Tag: pubmed

Br J Radiol. 2022 Jul 12:20220009. doi: 10.1259/bjr.20220009. Online ahead of print.

ABSTRACT

OBJECTIVES: To investigate the diagnostic value of tumor homogeneity on contrast-enhanced (CE) computed tomography (CT) to differentiate multiple myeloma (MM) from osteolytic bone metastases (Mets).

METHODS: This retrospective study included patients who were diagnosed with MM or Mets and had multiple (≥2) osteolytic bone tumors on pre-treatment CE-CT. Intra tumoral homogeneity was assessed by coefficient of variation (CV, ratio of standard deviation to mean) of the density of a single lesion (CV-lesion). Inter tumoral homogeneity was assessed as the CV of the densities of multiple lesions in one patient (CV-patient). A classification model was built from CT parameters using classification and regression tree (CART) analysis. Diagnostic performance of the model was evaluated using C-statistics.

RESULTS: A total of 272 lesions (81 MM and 191 Mets) of 105 patients were analyzed. The mean CV-lesion and CV-patient of MM were significantly lower than those of Mets: 0.17 vs 0.26 for CV-lesion (p = 0.005) and 0.16 vs 0.23 for CV-patient (p = 0.013). Thickened struts were more common in MM than in Mets (49.1% vs 12.8%, p ≤ 0.001). In CART analysis, CV-lesion was the first partitioning predictor, followed by thickened struts and by CV-patient. The CART model could distinguish MM from Mets in both the model development cohort (C-statistic: 0.843) and the temporal validation cohort (0.721, 0.686, and 0.686 for three reviewers, respectively).

CONCLUSIONS: MM showed intra tumoral and inter tumoral homogeneity compared with Mets on CE-CT. The combination of CV-lesion and CV-patient can be helpful to radiologists in differentiation of MM from Mets.

ADVANCES IN KNOWLEDGE: Our study showed that MM had intra tumoral and inter tumoral homogeneity compared with Mets on contrast-enhanced CT.

PMID:35819897 | DOI:10.1259/bjr.20220009

J Cosmet Dermatol. 2022 Jul 12. doi: 10.1111/jocd.15237. Online ahead of print.

ABSTRACT

PURPOSE: The purpose of the study was to compare Retinal Pigment Epithelium (RPE) thickness in patients with Psoriasis and Vitiligo.

MATERIALS AND METHODS: The right eyes of 67 Psoriasis and 65 Vitiligo patients and 71 healthy individuals were included in the study. The RPE thicknesses were analyzed with the Spectral Domain Optical Coherence Tomography after routine ophthalmological examinations (SD-OCT).

RESULTS: No statistically significant differences were detected when Psoriasis and Vitiligo patients were compared in terms of RPE levels (p= 0.033). When compared with the control group, no significant differences were found with Psoriasis patients, but a significant difference was detected with Vitiligo patients (p=0.515, p=0.001, respectively).

CONCLUSION: Although no changes were detected in RPE in Psoriasis, the decreased RPE thickness in Vitiligo may be an indicator of the effect of melanin loss on the posterior segment of the eye in Vitiligo. For this reason, measurement of RPE thickness with OCT can help in detecting the damage in Vitiligo patients.

PMID:35819889 | DOI:10.1111/jocd.15237

Anesthesiology. 2022 Jul 12. doi: 10.1097/ALN.0000000000004282. Online ahead of print.

ABSTRACT

For the task of estimating a target benchmark dose such as the ED50 (the dose that would be effective for half the population), an adaptive dose-finding design is more effective than the standard approach of treating equal numbers of patients at a set of equally spaced doses. Up-and-down is the most popular family of dose-finding designs and is in common use in anesthesiology. Despite its widespread use, many aspects of up-and-down are not well known, implementation is often misguided, and standard, up-to-date reference material about the design is very limited. This article provides an overview of up-and-down properties, recent methodologic developments, and practical recommendations, illustrated with the help of simulated examples. Additional reference material is offered in the Supplemental Digital Content.

PMID:35819863 | DOI:10.1097/ALN.0000000000004282

J Plast Surg Hand Surg. 2022 Jul 12:1-6. doi: 10.1080/2000656X.2022.2097250. Online ahead of print.

ABSTRACT

The stromal vascular fraction (SVF) is isolated from adipose tissue and has tremendous regenerative potential for proliferation and differentiation. This study aimed to investigate the factors affecting the cell yield and viability of the SVF to improve the outcomes of its clinical applications and enhance its clinical usage. We performed a retrospective analysis with 121 patients who underwent liposuction to harvest adipose-derived SVF. We recorded patient demographic and clinical characteristics, including age, sex, body mass index (BMI), blood type, medical comorbidities, and smoking and alcohol consumption. As for operative variables, we noted the amount of lipoaspirate and the donor areas, including the lower and entire abdomen. The viability and the cell count of SVF were documented. Sex was a statistically significant factor for viability rate (p < 0.015) and cell count (p < 0.009). Men had higher viability, while women had higher cell counts. We found a statistically significant difference in the presence of hypertension (p = 0.024) and alcohol consumption (p = 0.024). There was a statistically significant relationship between cell count and age (p < 0.001), BMI (p = 0.006), and amount of lipoaspirate (p < 0.001). Sex had significant associations with cell count and viability, while age, BMI, and lipoaspirate amount were significantly associated with cell count. Hypertension and alcohol consumption significantly affected cell count, which is the first such report of this association. Surgeons could apply this knowledge to patient selection for optimal treatment outcomes. Additionally, understanding these factors can help manage patient expectations.

PMID:35819816 | DOI:10.1080/2000656X.2022.2097250

Clin Exp Rheumatol. 2022 Jul 11. doi: 10.55563/clinexprheumatol/5epyh7. Online ahead of print.

ABSTRACT

OBJECTIVES: Biologic disease-modifying anti-rheumatic drugs (b-DMARDs) have qualitatively improved the management of axial spondyloarthritis (axSpA), but up to 30-40% of patients do not respond. Although lymphocytes are clearly implicated in the pathology of SpA, circulating lymphocyte subsets (LS) dynamics has been poorly studied. The objective of this pilot study was to comprehensively analyse circulating LS abnormalities in axSpA, and to determine their potential association with response to b-DMARDs.

METHODS: Sixty-nine patients with axSpA and 141 control subjects (HC) were included. The clinical features were measured at baseline, and additionally at 6 months in a subgroup of patients who received TNFi (n=36) or IL17i (n=26). Clinical response was defined as a 50% reduction of BASDAI or decrease in ASDAS of 1.1 point. CD4/CD8 T-cells, B-cells and NK-cells and their subsets were analysed by flow cytometry at inclusion.

RESULTS: At baseline, alterations in LS were observed in axSpA with reduced/increased frequencies of 10/27 subsets (p<0.003 after correction) and trends for another 5. There was no association of response to bDMARDs with clinical data. Response to IL17i (61% cases) was associated with a higher frequency of NK-cells (p=0.003), trends for change in naïve/memory-CD8+T-cells (p<0.055) and increased expression of KIR3DL2 on Th17-cells (p=0.052). No LS was associated with response to TNFi (69% cases) although trends were observed (CD4+T-cells subsets, higher IL-6R on CD4+/CD8+T-cells).

CONCLUSIONS: This pilot work demonstrated a dysregulation of LS in axSpA. The association observed between several LS and clinical response to IL17i (NK/CD8 subsets/Th17-KIR3DL2) was very different to that observed for TNFi (CD4/IL-6R).

PMID:35819806 | DOI:10.55563/clinexprheumatol/5epyh7

Clin Exp Rheumatol. 2022 Jul 11. doi: 10.55563/clinexprheumatol/0gs167. Online ahead of print.

ABSTRACT

OBJECTIVES: To determine whether early damage and its kinetics measured by the Damage Index for Antiphospholipid Syndrome (DIAPS) predicts mortality.

METHODS: We carried out a single-centre retrospective analysis of thrombotic APS patients (2006 Sydney criteria), using the DIAPS for damage assessment. Early damage was considered to be at six months after disease onset; early damage increase (delta-DIAPS) was deemed to be at least a one-point rise in DIAPS within the first five years of illness. Groups were compared using appropriate statistical tests. Survival was analysed by the Kaplan-Meier method. Cox regression analysis was performed to investigate predictors of mortality.

RESULTS: A total of 197 patients (71.1% female; 65.9% primary APS; 72.4% Caucasian) were followed for up to 43 years (median 10). Damage developed in 143 (73.6%) patients. Twenty-three patients (12%) died. Secondary APS (HR 3.07, 95%CI 1.32-7.12, p=0.009), male sex (HR 3.14, 95%CI 1.35-7.33, p=0.008) and age at APS onset ≥40 years (HR 5.34, 95%CI 1.96-14.53, p=0.001) were risk factors for death. Early damage (n=69, 35.0%) was not associated with death (p=0.231). Having a first arterial event was associated with early damage (p<0.001), but not with delta-DIAPS (p=0.539) nor with the risk of death (p=0.151). Delta-DIAPS (n=53/181, 29.3%) predicted mortality (HR 5.40, 95%CI 2.33-12.52, p<0.001), even after adjusting individually for APS category (secondary), sex (male), early damage and age at APS onset (≥40 years) (all p<0.005).

CONCLUSIONS: Evolving damage in the first five years of illness, but not early damage, predicted mortality regardless of the nature of the first thrombotic event, sex, APS category and age.

PMID:35819804 | DOI:10.55563/clinexprheumatol/0gs167

JAMA Netw Open. 2022 Jul 1;5(7):e2220696. doi: 10.1001/jamanetworkopen.2022.20696.

ABSTRACT

IMPORTANCE: The effect of pediatric advance care planning (pACP) on the sustainability of end-of-life treatment preference congruence between adolescents with cancer and their families has not been examined.

OBJECTIVE: To evaluate the longitudinal efficacy of the Family-Centered Advance Care Planning for Teens with Cancer (FACE-TC) intervention to sustain adolescent-family congruence about end-of-life treatment preferences.

DESIGN, SETTING, AND PARTICIPANTS: This multisite, assessor-blinded, randomized clinical trial enrolled adolescents with cancer (aged 14-21 years) and their family members from 4 pediatric hospitals between July 16, 2016, and April 30, 2019. Participants were randomized 2:1 to FACE-TC (intervention group) or treatment as usual (control group) and underwent 5 follow-up visits over an 18-month postintervention period. Intention-to-treat analyses were conducted from March 9, 2021, to April 14, 2022.

EXPOSURES: Adolescent-family dyads randomized to the FACE-TC group received 3 weekly 60-minute sessions consisting of the discussion and/or completion of the Lyon Family-Centered Advance Care Planning Survey (session 1), Respecting Choices Next Steps pACP conversation (session 2), and Five Wishes advance directive (session 3). Dyads in the control group received treatment as usual. Both groups received pACP information.

MAIN OUTCOMES AND MEASURES: Congruence was measured by completion of the Statement of Treatment Preferences (a document that discusses 4 hypothetical clinical situations and treatment choices for each scenario: continue all treatments, stop all efforts to keep me alive, or unsure) after session 2 (time 1) and at 3 months (time 2), 6 months (time 3), 12 months (time 4), and 18 months (time 5) after intervention. The influence of FACE-TC on the trajectory of congruence over time was measured by longitudinal latent class analysis.

RESULTS: A total of 252 participants (126 adolescent-family dyads) were randomized. Adolescents (mean [SD] age, 17 [1.9] years) and family members (mean [SD] age, 46 [8.3] years) were predominantly female (72 [57%] and 104 [83%]) and White individuals (100 [79%] and 103 [82%]). There was an 83% (104 of 126) retention at the 18-month assessment. Two latent classes of congruence over time were identified: high-congruence latent class (69 of 116 [60%]) and low-congruence latent class (47 of 116 [41%]). The dyads in the FACE-TC group had a 3-fold odds of being in the high-congruence latent class (odds ratio [OR], 3.22; 95% CI, 1.09-9.57) compared with the control group. Statistically significant differences existed at 12 months (β [SE] = 1.17 [0.55]; P = .03]) but not at 18 months (OR, 2.08; 95% CI, 0.92-4.69). In the high-congruence latent class, good agreement (agreement on 2 or 3 of 4 situations) increased over 12 months. White adolescents and families had significantly greater odds of congruence than a small population of American Indian or Alaska Native, Asian, Black or African American, Hispanic or Latino, or multiracial adolescents and families (OR, 3.97; 95% CI, 1.07-14.69).

CONCLUSIONS AND RELEVANCE: Results of this trial showed that, for those who received the FACE-TC intervention, the families’ knowledge of their adolescents’ end-of-life treatment preferences was sustained for 1 year, suggesting yearly follow-up sessions. Race and ethnicity-based differences in the sustainability of this knowledge reflect a difference in the effect of the intervention and require further study.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02693665.

PMID:35819787 | DOI:10.1001/jamanetworkopen.2022.20696

Acta Orthop. 2022 Jul 5;93:634-642. doi: 10.2340/17453674.2022.3909.

ABSTRACT

BACKGROUND AND PURPOSE: Developing meaningful thresholds for the Oxford Knee Score (OKS) advances its clinical use. We determined the minimal important change (MIC), patient acceptable symptom state (PASS), and treatment failure (TF) values as meaningful thresholds for the OKS at 3-, 12-, and 24-month follow-up in patients undergoing unicompartmental knee arthroplasty (UKA).

PATIENTS AND METHODS: This is a cohort study with data from patients undergoing UKA collected at a hospital in Denmark between February 2016 and September 2021. The OKS was completed preoperatively and at 3, 12, and 24 months postoperatively. Interpretation threshold values were calculated with the anchor-based adjusted predictive modeling method. Non-parametric bootstrapping was used to derive 95% confidence intervals (CI).

RESULTS: Complete 3-, 12-, and 24-month postoperative data was obtained for 331 of 423 (78%), 340 of 479 (71%), and 235 of 338 (70%) patients, median age of 68-69 years (58-59% females). Adjusted OKS MIC values were 4.7 (CI 3.3-6.0), 7.1 (CI 5.2-8.6), and 5.4 (CI 3.4- 7.3), adjusted OKS PASS values were 28.9 (CI 27.6-30.3), 32.7 (CI 31.5-33.9), and 31.3 (CI 29.1-33.3), and adjusted OKS TF values were 24.4 (CI 20.7-27.4), 29.3 (CI 27.3-31.1), and 28.5 (CI 26.0-30.5) at 3, 12, and 24 months postoperatively, respectively. All values statistically significantly increased from 3 to 12 months but not from 12 to 24 months.

INTERPRETATION: The UKA-specific measurement properties and clinical thresholds for the OKS can improve the interpretation of UKA outcome and assist quality assessment in institutional and national registries.

PMID:35819794 | DOI:10.2340/17453674.2022.3909

JAMA Netw Open. 2022 Jul 1;5(7):e2221140. doi: 10.1001/jamanetworkopen.2022.21140.

ABSTRACT

IMPORTANCE: Platform trial design allows the introduction of new interventions after the trial is initiated and offers efficiencies to clinical research. However, limited guidance exists on the economic resources required to establish and maintain platform trials.

OBJECTIVE: To compare cost (US dollars) and time requirements of conducting a platform trial vs a series of conventional (nonplatform) trials using a real-life example.

DESIGN, SETTING, AND PARTICIPANTS: For this economic evaluation, an online survey was administered to a group of international experts (146 participants) with publication records of platform trials to elicit their opinions on cost and time to set up and conduct platform, multigroup, and 2-group trials. Using the reported entry dates of 10 interventions into Systemic Therapy in Advancing Metastatic Prostate Cancer: Evaluation of Drug Efficacy, the longest ongoing platform trial, 3 scenarios were designed involving a single platform trial (scenario 1), 1 multigroup followed by 5 2-group trials (scenario 2), and a series of 10 2-group trials (scenario 3). All scenarios started with 5 interventions, then 5 more interventions were either added to the platform or evaluated independently. Simulations with the survey results as inputs were used to compare the platform vs conventional trial designs. Data were analyzed from July to September 2021.

EXPOSURE: Platform trial design.

MAIN OUTCOMES AND MEASURES: Total trial setup and conduct cost and cumulative duration.

RESULTS: Although setup time and cost requirements of a single trial were highest for the platform trial, cumulative requirements of setting up a series of multiple trials in scenarios 2 and 3 were larger. Compared with the platform trial, there was a median (IQR) increase of 216.7% (202.2%-242.5%) in cumulative setup costs for scenario 2 and 391.1% (365.3%-437.9%) for scenario 3. In terms of total cost, there was a median (IQR) increase of 17.4% (12.1%-22.5%) for scenario 2 and 57.5% (43.1%-69.9%) for scenario 3. There was a median (IQR) increase in cumulative trial duration of 171.1% (158.3%-184.3%) for scenario 2 and 311.9% (282.0%-349.1%) for scenario 3. Cost and time reductions in the platform trial were observed in both the initial and subsequently evaluated interventions.

CONCLUSIONS AND RELEVANCE: Although setting up platform trials can take longer and be costly, the findings of this study suggest that having a single infrastructure can improve efficiencies with respect to costs and efforts.

PMID:35819785 | DOI:10.1001/jamanetworkopen.2022.21140

Ir J Med Sci. 2022 Jul 11. doi: 10.1007/s11845-022-03075-x. Online ahead of print.

ABSTRACT

BACKGROUND: Apatinib, a small molecule targeting VEGFR2, is commonly used for advanced gastric cancer treatment. This prospective cohort study further investigated the efficacy and safety of neoadjuvant apatinib plus chemotherapy in locally advanced gastric carcinoma patients.

METHODS: Ninety-six locally advanced gastric carcinoma patients were divided into the apatinib plus chemotherapy group (N = 45) and chemotherapy group (N = 51) according to their chosen treatment. Apatinib was administered (375 mg/day), and S-1 plus oxaliplatin (SOX) or oxaliplatin plus capecitabine (CapOx) was given as chemotherapy, for 3 cycles with 3 weeks a cycle before surgery.

RESULTS: The objective response rate (62.2% vs. 37.3%, P = 0.015) and pathological response grade (P = 0.011) were better; meanwhile, the tumor-resection rate (95.6% vs. 84.3%, P = 0.143) and pathological complete response rate (23.3% vs. 9.3%, P = 0.080) exhibited increasing trends (without statistical significance) in the apatinib plus chemotherapy group compared with the chemotherapy group. Additionally, the apatinib plus chemotherapy group achieved prolonged disease-free survival (DFS) (P = 0.019) and overall survival (OS) (P = 0.047) compared with the chemotherapy group. After adjusted by multivariate Cox’s regression analysis, neoadjuvant apatinib plus chemotherapy was still superior to chemotherapy regarding DFS (hazard ratio (HR): 0.277, P = 0.014) and OS (HR: 0.316, P = 0.038). Notably, the incidences of adverse events between the two groups were not different (P > 0.050). Moreover, the most common adverse events of neoadjuvant apatinib plus chemotherapy were leukopenia (42.2%), fatigue (37.8%), hypertension (37.8%), and anemia (31.1%).

CONCLUSION: Neoadjuvant apatinib plus chemotherapy realizes better clinical response, pathological response, survival profile, and non-inferior safety profile compared to chemotherapy in locally advanced gastric carcinoma.

PMID:35819743 | DOI:10.1007/s11845-022-03075-x