We investigated the feasibility of creating a baseline model to determine which of these would be among patients beginning ADM treatment in the US Veterans Health Administration (VHA).

METHODS: A 2018-2020 national sample of n = 660 VHA patients receiving ADM treatment for MDD completed an extensive baseline self-report assessment near the beginning of treatment and a 3-month self-report follow-up assessment. Using baseline self-report data along with administrative and geospatial data, an ensemble machine learning method was used to develop a model for 3-month treatment response defined by the Quick Inventory of Depression Symptomatology Self-Report and a modified Sheehan Disability Scale. The model was developed in a 70% training sample and tested in the remaining 30% test sample.

RESULTS: In total, 35.7% of patients responded to treatment. The prediction model had an area under the ROC curve (s.e.) of 0.66 (0.04) in the test sample. A strong gradient in probability (s.e.) of treatment response was found across three subsamples of the test sample using training sample thresholds for high [45.6% (5.5)], intermediate [34.5% (7.6)], and low [11.1% (4.9)] probabilities of response. Baseline symptom severity, comorbidity, treatment characteristics (expectations, history, and aspects of current treatment), and protective/resilience factors were the most important predictors.

CONCLUSIONS: Although these results are promising, parallel models to predict response to alternative treatments based on data collected before initiating treatment would be needed for such models to help guide treatment selection.

PMID:37650342 | DOI:10.1017/S0033291722001982

Twin Res Hum Genet. 2023 Aug 31:1-8. doi: 10.1017/thg.2023.25. Online ahead of print.

ABSTRACT

Aging plays a crucial role in the mechanisms of the impacts of genetic and environmental factors on blood pressure and serum lipids. However, to our knowledge, how the influence of genetic and environmental factors on the correlation between blood pressure and serum lipids changes with age remains to be determined. In this study, data from the Chinese National Twin Registry (CNTR) were used. Resting blood pressure, including systolic and diastolic blood pressure (SBP and DBP), and fasting serum lipids, including total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C) and triglycerides (TGs) were measured in 2378 participants (1189 twin pairs). Univariate and bivariate structural equation models examined the genetic and environmental influences on blood pressure and serum lipids among three age groups. All phenotypes showed moderate to high heritability (0.37-0.59) and moderate unique environmental variance (0.30-0.44). The heritability of all phenotypes showed a decreasing trend with age. Among all phenotypes, SBP and DBP showed a significant monotonic decreasing trend. For phenotype-phenotype pairs, the phenotypic correlation (Rph) of each pair ranged from -0.04 to 0.23, and the additive genetic correlation (Ra) ranged from 0.00 to 0.36. For TC&SBP, TC&DBP, TG&SBP and TGs&DBP, both the Rph and Ra declined with age, and the Ra difference between the young group and the older adult group is statistically significant (p < .05). The unique environmental correlation (Re) of each pair did not follow any pattern with age and remained relatively stable with age. In summary, we observed that the heritability of blood pressure was affected by age. Moreover, blood pressure and serum lipids shared common genetic backgrounds, and age had an impact on the phenotypic correlation and genetic correlations.

PMID:37650338 | DOI:10.1017/thg.2023.25

J Telemed Telecare. 2023 Aug 31:1357633X231187432. doi: 10.1177/1357633X231187432. Online ahead of print.

ABSTRACT

BACKGROUND: Breast cancer causes significant distress in patient-caregiver dyads. While psychosocial and/or mHealth-based interventions have shown efficacy in improving their psychosocial well-being, no reviews have synthesised the effectiveness of such interventions delivered specifically to the breast cancer patient-caregiver dyad.

OBJECTIVE: To synthesise available evidence examining the effectiveness of mHealth-based psychosocial interventions among breast cancer patient-caregiver dyads in improving their psychosocial well-being (primary outcomes: dyadic adjustment, depression and anxiety; secondary outcomes: stress, symptom distress, social well-being and relationship quality), compared to active or non-active controls.

DESIGN: A systematic review and meta-analysis.

METHODS: Randomised controlled trials and quasi-experimental studies were comprehensively searched from seven electronic databases (PubMed, CENTRAL, CINAHL, Embase, PsycINFO, Scopus, Web of Science), ongoing trial registries (ClinicalTrials.gov, WHO ICTRP) and grey literature (ProQuest Dissertations and Theses Global) from inception of databases till 23 December 2022. Studies involving breast cancer patient-caregiver dyads participating in mHealth-based psychosocial interventions, compared to active or non-active controls, were included. Exclusion criteria were terminally ill patients and/or participants with psychiatric disorders or cognitive impairment and interventions collecting symptomatic data, promoting breast cancer screening or involving only physical activities. Screening, data extraction and quality appraisal of studies were conducted independently by two reviewers. Cochrane Risk of Bias Tool version 1 and JBI Critical Appraisal Checklist were used to appraise the randomised controlled trials and quasi-experimental studies, respectively. Meta-analyses using Review Manager 5.4.1 synthesised the effects of outcomes of interest. Sensitivity and subgroup analyses were conducted. The GRADE approach appraised the overall evidence quality.

RESULTS: Twelve trials involving 1204 breast cancer patient-caregiver dyads were included. Meta-analyses found statistically significant increase in caregiver anxiety (standardised mean difference (SMD) = 0.43, 95% confidence interval (CI) [0.09, 0.77], Z = 2.47, p = 0.01), involving 479 caregivers in 5 studies, and stress (SMD = 0.25, 95% CI [0.05, 0.45], Z = 2.44, p = 0.01), involving 387 caregivers in 4 studies post-intervention, favouring control groups. The intervention effects on the remaining outcomes were statistically insignificant. Beneficial effects of such interventions remain uncertain. The overall quality of evidence was very low for all primary outcomes.

CONCLUSIONS: Results of the effectiveness of mHealth-based psychosocial interventions on the psychosocial well-being of breast cancer patient-caregiver dyads are inconclusive. The high heterogeneity shown in the meta-analyses and very-low overall quality of evidence imply the need for cautious interpretation of findings. Higher-quality studies are needed to assess the effects of psychosocial interventions on dyadic outcomes and determine optimal intervention regimes.

PMID:37650270 | DOI:10.1177/1357633X231187432

Mol Nutr Food Res. 2023 Aug 31:e2300003. doi: 10.1002/mnfr.202300003. Online ahead of print.

ABSTRACT

SCOPE: Ultra-processing food (UPF) has been a nutrition and health interest. This study is aimed to investigate the association between UPF consumption and the risk of obesity or dyslipidemia.

METHODS AND RESULTS: This study is performed using an ongoing cohort study including 17 310 individuals aged ≥40 years in South Korea. UPF is categorized by the NOVA system and FCS, respectively. After an average 5-year follow-up, there is a positive association between NOVA-defined UPF and dyslipidemia. The risk of the Q4 group is almost 20% higher than that of the Q1 group (men, adjusted HR = 1.209 [95% CI 1.039-1.407], women, adjusted HR = 1.195 [95% CI 1.096-1.303]). Consuming high-FCS foods (less processed and healthier foods) show a lower risk for dyslipidemia in both sexes and lower obesity risk in women compared to low-FCS consumption (men, dyslipidemia, adjusted HR = 0.857 [95% CI 0.744-0.988]; women, dyslipidemia, adjusted HR = 0.919 [95% CI 0.850-0.993], obesity, adjusted HR = 0.759 [95% CI 0.628-0.916]).

CONCLUSION: Higher UPF intakes assessed by the NOVA system and FCS are associated with increased incidences of dyslipidemia and obesity. Furthermore, NOVA-defined UPF shows a statistically significant negative association with AMED score, indicating poor diet quality.

PMID:37650269 | DOI:10.1002/mnfr.202300003

J Infect Dis. 2023 Aug 31;228(Supplement_2):S101-S110. doi: 10.1093/infdis/jiad285.

ABSTRACT

Most clinical trials evaluating coronavirus disease 2019 (COVID-19) therapeutics include assessments of antiviral activity. In recently completed outpatient trials, changes in nasal severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) RNA levels from baseline were commonly assessed using analysis of covariance (ANCOVA) or mixed models for repeated measures (MMRM) with single imputation for results below assay lower limits of quantification (LLoQ). Analyzing changes in viral RNA levels with singly imputed values can lead to biased estimates of treatment effects. In this article, using an illustrative example from the ACTIV-2 trial, we highlight potential pitfalls of imputation when using ANCOVA or MMRM methods, and illustrate how these methods can be used when considering values <LLoQ as censored measurements. Best practices when analyzing quantitative viral RNA data should include details about the assay and its LLoQ, completeness summaries of viral RNA data, and outcomes among participants with baseline viral RNA ≥ LLoQ, as well as those with viral RNA < LLoQ. Clinical Trials Registration. NCT04518410.

PMID:37650235 | DOI:10.1093/infdis/jiad285