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Nevin Manimala Statistics

Outcomes for Patients With Chronic Lymphocytic Leukemia (CLL) Previously Treated With Both a Covalent BTK and BCL2 Inhibitor in the United States: A Real-World Database Study

Clin Lymphoma Myeloma Leuk. 2022 Oct 7:S2152-2650(22)01691-3. doi: 10.1016/j.clml.2022.09.007. Online ahead of print.

ABSTRACT

PURPOSE: This study describes the treatment patterns and outcomes of patients with CLL/SLL in a de-identified real-world oncology electronic health records database.

METHODS: Adult patients with CLL/SLL were eligible if they had received cBTKi therapy, both a cBTKi and a BCL2i, or all 4 drug classes (cBTKi, BCL2i, rituximab, and chemotherapy) at any time during the first 5 lines of therapy. Time-to-event outcomes were evaluated using Kaplan Meier method. No statistical comparisons were conducted; all analyses were descriptive and conducted using SAS Enterprise.

RESULTS: A total of 9578 patients were eligible: 52.0% (n = 4983) received at least one cBTKi, 6.1% (n = 581) received both a cBTKi and BCL2i, and 2.3% (n = 218) received all four therapies (cBTKi, BCL2i, rituximab, and chemotherapy). Of those who discontinued these treatments, only 39.5% (n = 1 206/3 577), 59.7% (n = 228/382), and 55.0% (n = 82/149) received subsequent therapy (post-cBTKi, post-cBTKi/post-BCL2i, and post-all 4 therapies, respectively). Median time from treatment discontinuation of these therapies to the discontinuation of subsequent therapy or death was 9.5 months (all patients who discontinued the cBTKi) 5.6 months (those who discontinued both a cBTKi and BCL2i) and 3.9 months (patients who discontinued all four therapies). The median duration of the next treatment among those who received additional therapy was post-cBTKi treatment duration = 4.1 months; post-cBTKi/post-BCL2i treatment duration = 5.5 months; and median duration of the immediate next therapy after discontinuation of all 4 therapies = 5.1 months.

CONCLUSIONS: The poor outcomes observed across cohorts in this study demonstrate the need for effective treatments that can improve outcomes in patients with CLL/SLL.

PMID:36335022 | DOI:10.1016/j.clml.2022.09.007

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Nevin Manimala Statistics

Exploring determinants and regional variation of diagnostic imaging utilization rates in German inpatient care

Z Evid Fortbild Qual Gesundhwes. 2022 Nov 2:S1865-9217(22)00171-4. doi: 10.1016/j.zefq.2022.09.004. Online ahead of print.

ABSTRACT

INTRODUCTION: Germany ranks high concerning the per capita supply of computer tomographs (CT) and positron emission tomographs (PET) which may incentivize supply-induced use. Beyond that, international comparison shows high per capita examinations. However, misuse of diagnostic imaging may cause harm to patients and the health care system. The use of diagnostic imaging in Germany has been insufficiently studied so far. Therefore, the study aimed to determine the extent of regional differences as well as supply and demand side factors of per capita CT and PET examinations in German inpatient care.

METHODS: Cartographic visualizations and a random intercept model controlling for the regional disease burden, ambulatory provided supply and demand, and population deprivation between 2010 and 2017 for CT and between 2016 and 2017 for PET were applied. For this purpose, the Nationwide hospital discharge data (DRG statistics), hospital structured quality reports, the National Association of Statutory Health Insurance Physicians, the Central Research Institute of Ambulatory Health Care in Germany, and the German Index of Socioeconomic Deprivation were used.

RESULTS: We found a substantial regional variation of examination rates (-63 to +108% for CT and from -94 up to +847% for PET). Regarding PET, the supply structures have a significant impact on examinations per 1,000 inhabitants (28.46, p < .000). Both devices were used in correlation with the regional disease burden. Ambulatory and inpatient CT examination rates were positively associated.

DISCUSSION: The regional differences identified are to some extent attributable to the regional burden of disease and thus warranted. Although the inpatient PET supply influences utilization rates, the direction of the effect should be investigated more closely for valid statements. The findings in terms of CT should be treated with caution. The cartographic distribution and examination rates indicate global overuse. The clear separation of inpatient and ambulatory sectors leads to misallocation of scarce resources, medically unnecessary multiple examinations, and capacity utilization problems.

CONCLUSION: The results obtained have great potential for assessing and analyzing the adoption and rapid expansion of imaging technologies. Capacity utilization figures should be the focus of further research to assess utilization rates both economically and medically. Policy makers should address ongoing issues of operational and organizational separation of inpatient and ambulatory sectors in the German health care system.

PMID:36335010 | DOI:10.1016/j.zefq.2022.09.004

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Nevin Manimala Statistics

Impact of cystectomy versus ablation for endometrioma on ovarian reserve: a systematic review and meta-analysis

Fertil Steril. 2022 Nov 2:S0015-0282(22)01382-6. doi: 10.1016/j.fertnstert.2022.08.860. Online ahead of print.

ABSTRACT

OBJECTIVE: To investigate whether cystectomy or ablation for endometrioma has less impact on ovarian reserve as evaluated by antral follicle count (AFC) and antimüllerian hormone (AMH) levels.

DESIGN: Systematic review and meta-analysis.

SETTING: Not applicable.

PATIENT(S): Patients with endometriomas undergoing cystectomy or ablation.

INTERVENTION(S): All prospective studies comparing cystectomy with ablation for endometrioma in the PubMed, EMBASE, MEDLINE and Web of Science until April 3, 2022 were retrieved and reviewed. Medical treatment used as adjuvant therapy for the surgery was excluded. Two authors assessed eligibility and risk of bias independently. The statistical data were pooled using the Review Manager software.

MAIN OUTCOME MEASURE(S): The changes of AMH levels and AFC values in cystectomy group and ablation group, including intergroup comparisons and intragroup comparisons.

RESULT(S): Four randomized clinical trials and 2 prospective cohort studies were eligible for the meta-analysis, with a total of 294 patients. In the intergroup comparisons, preoperative AFC values were similar with low heterogeneity, but postoperative AFC values were significantly lower in cystectomy than ablation (mean differences [MD], -1.33; 95% credible interval, -2.15 to -0.51; I2 = 57%). In the intragroup comparisons of AFC values, sensitivity analyses showed a significant decrease in cystectomy (MD, -1.93; 95% credible interval, -2.40 to -1.45; I2 = 0%) at 6-month follow-up, compared with no reduction in ablation. The intragroup comparisons of AMH levels supported negative effects on ovarian reserve of both cystectomy (MD, -1.26; 95% credible interval, -1.64 to -0.88; I2 = 45%) and ablation (MD, -0.70; 95% credible interval, -1.07 to -0.32; I2 = 0%).

CONCLUSION(S): Both ablation and cystectomy have significantly detrimental effects on ovarian reserve as evaluated by AMH, but the ablation causes relatively less damage to ovarian reserve as appraised by AFC.

CLINICAL TRIAL REGISTRATION NUMBER: CRD42020152823;PROSPERO (york.ac.uk).

PMID:36334993 | DOI:10.1016/j.fertnstert.2022.08.860

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Nevin Manimala Statistics

Connector design effects on the in vitro fracture resistance of 3-unit monolithic prostheses produced from 4 CAD-CAM materials

J Prosthet Dent. 2022 Nov 2:S0022-3913(22)00637-0. doi: 10.1016/j.prosdent.2022.09.018. Online ahead of print.

ABSTRACT

STATEMENT OF PROBLEM: Studies that compared the fracture strength of monolithic lithium disilicate and 5-mol% yttria partially stabilized zirconia multiunit fixed dental prostheses are sparse.

PURPOSE: As the connector is the weakest part of a fixed dental prosthesis, the purpose of this in vitro study was to investigate the effect of connector designs and material on the fracture strength of 3-unit monolithic fixed dental prostheses.

MATERIAL AND METHODS: Resin-ceramic canine and premolar teeth (N=144) were prepared for fixed dental prosthesis abutments. Prostheses with 3 connector designs (width=height, width<height, and width>height) were made from 2 types of lithium disilicate (IPS e.max CAD and Amber Mill) and 5-mol% yttria partially stabilized zirconia (3M Lava Esthetic and Katana Zirconia UTML). Fracture strengths were measured after 200 000 cycles of dynamic loading of 50 N and thermocycling at 5 °C and 55 °C, and the fracture patterns were analyzed. Two-way analysis of variance and the Fisher exact test were used for statistical analysis (α=.05).

RESULTS: The material and connector design affected the fracture strength of fixed dental prostheses (P<.05), and a significant interaction was found between the material and connector design (P<.05). The IPS e.max CAD material had significantly lower fracture strength than Amber Mill, 3M Lava Esthetic, or Katana Zirconia UTML (P<.05). Connector designs with a greater width versus height showed significantly lower fracture strengths than other designs (P<.05).

CONCLUSIONS: The connector design of 3-unit fixed dental prostheses, particularly the connector height, may affect fracture strength depending on the prosthesis material.

PMID:36334990 | DOI:10.1016/j.prosdent.2022.09.018

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Nevin Manimala Statistics

Corrigendum to “Recovery from opioid use disorder: A 4-year post-clinical trial outcomes study” [Drug Alcohol Depend., 234 (2022), 109389]

Drug Alcohol Depend. 2022 Nov 3:109687. doi: 10.1016/j.drugalcdep.2022.109687. Online ahead of print.

NO ABSTRACT

PMID:36334989 | DOI:10.1016/j.drugalcdep.2022.109687

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Nevin Manimala Statistics

Lessons learned after the disruption caused by COVID-19 in the management of urolithiasis: An example of adaptation in a high-volume center

Actas Urol Esp (Engl Ed). 2022 Aug 4:S2173-5786(22)00078-6. doi: 10.1016/j.acuroe.2022.08.003. Online ahead of print.

ABSTRACT

BACKGROUND: The aim was to determine the impact of COVID-19 pandemic on urolithiasis presentation and management.

METHODS: In this retrospective study, we comparatively evaluated urgent and elective procedures due to urolithiasis during the early eight months of the COVID-19 pandemic (March 1, 2020, to October 31, 2020) compared to the same period a year before, and between waves. The student’s t-test, chi-square test, Mann-Whitney U test and Fisher’s exact test were used to compare the patients’ characteristics and outcomes between the two periods and waves.

RESULTS: Five hundred and thirty procedures were included. The overall numbers of surgical procedures due to urolithiasis were similar between pre-pandemic and pandemic periods. Regarding elective surgery, our data draw attention to the increased complication rate in the pandemic times, but no statistically significant differences in terms of types of procedures and need for complementary treatments were observed. We noted that patterns of presentation of complicated renal colic were different during COVID-19 pandemic, with a higher number of days after the onset of symptoms and a higher proportion of patients presenting acute kidney injury. Furthermore, a significant increase of creatinine levels at presentation in first wave was detected, and a growth in the number of urgent procedures after the first wave was noted, owing to the delay in urolithiasis treatment and diagnosis.

CONCLUSION: The COVID-19 pandemic has negatively affected both urgent and elective management of urolithiasis. Lessons about the management of urolithiasis in this context should be learned to avoid fatal complications and improve standards of care.

PMID:36334974 | DOI:10.1016/j.acuroe.2022.08.003

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Nevin Manimala Statistics

Young Age on Starting Prostate-specific Antigen Testing Is Associated with a Greater Reduction in Prostate Cancer Mortality: 24-Year Follow-up of the Göteborg Randomized Population-based Prostate Cancer Screening Trial

Eur Urol. 2022 Nov 2:S0302-2838(22)02715-4. doi: 10.1016/j.eururo.2022.10.006. Online ahead of print.

ABSTRACT

BACKGROUND: The risk of death from prostate cancer (PC) depends on age, but the age at which to start prostate-specific antigen (PSA) screening remains uncertain.

OBJECTIVE: To study the relationship between risk reduction for PC mortality and age at first PSA screening.

DESIGN, SETTING, AND PARTICIPANTS: The randomized Göteborg-1 trial invited men for biennial PSA screening between the ages of 50 and 70 yr (screening, n = 10 000) or no invitation but exposure to opportunistic PSA testing (control, n = 10 000).

INTERVENTION: Regular versus opportunistic PSA screening or no PSA.

OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: We modeled the nonlinear association between starting age and the absolute risk reduction in PC mortality in three settings: (1) intention-to-screen (randomized arms); (2) historical control (screening group and 1990-1994 registry data); and (3) attendees only (screening attendees and matched controls). We tested whether the effect of screening on PC mortality depends on the age at starting screening by comparing survival models with and without an interaction between trial arm and age (intention-to-screen and attendees only).

RESULTS AND LIMITATIONS: Younger age on starting PSA testing was associated with a greater reduction in PC mortality. Starting screening at age 55 yr approximately halved the risk of PC death compared to first PSA at age 60 yr. The test of association between starting age and the effect of screening on PC mortality was slightly greater than the conventional level of statistical significance (p = 0.052) for the entire cohort, and statistically significant among attendees (p = 0.002). This study is limited by the low number of disease-specific deaths for men starting screening before age 55 yr and the difficulty in discriminating between the effect of starting age and screening duration.

CONCLUSIONS: Given that prior screening trials included men aged up to 70 yr on starting screening, our results suggest that the effect size reported in prior trials underestimates that of currently recommended programs starting at age 50-55 yr.

PATIENT SUMMARY: In this study from the Göteborg-1 trial, we looked at the effect of prostate-specific antigen (PSA) screening in reducing men’s risk of dying from prostate cancer given the age at which they begin testing. Starting at a younger age reduced the risk of prostate cancer death by a greater amount. We recommend that PSA screening should start no later than at age 55 yr.

PMID:36334968 | DOI:10.1016/j.eururo.2022.10.006

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Nevin Manimala Statistics

Comparative Study of 2 Extended-Release Tacrolimus Formulations in Kidney Transplantation

Transplant Proc. 2022 Nov 2:S0041-1345(22)00659-5. doi: 10.1016/j.transproceed.2022.10.001. Online ahead of print.

ABSTRACT

BACKGROUND: During the 1900s, tacrolimus became the mainstay immunosuppressive agent to prevent rejection after kidney transplant. Subsequently, an extended-release tacrolimus (ER-Tac) formulation was developed to improve adherence, and its generic version has been marketed over the last years. This study examines the differences in efficacy and safety between the generic ER-Tac (Conferoport) and the reference brand-name drug (Advagraf).

METHODS: Prospective, randomized and parallel single-center study (May 2020 to June 2021) with 52 kidney transplant recipients who were randomly assigned to 1 of the following groups: study group (Conferoport, n = 31) and control group (Advagraf, n = 21). The variables of interest were collected and analyzed to compare tacrolimus efficacy and safety between them. Demographic characteristics of the patients and clinical donor data were homogeneous in both groups (P > .05).

RESULTS: No statistically significant differences were found among treatments regarding dosage used, levels, creatinine, and proteinuria (P > .05), with these variables presenting a downward trend during follow-up and, consequently, the improvement of graft function. Analyses also revealed the absence of differences concerning the incidence of acute rejection and intrapatient variability (coefficient of variation) throughout the first year of evolution between both formulations (P > .05). A total of 5 graft losses occurred, 2 resulting from patient death.

CONCLUSIONS: In our experience, we found no significant differences between the measured parameters in relation to the efficacy and safety profile of both drugs, with generic ER-Tac being an alternative comparable with the reference brand-name ER-Tac.

PMID:36334963 | DOI:10.1016/j.transproceed.2022.10.001

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Nevin Manimala Statistics

Three families of automated text analysis

Soc Sci Res. 2022 Nov;108:102798. doi: 10.1016/j.ssresearch.2022.102798. Epub 2022 Oct 1.

ABSTRACT

Since the beginning of this millennium, data in the form of human-generated text in a machine-readable format has become increasingly available to social scientists, presenting a unique window into social life. However, harnessing vast quantities of this highly unstructured data in a systematic way presents a unique combination of analytical and methodological challenges. Luckily, our understanding of how to overcome these challenges has also developed greatly over this same period. In this article, I present a novel typology of the methods social scientists have used to analyze text data at scale in the interest of testing and developing social theory. I describe three “families” of methods: analyses of (1) term frequency, (2) document structure, and (3) semantic similarity. For each family of methods, I discuss their logical and statistical foundations, analytical strengths and weaknesses, as well as prominent variants and applications.

PMID:36334926 | DOI:10.1016/j.ssresearch.2022.102798

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Nevin Manimala Statistics

Researcher reasoning meets computational capacity: Machine learning for social science

Soc Sci Res. 2022 Nov;108:102807. doi: 10.1016/j.ssresearch.2022.102807. Epub 2022 Oct 29.

ABSTRACT

Computational power and big data have created new opportunities to explore and understand the social world. A special synergy is possible when social scientists combine human attention to certain aspects of the problem with the power of algorithms to automate other aspects of the problem. We review selected exemplary applications where machine learning amplifies researcher coding, summarizes complex data, relaxes statistical assumptions, and targets researcher attention to further social science research. We aim to reduce perceived barriers to machine learning by summarizing several fundamental building blocks and their grounding in classical statistics. We present a few guiding principles and promising approaches where we see particular potential for machine learning to transform social science inquiry. We conclude that machine learning tools are increasingly accessible, worthy of attention, and ready to yield new discoveries for social research.

PMID:36334925 | DOI:10.1016/j.ssresearch.2022.102807