Category: Statistics

Ann Intern Med. 2023 Jun 27. doi: 10.7326/M23-0052. Online ahead of print.

ABSTRACT

BACKGROUND: Time-restricted eating (TRE), without calorie counting, has become a popular weight loss strategy, yet long-term randomized trials evaluating its efficacy are limited.

OBJECTIVE: To determine whether TRE is more effective for weight control and cardiometabolic risk reduction compared with calorie restriction (CR) or control.

DESIGN: 12-month randomized controlled trial. (ClinicalTrials.gov: NCT04692532).

SETTING: University of Illinois Chicago from January 2021 to September 2022.

PARTICIPANTS: 90 adults with obesity.

INTERVENTION: 8-hour TRE (eating between noon and 8:00 p.m. only, without calorie counting), CR (25% energy restriction daily), or control (eating over a period of 10 or more hours per day). Participants were not blinded.

MEASUREMENTS: Change in body weight, metabolic markers, and energy intake by month 12.

RESULTS: Seventy-seven persons completed the study. Mean age was 40 years (SD, 11), 33% were Black, and 46% were Hispanic. Mean reduction in energy intake was -425 kcal/d (SD, 531) for TRE and -405 kcal/d (SD, 712) for CR. Compared with the control group, weight loss by month 12 was -4.61 kg (95% CI, -7.37 to -1.85 kg; P ≤ 0.01) (-4.87% [CI, -7.61% to -2.13%]) for the TRE group and -5.42 kg (CI, -9.13 to -1.71 kg; P ≤ 0.01) (-5.30% [CI, -9.06% to -1.54%]) for the CR group, with no statistically significant difference between TRE and CR (0.81 kg [CI, -3.07 to 4.69 kg; P = 0.68]) (0.43% [CI, -3.48% to 4.34%]).

LIMITATION: Not blinded, not powered to detect relatively large differences in weight loss, and lack of adjustment for multiple comparisons.

CONCLUSION: Time-restricted eating is more effective in producing weight loss when compared with control but not more effective than CR in a racially diverse population.

PRIMARY FUNDING SOURCE: National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases.

PMID:37364268 | DOI:10.7326/M23-0052

J Neuroophthalmol. 2023 Jun 26. doi: 10.1097/WNO.0000000000001908. Online ahead of print.

ABSTRACT

BACKGROUND: Prospective evaluation of optical coherence tomography (OCT) and OCT angiography (OCT-A) characteristics in different stages of papilledema in idiopathic intracranial hypertension (IIH).

METHODS: In this prospective, observational study patients of IIH with papilledema were recruited and divided into 3 groups-early/established (Group 1), chronic (Group 2), and atrophic papilledema (Group 3). Peripapillary retinal nerve fiber layer (RNFL) and macular ganglion cell inner plexiform layer (GC-IPL) were recorded on OCT. Peripapillary and macular perfusion was documented at superficial retinal, deep retinal, and choriocapillary level using OCT-A. The investigations were repeated at 3 months.

RESULTS: RNFL showed significant thinning in all groups on follow-up with the atrophic group showing maximum thinning (P = 0.01-Group 3). GC-IPL was significantly reduced in all stages of papilledema at baseline compared with the controls. Thinnest GC-IPL was noted in the atrophic group (52.75 ± 7.44 μm; P = 0.00 in Group 3 vs controls) that showed further deterioration on follow-up. On Image J analysis, significant decrease was noted at various levels in the peripapillary and macular perfusion at baseline especially in the atrophic group which showed further deterioration noted on follow-up. The final visual acuity showed a statistically significant weak negative correlation with baseline RNFL (r = -0.306) and GC-IPL (r = -0.384) and moderately negative correlation with baseline superficial peripapillary retinal perfusion (r = -0.553). A significant negative correlation was seen between increasing grade of papilledema and superficial peripapillary retinal perfusion with both Image J and automated indices (r = -0.46; r = -0.61), respectively.

CONCLUSIONS: GC-IPL may help identify early damage in papilledema even in the presence of thicker RNFL. Significant vascular changes can be observed on OCT-A that may help predict the final visual outcome in papilledema due to IIH.

PMID:37364246 | DOI:10.1097/WNO.0000000000001908

Rev Esc Enferm USP. 2023 Jun 26;57(spe):e20230030. doi: 10.1590/1980-220X-REEUSP-2023-0030en. eCollection 2023.

ABSTRACT

OBJECTIVE: To analyze the migratory process, ways of living, and working conditions of Haitians residing in the municipality of Cascavel, Paraná, as well as their impact on health conditions, consumption patterns, and political and ideological life.

METHOD: cross-sectional observational design. Data was collected through semi-structured interviews conducted from December 2019 to December 2020 with 128 participants who were Haitian immigrants residing in the municipality. Simple descriptive statistics were used for the data analysis, and the findings were discussed in conjunction with relevant literature, with the social determination theory serving as a reference.

RESULTS: The majority of participants were male 75.0% (n = 96), young adults 71.0% (n = 91), speakers of two or more languages 87.5% (n = 112), catholic 61.7% (n = 79), high school education or higher 57.0% (n = 73). They consider their life and health conditions good but are unsatisfied with the working conditions and salary.

CONCLUSION: Haitian immigrants’ arrival facilitation to work in cold stores may indicate labor exploitation of economically and socially vulnerable groups. Immigration policies and the recognition of the educational level of their country of origin may contribute to improving the living condition of this population.

PMID:37364238 | DOI:10.1590/1980-220X-REEUSP-2023-0030en

J Phys Chem Lett. 2023 Jun 26:6119-6126. doi: 10.1021/acs.jpclett.3c01504. Online ahead of print.

ABSTRACT

The structural factors affecting triplet-triplet annihilation (TTA) at the molecular level are not well-understood. Here, our steady-state photoluminescence and transient absorption results demonstrate that the spin statistical factor, η, decreases from 0.60 to 0.46 and 0.14 going from 9,10-diphenylanthracene (DPA) to the 1,5-DPA and 2,6-DPA isomers, respectively, during photon upconversion with a platinum octaethylporphyrin sensitizer. Density functional theory (DFT) shows that η depends on the energetics of hot triplet states and molecular rigidity. The significantly high conical intersection energy between the S₀ and T₁ states for 9,10-DPA gives its longer triplet lifetime. Time-dependent DFT calculations show that 9,10-DPA and 1,5-DPA can undergo high-level reverse intersystem crossing from their T₂ and T₃ states, respectively, to the bright S₁ state, increasing the limit of the spin statistical factor. Both factors ultimately serve to enhance the TTA efficiency. This work provides insight into designing molecules for efficient light-emitting and photon upconversion applications.

PMID:37364235 | DOI:10.1021/acs.jpclett.3c01504

J Clin Oncol. 2023 Jun 26:JCO2202624. doi: 10.1200/JCO.22.02624. Online ahead of print.

ABSTRACT

PURPOSE: Despite therapeutic advances, outcomes for patients with platinum-resistant/refractory ovarian cancer remain poor. Selective glucocorticoid receptor modulation with relacorilant may restore chemosensitivity and enhance chemotherapy efficacy.

METHODS: This three-arm, randomized, controlled, open-label phase II study (ClinicalTrials.gov identifier: NCT03776812) enrolled women with recurrent, platinum-resistant/refractory, high-grade serous or endometrioid epithelial ovarian, primary peritoneal, or fallopian tube cancer, or ovarian carcinosarcoma treated with ≤4 prior chemotherapeutic regimens. Patients were randomly assigned 1:1:1 to (1) nab-paclitaxel (80 mg/m²) + intermittent relacorilant (150 mg the day before, of, and after nab-paclitaxel); (2) nab-paclitaxel (80 mg/m²) + continuous relacorilant (100 mg once daily); or (3) nab-paclitaxel monotherapy (100 mg/m²). Nab-paclitaxel was administered on days 1, 8, and 15 of each 28-day cycle. The primary end point was progression-free survival (PFS) by investigator assessment; objective response rate (ORR), duration of response (DOR), overall survival (OS), and safety were secondary end points.

RESULTS: A total of 178 women were randomly assigned. Intermittent relacorilant + nab-paclitaxel improved PFS (hazard ratio [HR], 0.66; log-rank test P = .038; median follow-up, 11.1 months) and DOR (HR, 0.36; P = .006) versus nab-paclitaxel monotherapy, while ORR was similar across arms. At the preplanned OS analysis (median follow-up, 22.5 months), the OS HR was 0.67 (P = .066) for the intermittent arm versus nab-paclitaxel monotherapy. Continuous relacorilant + nab-paclitaxel showed numerically improved median PFS but did not result in significant improvement over nab-paclitaxel monotherapy. Adverse events were comparable across study arms, with neutropenia, anemia, peripheral neuropathy, and fatigue/asthenia being the most common grade ≥3 adverse events.

CONCLUSION: Intermittent relacorilant + nab-paclitaxel improved PFS, DOR, and OS compared with nab-paclitaxel monotherapy. On the basis of protocol-prespecified Hochberg step-up multiplicity adjustment, the primary end point did not reach statistical significance (P < .025). A phase III evaluation of this regimen is underway (ClinicalTrials.gov identifier: NCT05257408).

PMID:37364223 | DOI:10.1200/JCO.22.02624

Am J Dent. 2023 Jun;36(3):156-1160.

ABSTRACT

PURPOSE: To evaluate the effects of toothpaste tablets on the gloss and surface roughness of resin-based composite materials and determine the relationship between gloss and roughness.

METHODS: Rectangular jigs were designed and printed. Wells (2 mm deep x 7 mm diameter) were filled with Filtek Supreme Ultra A2B, light-cured and polished. A small-area glossmeter was used for gloss (GU) measurements and a profilometer for roughness measurements (Ra) at baseline and after challenge with each toothpaste. An automated tooth-brushing machine was set at 120 strokes/minute for a total of 10,000 strokes to evaluate four test groups with 16 specimens in each group. NC: Brushing with distilled water; TABS: Colgate Anywhere Travel Tooth Tabs; CP: Colgate Cavity Protection Toothpaste and AW: Colgate Whitening Advanced Toothpaste. Kruskal-Wallis test was used to test the difference in gloss and surface roughness among the groups and Pearson correlation was used to compare the relationship between gloss and roughness.

RESULTS: There was no statistically significant difference in gloss and roughness among the four groups at baseline. At post-brushing, there was a statistically significant difference among the groups (P< 0.001) with increased roughness and decreased gloss for CP and AW when compared to TABS. There was a statistically significant correlation between post-brushing roughness and post-brushing gloss (P< 0.001, rho: -0.815). Thus, the higher the surface roughness the lower the gloss.

CLINICAL SIGNIFICANCE: Toothpaste tablets retain better gloss and roughness of resin-based composite materials when compared to conventional toothpastes.

PMID:37364194

Am J Dent. 2023 Jun;36(3):151-155.

ABSTRACT

PURPOSE: To assess tooth color changes and tolerability with use of a hydrogen peroxide whitening strip compared to a regimen of a strip, rinse and paste for tooth whitening.

METHODS: This was a single-center, parallel-group, double-blind, randomized controlled clinical trial. Qualified generally healthy adult participants were assigned to one of two treatment groups. The test group included peroxide-free strips, a fluoride-free whitening toothpaste, and a whitening mouthwash (all Lumineux Oral Essentials); all test products contain plant-based oils (coconut, sage, and lemon peel) and Dead Sea salt. The control group included hydrogen peroxide whitening strips (Crest 3DWhitestrips Classic White) and a sodium fluoride non-whitening toothpaste (Crest). Both groups used a soft manual toothbrush (Oral-B). Strips (for both groups) and rinse (for test group) were used once daily. Changes in tooth color were assessed objectively and quantitatively by digital image analysis after 7, 10 and 14 treatments.

RESULTS: 50 participants were enrolled and randomized to treatment and 48 completed the trial. Participants had an average age of 40.8 years (range 18 to 62 years) and 64% were female. At the end of treatment, the test group did not provide statistically significant changes in yellowness (b*) or lightness (L*) from baseline (P≥ 0.411), whereas the control group demonstrated a statistically significant mean yellowness reduction (SD) of 1.55 (0.703) and a mean lightness improvement (SD) of 1.57 (1.141) compared to baseline (P< 0.001 for both). The control group also provided statistically significantly greater mean yellowness reductions and mean lightness improvements compared to the test group at all time points (P< 0.002). Products in both groups were well tolerated, with minor oral irritation and tooth sensitivity representing the most common findings during treatment.

CLINICAL SIGNIFICANCE: The Crest Whitestrips control whitening strip provided significant tooth whitening efficacy, whereas the Lumineux Oral Essentials test regimen containing plant-based oils and Dead Sea salt did not. This evidence is important for dental professionals to consider when making recommendations for patients seeking at-home whitening treatments.

PMID:37364193

Am J Dent. 2023 Jun;36(3):123-129.

ABSTRACT

PURPOSE: To determine the effects of rubber-cup polishing with different prophylaxis polishing pastes (PPP) on the color stability and surface properties of enamel and dental restorations.

METHODS: Direct (DC) and indirect composite (IC) samples were produced in disc-shaped plexiglass molds (10 x 2 mm). Computer-aided design and computer-aided manufacturing (CAD-CAM) composite blocks (CC) were sliced at a 2 mm thickness and the vestibular enamel surfaces (ES) of human incisors were included. A total of 96 samples were prepared and randomly divided into three subgroups (n= 8). The color, surface gloss and roughness measurements were performed before and after rubber-cup polishing at 2000 rpm for 12 seconds. Analysis of variance was used for statistical evaluation.

RESULTS: No significant difference was observed between the surface roughness change values after polishing with all three PPPs in DC, IC, and ES. However, in the CC group, Cleanic paste caused the highest roughness values and gloss reduction. The highest color change has occurred in the ES, and the least was observed in IC and CC groups. The type of PPP has a significant effect on the color stability and surface properties of enamel and dental restorations as well as the restorative material type.

CLINICAL SIGNIFICANCE: Prophylaxis polishing pastes may have detrimental effects on the surface properties of restorative materials in relation to the type of abrasive they contained and the roughness value.

PMID:37364189

Am J Dent. 2023 Jun;36(3):118-122.

ABSTRACT

PURPOSE: To investigate the effect of over-etching and subsequent use of different adhesive application approaches including active, double, preheated, and ultrasonic application on dentin bond strength.

METHODS: Dentin specimens from sound human third molars were prepared and allocated into six groups (n= 10 per group). In Group 1 (negative control), the dentin specimens were over-etched with phosphoric acid for 30 seconds, and a two-step etch-and-rinse adhesive (Prime & Bond XP; Dentsply Sirona) was applied for 20 seconds according to the manufacturer’s instructions. In test Groups 2-5, the application of the adhesive varied: In Group 2, the adhesive was actively rubbed into the dentin surface, whereas in Group 3, a second adhesive layer was applied after light-curing of the first one. In Group 4, the adhesive was heated to 68°C prior to application, and in Group 5, the adhesive was ultrasonically activated. Acid-etching for 15 seconds and adhesive application for 20 seconds was performed in the positive control group (Group 6) according to the manufacturer’s instructions. After light-curing and composite build-up [Ceram.x Spectra ST (HV); Dentsply Sirona], microtensile bond strength and fracture types were determined. Data were statistically analyzed by Kruskal-Wallis rank test, followed by post-hoc pairwise comparisons using Conover tests and P-value adjustment according to Holm (α= 0.05).

RESULTS: Active, double, preheated, or ultrasonic adhesive application showed no significant effect on dentin bond strength when compared to the control groups. Predominantly adhesive failures were observed in all groups.

CLINICAL SIGNIFICANCE: A modification of adhesive application by using active, double, preheated, or ultrasonic application does not improve bonding to accidentally over-etched dentin.

PMID:37364188

J Am Mosq Control Assoc. 2023 Jun 1;39(2):96-107. doi: 10.2987/22-7109.

ABSTRACT

Within the contiguous USA, Florida is unique in having tropical and subtropical climates, a great abundance and diversity of mosquito vectors, and high rates of human travel. These factors contribute to the state being the national ground zero for exotic mosquito-borne diseases, as evidenced by local transmission of viruses spread by Aedes aegypti, including outbreaks of dengue in 2022 and Zika in 2016. Because of limited treatment options, integrated vector management is a key part of mitigating these arboviruses. Practical knowledge of when and where mosquito populations of interest exist is critical for surveillance and control efforts, and habitat predictions at various geographic scales typically rely on ecological niche modeling. However, most of these models, usually created in partnership with academic institutions, demand resources that otherwise may be too time-demanding or difficult for mosquito control programs to replicate and use effectively. Such resources may include intensive computational requirements, high spatiotemporal resolutions of data not regularly available, and/or expert knowledge of statistical analysis. Therefore, our study aims to partner with mosquito control agencies in generating operationally useful mosquito abundance models. Given the increasing threat of mosquito-borne disease transmission in Florida, our analytic approach targets recent Ae. aegypti abundance in the Tampa Bay area. We investigate explanatory variables that: 1) are publicly available, 2) require little to no preprocessing for use, and 3) are known factors associated with Ae. aegypti ecology. Out of our 4 final models, none required more than 5 out of the 36 predictors assessed (13.9%). Similar to previous literature, the strongest predictors were consistently 3- and 4-wk temperature and precipitation lags, followed closely by 1 of 2 environmental predictors: land use/land cover or normalized difference vegetation index. Surprisingly, 3 of our 4 final models included one or more socioeconomic or demographic predictors. In general, larger sample sizes of trap collections and/or citizen science observations should result in greater confidence in model predictions and validation. However, given disparities in trap collections across jurisdictions, individual county models rather than a multicounty conglomerate model would likely yield stronger model fits. Ultimately, we hope that the results of our assessment will enable more accurate and precise mosquito surveillance and control of Ae. aegypti in Florida and beyond.

PMID:37364184 | DOI:10.2987/22-7109