Category: Statistics

J Investig Med. 2021 Apr 12:jim-2021-001818. doi: 10.1136/jim-2021-001818. Online ahead of print.

ABSTRACT

Undoubtedly, identification of the chemical composition of organic extracts or secondary metabolites of plant materials and evaluation of their potential bioactivity are among the main objectives of natural products-based investigations. In the present study, we report the chemical composition and antidiabetic activity of Sophora pachycarpa (Family Fabaceae) seeds extract (SPE) for the first time. First, the plant seeds were macerated in ethanol. The extract was subjected to analysis on a gas chromatography-mass spectrometry (GC-MS) system to identify the chemical composition. In vivo assay was run to evaluate the antidiabetic activity of the extract. Forty mice were divided into four groups, namely healthy mice, untreated diabetic mice, diabetic mice treated with metformin and diabetic mice treated with SPE. The antidiabetic activity of SPE was analyzed using three statistical methods, namely analysis of variance, K-means, and principal component analysis. According to GC-MS analysis, alkaloids of sophoridine, oleic acid, linoleic acid, and n-hexadecanoic acid were among the most abundant constituent components of SPE. The extract also exhibited a notable antidiabetic activity and remarkably decreased the levels of alkaline phosphatase (ALP), serum glutamic pyruvic transaminase (SGPT), and serum glutamic oxaloacetic transaminase (SGOT) enzymes. The statistical analyses revealed there are no significant differences between the ability of SPE and metformin in the regulation of fasting blood sugar level and liver enzymes (ALP, SGPT, and SGOT). A quinolizidine alkaloid, namely sophoridine, along with fatty acids, viz oleic, linoleic, and n-hexadecanoic acid, were characterized as the major compounds in S. tachycardia seeds extract. The plant extract was also found as a potent agent to reduce blood glucose and liver enzymes.

PMID:33846211 | DOI:10.1136/jim-2021-001818

Br J Sports Med. 2021 Apr 12:bjsports-2020-103604. doi: 10.1136/bjsports-2020-103604. Online ahead of print.

ABSTRACT

The inter-relationship between physical activity, sedentary behaviour and sleep (collectively defined as physical behaviours) is of interest to researchers from different fields. Each of these physical behaviours has been investigated in epidemiological studies, yet their codependency and interactions need to be further explored and accounted for in data analysis. Modern accelerometers capture continuous movement through the day, which presents the challenge of how to best use the richness of these data. In recent years, analytical approaches first applied in other scientific fields have been applied to physical behaviour epidemiology (eg, isotemporal substitution models, compositional data analysis, multivariate pattern analysis, functional data analysis and machine learning). A comprehensive description, discussion, and consensus on the strengths and limitations of these analytical approaches will help researchers decide which approach to use in different situations. In this context, a scientific workshop and meeting were held in Granada to discuss: (1) analytical approaches currently used in the scientific literature on physical behaviour, highlighting strengths and limitations, providing practical recommendations on their use and including a decision tree for assisting researchers’ decision-making; and (2) current gaps and future research directions around the analysis and use of accelerometer data. Advances in analytical approaches to accelerometer-determined physical behaviours in epidemiological studies are expected to influence the interpretation of current and future evidence, and ultimately impact on future physical behaviour guidelines.

PMID:33846158 | DOI:10.1136/bjsports-2020-103604

Eur Urol Oncol. 2021 Apr 10:S2588-9311(21)00048-1. doi: 10.1016/j.euo.2021.03.004. Online ahead of print.

ABSTRACT

BACKGROUND: While magnetic resonance imaging (MRI)-targeted biopsy (TBx) results in better prostate cancer (PCa) detection relative to systematic biopsy (SBx), the combination of both methods increases clinically significant PCa detection relative to either Bx method alone. However, combined Bx subjects patients to higher number of Bx cores and greater detection of clinically insignificant PCa.

OBJECTIVE: To determine if prebiopsy prostate MRI can identify men who could forgo combined Bx without a substantial risk of missing clinically significant PCa (csPC).

DESIGN, SETTING, AND PARTICIPANTS: Men with MRI-visible prostate lesions underwent combined TBx plus SBx.

OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The primary outcomes were detection rates for grade group (GG) ≥2 and GG ≥3 PCa by TBx and SBx, stratified by Prostate Imaging-Reporting and Data System (PI-RADS) score.

RESULTS AND LIMITATIONS: Among PI-RADS 5 cases, nearly all csPCs were detected by TBx, as adding SBx resulted in detection of only 2.5% more GG ≥2 cancers. Among PI-RADS 3-4 cases, however, SBx addition resulted in detection of substantially more csPCs than TBx alone (7.5% vs 8%). Conversely, TBx added little to detection of csPC among men with PI-RADS 2 lesions (2%) relative to SBx (7.8%).

CONCLUSIONS: While combined Bx increases the detection of csPC among men with MRI-visible prostate lesions, this benefit was largely restricted to PI-RADS 3-4 lesions. Using a strategy of TBx only for PI-RADS 5 and combined Bx only for PI-RADS 3-4 would avoid excess biopsies for men with PI-RADS 5 lesions while resulting in a low risk of missing csPC (1%).

PATIENT SUMMARY: Our study investigated an optimized strategy to diagnose aggressive prostate cancer in men with an abnormal prostate MRI (magnetic resonance imaging) scan while minimizing the risk of excess biopsies. We used a scoring system for MRI scan images called PI-RADS. The results show that MRI-targeted biopsies alone could be used for men with a PI-RADS score of 5, while men with a PI-RADS score of 3 or 4 would benefit from a combination of MRI-targeted biopsy and systematic biopsy. This trial is registered at ClinicalTrials.gov as NCT00102544.

PMID:33846112 | DOI:10.1016/j.euo.2021.03.004

BMJ Support Palliat Care. 2021 Apr 12:bmjspcare-2020-002878. doi: 10.1136/bmjspcare-2020-002878. Online ahead of print.

ABSTRACT

OBJECTIVES: To ask all clinical, administrative and support staff affiliated with a large network of healthcare facilities to identify the conditions that they consider as non-negotiable for their own deaths to be regarded as good.

METHODS: All 3495 staff of a healthcare network were asked to rank 10 conditions according to how non-negotiable they would be for themselves during their final 3 months or few hours for their own deaths to be considered as good. They were also asked about whether they had thought about their own death in the last 3 months, if they had a will, believed in God, and in the possibility of a good death, and the intensity of their fear of death.

RESULTS: 2971 (85%) completed the survey. Most were female (79%) and clinical staff (65%). 93% believed in God, 60% had thought about their death recently, 33% had an intense fear of death, and 4% had a will. 64% considered a good death possible. Participants ranked dying at a preferred place, emotional support from family and friends and relief from physical symptoms as their top priorities. The lowest ranked conditions were (from the bottom) relief from psychological distress, performance of rituals and the right to terminate life. There were no statistically significant differences across genders or individual occupational groups.

CONCLUSION: Most of conditions for a good death of interest to healthcare professionals could be provided without sophisticated medical infrastructure or specialised knowledge, opening the door for new support services to make it possible for everyone, anywhere.

PMID:33846127 | DOI:10.1136/bmjspcare-2020-002878

Antimicrob Agents Chemother. 2021 Apr 12:AAC.01573-20. doi: 10.1128/AAC.01573-20. Online ahead of print.

ABSTRACT

Discordant results for Mycobacterium tuberculosis isolates with disputed mutations between genotypic drug susceptibility testing (DST) (gDST) and phenotypic DST (pDST) impact RIF-resistant (RR) and multidrug-resistant (MDR) tuberculosis (TB) treatments due to a lack of practical clinical guidelines. To investigate the role of disputed rpoB mutations in M. tuberculosis and TB treatment outcomes, initial isolates of 837 clinical RR or MDR-TB cases confirmed during 2014-2018 were retested using agar-based RIF pDST and rpoB gene sequencing. Minimum inhibitory concentrations (MICs) were determined for isolates with disputed rpoB mutations. Disputed rpoB mutations were identified in 77 (9.2%) M. tuberculosis isolates, including 50 (64.9%) and 14 (18.2%) phenotypic RIF- and rifabutin (RFB)-resistant isolates, respectively. The predominant single mutations were L533P (44.2%) and L511P (20.8%). Most of the isolates harboring L511P (87.5%), H526N (100%), D516Y (70.0%) and L533P (63.6%) mutations had MICs ≤1 mg/L, whereas isolates harboring H526L (75%) had MICs > 1 mg/L. Of the 63 cases with treatment outcomes, 11 (17.5%) cases died, 1 (1.6%) case transferred out and 51 (81%) cases had favorable outcomes, including 8 and 20 cases treated with standard-dose RIF- and RFB-containing regimens, respectively. Excluding cases transferred out, received no or 1-day treatment, we observed statistically significant differences between active and inactive fluoroquinolones (FQs) [P =0.004, Odds ratio =0.05 (95% confidence intervals, 0.01-0.38)] in 57 cases. We concluded that disputed rpoB mutations are not rare. Depending on resources, sequencing and/or MIC testing is recommended for better management of RR and MDR-TB cases.

PMID:33846134 | DOI:10.1128/AAC.01573-20

Res Social Adm Pharm. 2021 Mar 20:S1551-7411(21)00116-9. doi: 10.1016/j.sapharm.2021.03.010. Online ahead of print.

ABSTRACT

BACKGROUND: For patients that face barriers to filling their prescriptions, the availability of medication access services at their site of care can mean the difference between receiving prescribed drug therapy, and undue interruptions in care. Hospitals often provide medication access services that are not reimbursed by payers; however, they can be challenging to sustain. The 340B Drug Pricing Program allows covered entities to generate savings through discounted pricing for certain outpatient medications, which can then be used to provide more comprehensive services, including medication access services.

OBJECTIVE: To characterize medication access services provided at hospitals that participate in the 340B Drug Pricing Program compared to hospitals that do not participate in the 340B Program.

METHODS: Primary questionnaire response data was collected from a national sample of Directors of Pharmacy at non-federal acute care hospitals from March 2019 to May 2019. American Hospital Association Data Viewer was used to collect demographic information on 1,531 hospitals. Hospitals were excluded if they had 199 beds or fewer, did not have a unique Medicare provider ID, were federally owned, were located outside the continental U.S., or were non-acute care hospitals that served niche patient populations. This study utilized a proportional stratified sampling strategy to administer an electronic questionnaire to 340B and non-340B hospitals to assess the number and type of medication access service offerings. A final randomized sample of 500 hospitals were administered the questionnaire, and data was collected through recorded responses in Qualtrics software.

RESULTS: 340B hospitals provided a significantly higher average number of medication access services compared to non-340B hospitals (6.20 vs. 3.91, p = 0.0001), adjusted for differences in hospital size and ownership type. For all nine medication access services that were assessed, a higher percentage of 340B hospitals reported providing the service compared to non-340B hospitals. This difference was statistically significant for six out of nine programs assessed.

CONCLUSIONS: 340B hospitals provided more medication access services, on average, than comparably sized non-340B hospitals, suggesting that hospitals participating in the 340B Drug Pricing Program may be better positioned to create and administer programs that support medication access services.

PMID:33846100 | DOI:10.1016/j.sapharm.2021.03.010

Z Evid Fortbild Qual Gesundhwes. 2021 Apr 9:S1865-9217(21)00039-8. doi: 10.1016/j.zefq.2021.02.010. Online ahead of print.

ABSTRACT

BACKGROUND: Evidence-based medicine (EbM) as a teaching subject is increasingly taken into account in the Master Plan 2020. To date, neither theoretical requirements nor practical applications of EbM have been consistently implemented in the clinical curriculum. To fill this gap, a digital and tutor-based EbM course has been developed. The aim is to identify the student characteristics (statistical competence, Need for Cognition (NFC), work and experience patterns (AVEM), diagnostic uncertainty) of the first cohort in order to ensure successful course implementation and to prepare future doctors for their role as mediators of health literacy using EbM methods.

METHODS: The long-term study started in the summer term 2019 with 10 medical students during their clinical training. The measurements were conducted before (t0) and after course attendance (t1). Socio-demographic variables were taken at t0, the Quick Risk Test, PRU questionnaire, the NFC scale and the AVEM were collected at t0 and t1.

RESULTS: Half of the students started their doctoral thesis before attending the course. The first test results of the Quick Risk Test (t0) were between 50 % and 90 % and at t1 between 60 % and 100 %. The students showed high scores on the NFC scale (X¯=4.6, SD=0.52, Δ X¯ t0 – t1=0.1) and medium scores on the Perfectionism scale (X¯=3.8, SD=0.51, Δ X¯ t0 – t1=0.1), Resignation Tendency (X¯=3.8, SD=1.17, Δ X¯ t0 – t1=0.1) and on the scale Aggressive Problem Solving (X¯=3.9, SD=1.06, Δ X¯ t0 – t1=0.2). They achieved high levels of Anxiety Due to Diagnostic Uncertainty (X¯=4.8, SD=0.69, Δ X¯ t0 – t1=0.4) and on the scale Concern about Poor Outcomes (X¯=3.9, SD=1.54, Δ X¯ t0 – t1=0.6). The scale Restraint in Disclosing Uncertainty to Patients was more pronounced than the scale Restraint in Disclosing Errors to Physicians (X¯=3.5, SD=0.93, Δ X¯ t0 – t1=-0.3 compared to X¯=2.3, SD=1.20, Δ X¯ t0 – t1=0.1).

DISCUSSION: Statistical competence improved with course attendance, with only one student being able to correctly answer all items at t1. NFC and AVEM were strongly expressed and were not very sensitive to change in the sample. The greatest changes were observed on the scales of concern about poor results and fear of diagnostic uncertainty, both of which decreased with course participation.

CONCLUSION: In the long term, the development of a new measuring instrument to assess EbM competencies instead of the Quick Risk Test is conceivable. The longitudinal design will also enable us to make causal interpretations and to track changes in students’ competence feelings, behaviour and attitudes.

PMID:33846106 | DOI:10.1016/j.zefq.2021.02.010

J Surg Educ. 2021 Apr 9:S1931-7204(21)00064-7. doi: 10.1016/j.jsurg.2021.03.011. Online ahead of print.

ABSTRACT

INTRODUCTION: The American Board of Surgery In-Training Examination (ABSITE) is a crucial, objective assessment of surgical knowledge during training. In 2014, the American Board of Surgery (ABS) announced the alignment of the ABSITE to the SCORE® (Surgical Council on Resident Education) Curriculum Outline for General Surgery Residency. We hypothesized that implementing a pre-ABSITE SCORE-based exam would help identify underperforming residents and provide early guidance to improve performance on the ABSITE.

METHODS: In October 2014, our university-based surgical residency program began administering a yearly comprehensive pre-ABSITE SCORE-based exam consisting of 225 to 250 multiple-choice questions selected from the SCORE question bank to all our general surgery residents, preliminary and categorical. The 4-hour exam addresses both clinical management (80%) and applied sciences (20%). Residents receive reports with their scores (percentage correct). Residents performing at less than 60% meet with the Program Director for discussion and formulation of a study plan. Correlational analysis was performed between resident ABSITE scores, pre-ABSITE SCORE-based exam scores, gender, resident status (preliminary vs. categorical), postgraduate year (PGY), and the United States Medical Licensing Examination (USMLE) Step 1 and Step 2 scores.

RESULTS: A total of 244 exam scores (122 pre-ABSITE SCORE-based exams and 122 matched ABSITE) were completed by 51 residents at different PGY levels (32 PGY1, 32 PGY2, 20 PGY3, 19 PGY4, and 18 PGY5). Fifty-seven percent were males, 62% were categorical residents, and 38% were preliminary residents. October pre-ABSITE SCORE-based exam scores were compared to the subsequent January ABSITE scores. Categorical residents completed 101 (83%) of the January exams, while preliminary residents completed 21 (17%) of these paired exams. We found strong correlations between the correct percentage on ABSITE and pre-ABSITE SCORE-based scores (r = 0.637, p < 0.001), between the correct percentage on ABSITE and PGY (r = 0.688, p < 0.001), and between ABSITE and resident status (r = 0.462, p < 0.001). Additionally, there was a weak to negligible correlation between the correct percentage on ABSITE and resident gender (r = 0.274, p = 0.001), USMLE-2 (r = 0.12, p = 0.16), and USMLE-1 (r = 0.04, p = 0.653). Multiple regression analysis, with all predictors, was performed to predict the percentage score on the ABSITE and produced R² 0.58, with an adjusted R² of 0.57, with a large size effect, p < 0.001. After controlling for the other variables, three factors reached statistical significance (p < 0.05): pre-ABSITE SCORE-based exam scores, PGY, and resident gender.

CONCLUSION: We found a strong correlation between performance on the pre-ABSITE SCORE-based exam and performance on the ABSITE exam. Surgery residents are encouraged to start studying earlier and to utilize SCORE contents as outlined by the ABS in their study plan.

PMID:33846109 | DOI:10.1016/j.jsurg.2021.03.011

Explore (NY). 2021 Mar 18:S1550-8307(21)00054-9. doi: 10.1016/j.explore.2021.03.003. Online ahead of print.

ABSTRACT

CONTEXT: The analgesic effect of music has long been reported.

OBJECTIVE: To assess how anxiety-related psychological states affect the analgesic effect of music using the cold pressor task (CPT).

DESIGN: A 3-period × 3-sequence crossover design was adopted; three conditions were used: “no sound,” “music-listening,” and “news-listening.”

SETTING: PARTICIPANTS: Forty-nine participants were included.

INTERVENTIONS: After completing five anxiety-related psychological instruments (Anxiety Sensitivity Index [ASI]-16, ASI-Revised, State-Trait Anxiety Inventory [STAI]-S, STAI-T, and Pain Anxiety Symptoms Scale-20), the participants were allocated to the low- or high-anxiety group. The high- and low-anxiety groups were defined based on cutoff points according to the distributions and characteristics of the five instruments.

MAIN OUTCOME MEASURES: Pain responses, such as pain tolerance time, pain intensity, and pain unpleasantness, were measured on the CPT. Pain responses in the music-listening condition were also compared to those in the other two conditions via pairwise comparisons within each anxiety group.

RESULTS: The Cronbach alpha of the five instruments ranged from 0.866 to 0.95, indicating that they were reliable. Pain responses in the music-listening condition in the low-anxiety groups based on any of the five scales were significantly different from those in the other conditions, but this effect was not found in the high-anxiety groups. This study demonstrates that anxiety-related psychological states can predict the analgesic effect of music on pain responses measured by the CPT and suggests that music may be beneficial as a pain management tool in low-anxiety groups.

PMID:33846083 | DOI:10.1016/j.explore.2021.03.003

Clin Breast Cancer. 2021 Mar 5:S1526-8209(21)00055-0. doi: 10.1016/j.clbc.2021.02.012. Online ahead of print.

ABSTRACT

BACKGROUND: Although patients diagnosed with ductal carcinoma in situ (DCIS) harbor excellent overall survival (OS) after breast-conserving therapy, the evidence regarding to surgical management for ipsilateral breast tumor recurrence (IBTR) is scarce. This study aimed to assess the prognosis of repeated breast-conserving surgery (BCS) versus mastectomy for IBTR in DCIS survivors.

MATERIALS AND METHODS: Herein, 5344 DCIS cases with IBTR were identified during 702,748 person-years of follow-up, 3532 (66.09%) received mastectomy, and 1812 (33.91%) received repeated BCS. Cox regression and competing risk regression were employed to estimate multivariable-adjusted hazard ratios (HRs) and 95% confidence intervals (CIs) for OS and breast cancer-specific survival (BCSS), which was respectively calculated within spontaneous and matched cohorts.

RESULTS: After adjustment for confounders, no statistically significant survival difference was observed between the repeated BCS and mastectomy for patients with DCIS with IBTR. The stratified analyses further revealed that patients with DCIS with IBTR receiving repeated BCS combined with radiation therapy were associated with both superior OS (HR, 0.79; CI, 0.64-0.98; P = .04) and BCSS (HR, 0.54; CI, 0.33-0.90; P = .02) compared with counterparts undergoing mastectomy. Furthermore, patients with DCIS who were age older than 60 years at IBTR diagnosis benefit from repeated BCS with radiotherapy (HR, 0.44; CI, 0.24-0.84; P = .01) than mastectomy.

CONCLUSION: We suggest that repeated BCS with radiation therapy deserves consideration when DCIS survivors suffered IBTR. The choice of surgical management should be tailored based on patients’ age at IBTR diagnosis and size of recurrent disease.

PMID:33846099 | DOI:10.1016/j.clbc.2021.02.012