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Nevin Manimala Statistics

Implementation of an academic detailing intervention to increase naloxone distribution and foster engagement in harm reduction from the community clinician

J Am Pharm Assoc (2003). 2022 Dec 7:S1544-3191(22)00397-1. doi: 10.1016/j.japh.2022.12.001. Online ahead of print.

ABSTRACT

BACKGROUND: Respond to Prevent (R2P) is a randomized clinical trial which sought to accelerate distribution of naloxone and other harm reduction materials from community pharmacies. R2P combined an online continuing education course with in-store materials, specifically designed for use in community pharmacies, and then supported implementation through the one-on-one educational technique of academic detailing.

OBJECTIVE: The objective of this paper is to describe and synthesize our experiences providing academic detailing as part of the R2P randomized trial.

METHODS: Closed-ended items from standardized post detailing questionnaires were analyzed with descriptive statistics. Open-ended items were content analyzed for key themes using immersion-crystallization qualitative methods.

RESULTS: A total of 176 pharmacies participated in R2P with 175 receiving their initial academic detailing visit between August 2019 and May 2021. Initial visits were in-person and lasted a median of 35 minutes (interquartile range, 20-45 minutes). The R2P naloxone guide was the most common topic covered (n = 162, 92.6%). Following a fidelity check to assess adequacy of the R2P program implementation, 80 pharmacies (45.7%) required secondary academic detailing. Secondary detailing was more targeted and most frequently focused on the sale of nonprescription syringes (n = 28; 35.2%) or disposal container distribution (n = 30; 37.5%). Analysis of the open-ended items identified factors that the detailers perceived to affect the quality of academic detailing sessions, including the pharmacy environment, participant knowledge of and attitudes toward the subject matter, and ability of the detailer to remain flexible yet consistent.

CONCLUSION: R2P provided a standardized process to foster naloxone distribution and engagement in harm reduction with demonstrated implementation in 175 community pharmacies across 4 states. Academic detailing was perceived to be well-received and effective at providing education and promoting distribution of naloxone and nonprescription syringes in community pharmacies. Additional research is needed to confirm these perceptions through evaluation post-intervention behavioral and attitude changes.

PMID:36567216 | DOI:10.1016/j.japh.2022.12.001

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A Diagnostic Impact of Serum Autotaxin Levels in Patients with Bone Marrow Fibrosis

Clin Lymphoma Myeloma Leuk. 2022 Dec 7:S2152-2650(22)01751-7. doi: 10.1016/j.clml.2022.12.006. Online ahead of print.

ABSTRACT

BACKGROUND: Bone marrow (BM) fibrosis is a condition characterized by deposition of reticulin and collagen fibers in BM. It may confer a poor prognosis in some of hematological malignancies. However, the relationship between fibrosis and the disease pathology is not fully understood and no biomarkers for BM fibrosis are available in clinical practice. Autotaxin (ATX) is a secreted enzyme that is associated with various pathophysiological responses, including fibrosis. We conducted a pilot study to investigate the serum ATX levels in various hematological disorders in patients with or without BM fibrosis.

PATIENTS AND METHODS: The serum levels of ATX in a total of 198 patients with hematological disorders and 160 healthy subjects were analyzed. Because of sexual difference in ATX level, the ATX ratio-determined by dividing the ATX level by the mean value of ATX of control subjects of the same sex-was calculated for further comparative analysis. A trephine biopsy samples from 53 patients were also evaluated to determine the Reticulin Fibrosis Index and Collagen Fibrosis Index of each sample.

RESULTS: In comparison to the control group, the ATX ratio was significantly higher in patients, especially those with malignant lymphoma. The ATX ratio in lymphoma patients with BM fibrosis was significantly higher than that in patients without BM fibrosis. The Collagen Fibrosis Index showed statistically significant negative correlation with the ATX ratio.

CONCLUSION: Our results suggest that the ATX ratio may be a candidate diagnostic biomarker for BM fibrosis in selected patients, including those with malignant lymphoma.

PMID:36567212 | DOI:10.1016/j.clml.2022.12.006

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Treatment Patterns, Survival, Quality of Life, and Healthcare Resource Use Among Patients With Triple-Class Refractory Multiple Myeloma in US Clinical Practice: Findings From the Connect MM Disease Registry

Clin Lymphoma Myeloma Leuk. 2022 Nov 23:S2152-2650(22)01741-4. doi: 10.1016/j.clml.2022.11.008. Online ahead of print.

ABSTRACT

BACKGROUND: Adults with triple-class refractory (TCR) multiple myeloma (MM) have limited treatment options and poor prognosis, but the burden of TCR MM has not been well characterized. This study evaluated treatment patterns, overall survival (OS), health-related quality of life (HRQoL), and healthcare resource use (HCRU) among patients with TCR MM in US clinical practice.

PATIENTS AND METHODS: Patients with TCR MM in the Connect MM Registry (NCT01081028; a large, US, multicenter, prospective observational cohort study of patients with newly diagnosed MM) were included. Patient characteristics, treatment patterns, HRQoL, and HCRU were analyzed using descriptive statistics. OS was calculated using Kaplan-Meier methodology for the overall cohort and for patients with/without ≥1 post-TCR line of therapy (LOT).

RESULTS: A total of 232 patients with TCR MM were included; 155 (67%) had ≥1 post-TCR LOT (post-TCR-Treated subgroup; median 9.9 months of follow-up). Most common post-TCR treatments were carfilzomib (47%), pomalidomide (40%), and daratumumab (26%); median treatment duration was 3.3 months. Median OS was 9.9 months in the overall population, 10.8 months in post-TCR-Treated patients, and 2.6 months for those with no new post-TCR LOT. HRQoL deteriorated and pain increased over 1 year of follow-up, with clinically meaningfully changes in EQ-5D (mean, -0.06 points) and FACT-G (mean, -9.9 points). 124 (53%) patients had ≥1 all-cause hospitalization and 58 (25%) had ≥1 MM-related hospitalization; median annualized length of stay was 35.3 and 42.9 days, respectively.

CONCLUSION: The burden of TCR MM is substantial, emphasizing the need for more effective treatment options in the TCR setting.

PMID:36567211 | DOI:10.1016/j.clml.2022.11.008

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Fresh vs. frozen embryo transfer: new approach to minimize the limitations of using national surveillance data for clinical research

Fertil Steril. 2022 Dec 23:S0015-0282(22)01971-9. doi: 10.1016/j.fertnstert.2022.10.021. Online ahead of print.

ABSTRACT

OBJECTIVE: To assess the benefit of frozen vs. fresh elective single embryo transfer using traditional and novel methods of controlling for confounding.

DESIGN: Retrospective cohort study using data from the National Assisted Reproductive Technology Surveillance System.

SETTING: Not applicable.

PATIENT(S): A total of 44,750 women aged 20-35 years undergoing their first lifetime oocyte retrieval and embryo transfer in 2016-2017, who had ≥4 embryos cryopreserved.

INTERVENTION(S): Fresh elective single embryo transfer and frozen elective single embryo transfer.

MAIN OUTCOME MEASURE(S): The primary outcome was a singleton live birth. Secondary outcomes included rates of total live birth (singleton plus multiple gestations), twin live birth, clinical intrauterine gestation, total pregnancy loss, biochemical pregnancy, and ectopic pregnancy. Outcomes for infants included gestational age at delivery, birth weight, and being small for gestational age.

RESULT(S): The eligibility criteria were met by 6,324 fresh and 2,318 frozen cycles. Patients undergoing fresh and frozen transfer had comparable mean age (30.69 [standard deviation {SD} 0.08] years vs. 31.06 [SD 0.08] years) and body mass index (24.76 [SD 0.20] vs. 25.65 [SD 0.15]); however, women in the frozen cohort created more embryos (8.1 [SD 0.12] vs. 6.8 [SD 0.08]). Singleton live birth rates in the fresh vs. frozen groups were 51.4% vs. 48.8% (risk ratio 1.05; 95% confidence interval [CI], 1.00-1.10). After adjustment with a log-linear regression model and propensity score analysis, the difference in singleton live birth rates remained nonsignificant (adjusted risk ratio, 1.05; 95% CI, 0.97-1.14 and 1.02; 95% CI, 0.96-1.08, respectively). A novel dynamical model confirmed inherent fertility (probability of ever achieving a pregnancy) was balanced between groups (odds ratio, 1.23; 95% CI 0.78-1.95]). The per-cycle probability of singleton live birth was not different between groups (odds ratio 1.11 [95% CI 0.94-1.3]).

CONCLUSION(S): In this retrospective cohort study of fresh vs. frozen elective single embryo transfer, there was no statistically significant difference in singleton live birth rate after adjustment using log-linear models and propensity score analysis. The successful application of a novel dynamical model, which incorporates multiple assisted reproductive technology cycles from the same woman as a surrogate for inherent fertility, offers a novel and complementary perspective for assessing interventions using national surveillance data.

PMID:36567206 | DOI:10.1016/j.fertnstert.2022.10.021

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Effects of Intensive Blood Glucose Control on Surgical Site Infection for Liver Transplant Recipients: A Randomized Controlled Trial

Transplant Proc. 2022 Dec 23:S0041-1345(22)00777-1. doi: 10.1016/j.transproceed.2022.10.062. Online ahead of print.

ABSTRACT

BACKGROUND: The evidence supporting intensive blood glucose control to prevent surgical site infections (SSIs) among liver transplant recipients is insufficient. We aimed to assess the effects of postoperative intensive blood glucose control (IBGC) against standard blood glucose control (SBGC) on the incidence of SSIs among adult liver transplant recipients.

METHODS: We performed a randomized controlled trial (ClinicalTrials.gov identifier NCT03474666). The IBGC target was 80 to 130 mg/dL, and the SBGC target was below 180 mg/dL. Analyses were made on an intention-to-treat basis.

RESULTS: Of the 41 recipients enrolled onto the trial, 20 were randomly allocated to the IBGC group and 21 to the SBGC group. There were no significant differences in SSIs among recipients allocated to either group (relative risk [RR], 0.78; 95% confidence interval [CI], 0.21-2.88; P = .69). Mean (SD) blood glucose levels were significantly lower in the IBGC group in the 24-hour period after surgery (145.0 [20.7] mg/dL and 230.2 [51.6] mg/dL; P = .001). While there were fewer episodes of hypoglycemia in the IBGC group, this was not statistically significant. There were no episodes of severe hypoglycemia in either group. Hyperglycemia and severe hyperglycemia were significantly more frequent in the SBGC group (RR, 0.70; 95% CI, 0.52-0.93; P = .001 and RR, 0.07; 95% CI, 0.01-0.48; P = .001, respectively). Length of hospital stay was significantly shorter for recipients in the IBGC group (13.1 [5.5] days vs 19.3 [12.1] days; P = .04).

CONCLUSIONS: Although this small trial did not find intensive control reduced SSI, it was associated with lower blood glucose levels, fewer episodes of hyperglycemia and severe hyperglycemia, and shorter length of hospital stay.

PMID:36567173 | DOI:10.1016/j.transproceed.2022.10.062

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Use of Full-quality DICOM Images Compared to Minimally Compressed Mammograms in JPEG Format for Radiology Training: A Study From Radiologist and Radiographer Perspectives

Acad Radiol. 2022 Dec 23:S1076-6332(22)00618-3. doi: 10.1016/j.acra.2022.11.012. Online ahead of print.

ABSTRACT

BACKGROUND: Running online training in mammography interpretation poses a challenge to radiologists and reporting radiographers due to the large size of digital mammograms in DICOM format and limited bandwidth capabilities of the users for image transmission. This study aims to compare image quality between the full-quality with minimal compressed JPEG and DICOM format of mammograms on a diagnostic monitor through the evaluation of radiologists and radiographers.

METHODS: Twelve participants including six radiologists and six radiographers participated as observers in this study. The observers viewed 60 2D digital mammography screening cases (22 cancer and 38 normal cases) in DICOM and minimal compressed JPEG formats on a 5MP diagnostic monitor. A 5-point Likert scale was provided for observers to compare the quality of mammograms between the two formats, with text anchors indicating to one image being significantly better, slightly better or of equal quality in terms of technical and diagnostic aspects. Nonparametric descriptive statistics were used to evaluate the ratings of radiologists and radiographers in different characteristics of mammograms of two image formats.

RESULTS: The DICOM and JPEG images were statistically equivalent through ratings from radiographers in brightness, contrast, dynamic range, sharpness, no significant distortion, no significant noise, and background homogeneity in all mammograms. Similarly, most radiologists rated DICOM and JPEG images clinically and statistically equivalent with respect to difficulty of interpretation, brightness, contrast, dynamic range, sharpness, the appearance of Cooper’s ligaments, visibility of subtle microcalcifications, visibility of structures at the margins of the breast. Normal cases were marginally favored by radiologists in DICOM format (ranging from 0.4% to 5.3%) while cancer cases in JPEG (ranging from 0.8% to 7.6%) received slightly higher rating.

CONCLUSIONS: Findings showed that baseline full-quality with minimal compression JPEG was equivalent to the DICOM format of full-field digital mammograms which suggests that this type of JPEG could be used for online training and education in radiology.

PMID:36567143 | DOI:10.1016/j.acra.2022.11.012

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Canadian older adults’ intention to use an electronic decision aid for housing decisions: a cross-sectional online survey

JMIR Aging. 2022 Dec 25. doi: 10.2196/43106. Online ahead of print.

ABSTRACT

BACKGROUND: Older adults experiencing disabilities such as loss of autonomy face the decision of whether to stay at home or move to a healthcare facility such as a nursing home. Thus, they may need support for this difficult decision.

OBJECTIVE: We assessed Canadian older adults’ intention to use an electronic decision aid (eDA) for making housing decisions and identified the factors that influenced their intention.

METHODS: We conducted a cross-sectional study using an online survey targeting older adults across the 10 Canadian provinces and 3 territories. We included respondents from an online panel who were aged 65 years or older, understood English or French, had access to an electronic device with an internet connection and had made a housing decision over the past few months or were planning to make a decision in the coming year. We based the online survey on the Unified Theory of Acceptance and Use of Technology (UTAUT). We adapted 17 UTAUT items to measure respondents’ intention to use the eDA for housing decisions, as well as items measuring 4 intention constructs (performance expectancy, effort expectancy, social influence and facilitating conditions). We also assessed e-Health literacy using subjective and objective scales. We used descriptive statistics and multivariable linear regression analyses to identify factors influencing the intention to use the eDA.

RESULTS: Of the 11,972 eligible panellists, 1,176 met the eligibility criteria and 1,000 (85%) respondents completed the survey. The mean age was 72.5 ± 5.59 years. Most respondents were male (54.8%), white (90.6%), English-speakers (62.9%) and living in Ontario or Quebec (62.8%) in urban areas (85%). Mean scores for subjective e-Health literacy were 27.8 ± 5.88 out of 40 and for objective e-Health literacy, 3.00 ± 0.97 out of 5. In our sample, the intention score was 4.74 ± 1.7 out of 7. Mean scores of intention constructs out of 7 were 5.63 ± 1.28 for facilitating conditions, 4.94 ± 1.48 for performance expectancy, 5.61 ± 1.35 for effort expectancy and 4.76 ± 1.59 for social influence. In the final model, factors associated with intention included mother tongue (β = .30; P <.001), objective e-Health literacy (β = -.06; P =.03), performance expectancy (β = .55; P <.001), social influence (β = .37; P <.001) and facilitating conditions (β = .15; P <.001).

CONCLUSIONS: Findings from this pan-Canadian online survey suggest that Canadian older adults’ intention to use an eDA to make housing decisions are similar to findings in other studies using UTAUT. Factors identified as influencing intention were mother tongue, objective e-Health literacy, performance expectancy, social influence and facilitating conditions. These will guide future strategies for implementing the eDA.

PMID:36566499 | DOI:10.2196/43106

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New idea for determining the optimal number of measurements in absorbed dose-to-water measurement of high-energy photon beam

Radiat Prot Dosimetry. 2022 Dec 24:ncac262. doi: 10.1093/rpd/ncac262. Online ahead of print.

ABSTRACT

This study presents a new idea for estimating the number of measurements required for determining the uncertainty in obtaining the desired water absorbed dose using the variation obtained from multicenter absorbed dose measurement data. The number of dose measurements depends on the performance of each linear accelerator (LINAC) tested and the dosimetry equipment and procedure used. However, optimising the number of data collected for the absorbed dose to water has been inadequately reported. Using the absorbed dose measurement data collected 10 times as a reference value, we will compare the changes in the variation of the measurement results caused by the difference in the number of repeated measurements of the absorbed dose. The number of measurements is determined statistically such that this variation would be smaller than the change in absorbed dose. Thus, we can determine the optimum number of measurements suitable for the variability of each LINAC.

PMID:36566494 | DOI:10.1093/rpd/ncac262

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Efficacy and safety of topical agents in the treatment of melasma: What’s evidence? A systematic review and meta-analysis

J Cosmet Dermatol. 2022 Dec 25. doi: 10.1111/jocd.15566. Online ahead of print.

ABSTRACT

BACKGROUND: Various topical agents have been used to treat melasma; however, a large-scale evaluation among the currently available treatment is lacking.

OBJECTIVES: The aim of this study was to evaluate the efficacy and safety of topical agents for melasma.

METHODS: The MEDLINE, Embase, Web of Science, Cochrane, and Alt-Healthwatch databases were searched in November 2021. Original studies that reported pre- and post-treatment Melasma Area Severity Index (MASI)/modified Melasma Area Severity Index (mMASI) scores and/or adverse effects (AEs) were eligible for inclusion. The main outcome was the efficacy analyzed by the changes in the pre- and post-treatment with standardized mean difference (SMD) of MASI/mMASI scores; the AEs were calculated with incidence proportion by the reported percentage of skin irritations.

RESULTS: A total of 45 studies (2359 patients) and 55 studies (4539 patients) met the inclusion criteria for efficacy and AEs, respectively. Hydroquinone (HQ) monotherapy (SMD -1.3, 95% CI [-1.6 to -1.0]), HQ-containing combination therapy (-1.4, [-1.7 to -1.1]), cysteamine (-1.6, [-2.0 to -1.2]), tranexamic acid (-1.5, [-2.0 to -1.1]), azelaic acid (-1.3, [-1.7 to -1.0]), and kojic acid (-0.9, [-1.3 to -0.5]) demonstrated comparable efficacy, while zinc sulfate did not exhibit statistically significant improvement (-1.2, [-2.7 to 0.4]). HQ-containing combination therapy (50.9%) and cysteamine (42.2%) demonstrated the highest incidence of irritation, while azelaic acid (18.7%), kojic acid (5.3%), and tranexamic acid (0.8%) revealed a lower risk.

CONCLUSIONS: In this meta-analysis, non-HQ agents except zinc sulfate may be considered as an alternative to HQ-containing agents. However, treatment should be guided by patient’s tolerance, availability, and physicians’ experience.

PMID:36566490 | DOI:10.1111/jocd.15566

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Diagnostic ability using fatty liver and metabolic markers for metabolic-associated fatty liver disease stratified by metabolic/glycemic abnormalities

J Diabetes Investig. 2022 Dec 25. doi: 10.1111/jdi.13966. Online ahead of print.

ABSTRACT

AIMS/INTRODUCTION: Although several noninvasive predictive markers for fatty liver and metabolic markers have been used for fatty liver prediction, whether such markers can also predict metabolic-associated fatty liver disease (MAFLD) remains unclear. We aimed to examine the ability of existing fatty liver or metabolic markers to predict MAFLD.

MATERIALS AND METHODS: Participants in a high-volume center in Tokyo were classified into groups with and without MAFLD, based on the presence of metabolic abnormalities and fatty liver diagnosed through abdominal ultrasonography, between 2008 and 2018. The diagnostic abilities of three fatty liver markers: fatty liver index (FLI), hepatic steatosis index (HSI), and lipid accumulation product (LAP), and three common metabolic markers: waist-to-height ratio (WHR), body mass index (BMI), and waist circumference (WC), for predicting MAFLD, were evaluated. Analyses stratified by MAFLD subtypes were performed.

RESULTS: Of 92,374 individuals, 19,392 (36.1%) had MAFLD. The diagnostic performances for MAFLD prediction, measured as c-statistics, for FLI, HSI, LAP, WHR, BMI, and WC were 0.906, 0.892, 0.878, 0.844, 0.877, and 0.878, respectively. Optimal cutoff values for diagnosing MAFLD for FLI, HSI, LAP, WHR, BMI, and WC were 20.3, 32.7, 20.0, 0.49, 22.9, and 82.1, respectively. Analyses stratified by MAFLD subtypes, based on BMI and metabolic/glycemic abnormalities, suggested that FLI and HSI had acceptable (c-statistics >0.700) diagnostic abilities throughout all the analyses.

CONCLUSIONS: All six markers were excellent predictors of MAFLD in diagnosing among the general population, with FLI and HSI particularly useful among all sub-populations.

PMID:36566480 | DOI:10.1111/jdi.13966