Tag: statistics

JAMA Netw Open. 2023 Feb 1;6(2):e2255626. doi: 10.1001/jamanetworkopen.2022.55626.

ABSTRACT

IMPORTANCE: Hypertension self-management is recommended for optimal blood pressure (BP) control, but self-identified residential contextual factors that hinder hypertension self-care are understudied.

OBJECTIVE: To quantify perceived neighborhood health and hypertension self-care and assess interactions with the area deprivation index (ADI) and healthy food availability at home.

DESIGN, SETTING, AND PARTICIPANTS: A cross-sectional study was conducted in Baltimore, Maryland, including primary care adults enrolled in the Achieving Blood Pressure Control Together trial between September 1, 2013, and June 30, 2014. Participants were Black and had at least 2 BP readings greater than or equal to 140/90 mm Hg in the 6 months before enrollment. Analyses were conducted from August 5, 2021, to January 28, 2022.

EXPOSURES: Participants’ perceived neighborhood health, defined as the mean standardized score across 4 subdomains of aesthetic quality, walkability, safety, and violence, with a higher score signifying better neighborhood health.

MAIN OUTCOMES AND MEASURES: Hypertension self-care behavior and self-efficacy. Multivariable generalized linear models were fit regressing each outcome on perceived neighborhood health (higher scores on each domain signify better perceived neighborhood health), adjusted for confounders, and interaction terms between neighborhood health and potential modifiers (ADI [higher percentiles correspond to more deprivation] and healthy food availability [higher scores indicate greater availability]) of the primary association were included.

RESULTS: Among 159 participants (median [IQR] age, 57 [49-64] years; mean [SD] age, 57 (11) years; 117 women [74%]), median (IQR) hypertension self-care behavior was 50 (45-56) and self-efficacy was 64 (57-72). Better perceived neighborhood health was associated with greater hypertension self-care behavior (β, 2.48; 95% CI, 0.63-4.33) and self-efficacy (β, 4.42; 95% CI, 2.25-6.59); these associations persisted for all neighborhood health subdomains except aesthetic quality. There were no statistically significant interactions between perceived neighborhood health or its subdomains with ADI on self-care behavior (P = .74 for interaction) or self-efficacy (P = .85 for interaction). However, better perceived neighborhood aesthetic quality had associations with greater self-care behavior specifically at higher healthy food availability at home scores: β at -1 SD, -0.29; 95% CI, -2.89 to 2.30 vs β at 1 SD, 2.97; 95% CI, 0.46-5.47; P = .09 for interaction). Likewise, associations of perceived worse neighborhood violence with lower self-care behavior were attenuated at higher healthy food availability at home scores (β for -1 SD, 3.69; 95% CI, 1.31-6.08 vs β for 1 SD, 0.01; 95% CI, -2.53 to 2.54; P = .04 for interaction).

CONCLUSIONS AND RELEVANCE: In this cross-sectional study, better perceived neighborhood health was associated with greater hypertension self-care among Black individuals with hypertension, particularly among those with greater in-home food availability. Thus, optimizing hypertension self-management may require multifaceted interventions targeting both the patients’ perceived contextual neighborhood barriers to self-care and availability of healthy food resources in the home.

PMID:36763360 | DOI:10.1001/jamanetworkopen.2022.55626

JAMA Netw Open. 2023 Feb 1;6(2):e2255697. doi: 10.1001/jamanetworkopen.2022.55697.

ABSTRACT

IMPORTANCE: Survivors of breast cancer present more severe symptoms of genitourinary syndrome of menopause (GSM) than patients without history of breast cancer. Recently, new treatments, such as vaginal laser therapy, have appeared, but evidence of their efficacy remains scarce.

OBJECTIVE: To assess the safety and efficacy of carbon dioxide (CO2) vs sham vaginal laser therapy after 6 months of follow-up in survivors of breast cancer with GSM receiving aromatase inhibitors.

DESIGN, SETTING, AND PARTICIPANTS: This prospective double-blind sham-controlled randomized clinical trial with two parallel study groups was performed during October 2020 to March 2022 in a tertiary referral hospital. Survivors of breast cancer using aromatase inhibitors were assessed for eligibility, and eligible patients were randomized into the 2 treatment groups. Follow-up was conducted at 6 months. Data were analyzed in July 2022.

INTERVENTIONS: All patients from both groups were instructed to use the first-line treatment (FLT) based on nonhormonal moisturizers and vaginal vibrator stimulation. Patients for each group were allocated to 5 monthly sessions of fractional CO2 laser therapy (CLT) or sham laser therapy (SLT).

MAIN OUTCOMES AND MEASURES: The primary outcome was sexual function, evaluated through Female Sexual Function Index (FSFI) score. Other subjective measures of efficacy included a visual analog scale of dyspareunia, vaginal pH, a Vaginal Health Index, quality of life (assessed via Short-Form 12), and body image (assessed with the Spanish Body Image Scale). Objective measures of efficacy included vaginal maturation index, vaginal epithelial elasticity (measured in Pascals) and vaginal epithelial thickness (measured in millimeters). Measures were assessed before and after the intervention. Tolerance (measured on a Likert scale), adverse effects, and estradiol levels were recorded.

RESULTS: Among 211 survivors of breast cancer assessed, 84 women were deemed eligible and 72 women (mean [SD] age, 52.6 [8.3] years) were randomized to CLT (35 participants) or SLT (37 participants) and analyzed. There were no statistically significant differences between groups at baseline. At 6 months, both groups showed improvement in FSFI (mean [SD] score at baseline vs 6 months: CLT, 14.8 [8.8] points vs 20.0 [9.5] points; SLT, 15.6 [7.0] points vs 23.5 [6.5] points), but there was no significant difference between CLT and SLT groups in the improvement of sexual function evaluated through the FSFI test overall (mean [SD] difference, 5.2 [1.5] points vs 7.9 [1.2] points; P = .15) or after excluding women who were not sexually active (mean [SD] difference, 2.9 [1.4] points vs 5.5 [1.1] points; P = .15). There were also no differences between improvement of the 2 groups at 6 months of follow-up in the other assessed subjective outcomes, including dyspareunia (mean [SD] difference, -4.3 [3.4] vs -4.5 [2.3]; P = .73), Vaginal Health Index (mean [SD] difference, 3.3 [4.1] vs 5.0 [4.5]; P = .17), body image (mean [SD] difference, -3.7 [4.5] vs -2.7 [4.8]; P = .35), and quality of life (mean [SD] difference, -0.3 [3.6] vs -0.7 [3.2]; P = .39). Similarly, there were no differences in improvements in objective outcomes, including vaginal pH (mean [SD] difference, -0.6 [0.9] vs -0.8 [1.2]; P = .29), vaginal maturation index (mean [SD] difference, 10.2 [17.4] vs 14.4 [17.1]; P = .15), vaginal epithelial thickness (mean [SD] difference, 0.021 [0.014] mm vs 0.013 [0.012] mm; P = .30), vaginal epithelial elasticity (mean [SD] difference, -1373 [3197] Pascals vs -2103 [3771] Pascals; P = .64). There were significant improvements in the overall analysis regardless of group in many outcomes. The 2 interventions were well tolerated, but tolerance was significantly lower in the CLT group than the SLT group (mean [SD] Likert scale score, 3.3 [1.3] vs 4.1 [1.0]; P = .007). No differences were observed in complications or serum estradiol levels.

CONCLUSIONS AND RELEVANCE: In this randomized clinical trial, vaginal laser treatment was found to be safe after 6 months of follow-up, but no statistically significant differences in efficacy were observed between CLT and SLT.

TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT04619485.

PMID:36763359 | DOI:10.1001/jamanetworkopen.2022.55697

Diabetes Technol Ther. 2023 Feb 10. doi: 10.1089/dia.2022.0491. Online ahead of print.

ABSTRACT

BACKGROUND: The aim of this multicenter observational real-world study was to investigate glycemic outcomes in children and adolescents with type 1 diabetes over the first six-month use of MiniMed™ 780G. Secondary objective was to evaluate demographic and clinical factors that may be significantly associated with the achievement of therapeutic goals.

METHODS: Demographic, anamnestic, and clinical data of study participants were collected at time of enrolment. Data on ambulatory glucose profile were acquired at 3 and 6 months after activating Auto Mode. Aggregated glucose metrics and device settings of the entire study period were analyzed to identify predictors of optimal glycemic control, assessed by the concomitant achievement of time in range (TIR) > 70%, coefficient of variation (CV) < 36%, glucose management index (GMI) < 7%, and time below range (TBR) < 4%.

RESULTS: Our study cohort consisted of 111 children and adolescents (54.1% female) aged 7-18 years. All the most relevant clinical targets were achieved according to recommendations from the International Consensus both at 3 and 6 months. When considering aggregated data, primary goals in terms of TIR, CV, GMI, and TBR were achieved respectively by 72.1%, 74.8%, 68.5%, and 74.8% of participants. Additionally, 44 individuals (39.6%) concomitantly addressed all the above clinical targets. Regression analysis revealed that older age, briefer duration of disease, and shorter active insulin time were significant predictors of optimal glucose control. Comparing two groups of individuals stratified according to the HbA1c mean value in the year preceding MiniMed™ 780G use, achieving glycemic targets was observed in the subgroup with lower HbA1c.

CONCLUSIONS: Our study highlights the effectiveness and safety of MiniMed™ 780G in the pediatric population. More extensive and personalized training on advanced hybrid closed loop use should be considered for younger people and those with long disease duration.

PMID:36763343 | DOI:10.1089/dia.2022.0491

Transl Stroke Res. 2023 Feb 10. doi: 10.1007/s12975-023-01134-8. Online ahead of print.

ABSTRACT

Most ischemic stroke (IS) patients go untreated due to limited treatment windows, restrictive eligibility criteria, and poor availability of current clinical therapies. Neuroprotective treatments targeting protracted neurodegeneration are needed yet keep failing in clinical trials. Over half of IS patients are female, and the scarcity of neuroprotective studies using female animals hinders translational success. This pilot review and meta-analysis assessed the relationship between the risk of bias and efficacy of studies testing post-ischemic neuroprotective therapies using female rodent models of IS. We carried out a systematic search of the PubMed database for studies published between 1999 and May 2022, used the CAMARADES checklist to evaluate study quality, and extracted data pertaining to lesion volume and behavioral assessment. We found that 34 studies met our inclusion criteria, with pooled effect sizes depicting a significant treatment effect. However, researchers used mostly healthy young females, administered therapies within short time windows, ignored hormonal influences, and did not assess long-term outcomes. Interestingly, studies failing to report factors impacting internal validity, such as blinding and random allocation, had inflated effect sizes or did not reach statistical significance. There was also a relationship between low study quality and larger effect sizes for functional outcome, stressing the need to follow the existing translational design, reporting, and data analysis guidelines. In this review, we cover previous recommendations and offer our own in hopes that rigorous and meticulous research using female animal models of IS will increase our chances of successful bench-to-bedside translation.

PMID:36763321 | DOI:10.1007/s12975-023-01134-8

Pharmacoecon Open. 2023 Feb 10. doi: 10.1007/s41669-023-00393-3. Online ahead of print.

ABSTRACT

BACKGROUND: Innovative medicines are provided with dedicated funds and immediate market access in Italy. Innovativeness evaluation considers unmet need, added therapeutic value, and quality of the evidence.

OBJECTIVE: We aimed to evaluate the internal consistency and drivers of the innovativeness appraisal process.

METHODS: Appraisal reports on innovativeness refer to 1997-2021. We used both a descriptive approach and probabilistic multivariate analysis, using logistic regression models to compute odds ratios and 95% confidence intervals. The dependent variable is innovativeness status (innovative vs. non-innovative; full innovativeness vs. conditional innovativeness). Explanatory variables, besides the three above-mentioned domains, are the year of evaluation, drug type, target disease and population, and the number and type of available studies.

RESULTS: Among the 141 medicines scrutinized, 31.9%, 29.8%, and 38.3% were evaluated as fully innovative, conditionally innovative, and non-innovative, respectively. Added therapeutic value and the quality of the evidence were associated with the odds of receiving innovative status, and full compared with conditional innovativeness; unmet need was not a predictive variable. Other factors played a minor role: medicines for both solid tumours and rare diseases are more likely to be judged innovative; conditional innovativeness is more probable for medicines for rare diseases.

CONCLUSIONS: Innovativeness status is driven by the added therapeutic value and quality of evidence. The appraisal process is internally consistent and predictable. This provides industry with a clear indication of what is needed to ensure that access to their medicines is prioritized.

PMID:36763319 | DOI:10.1007/s41669-023-00393-3

Radiol Med. 2023 Feb 10. doi: 10.1007/s11547-023-01600-1. Online ahead of print.

ABSTRACT

PURPOSE: To evaluate the added value of the diffusion tensor imaging (DTI) parameters to abbreviated breast MRI protocol in differentiating recurrent breast cancer from post-operative changes in cases of breast conservative surgery (BCS).

METHODS: This prospective study was approved by our institutional review board. Written informed consent was obtained in all patients. 47 female patients (mean age, 49 years; range, 32-66 years) that previously underwent breast conservative surgery with a palpable mass were included in this study (62 breast lesions). Two abbreviated MRI protocols were compared using 1.5 Tesla MRI, AB-MRI 1 (axial T1, T2, pre-contrast T1, 1st post-contrast and subtracted images) and AB-MRI 2 (same sequences plus adding DTI). In both protocols, the wash-in rate was calculated. Histopathology was used as the standard of reference. Appropriate statistical tests were used to assess sensitivity, specificity, and diagnostic accuracy for each protocol.

RESULTS: The mean total acquisition time was of 6 min for AB-MRI 1 and 10 min for AB-MRI 2 protocols while the mean interpretation time was of 57.5 and 75 s, respectively. Among analyzed DTI parameters, MD (mean diffusivity) showed the highest sensitivity (96.43%) and specificity (91.18%) (P value = < 0.001). FA (fractional anisotropy), AD (axial diffusivity) and RD (radial diffusivity) showed sensitivity = (78.57%, 82.14% and 85.71%), specificity = (88.24, 85.29% and 79.41%), respectively, P value (< 0.001).

CONCLUSION: DTI may be included in abbreviated MRI protocols without a significant increase in acquisition time and with the advantage of increasing specificity and clinical utility in the characterization of post-conservative breast lesions.

PMID:36763315 | DOI:10.1007/s11547-023-01600-1

J Assist Reprod Genet. 2023 Feb 10. doi: 10.1007/s10815-023-02732-z. Online ahead of print.

ABSTRACT

PURPOSE: The incidence of birth defects is increased in children born after assisted reproductive technologies (ART). However, changes in ART over time could influence this incidence. To investigate this issue, we present the frequency and trends of birth defects in ART and natural pregnancies in Lombardy, Northern Italy, during the period 2014-2020.

METHODS: This is a population-based study using automated system of healthcare utilization (HCU) databases. ART pregnancies included only those obtained with conventional IVF or ICSI. After identifying the total number of deliveries, the rate of newborns with birth defects was compared between natural and ART pregnancies. A logistic regression model was used to calculate the adjusted odd ratio (OR). Analyses were repeated for every calendar year.

RESULTS: Overall, 508,421 deliveries were identified, of which 14,067 (2.8%) were achieved after IVF-ICSI. A decreasing trend in birth defects over time was highlighted. The adjusted OR dropped from 1.40 (95%CI: 1.03-1.91) in 2014 to 0.92 (95%CI: 0.69-1.22) in 2020. During the study period, a significant reduction in multiple pregnancy and in the ratio of ICSI to conventional IVF was also observed, explaining at least in part the positive trend observed for birth defects.

CONCLUSION: The increased risk of birth defects in children born after IVF-ICSI is not steady over time. A decline of this risk emerged in our region. Policy changes in ART may explain this beneficial effect.

PMID:36763300 | DOI:10.1007/s10815-023-02732-z

Ann Surg Oncol. 2023 Feb 10. doi: 10.1245/s10434-023-13157-4. Online ahead of print.

NO ABSTRACT

PMID:36763287 | DOI:10.1245/s10434-023-13157-4

Infection. 2023 Feb 10. doi: 10.1007/s15010-023-01992-2. Online ahead of print.

ABSTRACT

RATIONALE: The ratio of neutrophil-to-lymphocyte (NLR), monocyte-to-lymphocyte (MLR) and platelet-to-lymphocyte (PLR) are biomarkers that have shown potential for predicting mortality in several diseases. For patients hospitalized with community-acquired pneumonia (CAP), the prognostic capabilities of these biomarkers are unknown.

OBJECTIVE: Investigate whether NLR, MLR or PLR were associated with 90-day mortality in CAP. Further, investigate whether the prediction rule CURB-65 could be improved by adding these biomarkers.

METHODS: A derivation-validation study using a Danish multicentre retrospective cohort as the derivation cohort (N = 831) and a European multicentre prospective cohort as the validation cohort (N = 2463). Associations between biomarkers and mortality were assessed using Cox proportional hazard models with adjustments for sex, CURB-65 and comorbidities. A cut-off value for biomarkers was determined using Youden’s J Statistics. The performance of CURB-65 with added biomarkers was evaluated using receiver-operating characteristics.

RESULTS: In both cohorts increasing NLR and PLR were associated with 90-day mortality. In the derivation cohort, the hazard ratios for NLR and PLR were 1.016 (95% confidence interval (CI) 1.001-1.032, P = 0.038) and 1.001 (95% CI 1.000-1.001, P = 0.035), respectively. Adding these biomarkers to CURB-65 did not improve its performance.

CONCLUSIONS: NLR and PLR were associated with 90-day mortality in CAP, but did not improve CURB-65.

PMID:36763284 | DOI:10.1007/s15010-023-01992-2

Environ Sci Pollut Res Int. 2023 Feb 10. doi: 10.1007/s11356-023-25731-0. Online ahead of print.

ABSTRACT

Previous studies on particulate matter (PM) exposure and neurodegenerative disorders showed inconsistent results, and few studies systematically examined the long-term effect of PM on neurodegenerative diseases, including all-cause dementia, Alzheimer’s disease, Parkinson’s disease, vascular dementia, amyotrophic lateral sclerosis, and cognitive function decline. We systematically searched for published studies in PubMed, Embase, Cochrane Library, and Web of Science up to October 31, 2022. To facilitate a comparison of effect sizes from different studies, we standardized units across studies to a 10 μg/m³ increase for PM. Heterogeneity was assessed by Cochran’s Q test and I² statistic. Publication bias was evaluated using funnel plots and Egger’s tests. Subgroup analysis, meta-regression, and sensitivity analysis were performed. The protocol for this review was registered with PROSPERO (CRD42021277112). Of the 3403 originally identified studies, a meta-analysis was finally performed in 49 studies. The results showed that there was a significant positive association between long-term PM_2.5 exposure and all-cause dementia, Alzheimer’s disease as well as Parkinson’s disease, with pooled OR of 1.30 (95%CI: 1.14, 1.47, I² = 99.3%), 1.65 (95%CI: 1.37, 1.94, I² = 98.2%), and 1.17 (95%CI: 1.00, 1.33, I² = 91.8%). A positive association between PM₁₀ and vascular dementia was observed (OR = 1.12, 95%CI: 1.04, 1.21, I² = 0.0%). Association between PM exposure and decreased cognitive function score was found. Our results highlight the important role of PM pollution, particularly PM_2.5, in the risk of age-related neurodegenerative diseases and cognitive function decline.

PMID:36763275 | DOI:10.1007/s11356-023-25731-0